Tevetenz 600mg Tablets
Out of date information, search anotherRef: 0992/280513/1/F
Teveten®600mg Film-coated Tablets
(eprosartan mesylate)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet.You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Teveten 600mg Film-coated Tablets but will be referred to as Teveten throughout this leaflet.
In this leaflet:
^ What Teveten is and what it is used for Before you take Teveten [4 How to take Teveten ,4 Possible side effects ,4 How to store Teveten r4 Further information
^ What Teveten is and what is it used for
What Teveten is used for
Teveten contains a medicine called eprosartan mesilate. This belongs to a group of medicines called ‘angiotensin II receptor antagonists'.
This medicine is used to treat high blood pressure, also called hypertension. The main cause of high blood pressure is narrowing of the blood vessels. This increases the amount of work your heart must do to pump blood around your body. You may not feel unwell, but, if high blood pressure is not treated, it can lead to heart disease and stroke.
How Teveten works
* Angiotensin II is a chemical found in the body which makes your blood vessels contract. This makes it more difficult for blood to pass through them
* This causes your blood pressure to rise
* Teveten works by preventing the chemical, angiotensin II, from causing your blood vessels to contract. This has the effect of lowering your blood pressure.
You may be given Teveten on its own or with another medicine used to treat high blood pressure. Using both medicines together will lower your blood pressure more than one on its own.
The active ingredient in this medicine is eprosartan mesilate. This is the new name for eprosartan mesylate. The active ingredient itself has not changed.
[4 Before you take Teveten
Do not take Teveten if:
* You are allergic (hypersensitive) to eprosartan or any of the other
ingredients of Teveten (listed in Section 6 below)
* You have severe liver problems
* You are more than 3 months pregnant (it is also better to avoid Teveten in early pregnancy - see pregnancy section)
* If you have damaged blood flow to the kidneys or serious constrictions in a single functioning kidney
Do not take Teveten if any of the above apply to you. If you are not sure, talk
to your doctor or pharmacist before taking Teveten.
Take special care with Teveten
Check with your doctor or pharmacist before taking your medicine if:
* You have heart, kidney or liver problems, especially severe heart failure, narrowing of the heart valves, thickening of heart muscle (obstructive cardiomyopathy)
* You have narrowing or a blockage of the blood vessels leading to your kidneys or if you only have one kidney
* You have recently been sick or had diarrhoea
* You are taking water tablets (diuretics) and they make you feel dizzy when you stand up
* You are taking water tablets or potassium supplements and you also have a kidney problem. Your doctor might sometimes check your blood to make sure that Teveten is not affecting the amount of potassium in your blood
* You suffer from lactose intolerance (see section ‘Important information about some of the ingredients of Teveten')
* You think you are (or might become) pregnant. Teveten is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section)
* If you have been told you have Conn's syndrome (primary hyperaldosteronism) i.e. your body is making too much of the hormone aldosterone. Teveten may not work, so check with your doctor.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Teveten.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
* Medicines for pain and inflammation such as ibuprofen, diclofenac, celecoxib, etoricoxib or lumiracoxib (Non-steroidal anti-inflammatory medicines)
* Potassium supplements, potassium-sparing agents or potassium-containing salt substitutes
* Water tablets (Diuretics) such as hydrochlorothiazide and calcium channel blocker such as nifedipine, which may be used to help lower your blood pressure
* Aspirin (more than 3 g per day) used for pain, fever and to prevent blood clotting
* Lithium used for mental problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Teveten.
Pregnancy and breast-feeding Pregnancy
* You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Teveten before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Teveten. Teveten is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
* Tell your doctor if you are breast-feeding or about to start breast-feeding. Teveten is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
You may feel tired or dizzy when you start taking Teveten. If this happens, do not drive or use any tools or machines until these effects wear off. Important information about some of the ingredients of Teveten Teveten contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
Important information about some of the ingredients of Teveten
Teveten contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
How to take Teveten
Always take Teveten exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
* Your doctor will tell you how many tablets to take and for how long. It is important that you keep taking the tablets for as long as your doctor tells you
(eprosartan mesylate)
Patient Information Leaflet (continued)
* The pharmacist's label on your pack will also tell you how much your doctor would like you to take. Please read it carefully
* Only remove a tablet from the blister strip when it is time to take your medicine
* Take your tablet with or without food
* Take your tablets at about the same time each day.
Adults aged under 75 years
* The usual starting dose is 600 mg once a day
* Your doctor may increase your daily dose to 800 mg (two 400 mg tablets). Elderly people (aged 75 or over) and people with kidney or liver problems
* No dose adjustment is required in elderly people.
* If you have liver or kidney problems, consult your doctor. Your doctor will decide your daily dosage.
Children and adolescents
* Teveten should not be used in children and adolescents under 18 years.
If you take more Teveten than you should
If you take more Teveten than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Teveten
* If you forget to take a dose, take it as soon as you remember
* Take your next dose at the normal time
* Do not take two doses within 12 hours of each other.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
How to store Teveten
* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 25°C.
* Keep container in the outer carton.
* Do not use this medicine after the expiry date shown on the carton label or blister strip.
* If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.
^ Possible side effects
Like all medicines, Teveten can cause side effects, although not everybody gets them.
