VALSTRAN 160 mg. 28 tablets

What is Valstran and what it is used
Valstran 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. Valstran works by blocking the angiotensin II. This leads to dilation of blood vessels and lower blood pressure.

Valstran 160 mg film-coated tablets can be used in three different conditions:
for the treatment of high blood pressure in children and adolescents 6-18 years of age. 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 may lead to stroke, heart failure or renal insufficiency. High blood pressure increases the risk of heart attack. Lowering your blood pressure to normal reduces the risk of developing these disorders;
for the treatment of 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. Valstran is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medication to treat heart failure) can not be used, or in addition to ACE inhibitors when beta blockers (another medication to treat heart failure) can 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.
Valstran 320 mg tablets may be used:
for the treatment of high blood pressure in adults and children and adolescents 6-18 years of age. 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.

2. What you need to know before you take Valstran
Do not take Valstran:
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 pregnant after the third month (it is also better to avoid Valstran in early pregnancy - see "Pregnancy, lactation and fertility").
Do not take Valstran if any of these apply to you.

Warnings and Precautions
Talk to your doctor before taking Valstran:
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 have severe heart disease other than heart failure or heart attack;
if you have ever had swelling of the tongue or face, called angioedema caused by an allergic reaction while taking other medications (including ACE-inhibitors). If you experience these symptoms while taking Valstran immediately stop taking Valstran and never take it. See also section 4. Adverse reactions;
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 are under 18 years of age and taking Valstran 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 potassium levels in the 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 Valstran not recommended;
if you lost a lot of fluid (dehydration) caused by diarrhea, vomiting, or high doses of water pills (diuretics);
you should tell your doctor if you think you are pregnant or may become pregnant. Valstran 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 section "Pregnancy, lactation and fertility ").
If any of these apply to you, tell your doctor before taking Valstran.

Other medicines and Valstran
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 affected by taking medications simultaneously Valstran. 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);
certain antibiotics (group of rifampicin), a medicine used to prevent transplant rejection (cyclosporine) or antiretroviral drug used for the treatment of HIV / AIDS infection (ritonavir). These drugs may enhance the effect of Valstran;
Lithium - a medicine which is used in some mental disorders.
In addition:
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).
Valstran with food and drink
You may take Valstran with or without food.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this 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 Valstran before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead Valstran. Valstran 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. Valstran 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 Valstran. Like many other medicines for high blood pressure Valstran 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 Valstran.

3. How to take Valstran
Always take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects. If you are not sure, ask your doctor or pharmacist.
People with high blood pressure often do not 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.

Adult patients with high blood pressure:
The recommended dose is 80 mg daily. In some cases your doctor may prescribe higher doses (eg. 160 mg or 320 mg). It may also combine Valstran with additional drug (eg. A diuretic).

Children and adolescents (6 to 18 years of age) with high blood pressure:
In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once daily. For patients weighing 35 kg or more, the usual starting dose is 80 mg of valsartan once daily. In some cases, your doctor may prescribe a higher dose (the dose may be increased to 160 mg and a maximum of 320 mg).

Ages of patients 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. Valstran 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 usually starts with 40 mg twice daily. 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.

Valstran can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.
You can take Valstran with or without food. Swallow the tablet with a glass of water. Take Valstran at the same time each day.

If you take more dose Valstran
Severe dizziness and / or fainting, immediately contact your doctor and go to bed. If you take a large amount of the drug, contact your doctor or hospital.

If you forget to take Valstran
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.
Do not take a double dose to make up.

If you stop taking Valstran
Discontinuation of Valstran 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 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 have symptoms of angioedema (a specific allergic reaction), for example:
swelling of face, lips, tongue, or throat;
difficulty breathing or swallowing;
hives, itching.
If you experience any of these symptoms, stop taking Valstran and contact your doctor (see also section 2 "Warnings and precautions").
You should immediately contact your doctor if you experience any of them.

Side effects include:
Common, affects 1 to 10 in 100 patients:
dizziness;
low blood pressure with or without symptoms such as dizziness and feeling dizzy when getting up from a lying or sitting position;
decreased kidney function (signs of renal impairment).
Uncommon, affects 1 to 10 of 1000 patients:
angioneurotic edema (see section "Some symptoms need immediate medical attention");
sudden loss of consciousness (syncope);
dizziness (vertigo);
severely decreased kidney function (signs of acute renal failure);
muscle cramps, abnormal heart rhythm (signs of hyperkalaemia);
shortness of breath, difficulty breathing when lying down, swelling of the legs (signs of cardiac failure);
headache;
cough;
abdominal pain;
nausea;
diarrhea;
fatigue;
weakness.
Not known to available data:
can be observed allergic reactions with rash, itching and hives, symptoms of fever, swelling and joint pain, muscle pain, swollen lymph nodes and / or flu-like symptoms (signs of serum sickness);
purplish red spot, 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 impaired renal function);
low sodium in the blood (which can, in severe cases can cause fatigue, confusion, muscle twitching and / or convulsions).
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.
Side effects in children are similar to those seen in adults.

Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse It includes all listed in this leaflet. You can also report adverse events directly through the national reporting system to the BDA. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.

5. How to store Valstran
Do not store above 30 ° C. Store in the original package in order to protect from moisture.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.