Teveten 600mg Tablets
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By khilod ali at 12:10 pm, Mar 18, 2009
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Patient Information Leaflet
®
Teveten 600mg Tablets Eprosartan 600mg Tablets
(eprosartan mesilate)
Assessed against UK PIL dated June 2006
Your tablets are available using the above names, but will referred to as Teveten throughout this leaflet.
This leaflet tells you about Teveten. Please read it carefully before taking your tablets.
If there is anything you do not understand, or if you want to know more about your tablets, ask your doctor or a pharmacist (chemist).
Please keep this leaflet. You may want to read it again.
What is in Teveten?
Each tablet contains the active ingredient eprosartan mesilate (equivalent to 600mg eprosartan).
Your medicine also contains inactive ingredients. These are: lactose, microcrystalline cellulose, pregalatinised starch, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide (E171), polysorbate 80, polyethylene glycol and crospovidone.
Teveten 600mg tablets are stored in a cardboard box containing two blister strips of 14 tablets each. Each tablet is white, capsule shaped tablets and marked with '5046' on one side and 'SOLVAY' on the other.
Teveten is made by Solvay Pharmaceuticals B.V., Olst, The Netherlands.
The Product Licence holder is: BR Lewis Pharmaceuticals Ltd,
Kirk Sandall, Doncaster, DN3 1QR.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0038 POM
What is Teveten and how does it work?
Teveten is one of a group of medicines called angiotensin-II receptor antagonists. Angiotensin II is a chemical found in the body which makes your blood vessels contract and makes it more difficult for blood to pass through them, causing your blood pressure to rise. Teveten prevents this chemical from having this effect and so lowers your blood pressure.
What is Teveten used for?
Teveten is used for the treatment of 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 the heart must do to pump blood around the body. You may not feel unwell, but, if high blood pressure is not treated, it can lead to heart disease and stroke.
You may be given Teveten on its own. It may also be given with another drug used to treat high blood pressure as both drugs used together will lower your blood pressure (to a greater extent) than one alone.
Your doctor may give you additional advice on how you can help to lower your blood pressure.
Before taking your medicine
Do not take Teveten if:
■ You are allergic to eprosartan or any other ingredient in Teveten tablets (see 'What is in Teveten')
■ You are, or might become, pregnant
■ You are breast-feeding your baby
■ You have severe liver disease
■ you are more than 3 months pregnant. (It is also better to avoid Teveten in early pregnancy - see pregnancy section.)
Tell your doctor if any of the following apply to you
(go back to your doctor or pharmacist and ask what you should do. You may need to be given another medicine or the dose may need to be changed):
■ You have heart, kidney or liver problems
■ You have recently suffered from vomiting or diarrhoea
■ You suffer from lactose intolerance
■ You are taking potassium supplements, potassium sparing agents or potassium containing salt substitutes
■ You are taking diuretics (water tablets) to help lower your blood pressure, or for other reasons
■ You are taking lithium.
■ You are regularly taking non-steroidal anti-inflammatory painkillers (e.g. ibuprofen or diclofenac), COX-2 inhibitors (e.g. celecoxib, etoricoxib or lumiracoxib) or more than 3g per day of aspirin.
Special Warning: This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Take special care with Teveten
You must tell your doctor if 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).
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.
Do you drive or operate machinery?
If you feel tired or dizzy when you start to take Teveten, do not drive or operate machinery until these effects wear off.
Taking your medicine
Follow the doctor's instructions about how and when to take your medicine. The doctor will decide how many tablets you need to take each day and for how long.
The pharmacist's label on your pack will tell you how much your doctor would like you to take. Please read the label carefully. If you have any questions about your medicine and how to take it ask your doctor or pharmacist.
The usual dose of Teveten is 600 mg taken once a day. The doctor may increase the dose to 800 mg (two 400mg tablets) if required. If you are over 75 years of age or have kidney or liver problems, your doctor may start you on a lower dose of 300 mg (one tablet) once a day.
You should take the tablets with half a glass of water and with food.
Take your tablets at about the same time each day.
It is important that you keep taking the tablets for as long as your doctor tells you.
What if you have taken too much?
You should never take more tablets than your doctor recommends. If you take too many tell your doctor or hospital casualty department straight away. Show them your pack of tablets.
What if you miss a dose?
If you forget to take a tablet, 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.
Possible side effects of Teveten
Any medicine can cause side effects. Allergic reactions have occasionally been reported with Teveten.
Very rarely (in less than one in ten thousand patients), serious allergic reactions involving swelling of the face, lips or tongue and difficulty in breathing have been reported. If you develop any of these symptoms, stop taking Teveten and contact your doctor or hospital immediately.
Less serious side effects that have been experienced include runny nose, dizziness and pain in the joints. These are not necessarily due to Teveten as they have also been seen in patients not taking it. Other side effects which may occur are 'wind' and an increase in fats ('triglycerides') in the blood.
In less than one in a thousand patients, skin rashes, itching, headache or lethargy, have been reported.
In less than one in ten thousand patients, low blood pressure or dizziness when standing up, and nausea have been reported.
If your doctor takes a blood sample for testing, you should remind him that you are taking Teveten as it may affect the result.
Tell your doctor if you notice any unwanted effects (even if not mentioned in this leaflet) or feel unwell when you take Teveten.
Expiry Date
• Your medicine will have an expiry date on the pack. You should not use your tablets after this date.
Storing your medicine
• Do not store above 25°C. Keep the tablets in the original carton.
Keep all medicines where children cannot see or reach them - preferably in a locked cupboard or medicine cabinet.
If your tablets show and signs of deterioration or appear discoloured, take them back to your pharmacist (chemist), who will advise you what to do.
If your doctor tells you to stop taking these tablets, take them back to your pharmacist for safe disposal.
Teveten® is a registered trademark of Solvay Pharmaceuticals BV Leaflet revision and issue date (Ref): 12.03.09