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Valsartan Jubilant

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PACKAGE LEAFLET: INFORMATION FOR THE USER


Valsartan Jubilant 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:

What Valsartan Jubilant is and what it is used for

What you need to know before you take Valsartan Jubilant

How to take Valsartan Jubilant

Possible side effects

How to store Valsartan Jubilant

Contents of the pack and other information


1. What Valsartan Jubilant is and what it is used for


Valsartan Jubilant belongs to a class of medicines known as angiotensin II receptor antagonist, 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. Valsartan Jubilant works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.


Valsartan Jubilant 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 Valsartan Jubilant


Do not take Valsartan Jubilant:


If any of these apply to you, do not take Valsartan Jubilant


Warnings and precautions

Talk to your doctor or pharmacist before taking Valsartan Jubilant:


If any of these apply to you, tell your doctor before you take Valsartan Jubilant.


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 Valsartan Jubilant”.


Other medicines and Valsartan Jubilant

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 Valsartan Jubilant 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:



Valsartan Jubilant with food and drink

You can take Valsartan Jubilant with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Valsartan Jubilant before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan Jubilant. Valsartan Jubilant 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. Valsartan Jubilant 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 Valsartan Jubilant affects you. Like many other medicines used to treat high blood pressure, Valsartan Jubilant may in rare cases cause dizziness and affect the ability to concentrate.


Valsartan Jubilant contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


3. How to take Valsartan Jubilant


Always take Valsartan Jubilant exactly as your doctor has told you in order to get the best results and reduce the risk of side effects. You should 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 Valsartan Jubilant 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).


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

Take Valsartan Jubilant at about the same time each day.


If you take more Valsartan Jubilant than you should

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


If you forget to take Valsartan Jubilant

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

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.


If you stop taking Valsartan Jubilant

Stopping your treatment with Valsartan Jubilant 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 product, ask your doctor or pharmacist.


4. Possible side effects


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


Some symptoms need immediate medical attention:

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


If you get any of these, see a doctor immediately.


Other side effects include:


Common (may affect 1 to 10 users in 100):


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


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


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


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Valsartan Jubilant


Al/Al blister: This medicine does not require any special storage conditions.


6. Contents of the pack and other information


What Valsartan Jubilant 320 mg film-coated tablets contains

The active substance is valsartan.

Each film-coated tablet contains 320 mg valsartan.

The other ingredients are:

Microcrystalline cellulose (E460), crospovidone (E1202), dental type silica, magnesium stearate (E470b), lactose anhydrous, hypromellose (E464), titanium dioxide (E171), macrogol, and iron oxide yellow (E172).


What Valsartan Jubilant 320 mg film-coated tablets looks like and contents of the pack

Valsartan Jubilant 320 mg film-coated tablets are yellow coloured, oval shaped, biconvex film-coated tablets of approximately 20,45 mm length and 9,65 mm width, debossed with ‘C5’ on one side and plain on the other side.


The tablets are available in blister packs of 28, 56 or 98 tablets.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


Marketing Authorisation Holder

To be completed nationally


Manufacturer

PSI supply nv

Axxes Business Park

Guldensporenpark 22 – Block C

9820 Merelbeke

Belgium


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


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


Sweden: Valsartan Jubilant 320 mg Filmdragerade Tabletter

Cyprus: Valsartan Jubilant 320 mg Επικαλυμμένο με λεπτό υμένιο δισκίο

Denmark: Valsartan Jubilant 320 mg Filmovertrukket tablet

Germany: Valsartan Jubilant 320 mg Filmtabletten

Italy: Valsartan Jubilant 320 mg Compressa rivestita con film

The Netherlands: Valsartan Jubilant 320 mg filmomhulde tabletten

United Kingdom: Valsartan 320 mg film-coated tablets


This leaflet was last revised in 2014-09-22