SARTOVAL 160 mg. 28 capsules

WHAT SARTOVAL AND WHAT IT IS USED
SARTOVAL belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body, which causes constriction of blood vessels and thereby increases the blood pressure. SARTOVAL works by blocking the effect of angiotensin II. As a result, blood vessels dilate and blood pressure is lowered.

SARTOVAL 40 mg hard gelatine capsules can be used for three different conditions:
To treat high blood pressure in children and adolescents aged 6 to 18 years: High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart and kidneys and lead to 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 these disorders;
For the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means before 12 hours to 10 days;
To treat the symptoms of heart failure in elderly patients. SARTOVAL be used in cases where the drugs in the group called angiotensin converting enzyme (ACE) inhibitors (drugs for heart failure) can not be used or may be used in addition to ACE inhibitors when beta blockers (other drugs for heart failure) can not be used. The manifestations of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. This is due to the inability of heart muscle to pump blood sufficiently vigorous and it delivers the whole organism.
SARTOVAL 160 mg hard gelatine capsules can be used for three different conditions:
To treat high blood pressure in adults and children and adolescents aged 6 to 18 years. High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart and kidneys, causing stroke, heart or kidney failure. High blood pressure increases the risk of heart attacks. Lowering of blood pressure to normal values ​​reduces the risk of these diseases;
For the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means before 12 hours to 10 days;
To treat the symptoms of heart failure in elderly patients. SARTOVAL be used in cases where the drugs in the group called angiotensin converting enzyme (ACE) inhibitors (drugs for heart failure) can not be used or may be used in addition to ACE inhibitors when beta blockers (other drugs for heart failure) can not be used. The manifestations of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. This is due to the inability of heart muscle to pump blood sufficiently vigorous and it delivers the whole organism.

2. BEFORE YOU TAKE SARTOVAL
DO NOT take SARTOVAL
if you are allergic (hypersensitive) to valsartan or any of the other ingredients of SARTOVAL described at the end of this leaflet;
if you have severe liver disease;
if you are pregnant after the third month (it is better not to use SARTOVAL during and in early pregnancy - see pregnancy section).
If any of the above applies to you, do not take SARTOVAL.

Take special care with SARTOVAL:
If you have liver disease;
If you have severe kidney disease or are on dialysis;
If you have renal artery stenosis;
If you have recently undergone kidney transplantation (received a new kidney)
If you are treated after a heart attack or heart failure, your doctor may monitor your kidney function;
If you have severe heart disease other than heart failure or heart attack;
If you are taking medications that increase the amount of potassium in your blood. These are potassium supplements or salt substitutes containing potassium, potassium-sparing diuretics and heparin. You may need regular monitoring of the amount of potassium in your blood;
If you are aged under 18 and taking SARTOVAL in combination with other drugs that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may monitor your kidney function and the level of potassium in your blood at regular intervals ;
If you suffer from aldosteronism. This is a disease in which your adrenal glands produce a greater amount of the hormone aldosterone. If this applies to you, use SARTOVAL not recommended;
If any of these statements applies to you, talk to your doctor if you are taking SARTOVAL.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The effect of treatment can be influenced if SARTOVAL be taken with certain other medicines. You may need a dose adjustment, to take other precautions, or in some cases to stop taking one of the medicines. This applies to all types of medicines, especially:
other medicines that lower blood pressure, especially water pills (diuretics);
medicines that increase the amount of potassium in your body. These are potassium supplements and potassium containing salt substitutes, potassium-sparing medicines and heparin;
certain types of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs);
Lithium, a medicine used for the treatment of certain types of psychiatric disorders.
Furthermore:
if you are being treated for a heart attack, combination with ACE inhibitors (drugs used to treat heart attack) is not recommended;
if you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended.
Taking SARTOVAL with food and drink
You can take SARTOVAL with or without food.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
You should check with your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking SARTOVAL before you become pregnant or as soon as possible after they become pregnant and will advise you to start taking another medicine instead SARTOVAL. SARTOVAL not recommended in early pregnancy and must not be taken if you are pregnant after the third month, as it may cause serious harm to your baby if used after the third month of pregnancy;
Tell your doctor if you are breastfeeding or planning to start breast-feeding. SARTOVAL not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Before driving or operating machinery, or performing other activities that require concentration, make sure you know how you affect SARTOVAL. Like many other medicines for high blood pressure, SARTOVAL in rare cases cause dizziness and affect your ability to concentrate.

HOW TO TAKE SARTOVAL
Always take SARTOVAL exactly as your doctor has told you to get the best results and reduce the risk of side effects. If you're not sure, ask your doctor or pharmacist. People with high blood pressure often do not notice any symptoms or problems. Many of them may feel normal. It is therefore essential for you to follow hours of examination by your doctor, even if you feel better.
For doses that are not comfortable / practical with this concentration of the active substance is proposed another concentration of the active substance and other dosage forms of the medicinal product.

