VALSAR-DENK 80 Tablet

Used

- to treat high blood pressure in adults and in children and adolescents 6-18 years of age.

- to treat adult patients after a recent heart attack (myocardial infarction).

- to treat symptomatic heart failure in adult patients.

See the package insert about the details.

Dosage

Adult patients with high blood pressure

80mg once daily. In some cases, your doctor may prescribe higher doses (e.g. 160mg or 320mg). He may also combine with an additional medicine (e.g. diuretic).

Children and adolescents (6-18 years of age) with high blood pressure

In patients who weigh less than 35kg the usual dose is 40mg once daily.

In patients who weigh 35kg or more the usual staring dose is 80mg once daily.

In some cases your doctor may prescribe higher doses (the dose can be increased to 160mg and to a maximum of 320mg).

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 20mg twice daily.

Your doctor will increase this dose gradually over several weeks to a maximum of 160mg twice daily.

The final dose depends on what you as an individual patient can tolerate.

Valsar-Denk 80 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: See the package inserts.

General dosage recommendations

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

Valsar-Denk tablets of all strengths can be divided into two equal doses.

- if you are allergic to valsartan, soya, peanuts, or any of the other ingredients of this medicine.

- if you have severe liver disease.

- during the last 6 months of pregnancy. It is also better to avoid this medicine in early pregnancy.

- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

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.

Other side effects include:

Common

- dizziness

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

- decreased kidney function (signs of renal impairment)

Uncommon

- angioedema

- 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

- 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 levels of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function

- low sodium levels in the blood (which, in severe cases, may cause tiredness, confusion, muscle twitches and/or seizures)

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 about patients treated with high blood pressure than in adult patient treated for heart failure or after a recent heart attack.

Very rarely, lecithin from soya beans may cause allergic reactions.

Side effects in children and adolescents are similar to those seen in adults.

See the package insert about the details below.

- other medications 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 types of pain killers called NSAIDs.

- some antibiotics (rifamycin group), a medicine used to prevent transplant rejection (ciclosporin), or an antiretroviral agent used to treat HIV/AIDS (ritonavir). These medicines can enhance the effect of Valsar-Denk 80.

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

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

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

- if you are taking an ACE-inhibitor or aliskiren.

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

See the package insert about the details below.

Pregnancy

Valsar-Denk 80 is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby it is used after the third month of pregnancy.

Lactation

Valsar-Denk 80 is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Talk to your doctor or pharmacist before taking this medicine,

- if you have liver disease.

- if you have a 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, while taking other medicines (including an ACE inhibitor), you have ever had swelling of the tongue and face, caused by an allergic reaction known as angioedema. If these symptoms occur while taking this medicine, stop taking it immediately and do not take it ever again.

- 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 this medicine 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 Valsar-Denk 80 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 that you are (or might become) pregnant, Valsar-Denk 80 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.

- 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.

- 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 (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol).

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

Valsar-Denk 80 belongs to a class of medicines known as angiotensinⅡreceptor antagonists, which help to control high blood pressure. AngiotensinⅡis a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase. Valsar-Denk 80 works by blocking the effect of angiotensinⅡ. As a result, blood vessels relax and blood pressure is lowered.