Tuesday, September 27, 2016

Teveten 300mg, 400mg & 600mg film-coated tablets






TEVETEN

300 mg, 400 mg and 600 mg Film-coated Tablets



Eprosartan



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




What Teveten is and what it is used for



What Teveten is used for


Teveten contains a medicine called eprosartan mesylate. 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.





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).

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) 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.





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 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


  • The usual starting dose is 300 mg once a day.


Children


  • Teveten should not be used in children.



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.




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.



Blood tests


If you need a blood sample taking for testing, you should remind your doctor that you are taking Teveten, as it may affect the result.





How to store Teveten


  • Keep out of the reach and sight 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 your tablets above 25°C. Keep them 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.




Further information



What Teveten contains


  • The active ingredient is eprosartan (as mesylate). Each tablet contains either 300 mg, 400 mg or 600 mg of eprosartan.

  • The other ingredients are: lactose, microcrystalline cellulose (E460), pregelatinised starch, magnesium stearate (E572), hypromellose, titanium dioxide (E171), polysorbate 80 (E433) and macrogol 400

  • The 300 mg and 400 mg tablets also contain croscarmellose sodium

  • The 400 mg tablets also contain iron oxides (E172)

  • The 600 mg tablets also contain crospovidone.



What Teveten looks like and contents of the pack


Teveten 300 mg Film-coated Tablets are white and oval-shaped with the markings Solvay & 5043.


Teveten 400 mg Film-coated Tablets are pink and oval-shaped with the markings Solvay & 5044.


Teveten 600 mg Film-coated Tablets are white and capsule-shaped with the marking 5046.


Teveten is available in blister packs containing 28 or 56 tablets.




Marketing Authorisation Holder and Manufacturer


The Marketing Authorisation holder is:



Solvay Healthcare Ltd

Southampton

SO18 3JD

UK


The Manufacturer is:



Solvay Pharmaceuticals

F-01400 Châtillon-sur-Chalaronne

France





This leaflet was last approved in October 2009


Registered trademark


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



0000000 CL 000





No comments:

Post a Comment