Document: Valsartan Sandoz film-coated tablet ENG PL change

• Valsartan Sandoz film-coated tablet PL
• Valsartan Sandoz film-coated tablet ENG PL

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Package leaflet: Information for the user

Valsartan Sandoz 40 mg film-coated tablets

Valsartan Sandoz 80 mg film-coated tablets

Valsartan Sandoz 160 mg film-coated tablets

Valsartan Sandoz 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 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 Valsartan Sandoz is and what it is used for

2. What you need to know before you take Valsartan Sandoz

3. How to take Valsartan Sandoz

4. Possible side effects

5. How to store Valsartan Sandoz

6. Contents of the pack and other information

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

Valsartan Sandoz 40 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure 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.

• 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. Valsartan Sandoz 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 medications 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.

Valsartan Sandoz 80 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in adult 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.

• 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. Valsartan Sandoz 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 medications 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.

Valsartan Sandoz 160 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in adult 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.

• 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. Valsartan Sandoz 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 medications 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.

Valsartan Sandoz 320 mg film-coated tablets can be used

2. What you need to know before you take Valsartan Sandoz

Do not take Valsartan Sandoz

• 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 Sandozin 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 Sandoz

Warnings and precautions

Talk to your doctor before taking Valsartan Sandoz

• 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). If these symptoms occur when you are taking Valsartan Sandoz, stop taking Valsartan Sandoz 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 are below 18 years of age and you take Valsartan Sandoz 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 Valsartan Sandoz 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 Sandoz 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

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

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 Sandoz”

Other medicines and Valsartan Sandoz

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 Sandoz 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-inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also information under the headings “Do not take Valsartan Sandoz” 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 medicine used to protect against transplant rejection (ciclosporin) or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan Sandoz.

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

In addition:

• if you are being treated after a heart attack, a combination with ACE-inhibitors (a medication to treat heart attack) is not recommended.

• if you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptor antagonist (MRA) (for example spironolactone, eplerenone) or beta blockers (for example metoprolol).

Valsartan Sandoz with food and drink

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

3. How to take Valsartan Sandoz

Always take this medicineexactly as your doctor has told you in order to get the best results and reduce the risk of side effects. 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 Sandoz 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 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. 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 Sandoz 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 Sandoz 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 Sandoz with or without food. Swallow Valsartan Sandoz with a glass of water.

Take Valsartan Sandoz at about the same time each day.

If you take more Valsartan Sandoz 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 or hospital.

If you forget to take Valsartan Sandoz

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 Sandoz

Stopping your treatment with Valsartan Sandoz 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicinecan 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 Sandoz and contact your doctor straight away (see also section 2 “Warnings and precautions”).

Side effects include:

Common, affects 1 to 10 per 100 users

• dizziness

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

• decreased kidney function (signs of renal impairment)

Uncommon, affects 1 to 10 per 1,000 users

• 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

Frequency not known, according to 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 possible side effects not listed in this leaflet. You can also report side effects directly via [the national reporting system; to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Valsartan Sandoz

• Do not store above 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. The expiry date refers to the last day of that month.

• Do not use Valsartan Sandoz 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 Sandoz contains

Valsartan Sandoz40 mg film-coated tablets

One film-coated tablets contains 40 mg of valsartan.

Valsartan Sandoz80 mg film-coated tablets

One film-coated tablet contains 80 mg of valsartan.

Valsartan Sandoz] 160 mg film-coated tablets

One film-coated tablet contains 160 mg of valsartan.

Valsartan Sandoz320 mg film-coated tablets

One film-coated tablet contains 320 mg of valsartan.

Core:

Microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate

Film-coat:

hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), yellow iron oxide (E172); additionally for Valsartan Sandoz 40 mg/ -160 mg/ -320 mg film-coated tablets: Black iron oxide (E172)

What Valsartan Sandoz looks like and contents of the pack

Valsartan Sandoz40mg film-coated tablets:

Yellow, ovaloid film-coated tablet, with bevelled edges, slightly convex, scored on one side with debossing “D” on one side of the score and “O” on the other side of the score and “NVR” on the reverse side of the tablet.

The tablet can be divided into equal halves.

Valsartan Sandoz80mg film-coated tablets:

Pale-red, round film-coated tablet with bevelled edges, scored on one side with debossing “D” on one side of the score and “V” on the other side of the score and “NVR” on the reverse side of the tablet.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Valsartan Sandoz160mg film-coated tablets:

Grey-orange, ovaloid film-coated tablet, slightly convex, scored on one side with debossing “DX” on one side of the score and “DX” on the other side of the score and “NVR” on the reverse side of the tablet.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Valsartan Sandoz320mg film-coated tablets:

Dark grey violet, ovaloid with bevelled edges, slightly convex, scored on one side with debossing “DC” on one side of the score and “DC” on the other side of the score and “NVR” on the reverse side of the tablet.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Pack sizes: one pack containing 7, 10, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100 or 280 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 2014-11-07