Valsartan 80mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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DekceI
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Valsartan 40 mg film-coated Tablets Valsartan 80 mg film-coated Tablets Valsartan 160 mg film-coated Tablets Valsartan 320 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. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Valsartan tablets are and what are they used for
2. What you need to know before you take Valsartan tablets
3. How to take Valsartan tablets
4. Possible side effects
5. How to store Valsartan tablets
6. Content of the pack and other information
1. What Valsartan tablets are and what are they used for
The name of your medicine is Valsartan 40 mg, 80 mg, 160 mg or 320 mg film-coated Tablets (referred to as Valsartan tablets throughout this leaflet).
The active ingredient of Valsartan tablets is valsartan.
Valsartan belong to a class of medicines known as “angiotensin II receptor antagonist”.
Valsartan helps blood vessels relax and so reduces strain on the heart.
Valsartan 40mg, 80mg, 160mg & 320mg tablets can be used to treat:
• High blood pressure in children and adolescents aged 6 to 18 yrs.
High blood pressure may damage the body's blood vessels and may result in a stroke, heart failure or kidney failure. Lowering 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.
Valsartan 40mg, 80mg & 160mg tablets can be used to treat: • Adults after a recent heart attack
“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.
Valsartan tablets are 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 tablets may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure) cannot be used.
Valsartan 80mg, 160mg & 320mg tablets can be used to treat:
• High blood pressure in adults
High blood pressure may damage the body's blood vessels and may result in a stroke, heart failure or kidney failure. Lowering 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.
2. What you need to know before you take Valsartan tablets Do not take Valsartan tablets if you:
• if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Valsartan tablets.
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is also better to avoid Valsartan tablets 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 the above apply to you, do not take Valsartan tablets
Warnings and precautions:
Talk to your doctor or pharmacist before taking Valsartan tablets:
• if you have liver disease.
• if you have severe kidney disease or if you are undergoing dialysis.
• if you are known to have narrowing of the kidney arteries.
• if you have recently had a kidney transplant.
• if you are receiving treatment after a heart attack or for heart failure then your doctor may check how your kidneys are working.
• 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 tablets, stop taking Valsartan tablets 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, 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 are known to have “primary aldosteronism”, a hormone imbalance. If this applies to you then the use of Valsartan tablets is not recommended.
• if you have lost a lot of fluid by diarrhea, vomiting, or high doses of water pills (diuretics).
• if you think you are (or might become) pregnant. Valsartan tablets 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 Tablets”
Children and adolescents:
• if you are below the age of 18 years and you take Valsartan tablets with other medicines then your doctor may request tests to check your salt balance and how your kidneys are working.
If any of the above apply to you, tell your doctor before you take Valsartan tablets.
Other medicines and Valsartan Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including:
• medicines that lower blood pressure, especially “water tablets” (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, 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 tablets.
• lithium, a medicine used to treat mental health.
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 beta blockers
(medicines also used 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 Tablets" 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).
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Valsartan tablets with food and drink
You can take Valsartan 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 tablets before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan tablets.
Valsartan tablets 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 tablets 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 tablets affect you. Like many other medicines used to treat high blood pressure, Valsartan tablets may cause dizziness and affect the ability to concentrate.
3. How to take Valsartan tablets
Always take Valsartan tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is:
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 a 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 tablets 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.
Valsartan tablets can be given together with other treatment for heart failure: 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. 160mg or 320mg). He may also combine Valsartan tablets with an additional medicine e.g. a diuretic (“water tablet").
Children and adolescents (ages 6 to 18 yrs) with high blood pressure
In patients who weigh less than 35 kg the usual dose is 40 mg of Valsartan tablets once daily. In patients who weigh 35 kg or more the usual starting dose is 80 mg of Valsartan tablets 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).
You can take Valsartan tablets with or without food. Swallow Valsartan tablets with a glass of water. Take Valsartan tablets at about the same time each day.
If you take more Valsartan tablets 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 Valsartan tablets
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 Valsartan tablets
Stopping your treatment with Valsartan 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 tablets can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
• symptoms of angioedema (a specific allergic reaction):
• swollen face, lips, tongue or throat
• difficulty in breathing or swallowing
• hives, itching
The following side-effects have also been reported:
Common, affecting up to 1 in 10 people:
• dizziness, dizziness on standing
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• kidney problems that may become severe
• changes in blood test results that show how the kidneys are working
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) (see section “Some symptoms need immediate medical attention")
• sudden loss of consciousness (syncope)
• fainting, spinning sensation (vertigo)
• heart failure (causing breathlessness, fluid retention)
• headache
• cough
• abdominal pain, nausea, diarrhoea
• tiredness,, fatigue
• increase in blood potassium (may affect the heart and cause muscle symptoms)
• severely decreased kidney function (signs of acute renal failure)
Frequency not known:
• blistering skin (sign of dermatitis bullous)
• allergic reaction with skin rash, itching and hives, joint pains and swollen glands and/or flu-like symptoms
• decrease of level of haemoglobin and of the percentage of red blood cells in the blood which can lead to anemia in severe cases.
• increased susceptibility to infection such as fever, sore throat or mouth ulcers
• bleeding or bruising more easily than normal
• changes in blood test results that show how the liver is working
• low blood sodium (may cause nausea, tiredness, confusion, malaise, convulsions)
• increase of level of blood urea nitrogen and increase of level of serum creatinine in the blood test results (can indicate disruption of kidney function)
• muscle pain
• inflammation of small blood vessels ( you may experience the itching, fever and appearance of purlish-red spots)
Side effects in children and adolescents are similar to those seen in adults.
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 out of the reach and sight 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.
• Keep your tablets in their original pack at a temperature below 30°C.
• 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 tablets contain
The active ingredient is valsartan.
Valsartan tablets also contain the following inactive ingredients: mannitol, copovidone, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate, hypromellose (E- 464), titanium dioxide (E-171), talc, macrogol, carnauba wax.
Valsartan 40 mg and 160 mg tablets also contain iron oxide yellow (E-172).
Valsartan 80 mg and 320 mg tablets also contain iron oxide red (E-172).
What Valsartan tablets look like and content of the pack
Valsartan 40 mg tablet is oblong biconvex, yellow tablet. There is a score line on one side.
Pack sizes of 7 and 28 tablets are registered.
Valsartan 80 mg tablet is oblong biconvex, pink tablet. There is a score line on one side.
A pack size of 28 tablets is registered.
Valsartan 160 mg tablet is oblong biconvex, yellow tablet. A pack size of 28 tablets is registered. Valsartan 320 mg tablet is oblong biconvex, pink tablet. A pack size of 28 tablets is registered.
Marketing Authorisation Holder and Manufacturer
Dexcel® Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK.. Date of revision of the text: August 2014
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