VANATEX 80 mg. 28 tablets

WHAT VANATEX AND WHAT IT IS USED
Vanatex belongs to a group of medicines called angiotensin II receptor blockers and is used to control high blood pressure. Angiotensin II is a substance that causes constriction of blood vessels in the body and can cause high blood pressure. Vanateks works by blocking the angiotensin II. This leads to dilation of blood vessels and lower blood pressure.

Vanatex 80 mg and 160 mg film-coated tablets can be used in three different conditions:
to treat high blood pressure - 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 cause 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 people after a recent heart attack (myocardial infarction). "Recent" here means between 12 hours and 10 days;
for the treatment of symptomatic heart failure - Vanateks be used when a group of drugs called angiotensin converting enzyme (ACE) inhibitors (a drug for the treatment of heart failure) can be used either in addition to ACE inhibitors when beta-blockers ( other medicines used to treat heart failure) can not be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. This occurs when the heart muscle can not pump blood strongly enough to supply the body with blood needed.
2. BEFORE YOU TAKE VANATEX
Do not take Vanateks:
if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Vanatex;
if you have severe liver disease;
if you are pregnant after the third month (it is also better to avoid Vanateks in early pregnancy - see "Pregnancy").
Do not take Vanateks if any of these apply to you.

Take special care with Vanatex:
if you have liver disease;
if you have severe kidney disease or are on dialysis;
if you suffer from a narrowing of the renal artery;
if you have recently undergone kidney transplantation (received a new kidney);
if you are being treated after a heart attack or heart failure, your doctor may check your kidney function;
if you are taking medicines that increase the level of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. You may need to check the amount of potassium in your blood at regular intervals;
if you suffer from aldosteronism - a disease in which your adrenal glands make too much of the hormone aldosterone. In this case the use of Vanateks not recommended;
if you lost a lot of fluid (dehydration) caused by diarrhea, vomiting, or high doses of water pills (diuretics).
Not recommended for use Vanateks in children and adolescents (under 18 years).
You should tell your doctor if you think you are pregnant or may become pregnant. Vanateks not recommended in early pregnancy, and must not be taken if you are pregnant more than three months, as it may cause serious harm to your baby if used at that stage (see "Pregnancy").
If any of these apply to you, tell your doctor before taking Vanateks.

Taking other medicines
Please 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 the treatment can be affected by taking medications simultaneously Vanateks. 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 prescription drugs, and the non- prescription, especially:
other medicines that lower blood pressure, especially water pills (diuretics);
medications that increase potassium levels in your blood. These include potassium supplements or salt substitutes, potassium-sparing diuretics and heparin;
type of pain killers called non-steroidal anti-inflammatory drugs (NSAIDs);
Lithium - a medicine which is used in some mental disorders.
Additional:
if you are treated after a heart attack is not recommended combination with ACE inhibitors (a medication to treat heart attack);
if you are being treated for heart failure is not recommended triple combination with ACE inhibitors and beta blockers (medications to treat heart failure).
Taking Vanateks with food and drink
You may take Vanateks with or without food.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
You should tell your doctor if you think you are pregnant or may become pregnant. Your doctor will normally advise you to stop taking Vanateks before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead Vanateks. Vanateks not recommended in early pregnancy, and must not be taken 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 plan to breastfeed. Vanateks not recommended for nursing mothers, and your doctor may prescribe other treatments, if you want to breastfeed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Before driving, operating machinery, or other activities that require concentration, make sure you know how you react to the effects of Vanateks. Like many other medicines for high blood pressure Vanateks may cause dizziness or affect the focus in some cases. Therefore before driving, operating machinery, or other activities that require concentration, make sure how you react to the effects of Vanateks.

Important information about some of the ingredients of Vanateks
Vanateks contain the milk sugar lactose. If your doctor told you that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

3. HOW TO TAKE VANATEX
Always take Vanateks exactly as your doctor tells you to achieve the best results and avoid side effects. Take this medicine only on prescription. If you are not sure, ask your doctor or pharmacist. Patients with high blood pressure do not always recognize the symptoms of this disease. Many of them feel normal. It is important to carry with you your medicine as prescribed by your doctor when you go to visit him, even if you feel well.

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). It may also combine Vanateks with additional drug (eg. A diuretic).

After a recent heart attack: After a heart attack, treatment can begin after 12 hours, usually at a low dose of 20 mg twice daily. You get a dose of 20 mg, dividing the tablet of 40 mg. Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on how each patient can tolerate.
Vanateks can be given together with other treatment for heart attack, and your doctor will decide which treatment is suitable for you.

Heart failure: Treatment usually starts with 40 mg twice daily. You get a dose of 40 mg, dividing the tablet 80 mg. Your doctor may prescribe a higher dose through gradual increase to a maximum of 160 mg twice daily. The final dose depends on how each patient can tolerate. Vanateks can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.

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

If you take more dose Vanatex
Severe dizziness and / or fainting, lay down and immediately contact your doctor. If you take a large amount of the drug, contact your doctor, pharmacist or hospital.

If you forget to take Vanatex
Do not take a double dose to make up.
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the dose not taken.

If you stop taking Vanatex
Discontinuation of Vanatex may worsen your condition. Do not stop taking your medicine unless your doctor tells you to do.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Vanatex can cause side effects, although not everybody gets them.
These side effects may occur with a frequency defined as follows:
very common: affects more than 1 in 10 patients;
common: affects 1 to 10 of 100 patients;
uncommon: affects 1 to 10 of 1000 patients;
rare: affects 1 to 10 of 10,000 patients;
very rare: affects less than 1 in 10,000 patients;
Not known: from the available data can not be estimated.
Some symptoms need immediate medical attention:
You may have symptoms of angioedema, such as:
swelling of the face, tongue or throat;
difficulty swallowing;
hives and difficulty breathing.
You should immediately contact your doctor if you experience any of them.

Other side effects include:
Common:
dizziness, feeling dizzy when getting up from a lying or sitting position;
low blood pressure with symptoms such as dizziness;
decreased kidney function (signs of renal impairment).
Uncommon:
allergic reaction with symptoms such as rash, itching, dizziness, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, dizziness (signs of angioedema);
sudden loss of consciousness;
dizziness;
severely decreased kidney function (signs of acute renal failure);
muscle spasms, abnormal heart rhythm (signs of hyperkalaemia);
shortness of breath, difficulty breathing when lying down, swelling of the feet and legs (signs of cardiac failure);
headache;
cough;
abdominal pain;
nausea;
diarrhea;
fatigue;
weakness.
Not known
rash, itching, accompanied by some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and / or flu-like symptoms (signs of serum sickness);
purplish 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 called neutropenia);
reduced level of hemoglobin and decrease of the percentage of red blood cells in the blood (which can, in severe cases, lead to anemia);
increased levels of potassium in the blood (which can, in severe cases can cause muscle spasms and abnormal heart rhythm);
elevated liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can, in severe cases can cause yellowing of the skin or eyes);
increasing the level of blood urea nitrogen and increase of serum creatinine level (which may be indicative of renal dysfunction).
The frequency of certain adverse events may vary depending on your illness. For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in patients treated with high blood pressure than in patients treated for heart failure or after a recent heart attack.

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 VANATEX
Keep out of the reach and sight of children.
Do not store above 30 ° C. Tablets of 80 mg should also be stored in the original container to protect from light.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of that month.