Valsartan 80mg Capsules
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PACKAGE LEAFLET: INFORMATION FOR THE USER
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Valsartan 40 mg Capsules Valsartan 80 mg Capsules Valsartan 160 mg Capsules
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. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Valsartan capsules are and what are they 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. Content of the pack and other information
1. What Valsartan Capsules are and what are they used for
The name of your medicine is Valsartan 40 mg or 80 mg or 160 mg Capsules (referred to as Valsartan capsules throughout this leaflet).
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 mg capsules can be used for two different conditions:
• to treat people after a recent heart attack (myocardial infarction). “Recent” here means between 12 hours and 10 days.
• to treat symptomatic heart failure. Valsartan 40 mg capsules can be used to treat symptomatic heart failure in adult patients. Valsartan 40 mg capsules 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 other medications to treat heart failure cannot be used. Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid buildup. It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body.
Valsartan 80 mg and 160 mg capsules can be used for three different conditions:
• to treat high blood pressure. 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 people after a recent heart attack (myocardial infarction). “Recent” here means between 12 hours and 10 days.
• to treat symptomatic heart failure. Valsartan 80 mg and 160 mg capsules can be used to treat symptomatic heart failure in adult patients. Valsartan 80 mg and 160 mg 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 other medications 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 (These are 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 have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
If any of these apply to you, do not take Valsartan capsules, speak to your doctor.
Warnings and precautions
Take special care with Valsartan capsules and talk to you 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.
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• 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 capsules, stop taking Valsartan capsules immediately and never take them 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 taking any of the following medicines used to treat high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril, etc.), 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, etc) or betablockers (for example metoprolol).
• 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).
• the use of Valsartan capsules in children and adolescents is not recommended (below the age of 18 years).
• you must tell your doctor if you think you are (or might become) pregnant. Valsartan capsules are 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).
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium)
in your blood at regular intervals.
See also information under the heading "Do not take Valsartan Capsules"
If any of these apply to you, tell your doctor before you take Valsartan capsules.
Other medicines and Valsartan capsules
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including:
• other medicines that lower blood pressure, especially water pills (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.) and medicine which is called 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 an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Valsartan capsules.
• 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.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings "Do not take Valsartan capsules" and "Warnings and precautions"
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, etc) or betablockers (for example metoprolol).
Valsartan capsules with food and drink
You can take this medicine 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 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 are 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 are 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 Valsartan capsules 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.
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. You should not try to break the 40mg capsule. If your doctor has prescribed 20mg twice per day but you only have the capsule presentation then you should consult your doctor or pharmacist so that you can be given the 40mg tablet which can be broken to provide 20mg 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 capsules can be given together with other treatment for heart attack, and 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.
Valsartan capsules can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.
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 this medicine with an additional medicine (e.g. a diuretic).
You can take Valsartan capsules with or without food. Swallow this medicine 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, lay down and contact your doctor immediately. If you have accidentally taken too many capsules, contact your doctor, pharmacist, or hospital.
If you forget to take Valsartan capsules
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.
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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Valsartan capsules can cause side effects, although not everybody gets them.
Some symptoms need immediate medical attention:
You may experience symptoms of angioedema, 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.
Other side effects include:
Common, affecting up to 1 in 10 people:
• dizziness, postural 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:
• allergic reaction with symptoms such as rash, itching, dizziness, swelling of face or lips or tongue or throat, difficulty breathing or swallowing (signs of 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:
• blistering skin (sign of dermatitis bullous)
• allergic reactions with rash, itching and hives, together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
• purple-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)
• 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 patients treated with high blood pressure than in patients treated for heart failure or after a recent heart attack.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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
5. How to store valsartan capsules
• Keep this medicine out of the reach and sight of children.
• Do not use Valsartan capsules after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
• Keep your capsules in their original pack.
• Do not store above 30°C. Protect from moisture and heat.
• Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
• Do not throw away any medicines 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. Content of the pack and other information
What Valsartan capsule contains
The active ingredient is valsartan.
The capsules also contain the following inactive ingredients: mannitol, copovidone, Croscarmellose sodium, silica colloidal anhydrous, magnesium stearate, hypromellose, titanium dioxide (E-171), talc, macrogol, carnauba wax and gelatin.
Valsartan 40mg and 160 mg capsule contains also iron oxide yellow (E-172) and quinoline yellow (E-104). Valsartan 80 mg and 160 mg capsule contains also iron oxide red (E-172).
What Valsartan capsule looks like and contents of the pack
Valsartan 40mg capsule is hard gelatin capsule with yellow cap marked “DV” and yellow body marked “40”. Valsartan 80mg capsule is hard gelatin capsule with pink cap marked “DV” and pink body marked “80”. Valsartan 160mg capsule is hard gelatin capsule with pink cap marked “DV” and yellow body marked “160”. Pack size of 28 capsules is registered.
Marketing Authorisation Holder and Manufacturer:
Dexcel® Pharma Ltd. 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK.
If you would like any more information or would like this leaflet in a different format, please contact Medical information at Dexcel Pharma UK phone number 01748828784
Date of revision of the text: October 2014
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