Package leaflet: Information for the user

Vapress 40 mg film-coated tablets

Vapress 80 mg film-coated tablets

Vapress 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.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. 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 Vapress is and what it is used for

2. What you need to know before you take Vapress

3. How to take Vapress

4. Possible side effects

5. How to store Vapress

6. Contents of the pack and other information

1. What Vapress is and what it is used for

Vapress contains valsartan that 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. Vapress works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.

Vapress can be used for three different conditions:

• to treat high blood pressure in adults, children and adolescents 6 to 18 years of age. The doctor will use the 80 mg or 160 mg tablet for treating high blood pressure in adults. 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.

• to treat adult patients after a recent heart attack (myocardial infarction). “Recent” here means between 12 hours and 10 days.

• to treat symptomatic heart failure in adult patients. Vapress is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE- inhibitors when other medication to treat heart failure cannot be used.

Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid build-up. It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body.

2. What you need to know before you take Vapress

Do not take Vapress:

• 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 Vapress 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.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Vapress:

• 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 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 are below 18 years of age and you take Vapress in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and 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 Vapress 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. Vapress 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 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 Vapress, stop taking Vapress immediately and never take it again. See also section 4.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 Vapress.

Other medicines and Vapress

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 Vapress 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).

• 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).

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

Your doctor may need to change your dose and/or to take other precautions:

• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Vapress” and “Warnings and precautions”)

• If you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone) or betablockers (for example metoprolol).

Vapress with food and drink

You can take Vapress with or without food.

Pregnancy, breast-feeding and fertility

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 Vapress affects you. Like many other medicines used to treat high blood pressure, Vapress may in rare cases cause dizziness and affect the ability to concentrate.

3. How to take Vapress

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 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 Vapress with an additional medicine (e.g. a diuretic).

Use in 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 usual 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. The 20 mg dose cannot be obtained with Vapress tablets as these are not manufactured to break into two equal halves.

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.

Vapress 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.

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

You can take Vapress with or without food. Swallow Vapress with a glass of water. Take Vapress at about the same time each day.

If you take more Vapress 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 Vapress

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 Vapress

Stopping your treatment with Vapress 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.

Stop taking this medicine and tell your doctor straight away if:

You experience with the frequency uncommon (may affect upto 1 in 100 people) symptoms of angioedema (a specific allergic reaction), such as

• swollen face, lips, tongue or throat

• difficulty in breathing or swallowing

• hives, itching

Other side effects include the following:

Common side effects(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 side effects(may affect up to 1 in 100 people):

• 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 side effects (frequency cannot be estimated from the available data)

• 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 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. [To be completed nationally]

5. How to store Vapress

• Store below 30°C. Store in the original package in order to protect from moisture.

• 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 after EXP. The expiry date refers to the last day of that month.

• 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 or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Vapress contains

• The active substance is valsartan.

• One film-coated tablet contains 40 mg, 80 mg or 160 mg valsartan.

• The other ingredients are Microcrystalline cellulose 101, Crospovidone type A, Povidone K30, Colloidal anhydrous silica, Magnesium stearate.

The tablet coating contains,Polyvinyl alcohol, Titanium dioxide (E171),Macrogol,Talc, Quinoline yellow aluminiumlake (E104).

What Vapress looks like and contents of the pack

Vapress 40mg film-coated tablets: Yellow, round, convex, film- coated tablets with diameter of nucleus 8mm.

Vapress 80mg film-coated tablets: Yellow, round, convex, scored, film -coated tablets with diameter of nucleus 10.4mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Vapress 160mg film-coated tablets: Yellow, convex, scored on one side, embossed “MC” on the other side, capsule-shaped, film- coated tablets with dimensions of nucleus 17.5 x 8mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Tablets are packed in PVC/PE/PVDC-Alu blisters and PVC/PCTFE-Alu blisters.

Pack sizes: 7, 14, 28, 30, 56, 60, 90, 98, 100, 280 film- coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Manufacturer

Medochemie Ltd – Central Factory

1-10 Konstantinoupoleos Str. Zakaki,

Limassol, 3011, Cyprus

Marketing Authorization Holder

[To be completed nationally]

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:

Sweden	Vapress
Bulgaria	Vapress
Cyprus	Vapress
Czech Republic	Vapress
Estonia	Valsartan Medochemie
Greece	ValperOL
Latvia	Vapress
Lithuania	Vapress
Romania	Vapress
Slovak Republic	Vapress

This leaflet was revised in 2015-01-16