Valsartan 80 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Valsartan 80 mg Film-coated Tablets Valsartan 160 mg Film-coated Tablets
Valsartan
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- 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.
In this leaflet:
1. What Valsartan Film-coated Tablets are and what they are used for
2. Before you take Valsartan Film-coated Tablets
3. How to take Valsartan Film-coated Tablets
4. Possible side effects
5. How to store Valsartan Film-coated Tablets
6. Further information
1. WHAT VALSARTAN FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Valsartan belongs to a class of medicines known as angiotensin II receptor antagonist, 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. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.
Valsartan 80 mg and 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 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.
• to treat 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. Valsartan is used 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 beta blockers (another medication to treat heart failure) cannot be used.
Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid build-up. It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body.
2. BEFORE YOU TAKE VALSARTAN FILM-COATED TABLETS Do not take Valsartan Film-coated Tablets:
• if you are allergic (hypersensitive) to valsartan, soya oil, peanut oil or any of the other ingredients of Valsartan Film-coated Tablets.
• if you have a severe liver disease.
• if you are more than 3 months pregnant (it is better to avoid Valsartan Film-coated Tablets in early pregnancy - see pregnancy section).
If any of these apply to you, do not take Valsartan Film-coated tablets.
Take special care with Valsartan Film-coated Tablets
• if you have liver disease.
• if you have severe 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 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 Valsartan 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 Valsartan is not recommended.
• if you have lost a lot of fluid (dehydration) caused 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 these apply to you, tell your doctor before you take Valsartan Film-coated tablets.
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 pills (diuretics).
• medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium sparing diuretics and heparin.
• certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
• 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 (a medication to treat heart attack) is not recommended.
• if you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended.
Taking Valsartan Film-coated Tablets with food and drink
You can take Valsartan Film-coated Tablets 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 in rare cases cause dizziness and affect the ability to concentrate.
Important information about some of the ingredients of Valsartan Film-coated Tablets
This medicine contains lactose, if you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Valsartan Film-coated tablets contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.
3. HOW TO TAKE VALSARTAN FILM-COATED TABLETS
Always take Valsartan Film-coated Tablets exactly as your doctor has told you in order to get the best results and reduce the risk of side effects. You should 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 usual 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 Valsartan with an additional medicine (e.g. a diuretic).
Children and adolescents (6 to 18 years of age) with high blood pressure:
In patients who weigh less than 35 kg the usual dose is 40 mg of valsartan once daily.
In patients who weigh 35 kg or more the usual starting dose is 80 mg of valsartan once daily.
In some cases you doctor may prescribe higher doses (the dose can be increase 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 a day. 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.
Valsartan can be given 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 Film-coated tablets with or without food. Swallow Valsartan Film-coated Tablets with a glass of water.
Take Valsartan Film-coated Tablets at about the same time each day.
If you take more Valsartan Film-coated Tablets than you should
If you experience severe dizziness and/or fainting, lay down and contact your doctor immediately. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
If you forget to take Valsartan Film-coated Tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, 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 Film-coated Tablets
Stopping your treatment with Valsatan Film-coated tablets 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, Valsartan Film-coated Tablets can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:
• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency cannot be estimated from the available data.
Some symptoms need immediate medical attention:
You may experience symptoms of angioedema, such as
• swollen face, tongue or throat
• difficulty in breathing or swallowing
• hives, itching
If you get any of these, see a doctor immediately.
Other side effects include:
Common:
• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting when standing
• decreased kidney function (signs of renal impairment)
Uncommon:
• 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 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, in severe cases, lead to anaemia)
• increase of level of potassium in the blood (which can, in severe cases, trigger muscle spasms, abnormal heart rhythm)
• elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can, in severe cases, trigger yellow skin and eyes)
• 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 patients treated with high blood pressure than in 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 VALSARTAN FILM-COATED TABLETS
Keep out of the reach and sight of children.
PVC/PE/PVDC-Al blisters: Do not store above 30°C. Store in original carton in order to protect from moisture.
Polyethylene tablet containers: No special temperature storage conditions. Store in original container in order to protect from moisture.
Do not use Valsartan Film-coated Tablets after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of the month.
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.
6. FURTHER INFORMATION What Valsartan Film-coated Tablets contain
- The active substance is valsartan.
Each Valsartan 80 mg Film-coated tablet contains 80 mg of valsartan.
Each Valsartan 160 mg Film-coated tablet contains 160 mg of valsartan.
- The other ingredients are:
tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, colloidal anhydrous silica;
tablet coat: polyvinyl alcohol, macrogol 3350, talc, lecithin (contains soya oil) (E322), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
What Valsartan Film-coated Tablets look like and contents of the pack
Valsartan 80 mg Film-coated Tablets: Pink, round, biconvex, film-coated tablets, 8 mm in diameter, with a scoreline on both sides and marked with a "V" on one side.
Valsartan 160 mg Film-coated Tablets: Yellow, oval, biconvex, film-coated tablets, 15 x 6.5 mm, with a scoreline on one side and marked with a "V" on the other.
The tablets can be divided into equal halves.
7, 14, 28, 56, 98 and 280 tablets, PVC/PE/PVDC/aluminium foils and plastic bottles (securitainer, PE).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing
London
W5 5TL
Manufacturer:
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Iceland
This leaflet was last revised in August 2012.
6