160 mg:
Adults with high blood pressure: The usual dose is 80 mg daily. In some cases, your doctor may prescribe higher doses (eg. 160 mg or 320 mg). He / she may combine SARTOVAL with another drug (eg. A diuretic);
Children and adolescents (6-18 years) with high blood pressure: In patients weighing less than 35 kg the usual dose is 40 mg of valsartan once daily. In patients who weigh 35 kg or more, the usual initial dose is 80 mg of valsartan once daily. In certain 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: In general, treatment after heart attack begins as possible sooner after the 12th hour, usually at a low dose of 20 mg twice daily. You will receive a 20-mg dose by dividing the tablet of 40 mg. Your doctor will increase this dose gradually over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on individual tolerance of each patient;
SARTOVAL can be given together with other treatment for heart attacks and your doctor will decide which is the best treatment for you.
Adult patients with heart failure: Treatment usually starts with a dose of 40 mg twice daily. Your doctor will increase the dose gradually over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on your individual tolerance as a patient.
SARTOVAL can be administered concurrently with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.
You can take SARTOVAL with or without food. SARTOVAL swallow with a glass of water. Take SARTOVAL at the same time of day.

If you take a larger dose than necessary SARTOVAL
If you experience dizziness and / or fainting, immediately call your doctor and go to bed. If you accidentally take too many capsules, contact your doctor, pharmacist or hospital.

If you forget to take SARTOVAL
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up the missed dose.

If you stop taking SARTOVAL
Discontinuation of SARTOVAL can lead to worsening of your condition. Do not stop taking your medicine unless your doctor has advised you to do so.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, SARTOVAL can cause side effects, although not everybody gets them.
Side effects may occur with certain frequencies, which are defined as follows:
Very common: affects more than 1 user in 10;
Common: affects 1 to 10 users in 100;
Uncommon: affects 1 to 10 users in 1000;
Rare: affects 1 to 10 users in 10,000;
Very rare: affects less than 1 user in 10 000;
Not known: estimates of frequency can not be made from the available data.

Some symptoms need immediate medical attention:
You may have symptoms of angioedema (a specific allergic reaction) such as:
swelling of the face, lips, tongue or throat;
difficulty breathing or swallowing;
hives.
If you get any of these, immediately call your doctor.

Side effects include:
common:
dizziness;
hypotension with or without symptoms such as dizziness and fainting when you stand;
reduced kidney function (signs of renal impairment).
Uncommon:
angioedema (see section "Some symptoms need immediate medical attention");
sudden loss of consciousness (syncope);
feeling dizzy (vertigo);
strong decrease in kidney function (signs of acute renal failure);
muscle spasms, abnormal heart rhythm (signs of hyperkalemia);
shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure);
headache;
cough;
stomach ache;
nausea;
diarrhea;
tiredness;
weakness.
Not known:
allergic reactions with rash, itching and hives, can be symptoms of fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and / or flu-like symptoms (signs of serum sickness);
rozovocherveni 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);
reduced hemoglobin, and reduced the percentage of red blood cells in the blood (which in severe cases can lead to anemia);
increased level of potassium in the blood (which in severe cases leads to muscle spasms and abnormal heart rhythm);
Increases in liver enzymes (which can indicate liver damage) including an increase of bilirubin in the blood (which in severe cases leads to yellowing of the skin and eyes);
raising the level of nitrogen in blood urea nitrogen and serum creatinine increase (which indicates impaired renal function);
low sodium in the blood (which can trigger tiredness, confusion, muscle twitching and / or convulsions in severe cases).
The frequency of some side effects may depend on your condition. For example, side effects such as dizziness and decreased renal function were observed less frequently in adult patients treated for 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 observed in adults.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SARTOVAL
Keep out of reach of children.
Do not use SARTOVAL after the expiry date stated on the carton and blister after "EXP" The expiry date refers to the last day of that month.
Do not store above 25 ° C. Store in the original container to protect from moisture.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What SARTOVAL
The active substance is valsartan. Each hard capsule contains 40 mg valsartan. Each hard capsule contains 160 mg of valsartan.
The other ingredients are silica colloidal anhydrous, sodium starch glycolate (type A), crospovidone, microcrystalline cellulose, corn starch and magnesium stearate in the capsule. The capsule shell is made of titanium dioxide, gelatin, black iron oxide, capsules of 160 mg also contain red iron oxide and iron oxide yellow. The ink contains shellac, propylene glycol and iron oxide black.

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