1. What Tabuvan is and what it is used for 
The active ingredient of Tabuvan is valsartan.
Tabuvan belong 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 that causes vessels to tighten, thus causing your blood pressure to increase. Tabuvan works by blocking the effect of angiotensin II. As a result  blood vessels relax and blood pressure is lowered.
Tabuvan 40 mg, 80 mg, 160 mg & 320 mg tablets can be used to treat:
- High blood pressure in children and adolescents aged 6 to 18 years.
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.
Tabuvan 40 mg, 80 mg & 160 mg tablets can be used to treat:
- Adults after a recent heart attack (myocardial infarction). “Recent” here means between 12 hours and 10 days.
- Symptomatic heart failure in adults
Heart failure occurs when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure symptoms include shortness of breath and swelling of the feet and legs owing to fluid build-up. Tabuvan is used for heart failure 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.
Tabuvan 80 mg, 160 mg & 320 mg tablets can be used to treat:
- High blood pressure in adults.
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.

2. Before you take Tabuvan
Do not take Tabuvan if you
- Are allergic (hypersensitive) to valsartan or any of the other ingredients of Tabuvan tablets.
- Have severe liver disease.
- Are more than 3 months pregnant (it is also better to avoid Tabuvan in early pregnancy).
- If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
If any of the above apply to you, tell your doctor and do not take Tabuvan.
Talk to your doctor if you
- Have liver disease.
- Have severe kidney disease or if you are undergoing dialysis.
- Are known to have narrowing of the kidney arteries.
- Have recently had a kidney transplant (received a new kidney).
- Are receiving treatment after a heart attack or for heart failure then your doctor may check how your kidneys are working.
- Have severe heart disease other than heart failure or heart attack.
- Have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking another drug (including ACE inhibitors), tell your doctor. If these symptoms occur when you are taking Tabuvan, stop taking Tabuvan immediately and never take it again. 
- 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.
- Are known to have “primary aldosteronism”. This is a disease in which your adrenal glands make too much of the hormone aldosterone. If this applies to you then the use of Tabuvan tablets is not recommended.
- Have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water pills (diuretics).
- 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 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 (MRA) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol).
In addition:
- If you are below the age of 18 years and you take Tabuvan with other medicines then your doctor may request tests to check your salt balance and how your kidneys are working.
- You must tell your doctor if you think you are (or might become) pregnant. Tabuvan 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.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
If any of the above apply to you, tell your doctor before you take Tabuvan.
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 influenced if Tabuvan 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:
- Medicines that lower blood pressure, especially “water tablets” (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.,) or aliskiren.
- 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 drug used to protect against transplant rejection (ciclosporin) or antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Tabuvan.
- 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 (medicines used to treat heart attack) is not recommended.
- If you are being treated for heart failure, a triple combination with ACE inhibitors and other medicines to treat your heart failure which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, epleronone) or beta blockers (for example metoprolol) is not recommended.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Tabuvan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Tabuvan.
Tabuvan 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 if it is used after the third month of pregnancy.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Tabuvan 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.
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 Tabuvan affects you.
Like many other medicines used to treat high blood pressure, Tabuvan may in rare cases cause dizziness and affect the ability to concentrate.

3. How to take Tabuvan
Always take this medicine exactly 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 Tabuvan with an additional medicine (e.g. a diuretic).
Children and adolescents 6 to less than 18 years of age with high blood pressure: In patients who weigh less than 35 kg the recommended starting dose for Tabuvan tablet is 40 mg once daily.
In patients who weigh 35 kg or more the recommended starting dose for Tabuvan tablet is 80 mg 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).
Adults
- 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.
Tabuvan can be given together with other treatment for heart attack: your doctor will decide which treatment is suitable for you.
- 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. Tabuvan can be given together with other treatment for heart failure: your doctor will decide which treatment is suitable for you.
Taking Tabuvan with food and drink 
You can take Tabuvan with or without food. Swallow Tabuvan tablets with a glass of water.
Take Tabuvan at about the same time each day.
If you take more Tabuvan than you should
If you experience severe dizziness and/or fainting then lie down and contact your doctor immediately.
If you have accidentally taken too many tablets then contact your doctor, pharmacist or hospital.
If you forget to take Tabuvan
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose then take it as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed.
If you stop taking Tabuvan
Stopping your treatment with Tabuvan 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 product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Tabuvan can cause side effects, although not everybody gets them. The frequency of some side effects may vary depending on your condition.
The following side effects are important and will require immediate action if you experience them.
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 Tabuvan and contact your doctor straight away.
The following side effects have also been reported:
Common (affecting up to 1 in 10 people):
- Dizziness.
- low blood pressure with or without symptoms such as dizziness and - fainting when standing up.
decreased kidney function (signs of renal impairment).
Uncommon (affecting fewer than 1 in 100 people):
- 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 (frequency cannot bs estimated from 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Tabuvan
Keep out of reach of children.
Store below 30°C.
Do not use beyond the expiry date or if the product shows any sign of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help to protect the environment.