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Valsartan Teva Pharma

Information för alternativet: Valsartan Teva Pharma 160 Mg Filmdragerad Tablett, Valsartan Teva Pharma 80 Mg Filmdragerad Tablett, Valsartan Teva Pharma 40 Mg Filmdragerad Tablett, Valsartan Teva Pharma 120 Mg Filmdragerad Tablett, visa andra alternativ

Package leaflet: Information for the user


Valsartan Teva Pharma 40 mg film-coated tablets

Valsartan Teva Pharma 80 mg film-coated tablets

Valsartan Teva Pharma 120 mg film-coated tablets

Valsartan Teva Pharma 160 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 Valsartan Teva Pharma is and what it is used for

2. What you need to know before you take Valsartan Teva Pharma

3. How to take Valsartan Teva Pharma

4. Possible side effects

5. How to store Valsartan Teva Pharma

6. Contents of the pack and other information

1. What Valsartan Teva Pharma is and what it is used for

Valsartan Teva Pharma 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 Teva Pharma works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.


Valsartan Teva Pharma 40 mg can be used for three different conditions:


Valsartan Teva Pharma 80 mg / Valsartan Teva Pharma 120 mg / Valsartan Teva Pharma 160 mg can be used for three different conditions:

2. What you need to know before you take Valsartan Teva Pharma

Do not take Valsartan Teva Pharma

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Valsartan Teva Pharma

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 Teva Pharma”


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


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 Valsartan Teva Pharma in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure).

Other medicines and Valsartan Teva Pharma

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 Teva Pharma 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:

Valsartan Teva Pharma with food and drink

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

3. How to take Valsartan Teva Pharma

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.


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 once daily.

In patients who weigh 35 kg or more the recommended starting dose is 80 mg 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. Valsartan Teva Pharma 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.

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


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 Valsartan Teva Pharma 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 once daily.

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

Valsartan Teva Pharma 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.

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


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

Take Valsartan Teva Pharma at about the same time each day.

The tablet can be divided into equal doses.

If you take more Valsartan Teva Pharma 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 Valsartan Teva Pharma

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 Valsartan Teva Pharma

Stopping your treatment with Valsartan Teva Pharma 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 Valsartan Teva Pharma 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 Valsartan Teva Pharma

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 packs
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 Valsartan Teva Pharma contains

The active substance is valsartan.

Each tablet contains 40 mg valsartan.

Each tablet contains 80 mg valsartan.

Each tablet contains 120 mg valsartan.

Each tablet contains 160 mg valsartan.


The other ingredients are

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

40 mg:

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

80 mg:

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

120 mg:

Opadry II white containing polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E171), macrogol, talc.

160 mg:

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

What Valsartan Teva Pharma looks like and contents of the pack

Valsartan Teva Pharma 40 mg is a yellow, oval-shaped, scored film-coated tablet (dimension: approx. 3.6 x 9.1 mm).

Valsartan Teva Pharma 80 mg is a pale red, round, scored film-coated tablet (diameter approx. 8.1 mm).

Valsartan Teva Pharma 120 mg is a white, round, scored film-coated tablet (diameter approx. 9.2 mm).

Valsartan Teva Pharma 160 mg is a grey orange, oval-shaped, scored film-coated tablet (dimension: approx. 5.6 x 14.1 mm).


Blisters:

40 mg:

Packs of 14, 20, 28, 30, 60, 98, 100 film-coated tablets.

80 mg/120 mg/160 mg:

Packs of 14, 20, 28, 30, 56, 60, 98, 100 film-coated tablets.


Bottles:

100, 500 film-coated tablets.


Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]



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

<{Name of the Member State}> <{Name of the medicinal product}>


This leaflet was last revised in

2015-06-17


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