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Diovan

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Document: Diovan film-coated tablet ENG PL change

Package leaflet: Information for the user


Diovan 40 mg film-coated tablets

Diovan 80 mg film-coated tablets

Diovan 160 mg film-coated tablets

Diovan 320 mg film-coated tablets

Valsartan


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


What is in this leaflet:

1. What Diovan is and what it is used for

2. What you need to know before you take Diovan

3. How to take Diovan

4. Possible side effects

5. How to store Diovan

6. Contents of the pack and other information


1. What Diovan is and what it is used for


Diovan contains the active substance: valsartan and belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase. Diovan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.


Diovan 40 mg film-coated tablets can be used for three different conditions:


Diovan 80 mg film-coated tablets can be used for three different conditions:


Diovan 160 mg film-coated tablets can be used for three different conditions:


Diovan 320 mg film-coated tablets can be used

to treat high blood pressure in adults and in children and adolescents 6 to 18 years of age. High blood pressure increases the workload on the heart and arteries. If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.


2. What you need to know before you take Diovan


Do not take Diovan:

If any of the above apply to you, tell your doctor and do not take Diovan.


Warnings and precautions:

Talk to your doctor


Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.


See also information under the heading “Do not take Diovan”


You must tell your doctor if you think you are (or might become) pregnant. Diovan 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).


Other medicines and Diovan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.


The effect of the treatment can be influenced if Diovan is taken together with certain other medicines. It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:



In addition:


Pregnancy and breast-feeding


You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Diovan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan. Diovan 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 it is used after the third month of pregnancy.


Tell your doctor if you are breast-feeding or about to start breast-feeding. Diovan 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

Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Diovan affects you. Like many other medicines used to treat high blood pressure, Diovan may in rare cases cause dizziness and affect the ability to concentrate.


3. How to take Diovan


Always take this medicine exactly as your doctor has told you in order to get the best results and reduce the risk of side effects. Check with your doctor or pharmacist if you are not sure. People with high blood pressure often do not notice any signs of this problem. Many may feel quite normal. This makes it all the more important for you to keep your appointments with the doctor even if you are feeling well.


Adult patients with high blood pressure: The recommended dose is 80 mg daily. In some cases your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). He may also combine Diovan with an additional medicine (e.g. a diuretic).


Children and adolescents (6 to 18 years of age) with high blood pressure:

In patients who weigh less than 35 kg the recommended dose is 40 mg of valsartan once daily.

In patients who weigh 35 kg or more the recommended starting dose is 80 mg of valsartan once daily.

In some cases your doctor may prescribe higher doses (the dose can be increased to 160 mg and to a maximum of 320 mg).


Adult patients after a recent heart attack: After a heart attack the treatment is generally started as early as after 12 hours, usually at a low dose of 20 mg twice daily. You obtain the 20 mg dose by dividing the 40 mg tablet. Your doctor will increase this dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate.

Diovan can be given together with other treatment for heart attack, and your doctor will decide which treatment is suitable for you.


Adult patients with heart failure: Treatment starts generally with 40 mg twice daily. Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate.

Diovan can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.


You can take Diovan with or without food. Swallow Diovan with a glass of water.

Take Diovan at about the same time each day.


If you take more Diovan than you should

If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.


If you forget to take Diovan

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed.


Do not take a double dose to make up for a forgotten dose.


If you stop taking Diovan

Stopping your treatment with Diovan may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.


If you have further questions on the use of this medicine, ask your doctor or pharmacist.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


Some side effects can be serious and need immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

If you get any of these symptoms, stop taking Diovan and contact your doctor straight away (see also section 2 “Warnings and precautions”).


Other side effects include:


Common(may affect up to 1 in 10 people):


Uncommon(may affect up to 1 in 100 people):


Not known (frequency cannot be estimated from the available data):


The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in adult patients treated with high blood pressure than in adult patients treated for heart failure or after a recent heart attack.


Side effects in children and adolescents are similar to those seen in adults.


Reportingof side effects

If you getany side effects, talk to your doctor or pharmacist. This includes any possible side effectsnot listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Diovan



6. Contents of the pack and other information


What Diovan contains


What Diovan looks like and contents of the pack

Diovan 40 mg film-coated tablets are yellow, ovaloid tablets that are scored on one side. They have the letters “D” on one side of the score and “O” on the other side of the score and “NVR” on the reverse side of the tablet. The tablet can be divided into equal halves.


Diovan 80 mg film-coated tablets are pale red, round tablets that are scored on one side. They have the letters “D” on one side of the score and “V” on the other side of the score and “NVR” on the reverse side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.


Diovan 160 mg film-coated tablets are grey-orange, ovaloid tablets that are scored on one side. They have the letters “DX” on one side of the score and “DX” on the other side of the score and “NVR” on the reverse side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.


Diovan 320 mg film-coated tablets are dark grey-violet, ovaloid with bevelled edges and scored on one side. They have the letters “DC” on one side of the score and “DC” on the other side of the score and “NVR” on the reverse side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.


The tablets are supplied in blister packs of 7, 14, 28, 30, 56, 90 or 98 tablets and in calendar blister packs of 14, 28, 56, 98 and 280 tablets. Perforated unit dose blister packs of 56x1, 98x1 or 280x1 tablets are also available.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer

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For any information about this medicine, please contact the Marketing Authorisation Holder.


This medicinal product is authorised in the Member States of the EEA under the following names:


Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, , Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

Diovan

Belgium, Luxembourg

Diovane

France, Italy

Tareg

Spain

Diovan Cardio


This leaflet was last revised in 2015-04-09