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Package leaflet: Information for the user


Valtsu 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.

- 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 signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.


What is in this leaflet:

1. What Valtsu 320 mg film-coated tablets is and what it is used for

2. What you need to know before you take Valtsu 320 mg film-coated tablets

3. How to take Valtsu 320 mg film-coated tablets

4. Possible side effects

5. How to store Valtsu 320 mg film-coated tablets

6. Contents of the pack and other information

1. What Valtsu 320 mg film-coated tablets is and what it is used for

Valtsu 320 mg film-coated tablets 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. Valtsu 320 mg film-coated tablets works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.


Valsartan 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 320 mg film-coated tablets

Do not take Valtsu 320 mg film-coated tablets


If any of these apply to you, do not take Valtsu 320 mg film-coated tablets

Warnings and precautions

Talk to your doctor or pharmacist before taking Valtsu 320 mg film-coated tablets

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 Valtsu 320 mg film-coated tablets”


If any of these apply to you, tell your doctor before you take Valtsu 320 mg film-coated tablets.


Children and adolescents

The doctor may check the kidney function and the amount of potassium in the blood at regular intervals in children and adolescents below 18 years of age, who take Valtsu 320 mg film-coated tablets in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure).

Other medicines and Valtsu 320 mg film-coated tablets

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 Valtsu 320 mg film-coated tablets 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:


lithium, a medicine used to treat some types of psychiatric illness.

Valtsu 320 mg film-coated tablets with food and drink

You can take Valtsu 320 mg film-coated tablets 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 Valtsu 320 mg film-coated tablets before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valtsu 320 mg film-coated tablets. Valtsu 320 mg film-coated tablets 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. Valtsu 320 mg film-coated tablets 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 Valtsu 320 mg film-coated tablets affects you. Like many other medicines used to treat high blood pressure, Valtsu 320 mg film-coated tablets may in rare cases cause dizziness and affect the ability to concentrate.

3. How to take Valtsu 320 mg film-coated tablets

Always take this medicine exactly as your doctor has told you. 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 usual 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 Valtsu 320 mg film-coated tablets 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 usual dose is 40 mg of Valtsu 320 mg film-coated tablets once daily.

In patients who weigh 35 kg or more the recommended starting dose is 80 mg of Valtsu 320 mg film-coated tablets 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 Valtsu 320 mg film-coated tablets with or without food. Swallow Valtsu 320 mg film-coated tablets with a glass of water.

Take Valtsu 320 mg film-coated tablets at about the same time each day.

The tablet can be divided into equal doses.

If you take more Valtsu 320 mg film-coated tablets 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 Valtsu 320 mg film-coated tablets

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 Valtsu 320 mg film-coated tablets

Stopping your treatment with Valtsu 320 mg film-coated tablets may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.


If you have any 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 symptoms 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 Valtsu 320 mg film-coated tablets and contact your doctor straight away (see also section 2 “Warnings and precautions”).


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.


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not 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 Valtsu 320 mg film-coated tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Blister packages: Do not store above 30 °C. Store in the original package in order to protect from moisture.

Bottles: Store in the original package in order to protect from moisture.

Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Valtsu 320 mg film-coated tablets contains

The active substance is valsartan.

Each film-coated tablet contains 320 mg valsartan.


The other ingredients are

Tablet core: Microcrystalline cellulose, povidone (K-30), colloidal anhydrous silica, croscarmellose sodium, magnesium stearate.
Film coating:

Opadry II brown containing polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E171), macrogol, talc, iron oxide red (E172), iron oxide black (E172).

What Valtsu 320 mg film-coated tabletslooks like and contents of the pack

Valtsu 320 mg film-coated tablets are dark grey-violet, biconvex,capsule shaped, scored and film-coated tablets (dimension approx. 8.1 x 17.7 mm).


Blisters:

Packs of 10, 14, 28, 30, 56, 60, 90, 98 and 100 film-coated tablets.

Bottles:

100 film-coated tablets.


Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

[To be completed nationally]



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

[To be completed nationally]


This leaflet was last revised in

2015-03-26


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