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Package leaflet: Information for the user

Valsartan Teva Pharma 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 Valsartan Teva Pharma 320 mg film-coated tablets is and what it is used for

2. What you need to know before you take Valsartan Teva Pharma 320 mg film-coated tablets

3. How to take Valsartan Teva Pharma 320 mg film-coated tablets

4. Possible side effects

5. How to store Valsartan Teva Pharma 320 mg film-coated tablets

6. Contents of the pack and other information

1. What Valsartan Teva Pharma 320 mg film-coated tablets is and what it is used for

Valsartan Teva Pharma 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. Valsartan Teva Pharma 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

2. What you need to know before you take Valsartan Teva Pharma 320 mg film-coated tablets

Do not take Valsartan Teva Pharma 320 mg film-coated tablets

• if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6).

• if you have severe liver disease.

• if you are more than 3 months pregnant (it is also better to avoid Valsartan Teva Pharma 320 mg film-coated tablets in early pregnancy - see pregnancy section).

• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Valsartan Teva Pharma film-coated tablets

• if you have liver disease.

• if you have severe kidney disease or if you are undergoing dialysis.

• if you are suffering from a narrowing of the kidney artery.

• if you have recently undergone kidney transplantation (received a new kidney).

• if you are treated after a heart attack or for heart failure, your doctor may check your kidney function.

• if you have severe heart disease other than heart failure or heart attack.

• if you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking another drug (including ACE inhibitors), tell your doctor. If these symptoms occur when you are taking Valsartan Teva Pharma 320 mg film-coated tablets, stop taking Valsartan Teva Pharma 320 mg film-coated tablets immediately and never take it again. See also section 4, “Possible side effects”.

• if you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. It may be necessary to check the amount of potassium in your blood at regular intervals.

• if you suffer from aldosteronism. This is a disease in which your adrenal glands make too much of the hormone aldosterone. If this applies to you, the use of Valsartan Teva Pharma 320 mg film-coated tablets is not recommended.

• if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets (diuretics).

• you must tell your doctor if you think you are (or might become) pregnant. Valsartan Teva Pharma 320 mg film-coated tablets 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 are taking any of the following medicines used to treat high blood pressure:
  - an ACE-inhibitor (for example enalapril, lisinopril, ramipril) in particular if you have diabetes-related kidney problems.
  - aliskiren.

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 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 Valsartan Teva Pharma 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 Valsartan Teva Pharma 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 Valsartan Teva Pharma 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:

• other medicines that lower blood pressure, especially water tablets (diuretics) , ACE-inhibitor or aliskiren (see also information under the headings “Do not take Valsartan Teva Pharma” and “Warnings and precautions”).

• medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.

• certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).

• some antibiotics (rifamycin group), a drug used to protect against transplant rejection (ciclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Valsartan Teva Pharma 320 mg film-coated tablets.

Taking Valsartan Teva Pharma 320 mg film-coated tablets with food and drink

You can take Valsartan Teva Pharma 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.

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 320 mg film-coated tablets affects you. Like many other medicines used to treat high blood pressure, Valsartan Teva Pharma 320 mg film-coated tablets may in rare cases cause dizziness and affect the ability to concentrate.

3. How to take Valsartan Teva Pharma 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 Valsartan Teva Pharma 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 Valsartan Teva Pharma 320 mg film-coated tablets once daily.

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

Take Valsartan Teva Pharma 320 mg film-coated tablets at about the same time each day.

The tablet can be divided into equal doses.

If you take more Valsartan Teva Pharma 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 Valsartan Teva Pharma 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 Valsartan Teva Pharma 320 mg film-coated tablets

Stopping your treatment with Valsartan Teva Pharma 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

• swollen face, lips, tongue or throat

• difficulty in breathing or swallowing

• hives, itching

If you get any of these symptoms, stop taking Valsartan Teva Pharma 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)

• dizziness

• low blood pressure with or without symptoms such as dizziness and fainting when standing up

• decreased kidney function (signs of renal impairment)

Uncommon (may affect up to 1 in 100 people)

• angioedema (see section “Some symptoms need immediate medical attention”)

• sudden loss of consciousness (syncope)

• spinning sensation (vertigo)

• severely decreased kidney function (signs of acute renal failure)

• muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)

• breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure)

• headache

• cough

• abdominal pain

• nausea

• diarrhoea

• tiredness

• weakness

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

• blistering skin (sign of dermatitis bullous)

• allergic reactions with rash, itching and hives; symptoms of fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)

• purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)

• unusual bleeding or bruising (signs of thrombocytopenia)

• muscle pain (myalgia)

• fever, sore throat or mouth ulcers due to infections (symptoms of low level of white blood cells also called neutropenia)

• decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases)

• increase of level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases)

• elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can trigger yellow skin and eyes in severe cases)

• increase of level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function)

• low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)

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 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.

 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 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 Valsartan Teva Pharma 320 mg film-coated tabletslooks like and contents of the pack

Valsartan Teva Pharma 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 and 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

2015-06-17