Stop taking Teveten and see a doctor straight away if you develop any of the following symptoms - you may need urgent medical treatment:
* Sudden swelling of your face, lips or tongue and breathing problems. These may be signs of a severe allergic reaction and may be life-threatening. This side effect is uncommon (at least 1 in 1000 and less than 1 in 100 patients).
A list of possible side effects reported in clinical studies with Teveten is given below:
Very common (at least 1 in 10 patients or more)
* Headache
Common (at least 1 in 100 and less than 1 in 10 patients)
* Skin rashes or itching
* Weakness or lack of strength
* Feeling dizzy
* Feeling sick (nausea or vomiting)
* Diarrhoea
* Joint pain
* Runny nose
* Flatulence
Uncommon (at least 1 in 1000 and less than 1 in 100 patients)
* Low blood pressure (hypotension)
* Sudden swelling of your face, lips or tongue and breathing problems. These may be signs of a severe allergic reactions and may be life threatening.
Undesirable effects have been reported since Teveten has been marketed but the frequency is not known
* Changes in kidney function including kidney failure in patients with existing kidney problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
[w Further information
What this medicine contains:
Each film-coated tablet contains 600mg eprosartan (as mesylate) as the active ingredient.
Your medicine also contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium stearate, crospovidone, purified water, hypromellose (E464), titanium dioxide (E171), polysorbate 80 (E433) and macrogol 400.
What this medicine looks like and contents of the pack
The tablets are white, capsule-shaped, film-coated tablets with ‘5046' engraved on one side and plain on the other side.
These tablets are available in calender blister strips of 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Abbott Healthcare SAS, Route de Belleville, Lieu dit Maillard, F-01400 Chatillon-sur-Chalaronne,
France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/0992 Teveten 600mg Film-coated Tablets
Teveten is a registered trademark of Solvay Pharmaceuticals Marketing & Licensing AG.
Revision date: 28/05/13
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
(eprosartan mesylate)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet.You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Tevetenz 600mg Film-coated Tablets but will be referred to as Tevetenz throughout this leaflet.
In this leaflet:
^ What Tevetenz is and what it is used for Before you take Tevetenz [4 How to take Tevetenz ,4 Possible side effects ,4 How to store Tevetenz r4 Further information
^ What Tevetenz is and what is it used for
What Tevetenz is used for
Tevetenz contains a medicine called eprosartan mesilate. This belongs to a group of medicines called ‘angiotensin II receptor antagonists'.
This medicine is used to treat high blood pressure, also called hypertension. The main cause of high blood pressure is narrowing of the blood vessels. This increases the amount of work your heart must do to pump blood around your body. You may not feel unwell, but, if high blood pressure is not treated, it can lead to heart disease and stroke.
How Tevetenz works
* Angiotensin II is a chemical found in the body which makes your blood vessels contract. This makes it more difficult for blood to pass through them
* This causes your blood pressure to rise
* Tevetenz works by preventing the chemical, angiotensin II, from causing your blood vessels to contract. This has the effect of lowering your blood pressure.
You may be given Tevetenz on its own or with another medicine used to treat high blood pressure. Using both medicines together will lower your blood pressure more than one on its own.
The active ingredient in this medicine is eprosartan mesilate. This is the new name for eprosartan mesylate. The active ingredient itself has not changed.
[4 Before you take Tevetenz
Do not take Tevetenz if:
* You are allergic (hypersensitive) to eprosartan or any of the other
ingredients of Tevetenz (listed in Section 6 below)
* You have severe liver problems
* You are more than 3 months pregnant (it is also better to avoid Tevetenz in early pregnancy - see pregnancy section)
* If you have damaged blood flow to the kidneys or serious constrictions in a single functioning kidney
Do not take Tevetenz if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Tevetenz.
Take special care with Tevetenz
Check with your doctor or pharmacist before taking your medicine if:
* You have heart, kidney or liver problems, especially severe heart failure, narrowing of the heart valves, thickening of heart muscle (obstructive cardiomyopathy)
* You have narrowing or a blockage of the blood vessels leading to your kidneys or if you only have one kidney
* You have recently been sick or had diarrhoea
* You are taking water tablets (diuretics) and they make you feel dizzy when you stand up
* You are taking water tablets or potassium supplements and you also have a kidney problem. Your doctor might sometimes check your blood to make sure that Tevetenz is not affecting the amount of potassium in your blood
* You suffer from lactose intolerance (see section ‘Important information about some of the ingredients of Tevetenz')
* You think you are (or might become) pregnant. Tevetenz is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section)
* If you have been told you have Conn's syndrome (primary hyperaldosteronism) i.e. your body is making too much of the hormone aldosterone. Tevetenz may not work, so check with your doctor.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tevetenz.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
* Medicines for pain and inflammation such as ibuprofen, diclofenac, celecoxib, etoricoxib or lumiracoxib (Non-steroidal anti-inflammatory medicines)
* Potassium supplements, potassium-sparing agents or potassium-containing salt substitutes
* Water tablets (Diuretics) such as hydrochlorothiazide and calcium channel blocker such as nifedipine, which may be used to help lower your blood pressure
* Aspirin (more than 3 g per day) used for pain, fever and to prevent blood clotting
* Lithium used for mental problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Tevetenz.
Pregnancy and breast-feeding Pregnancy
* You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Tevetenz before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Tevetenz. Tevetenz is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
* Tell your doctor if you are breast-feeding or about to start breast-feeding. Tevetenz is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
You may feel tired or dizzy when you start taking Tevetenz. If this happens, do not drive or use any tools or machines until these effects wear off. Important information about some of the ingredients of Tevetenz Tevetenz contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
Important information about some of the ingredients of Tevetenz
Tevetenz contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
[4 How to take Tevetenz
Always take Tevetenz exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
* Your doctor will tell you how many tablets to take and for how long. It is important that you keep taking the tablets for as long as your doctor tells you
(eprosartan mesylate)
Patient Information Leaflet (continued)
* The pharmacist's label on your pack will also tell you how much your doctor would like you to take. Please read it carefully
* Only remove a tablet from the blister strip when it is time to take your medicine
* Take your tablet with or without food
* Take your tablets at about the same time each day.
Adults aged under 75 years
* The usual starting dose is 600 mg once a day
* Your doctor may increase your daily dose to 800 mg (two 400 mg tablets). Elderly people (aged 75 or over) and people with kidney or liver problems
* No dose adjustment is required in elderly people.
* If you have liver or kidney problems, consult your doctor. Your doctor will decide your daily dosage.
Children and adolescents
* Tevetenz should not be used in children and adolescents under 18 years.
If you take more Tevetenz than you should
If you take more Tevetenz than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Tevetenz
* If you forget to take a dose, take it as soon as you remember
* Take your next dose at the normal time
* Do not take two doses within 12 hours of each other.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
How to store Tevetenz
* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 25°C.
* Keep container in the outer carton.
* Do not use this medicine after the expiry date shown on the carton label or blister strip.
* If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.
^ Possible side effects
Like all medicines, Tevetenz can cause side effects, although not everybody gets them.
Stop taking Tevetenz and see a doctor straight away if you develop any of the following symptoms - you may need urgent medical treatment:
* Sudden swelling of your face, lips or tongue and breathing problems.
These may be signs of a severe allergic reaction and may be life-threatening. This side effect is uncommon (at least 1 in 1000 and less than 1 in 100 patients).
A list of possible side effects reported in clinical studies with Tevetenz is given below:
Very common (at least 1 in 10 patients or more)
* Headache
Common (at least 1 in 100 and less than 1 in 10 patients)
* Skin rashes or itching
* Weakness or lack of strength
* Feeling dizzy
* Feeling sick (nausea or vomiting)
* Diarrhoea
* Joint pain
* Runny nose
* Flatulence
Uncommon (at least 1 in 1000 and less than 1 in 100 patients)
* Low blood pressure (hypotension)
* Sudden swelling of your face, lips or tongue and breathing problems. These may be signs of a severe allergic reactions and may be life threatening.
Undesirable effects have been reported since Tevetenz has been marketed but the frequency is not known
* Changes in kidney function including kidney failure in patients with existing kidney problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Further information
What this medicine contains:
Each film-coated tablet contains 600mg eprosartan (as mesylate) as the active ingredient.
Your medicine also contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium stearate, crospovidone, purified water, hypromellose (E464), titanium dioxide (E171), polysorbate 80 (E433) and macrogol 400.
What this medicine looks like and contents of the pack
The tablets are white, capsule-shaped, film-coated tablets with ‘5046' engraved on one side and plain on the other side.
These tablets are available in calender blister strips of 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Abbott Healthcare SAS, Route de Belleville, Lieu dit Maillard, F-01400 Chatillon-sur-Chalaronne,
France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
|POM| PL 15184/0992 Tevetenz 600mg Film-coated Tablets
Tevetenz is a registered trademark of Solvay Pharmaceuticals Marketing & Licensing AG.
Revision date: 28/05/13
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
(eprosartan mesylate)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet.You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Eprosartan 600mg Film-coated Tablets but will be referred to as Eprosartan Tablets throughout this leaflet.
In this leaflet:
^ What Eprosartan Tablets is and what it is used for Before you take Eprosartan Tablets [4 How to take Eprosartan Tablets ,4 Possible side effects ,4 How to store Eprosartan Tablets r4 Further information
^ What Eprosartan Tablets is and what is it used for
What Eprosartan Tablets is used for
Eprosartan Tablets contains a medicine called eprosartan mesilate. This belongs to a group of medicines called ‘angiotensin II receptor antagonists'. This medicine is used to treat high blood pressure, also called hypertension. The main cause of high blood pressure is narrowing of the blood vessels. This increases the amount of work your heart must do to pump blood around your body. You may not feel unwell, but, if high blood pressure is not treated, it can lead to heart disease and stroke.
How Eprosartan Tablets works
* Angiotensin II is a chemical found in the body which makes your blood vessels contract. This makes it more difficult for blood to pass through them
* This causes your blood pressure to rise
* Eprosartan tablets works by preventing the chemical, angiotensin II, from causing your blood vessels to contract. This has the effect of lowering your blood pressure.
You may be given Eprosartan Tablets on its own or with another medicine used to treat high blood pressure. Using both medicines together will lower your blood pressure more than one on its own.
The active ingredient in this medicine is eprosartan mesilate. This is the new name for eprosartan mesylate. The active ingredient itself has not changed.
[4 Before you take Eprosartan Tablets
Do not take Eprosartan Tablets if:
* You are allergic (hypersensitive) to eprosartan or any of the other
ingredients of Eprosartan Tablets (listed in Section 6 below)
* You have severe liver problems
* You are more than 3 months pregnant (it is also better to avoid Eprosartan Tablets in early pregnancy - see pregnancy section)
* If you have damaged blood flow to the kidneys or serious constrictions in a single functioning kidney
Do not take Eprosartan Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Eprosartan Tablets.
Take special care with Eprosartan Tablets
Check with your doctor or pharmacist before taking your medicine if:
* You have heart, kidney or liver problems, especially severe heart failure, narrowing of the heart valves, thickening of heart muscle (obstructive cardiomyopathy)
* You have narrowing or a blockage of the blood vessels leading to your kidneys or if you only have one kidney
* You have recently been sick or had diarrhoea
* You are taking water tablets (diuretics) and they make you feel dizzy when you stand up
* You are taking water tablets or potassium supplements and you also have a kidney problem. Your doctor might sometimes check your blood to make sure that Eprosartan Tablets is not affecting the amount of potassium in your blood
* You suffer from lactose intolerance (see section ‘Important information about some of the ingredients of Eprosartan Tablets')
* You think you are (or might become) pregnant. Eprosartan Tablets is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section)
* If you have been told you have Conn's syndrome (primary hyperaldosteronism) i.e. your body is making too much of the hormone aldosterone. Eprosartan Tablets may not work, so check with your doctor.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Eprosartan Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
* Medicines for pain and inflammation such as ibuprofen, diclofenac, celecoxib, etoricoxib or lumiracoxib (Non-steroidal anti-inflammatory medicines)
* Potassium supplements, potassium-sparing agents or potassium-containing salt substitutes
* Water tablets (Diuretics) such as hydrochlorothiazide and calcium channel blocker such as nifedipine, which may be used to help lower your blood pressure
* Aspirin (more than 3 g per day) used for pain, fever and to prevent blood clotting
* Lithium used for mental problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Eprosartan tablets.
Pregnancy and breast-feeding Pregnancy
* You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Eprosartan tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Eprosartan tablets.
Eprosartan tablets is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
* Tell your doctor if you are breast-feeding or about to start breast-feeding. Eprosartan tablets is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
You may feel tired or dizzy when you start taking Eprosartan Tablets. If this happens, do not drive or use any tools or machines until these effects wear off.
Important information about some of the ingredients of Eprosartan Tablets Eprosartan Tablets contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
Important information about some of the ingredients of Eprosartan Tablets
Eprosartan tablets contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
* The pharmacist's label on your pack will also tell you how much your doctor would like you to take. Please read it carefully
* Only remove a tablet from the blister strip when it is time to take your medicine
* Take your tablet with or without food
* Take your tablets at about the same time each day.
Adults aged under 75 years
* The usual starting dose is 600 mg once a day
* Your doctor may increase your daily dose to 800 mg (two 400 mg tablets). Elderly people (aged 75 or over) and people with kidney or liver problems
* No dose adjustment is required in elderly people.
* If you have liver or kidney problems, consult your doctor. Your doctor will decide your daily dosage.
Children and adolescents
* Eprosartan tablets should not be used in children and adolescents under 18 years.
If you take more Eprosartan tablets than you should
If you take more Eprosartan tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Eprosartan tablets
* If you forget to take a dose, take it as soon as you remember
* Take your next dose at the normal time
* Do not take two doses within 12 hours of each other.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Blood tests
If you need a blood sample taking for testing, you should remind your doctor that you are taking Eprosartan tablets, as it may affect the result.
How to store Eprosartan Tablets
* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 25°C.
* Keep container in the outer carton.
* Do not use this medicine after the expiry date shown on the carton label or blister strip.
* If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.
Possible side effects
Like all medicines, Eprosartan tablets can cause side effects, although not everybody gets them.
Stop taking Eprosartan tablets and see a doctor straight away if you develop any of the following symptoms - you may need urgent medical treatment:
* Sudden swelling of your face, lips or tongue and breathing problems. These may be signs of a severe allergic reaction and may be life-threatening. This side effect is uncommon (at least 1 in 1000 and less than 1 in 100 patients).
A list of possible side effects reported in clinical studies with Eprosartan tablets is given below:
Very common (at least 1 in 10 patients or more)
* Headache
Common (at least 1 in 100 and less than 1 in 10 patients)
* Skin rashes or itching
* Weakness or lack of strength
* Feeling dizzy
* Feeling sick (nausea or vomiting)
* Diarrhoea
* Joint pain
* Runny nose
* Flatulence
Uncommon (at least 1 in 1000 and less than 1 in 100 patients)
* Low blood pressure (hypotension)
* Sudden swelling of your face, lips or tongue and breathing problems. These may be signs of a severe allergic reactions and may be life threatening.
Undesirable effects have been reported since Eprosartan tablets has been marketed but the frequency is not known
* Changes in kidney function including kidney failure in patients with existing kidney problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
rp Further information
What this medicine contains:
Each film-coated tablet contains 600mg eprosartan (as mesylate) as the active ingredient.
Your medicine also contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium stearate, crospovidone, purified water, hypromellose (E464), titanium dioxide (E171), polysorbate 80 (E433) and macrogol 400.
What this medicine looks like and contents of the pack
The tablets are white, capsule-shaped, film-coated tablets with ‘5046' engraved on one side and plain on the other side.
These tablets are available in calender blister strips of 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Abbott Healthcare SAS, Route de Belleville, Lieu dit Maillard, F-01400 Chatillon-sur-Chalaronne,
France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
[pOmI PL 15184/0992 Eprosartan 600mg Film-coated Tablets Revision date: 28/05/13
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet.You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Teveten 600mg Film-coated Tablets but will be referred to as Teveten throughout this leaflet.
In this leaflet:
^ What Teveten is and what it is used for Before you take Teveten [3 How to take Teveten ,4 Possible side effects ,4 How to store Teveten r4 Further information
^ What Teveten is and what is it used for
What Teveten is used for
Teveten contains a medicine called eprosartan mesilate. This belongs to a group of medicines called ‘angiotensin II receptor antagonists'.
This medicine is used to treat high blood pressure, also called hypertension. The main cause of high blood pressure is narrowing of the blood vessels. This increases the amount of work your heart must do to pump blood around your body. You may not feel unwell, but, if high blood pressure is not treated, it can lead to heart disease and stroke.
How Teveten works
* Angiotensin II is a chemical found in the body which makes your blood vessels contract. This makes it more difficult for blood to pass through them
* This causes your blood pressure to rise
* Teveten works by preventing the chemical, angiotensin II, from causing your blood vessels to contract. This has the effect of lowering your blood pressure.
You may be given Teveten on its own or with another medicine used to treat high blood pressure. Using both medicines together will lower your blood pressure more than one on its own.
The active ingredient in this medicine is eprosartan mesilate. This is the new name for eprosartan mesylate. The active ingredient itself has not changed.
[4 Before you take Teveten
Do not take Teveten if:
* You are allergic (hypersensitive) to eprosartan or any of the other
ingredients of Teveten (listed in Section 6 below)
* You have severe liver problems
* You are more than 3 months pregnant (it is also better to avoid Teveten in early pregnancy - see pregnancy section)
* If you have damaged blood flow to the kidneys or serious constrictions in a single functioning kidney
Do not take Teveten if any of the above apply to you. If you are not sure, talk
to your doctor or pharmacist before taking Teveten.
Take special care with Teveten
Check with your doctor or pharmacist before taking your medicine if:
* You have heart, kidney or liver problems, especially severe heart failure, narrowing of the heart valves, thickening of heart muscle (obstructive cardiomyopathy)
* You have narrowing or a blockage of the blood vessels leading to your kidneys or if you only have one kidney
* You have recently been sick or had diarrhoea
* You are taking water tablets (diuretics) and they make you feel dizzy when you stand up
* You are taking water tablets or potassium supplements and you also have a kidney problem. Your doctor might sometimes check your blood to make sure that Teveten is not affecting the amount of potassium in your blood
* You suffer from lactose intolerance (see section ‘Important information about some of the ingredients of Teveten')
* You think you are (or might become) pregnant. Teveten is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section)
* If you have been told you have Conn's syndrome (primary hyperaldosteronism) i.e. your body is making too much of the hormone aldosterone. Teveten may not work, so check with your doctor.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Teveten.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
* Medicines for pain and inflammation such as ibuprofen, diclofenac, celecoxib, etoricoxib or lumiracoxib (Non-steroidal anti-inflammatory medicines)
* Potassium supplements, potassium-sparing agents or potassium-containing salt substitutes
* Water tablets (Diuretics) such as hydrochlorothiazide and calcium channel blocker such as nifedipine, which may be used to help lower your blood pressure
* Aspirin (more than 3 g per day) used for pain, fever and to prevent blood clotting
* Lithium used for mental problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Teveten.
Pregnancy and breast-feeding Pregnancy
* You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Teveten before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Teveten. Teveten is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
* Tell your doctor if you are breast-feeding or about to start breast-feeding. Teveten is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
You may feel tired or dizzy when you start taking Teveten. If this happens, do not drive or use any tools or machines until these effects wear off. Important information about some of the ingredients of Teveten Teveten contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
Important information about some of the ingredients of Teveten
Teveten contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
[3 How to take Teveten
Always take Teveten exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
* Your doctor will tell you how many tablets to take and for how long. It is important that you keep taking the tablets for as long as your doctor tells you
(eprosartan mesylate)
Patient Information Leaflet (continued)
* The pharmacist's label on your pack will also tell you how much your doctor would like you to take. Please read it carefully
* Only remove a tablet from the blister strip when it is time to take your medicine
* Take your tablet with or without food
* Take your tablets at about the same time each day.
Adults aged under 75 years
* The usual starting dose is 600 mg once a day
* Your doctor may increase your daily dose to 800 mg (two 400 mg tablets). Elderly people (aged 75 or over) and people with kidney or liver problems
* No dose adjustment is required in elderly people.
* If you have liver or kidney problems, consult your doctor. Your doctor will decide your daily dosage.
Children and adolescents
* Teveten should not be used in children and adolescents under 18 years.
If you take more Teveten than you should
If you take more Teveten than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Teveten
* If you forget to take a dose, take it as soon as you remember
* Take your next dose at the normal time
* Do not take two doses within 12 hours of each other.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
How to store Teveten
* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 25°C.
* Keep container in the outer carton.
* Do not use this medicine after the expiry date shown on the carton label or blister strip.
* If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.
^ Possible side effects
Like all medicines, Teveten can cause side effects, although not everybody gets them.
Stop taking Teveten and see a doctor straight away if you develop any of the following symptoms - you may need urgent medical treatment:
* Sudden swelling of your face, lips or tongue and breathing problems. These may be signs of a severe allergic reaction and may be life-threatening. This side effect is uncommon (at least 1 in 1000 and less than 1 in 100 patients).
A list of possible side effects reported in clinical studies with Teveten is given below:
Very common (at least 1 in 10 patients or more)
* Headache
Common (at least 1 in 100 and less than 1 in 10 patients)
* Skin rashes or itching
* Weakness or lack of strength
* Feeling dizzy
* Feeling sick (nausea or vomiting)
* Diarrhoea
* Joint pain
* Runny nose
* Flatulence
Uncommon (at least 1 in 1000 and less than 1 in 100 patients)
* Low blood pressure (hypotension)
* Sudden swelling of your face, lips or tongue and breathing problems. These may be signs of a severe allergic reactions and may be life threatening.
Undesirable effects have been reported since Teveten has been marketed but the frequency is not known
* Changes in kidney function including kidney failure in patients with existing kidney problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
[w Further information
What this medicine contains:
Each film-coated tablet contains 600mg eprosartan (as mesylate) as the active ingredient.
Your medicine also contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium stearate, crospovidone, purified water, hypromellose (E464), titanium dioxide (E171), polysorbate 80 (E433) and macrogol 400.
What this medicine looks like and contents of the pack
The tablets are white, capsule-shaped, film-coated tablets with ‘5046' engraved on one side and plain on the other side.
These tablets are available in calender blister strips of 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Abbott Products GmbH, Justus-von-Liebig-Strasse 33, D-31535 Neustadt, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/0992 Teveten 600mg Film-coated Tablets
Teveten is a registered trademark of Solvay Pharmaceuticals Marketing & Licensing AG.
Revision date: 28/05/13
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
(eprosartan mesylate)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet.You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Tevetenz 600mg Film-coated Tablets but will be referred to as Tevetenz throughout this leaflet.
In this leaflet:
^ What Tevetenz is and what it is used for Before you take Tevetenz [4 How to take Tevetenz ,4 Possible side effects ,4 How to store Tevetenz r4 Further information
^ What Tevetenz is and what is it used for
What Tevetenz is used for
Tevetenz contains a medicine called eprosartan mesilate. This belongs to a group of medicines called ‘angiotensin II receptor antagonists'.
This medicine is used to treat high blood pressure, also called hypertension. The main cause of high blood pressure is narrowing of the blood vessels. This increases the amount of work your heart must do to pump blood around your body. You may not feel unwell, but, if high blood pressure is not treated, it can lead to heart disease and stroke.
How Tevetenz works
* Angiotensin II is a chemical found in the body which makes your blood vessels contract. This makes it more difficult for blood to pass through them
* This causes your blood pressure to rise
* Tevetenz works by preventing the chemical, angiotensin II, from causing your blood vessels to contract. This has the effect of lowering your blood pressure.
You may be given Tevetenz on its own or with another medicine used to treat high blood pressure. Using both medicines together will lower your blood pressure more than one on its own.
The active ingredient in this medicine is eprosartan mesilate. This is the new name for eprosartan mesylate. The active ingredient itself has not changed.
[4 Before you take Tevetenz
Do not take Tevetenz if:
* You are allergic (hypersensitive) to eprosartan or any of the other
ingredients of Tevetenz (listed in Section 6 below)
* You have severe liver problems
* You are more than 3 months pregnant (it is also better to avoid Tevetenz in early pregnancy - see pregnancy section)
* If you have damaged blood flow to the kidneys or serious constrictions in a single functioning kidney
Do not take Tevetenz if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Tevetenz.
Take special care with Tevetenz
Check with your doctor or pharmacist before taking your medicine if:
* You have heart, kidney or liver problems, especially severe heart failure, narrowing of the heart valves, thickening of heart muscle (obstructive cardiomyopathy)
* You have narrowing or a blockage of the blood vessels leading to your kidneys or if you only have one kidney
* You have recently been sick or had diarrhoea
* You are taking water tablets (diuretics) and they make you feel dizzy when you stand up
* You are taking water tablets or potassium supplements and you also have a kidney problem. Your doctor might sometimes check your blood to make sure that Tevetenz is not affecting the amount of potassium in your blood
* You suffer from lactose intolerance (see section ‘Important information about some of the ingredients of Tevetenz')
* You think you are (or might become) pregnant. Tevetenz is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section)
* If you have been told you have Conn's syndrome (primary hyperaldosteronism) i.e. your body is making too much of the hormone aldosterone. Tevetenz may not work, so check with your doctor.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tevetenz.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
* Medicines for pain and inflammation such as ibuprofen, diclofenac, celecoxib, etoricoxib or lumiracoxib (Non-steroidal anti-inflammatory medicines)
* Potassium supplements, potassium-sparing agents or potassium-containing salt substitutes
* Water tablets (Diuretics) such as hydrochlorothiazide and calcium channel blocker such as nifedipine, which may be used to help lower your blood pressure
* Aspirin (more than 3 g per day) used for pain, fever and to prevent blood clotting
* Lithium used for mental problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Tevetenz.
Pregnancy and breast-feeding Pregnancy
* You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Tevetenz before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Tevetenz. Teveten is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
* Tell your doctor if you are breast-feeding or about to start breast-feeding. Teveten is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
You may feel tired or dizzy when you start taking Tevetenz. If this happens, do not drive or use any tools or machines until these effects wear off. Important information about some of the ingredients of Tevetenz Tevetenz contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
Important information about some of the ingredients of Tevetenz
Tevetenz contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
[4 How to take Tevetenz
Always take Tevetenz exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
* Your doctor will tell you how many tablets to take and for how long. It is important that you keep taking the tablets for as long as your doctor tells you
(eprosartan mesylate)
Patient Information Leaflet (continued)
* The pharmacist's label on your pack will also tell you how much your doctor would like you to take. Please read it carefully
* Only remove a tablet from the blister strip when it is time to take your medicine
* Take your tablet with or without food
* Take your tablets at about the same time each day.
Adults aged under 75 years
* The usual starting dose is 600 mg once a day
* Your doctor may increase your daily dose to 800 mg (two 400 mg tablets). Elderly people (aged 75 or over) and people with kidney or liver problems
* No dose adjustment is required in elderly people.
* If you have liver or kidney problems, consult your doctor. Your doctor will decide your daily dosage.
Children and adolescents
* Tevetenz should not be used in children and adolescents under 18 years.
If you take more Tevetenz than you should
If you take more Tevetenz than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Tevetenz
* If you forget to take a dose, take it as soon as you remember
* Take your next dose at the normal time
* Do not take two doses within 12 hours of each other.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
How to store Tevetenz
* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 25°C.
* Keep container in the outer carton.
* Do not use this medicine after the expiry date shown on the carton label or blister strip.
* If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.
^ Possible side effects
Like all medicines, Tevetenz can cause side effects, although not everybody gets them.
Stop taking Tevetenz and see a doctor straight away if you develop any of the following symptoms - you may need urgent medical treatment:
* Sudden swelling of your face, lips or tongue and breathing problems.
These may be signs of a severe allergic reaction and may be life-threatening. This side effect is uncommon (at least 1 in 1000 and less than 1 in 100 patients).
A list of possible side effects reported in clinical studies with Tevetenz is given below:
Very common (at least 1 in 10 patients or more)
* Headache
Common (at least 1 in 100 and less than 1 in 10 patients)
* Skin rashes or itching
* Weakness or lack of strength
* Feeling dizzy
* Feeling sick (nausea or vomiting)
* Diarrhoea
* Joint pain
* Runny nose
* Flatulence
Uncommon (at least 1 in 1000 and less than 1 in 100 patients)
* Low blood pressure (hypotension)
* Sudden swelling of your face, lips or tongue and breathing problems. These may be signs of a severe allergic reactions and may be life threatening.
Undesirable effects have been reported since Tevetenz has been marketed but the frequency is not known
* Changes in kidney function including kidney failure in patients with existing kidney problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Further information
What this medicine contains:
Each film-coated tablet contains 600mg eprosartan (as mesylate) as the active ingredient.
Your medicine also contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium stearate, crospovidone, purified water, hypromellose (E464), titanium dioxide (E171), polysorbate 80 (E433) and macrogol 400.
What this medicine looks like and contents of the pack
The tablets are white, capsule-shaped, film-coated tablets with ‘5046' engraved on one side and plain on the other side.
These tablets are available in calender blister strips of 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Abbott Products GmbH, Justus-von-Liebig-Strasse 33, D-31535 Neustadt, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
|POM PL 15184/0992 Tevetenz 600mg Film-coated Tablets
Tevetenz is a registered trademark of Solvay Pharmaceuticals Marketing & Licensing AG.
Revision date: 28/05/13
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
(eprosartan mesylate)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet.You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Eprosartan 600mg Film-coated Tablets but will be referred to as Eprosartan Tablets throughout this leaflet.
In this leaflet:
^ What Eprosartan Tablets is and what it is used for Before you take Eprosartan Tablets [4 How to take Eprosartan Tablets ,4 Possible side effects ,4 How to store Eprosartan Tablets r4 Further information
^ What Eprosartan Tablets is and what is it used for
What Eprosartan is used for
Eprosartan Tablets contains a medicine called eprosartan mesilate. This belongs to a group of medicines called ‘angiotensin II receptor antagonists'. This medicine is used to treat high blood pressure, also called hypertension. The main cause of high blood pressure is narrowing of the blood vessels. This increases the amount of work your heart must do to pump blood around your body. You may not feel unwell, but, if high blood pressure is not treated, it can lead to heart disease and stroke.
How Eprosartan Tablets works
* Angiotensin II is a chemical found in the body which makes your blood vessels contract. This makes it more difficult for blood to pass through them
* This causes your blood pressure to rise
* Eprosartan tablets works by preventing the chemical, angiotensin II, from causing your blood vessels to contract. This has the effect of lowering your blood pressure.
You may be given Eprosartan Tablets on its own or with another medicine used to treat high blood pressure. Using both medicines together will lower your blood pressure more than one on its own.
The active ingredient in this medicine is eprosartan mesilate. This is the new name for eprosartan mesylate. The active ingredient itself has not changed.
[4 Before you take Eprosartan Tablets
Do not take Eprosartan Tablets if:
* You are allergic (hypersensitive) to eprosartan or any of the other
ingredients of Eprosartan Tablets (listed in Section 6 below)
* You have severe liver problems
* You are more than 3 months pregnant (it is also better to avoid Eprosartan Tablets in early pregnancy - see pregnancy section)
* If you have damaged blood flow to the kidneys or serious constrictions in a single functioning kidney
Do not take Eprosartan Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Eprosartan Tablets.
Take special care with Eprosartan Tablets
Check with your doctor or pharmacist before taking your medicine if:
* You have heart, kidney or liver problems, especially severe heart failure, narrowing of the heart valves, thickening of heart muscle (obstructive cardiomyopathy)
* You have narrowing or a blockage of the blood vessels leading to your kidneys or if you only have one kidney
* You have recently been sick or had diarrhoea
* You are taking water tablets (diuretics) and they make you feel dizzy when you stand up
* You are taking water tablets or potassium supplements and you also have a kidney problem. Your doctor might sometimes check your blood to make sure that Eprosartan Tablets is not affecting the amount of potassium in your blood
* You suffer from lactose intolerance (see section ‘Important information about some of the ingredients of Eprosartan Tablets')
* You think you are (or might become) pregnant. Eprosartan Tablets is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section)
* If you have been told you have Conn's syndrome (primary hyperaldosteronism) i.e. your body is making too much of the hormone aldosterone. Eprosartan Tablets may not work, so check with your doctor.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Eprosartan Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
* Medicines for pain and inflammation such as ibuprofen, diclofenac, celecoxib, etoricoxib or lumiracoxib (Non-steroidal anti-inflammatory medicines)
* Potassium supplements, potassium-sparing agents or potassium-containing salt substitutes
* Water tablets (Diuretics) such as hydrochlorothiazide and calcium channel blocker such as nifedipine, which may be used to help lower your blood pressure
* Aspirin (more than 3 g per day) used for pain, fever and to prevent blood clotting
* Lithium used for mental problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Eprosartan tablets.
Pregnancy and breast-feeding Pregnancy
* You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Eprosartan tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Eprosartan tablets. Eprosartan tablets is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
* Tell your doctor if you are breast-feeding or about to start breast-feeding. Eprosartan tablets is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
You may feel tired or dizzy when you start taking Eprosartan Tablets. If this happens, do not drive or use any tools or machines until these effects wear off.
Important information about some of the ingredients of Eprosartan Tablets Eprosartan Tablets contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
Important information about some of the ingredients of Eprosartan Tablets
Eprosartan tablets contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
* The pharmacist's label on your pack will also tell you how much your doctor would like you to take. Please read it carefully
* Only remove a tablet from the blister strip when it is time to take your medicine
* Take your tablet with or without food
* Take your tablets at about the same time each day.
Adults aged under 75 years
* The usual starting dose is 600 mg once a day
* Your doctor may increase your daily dose to 800 mg (two 400 mg tablets). Elderly people (aged 75 or over) and people with kidney or liver problems
* No dose adjustment is required in elderly people.
* If you have liver or kidney problems, consult your doctor. Your doctor will decide your daily dosage.
Children and adolescents
* Eprosartan tablets should not be used in children and adolescents under 18 years.
If you take more Eprosartan tablets than you should
If you take more Eprosartan tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Eprosartan tablets
* If you forget to take a dose, take it as soon as you remember
* Take your next dose at the normal time
* Do not take two doses within 12 hours of each other.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Blood tests
If you need a blood sample taking for testing, you should remind your doctor that you are taking Eprosartan tablets, as it may affect the result.
How to store Eprosartan Tablets
* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store above 25°C.
* Keep container in the outer carton.
* Do not use this medicine after the expiry date shown on the carton label or blister strip.
* If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.
^ Possible side effects
Like all medicines, Eprosartan tablets can cause side effects, although not everybody gets them.
Stop taking Eprosartan tablets and see a doctor straight away if you develop any of the following symptoms - you may need urgent medical treatment:
* Sudden swelling of your face, lips or tongue and breathing problems. These may be signs of a severe allergic reaction and may be life-threatening. This side effect is uncommon (at least 1 in 1000 and less than 1 in 100 patients).
A list of possible side effects reported in clinical studies with Eprosartan tablets is given below:
Very common (at least 1 in 10 patients or more)
* Headache
Common (at least 1 in 100 and less than 1 in 10 patients)
* Skin rashes or itching
* Weakness or lack of strength
* Feeling dizzy
* Feeling sick (nausea or vomiting)
* Diarrhoea
* Joint pain
* Runny nose
* Flatulence
Uncommon (at least 1 in 1000 and less than 1 in 100 patients)
* Low blood pressure (hypotension)
* Sudden swelling of your face, lips or tongue and breathing problems. These may be signs of a severe allergic reactions and may be life threatening.
Undesirable effects have been reported since Eprosartan tablets has been marketed but the frequency is not known
* Changes in kidney function including kidney failure in patients with existing kidney problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
rp Further information
What this medicine contains:
Each film-coated tablet contains 600mg eprosartan (as mesylate) as the active ingredient.
Your medicine also contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium stearate, crospovidone, purified water, hypromellose (E464), titanium dioxide (E171), polysorbate 80 (E433) and macrogol 400.
What this medicine looks like and contents of the pack
The tablets are white, capsule-shaped, film-coated tablets with ‘5046' engraved on one side and plain on the other side.
These tablets are available in calender blister strips of 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Abbott Products GmbH, Justus-von-Liebig-Strasse 33, D-31535 Neustadt, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
[pOMI PL 15184/0992 Eprosartan 600mg Film-coated Tablets Revision date: 28/05/13