Teveten 600mg Film-Coated Tablets
Out of date information, search another500753/PL1g ®
Teveten 600 mg Film-Coated Tablets
500753/PL1g ®
Teveten 600 mg Film-Coated Tablets
The active ingredient in this medicine is eprosartan mesilate. This is the new name for eprosartan mesylate. The active ingredient itself has not changed.
®
®
(eprosartan mesilate)
Patient Information Leaflet
The name of your medicine is Teveten® 600 mg Film-Coated Tablets, throughout this leaflet it will be referred to as Teveten®. Other strengths are available.
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.
In this leaflet:
1) What Teveten® is and what it is used for
2) Before you take Teveten®
3) How to take Teveten®
4) Possible side effects
5) How to store Teveten®
6) Further information
1) WHAT TEVETEN® IS AND WHAT IT IS 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.
2) 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 (hypertrophic 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
• Medicines that increase potassium levels such as heparin
• 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 breastfeed, 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.
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
• 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 dose is 600 mg once a day
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.
Continued overleaf
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 ofpossible side effects reported in clinical studies with Teveten® is given below:
For more information on blood pressure, you may find the following organisation helpful:
The Blood Pressure Association 60 Cranmer Terrace London SW17 0QS Phone: 020 8772 4994 Website: www.bpassoc.org.uk
Both Ginova Ltd and Ginova UK Ltd are not associated with The Blood Pressure Association.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.
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 or being sick (nausea or vomiting)
• Diarrhoea
• Runny nose
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 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE TEVETEN®
• Keep out of the sight and reach of children
• You should lock this medicine in a cupboard or medicine cabinet
• Do not use the tablets after the expiry date which is printed on the carton and blister pack
• Do not store above 25°C. Store in the original container.
If your doctor stops your treatment, return any unused tablets to a pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
If you notice any signs of discolouration or deterioration of the tablets, please consult your pharmacist immediately.
|6) FURTHER INFORMATION!
Each film-coated tablet contains eprosartan mesilate equivalent to 600 mg eprosartan free base.
Your medicine also contains inactive ingredients. These are lactose monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium stearate, crospovidone, hypromellose, titanium dioxide (E171), polysorbate 80, macrogol 400 and purified water.
What Teveten® looks like and the contents of the pack
The tablets are capsule-shaped, bi-convex, white film-coated tablets with '5046' on one side and plain on the other.
Teveten® is available in calendar blister packs containing 28 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer:
Abbott Healthcare S.A.S, Route de Belleville, Lieu dit Maillard, F-01400 Chatillon-sur-Chalaronne, France.
Abbott Products GmbH, Justus-von-Liebig-Strasse 33, D-31535, Neustadt, Germany.
Teveten® 600 mg Film-Coated Tablets
PL No: 18067/0283 |POM|
Teveten® is a registered trademark.
This leaflet was last revised on 22nd July 2014.
500753/PL1g
1) WHAT EPROSARTAN IS AND WHAT IT IS USED FOR|
The active ingredient in this medicine is eprosartan mesilate. This is the new name for eprosartan mesylate. The active ingredient itself has not changed.
2) BEFORE YOU TAKE EPROSARTAN|
|3) HOW TO TAKE EPROSARTAN|
(eprosartan mesilate)
Patient Information Leaflet
The name of your medicine is Eprosartan 600 mg Film-Coated Tablets, throughout this leaflet it will be referred to as Eprosartan. Other strengths are available.
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.
In this leaflet:
1) What Eprosartan is and what it is used for
2) Before you take Eprosartan
3) How to take Eprosartan
4) Possible side effects
5) How to store Eprosartan
6) Further information
What Eprosartan is used for
Eprosartan 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 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 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 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.
Do not take Eprosartan if:
• You are allergic (hypersensitive) to eprosartan or any of the other ingredients of Eprosartan (listed in Section 6 below)
• You have severe liver problems
• You are more than 3 months pregnant (it is also better to avoid Eprosartan 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 if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Eprosartan.
Take special care with Eprosartan
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 (hypertrophic 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 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')
• You think you are (or might become) pregnant. Eprosartan 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 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.
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
• Medicines that increase potassium levels such as heparin
• 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.
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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Eprosartan. Eprosartan 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 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. 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
Eprosartan 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.
Always take Eprosartan 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
• 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 dose is 600 mg once a day
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 should not be used in children and adolescents under 18 years.
If you take more Eprosartan than you should
If you take more Eprosartan 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
• 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.
Continued overleaf
Like all medicines, Eprosartan can cause side effects, although not everybody gets them.
Stop taking Eprosartan 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 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 or being sick (nausea or vomiting)
• Diarrhoea
• Runny nose
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 severe allergic reactions and may be life threatening.
Undesirable effects have been reported since Eprosartan has been marketed but the frequency is not known
• Changes in kidney function including kidney failure in patients with existing kidney problems.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
For more information on blood pressure, you may find the following organisation helpful:
The Blood Pressure Association 60 Cranmer Terrace London SW17 0QS Phone: 020 8772 4994 Website: www.bpassoc.org.uk
Both Ginova Ltd and Ginova UK Ltd are not associated with The Blood Pressure Association.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.
|5) HOW TO STORE EPROSARTAN|
• Keep out of the sight and reach of children
• You should lock this medicine in a cupboard or medicine cabinet
• Do not use the tablets after the expiry date which is printed on the carton and blister pack
• Do not store above 25°C. Store in the original container.
If your doctor stops your treatment, return any unused tablets to a pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
If you notice any signs of discolouration or deterioration of the tablets, please consult your pharmacist immediately.
|6) FURTHER INFORMATION!
Each film-coated tablet contains eprosartan mesilate equivalent to 600 mg eprosartan free base.
Your medicine also contains inactive ingredients. These are lactose monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium stearate, crospovidone, hypromellose, titanium dioxide (E171), polysorbate 80, macrogol 400 and purified water.
What Eprosartan looks like and the contents of the pack
The tablets are capsule-shaped, bi-convex, white film-coated tablets with '5046' on one side and plain on the other.
Eprosartan is available in calendar blister packs containing 28 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer:
Abbott Healthcare S.A.S, Route de Belleville, Lieu dit Maillard, F-01400 Chatillon-sur-Chalaronne, France.
Abbott Products GmbH, Justus-von-Liebig-Strasse 33, D-31535, Neustadt, Germany.
Eprosartan 600 mg Film-Coated Tablets
PL No: 18067/0283 |POM|
This leaflet was last revised on 22nd July 2014.
500755/PL1g