WHAT VALSARTAN IS AND WHAT IT IS USED FOR
The active ingredient of Valsartan 80 mg film-coated tablets and Valsartan 160 mg film-coated tablets is valsartan.
Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists”. Valsartan helps blood vessels relax and so reduces strain on the heart.
Valsartan 80 mg film-coated tablets and Valsartan 160 mg film-coated tablets can be used for three different conditions:
to treat high blood pressure in adults and in children and adolescents 6 to 18 years of age.
High blood pressure may damage the body’s blood vessels and may result in a stroke, heart failure or kidney failure. Lowering your blood pressure reduces the risk of developing these disorders.
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.
• to treat adult patients after a recent heart attack. “Recent” here means between 12 hours and 10 days.
•to treat symptomatic heart failure in adult patients.
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.
Valsartan 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 valsartan may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure) cannot be used.
BEFORE YOU TAKE VALSARTAN
Do not take valsartan if you:
• are allergic (hypersensitive) to valsartan or any of the other ingredients of valsartan listed at the end of this leaflet.
• have severe liver disease.
• are more than 3 months pregnant (it is also better to avoid valsartan in early pregnancy – see pregnancy section).
If any of the above apply to you, do not take valsartan
Take special care with valsartan 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.
• 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.
• 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 valsartan in combination with other medicines that inhibit the rennin 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.
• are known to have “primary aldosteronism”, a hormone imbalance If this applies to you then the use of valsartan is not recommended.
• have lost a lot of fluid by diarrhoea, vomiting, or high doses of water pills (diuretics).
• you must tell your doctor if you think you are (or might become) pregnant. Valsartan 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 (see pregnancy section).
If any of the above apply to you, tell your doctor before you take valsartan.
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 valsartan 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:
• other medicines 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 type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
• lithium, a medicine used to treat some types of mental illness.
• 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 beta blockers (medicines also used to treat heart failure) is not recommended.
Taking valsartan with food and drink
You can take valsartan with or without food.
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 valsartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of valsartan. Valsartan 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. Valsartan 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 valsartan affects you. Like many other medicines used to treat high blood pressure, valsartan may cause dizziness and affect the ability to concentrate.
Important information about some of the ingredients of valsartan
This medicine contains lactose and sorbitol. If you have been told by your doctors that you have some intolerance to some sugars, contact your doctor before taking this medicinal product.
HOW TO TAKE VALSARTAN
Always take valsartan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adult patients with high blood pressure: The usual dose is 80 mg daily. In some cases your doctor may prescribe higher doses (e.g. 160mg or 320mg). He may also combine valsartan with an additional medicine e.g. a diuretic (“water tablet”).
Children and adolescents (6 to 18 years of age) with high blood pressure: For patients who weigh less than 35 kg the usual dose is 40 mg valsartan once daily. For patients who weigh 35 kg or more the usual starting dose is 80 mg valsartan 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).
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 20 mg twice daily. 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.
Valsartan 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 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.
Valsartan can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.
You can take valsartan with or without food. Swallow with a glass of water.
Take valsartan at about the same time each day.
If you take more valsartan than you should
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets then contact your doctor, pharmacist or hospital.
If you forget to take valsartan
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. Do not take a double dose to make up for a forgotten dose.
If you stop taking valsartan
Stopping your treatment with valsartan 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.
POSSIBLE SIDE EFFECTS
Like all medicines, valsartan can cause side effects, although not everybody gets them
Some symptoms need immediate medical attention:
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, see a doctor immediately.
Side effects include:
Common, affecting up to 1 in 10 people:
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• kidney problems, as shown by changes in certain blood test results.
Uncommon, affecting fewer than 1 in 100 people:
• angioedema (see section ‘Some symptoms need immediate medical attention’)
• 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 heart failure)
Frequency not known from the available data:
• 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)
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.
HOW TO STORE VALSARTAN
Do not store above 30°C.
Keep out of the reach and sight of children.
Do not use valsartan after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.
Do not use valsartan if you notice that the pack is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.