VALSARTAN 80MG CAPSULES

Active substance: VALSARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER 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. In addition Diovan 80 and 160 mg Capsules can be used o treat high blood pressure. High blood t 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.

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necessary to check the amount of potassium in your blood at regular intervals. I f 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 Diovan is not recommended. I f you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water pills (diuretics). T he use of Diovan in children and adolescents below the age of 18 years is not recommended. Y ou must tell your doctor if you think you are (or might become) pregnant. Diovan 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).

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Taking Diovan with food and drink Pregnancy and breast-feeding
You can take Diovan with or without food. Ask your doctor or pharmacist for advice before taking any medicine. ou must tell your doctor if you think that you Y are (or might become) pregnant. Your doctor will normally advise you to stop taking Diovan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan. Diovan 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. ell your doctor if you are breast-feeding or about T to start breast-feeding. Diovan is not recommended for mothers who are breastfeeding, 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.



40, 80 and 160 mg Capsules Valsartan
Read all of this leaflet carefully before you start taking this medicine.
eep this leaflet. You may need to read it again. K f you have any further questions, ask your I doctor or pharmacist. his medicine has been prescribed for you. Do T not pass it on to others. It may harm them, even if their symptoms are the same as yours. f any of the side effects gets serious, or if you I notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



2. BEFORE YOU TAKE DIOVAN Do not take Diovan:

In this leaflet:

1. What Diovan is and what it is used for 2. Before you take Diovan 3. How to take Diovan 4. Possible side effects 5. How to store Diovan 6. Further information

f you are allergic (hypersensitive) to valsartan or i any of the other ingredients of Diovan. These are listed in Section 6. f you have severe liver disease. i f you are more than 3 months pregnant (it is i also better to avoid Diovan in early pregnancy see pregnancy section). If any of these apply to you, speak to your doctor. You must be especially careful and talk to your doctor before taking Diovan if any of the following apply to you. If you have liver disease. f you have severe kidney disease or if you are I undergoing dialysis. f you are suffering from a narrowing of the I kidney artery. f you have recently undergone kidney I transplantation (received a new kidney). f you are being treated after a heart attack or for I heart failure. Your doctor may check your kidney function. f you have severe heart disease other than heart I failure or heart attack. I f you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassiumsparing medicines and heparin. It may be

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 Diovan 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: ther medicines that lower blood pressure, o especially water pills (diuretics). edicines that increase the amount of m potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. ertain type of pain killers called non-steroidal c anti-inflammatory medicines (NSAIDs). ithium, a medicine used to treat some types of l psychiatric illness.

Driving and using machines

1. HAT DIOVAN IS AND WHAT IT IS USED FOR W

Diovan belongs to a class of medicines known as angiotensin II receptor antagonists, 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. Diovan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. Diovan 40, 80 and 160 mg Capsules can be used o treat people after a recent heart attack t (myocardial infarction). Recent here means between 12 hours and 10 days. o treat symptomatic heart failure. Diovan is t 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.

Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Diovan affects you. Like many other medicines used to treat high blood pressure, Diovan may in rare cases cause dizziness and affect the ability to concentrate.

3. HOW TO TAKE DIOVAN

In addition:

f you are being treated after a heart attack, a i combination with ACE inhibitors (a medication to treat heart attack) is not recommended. f you are being treated for heart failure, a triple i combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended.

Always take Diovan 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 12hours, usually at a low dose of 20mg twice daily.
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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. Diovan can be given together with other treatments 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 160mg twice daily. The final dose depends on what you as an individual patient can tolerate. Diovan 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 Diovan with an additional medicine (e.g. a diuretic). You can take Diovan with or without food. Swallow Diovan with a glass of water. Take Diovan at about the same time each day. If you take more Diovan than you should If you experience severe dizziness and/or fainting, lie 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 Diovan 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 Diovan Stopping your treatment with Diovan 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. 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 ot known: frequency cannot be estimated from n the available data. Some symptoms need immediate medical attention: You may experience symptoms of angioedema, such as swollen face, tongue or throat difficulty in swallowing hives and difficulties in breathing If you get any of these, see a doctor immediately. Other side effects include: Common: dizziness, postural dizziness ow blood pressure with symptoms such l as dizziness ecreased kidney function (signs of d renal impairment) Uncommon: llergic reaction with symptoms such as rash, a itching, dizziness, swelling of face or lips or tongue or throat, difficulty breathing or swallowing (signs of angioedema) sudden loss of consciousness spinning sensation everely decreased kidney function (signs of s acute renal failure) uscle spasms, abnormal heart rhythm (signs m of hyperkalaemia) reathlessness, difficulty breathing when lying b down, swelling of the feet or legs (signs of cardiac failure) headache cough abdominal pain nausea diarrhoea tiredness weakness Not known: ash, itching, together with some of the following r signs or symptoms: fever, joint pain, muscle pain,

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swollen lymph nodes and/or flu-like symptoms (signs of serum sickness) p urple-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis) u nusual bleeding or bruising (signs of thrombocytopenia) muscle pain (myalgia) f ever, sore throat or mouth ulcers due to infections (symptoms of low level of white blood cells also called neutropenia) d ecrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can, in severe cases, lead to anaemia) i ncrease of level of potassium in the blood (which can, in severe cases, trigger muscle spasms, abnormal heart rhythm) e levation 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) i ncrease of level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function) l ow level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)

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Capsules, please take any unused capsules back to your pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.



6. FURTHER INFORMATION What Diovan contains

Diovan Capsules are available in three different strengths containing either 40, 80 or 160 mg of the active ingredient valsartan. The gelatin capsules also contain the following inactive ingredients: microcrystalline cellulose, polyvidone, crospovidone type A, sodium lauryl sulfate and magnesium stearate. Colouring materials used in the capsule shell and ink are titanium dioxide (E171) and iron oxides (E172). The ink also contains shellac and propylene glycol.

What Diovan looks like and contents of the pack



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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Diovan 40 mg Capsules are pale grey, marked CGHBH in black ink on the cap. Pack sizes of 7 or 28capsules are registered. Diovan 80 mg Capsules have a pale grey cap and flesh pink body and are marked CG FZF in black ink on the cap. Pack sizes of 28 or 98 capsules are registered. Diovan 160 mg Capsules have a dark grey cap and flesh pink body and are marked CG GOG in white ink on the cap. