Valsartan 80 Mg Capsules
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Valsartan 40, 80 and 160 mg Capsules
Valsartan
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Valsartan capsules are and what they are used for
2. What you need to know before you take Valsartan capsules
3. How to take Valsartan capsules
4. Possible side effects
5. How to store Valsartan capsules
6. Contents of the pack and other information
1. What Valsartan capsules are and what they are used for
Valsartan capsules belong 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 capsules work by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.
Valsartan 40 capsules can be used for three different conditions:
• to treat high blood pressure 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 horns and 10 days.
• to treat symptomatic heart failure in adult patients. Valsartan capsules are 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.
Valsartan capsules 80 and 160 mg capsules 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 capsules are 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. What you need to know before you take Valsartan capsules
Do not take Valsartan capsules:
• if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Valsartan capsules (listed in Section 6).
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is also better to avoid Valsartan capsules in early pregnancy - see pregnancy section).
• if you suffer from diabetes and are taking a medicine called aliskiren, you should not take Valsartan.
• if you have severe kidney disease and are taking a medicine called aliskiren, you should not take Valsartan.
•
If any of these apply to you, speak to your doctor.
Warnings and precautions
You must be especially careful and talk to your doctor before taking Valsartan capsules if any of the
following apply to you.
• 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 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 Valsartan Parke-Davis, stop taking Valsartan immediately and never take it again. See also section 4, “Possible side effects”.
• 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 capsules 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 capsules 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 Parke-Davis.
Other medicines and Valsartan Parke-Davis
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 influenced if Valsartan capsules are 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 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 an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Valsartan Parke-Davis.
• lithium, a medicine used to treat some types of psychiatric illness.
• aliskiren, a medicine used to treat high blood pressure, in patients with diabetes and/or moderate to severe kidney disease.
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 capsules with food and drink
You can take Valsartan capsules with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 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 capsules before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan capsules. Valsartan capsules 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 capsules 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 capsules affect you. Like many other medicines used to treat high blood pressure, Valsartan capsules may in rare cases cause dizziness and affect the ability to concentrate.
3. How to take Valsartan capsules
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. 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 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. 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 capsules 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 capsules 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 capsules with or without food. Swallow Valsartan capsules with a glass of water.
Take Valsartan capsules at about the same time each day.
If you take more Valsartan capsules 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 capsules, contact your doctor, pharmacist, or hospital.
If you forget to take Valsartan capsules
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 capsules
Stopping your treatment with Valsartan capsules 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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 (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 Valsartan and contact your doctor straight away (see also section 2 “Warnings and precautions”).
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 (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 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 you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Valsartan capsules
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
• Store below 30°C.
• Store in the original package in order to protect from moisture and heat.
• Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
• If your doctor tells you to stop taking Valsartan capsules, please take any unused capsules back to your pharmacist to be destroyed.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Valsartan capsules contain
Valsartan capsules are available in three different strengths containing 40 mg, 80 mg or 160 mg of the active ingredient valsartan. The gelatine capsules also contain the following inactive ingredients: microcrystalline cellulose, colloidal anhydrous silica, crospovidone, povidone, sodium lauryl sulphate and magnesium stearate . Capsule shell: Iron oxide black (E172), titanium dioxide (E171), gelatin, sodium lauryl sulfate.
Printing ink: Shellac (E904), propylene glycol, black iron oxide, titanium dioxide (for 160 mg capsules only), potassium hydroxide.
What Valsartan capsules look like and contents of the pack
Capsules, hard
Valsartan 40 mg hard gelatine capsules of size ‘4’, imprinted ‘I’ on opaque light grey Cap and ‘70’ on Opaque light grey body in black ink.
Pack sizes of 28 capsules are registered.
Valsartan 80 mg hard gelatine capsules of size ‘3’, imprinted ‘I’ on opaque light grey Cap and ‘71’ on flesh opaque body in black ink.
Pack sizes of 14 or 28 capsules are registered.
Valsartan 160 mg hard gelatine capsules of size ‘1’, imprinted ‘I’ on opaque dark grey Cap in white ink and ‘72’ on flesh opaque body in black ink.
Pack sizes of 14 or 28 capsules are registered.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay,
Dublin 2,
Ireland.
Manufacturer
Pfizer Service Company BVBA
Hoge Wei 10 , 1930
Zaventem
Belgium
Or
Pfizer PGM
Zone Industrielle 29, route des Industries
37530 Poce -Sur-Cisse
France
Or
Pfizer Italia s.r.l.
Localita Marino Del Tronto 63100 - Ascoli Piceno (AP)_
Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Portugal |
Valsartan Parke-Davis |
|
United Kingdom |
Valsartan 40mg, 80mg or 160mg Capsules |
This leaflet was last approved in 08/2013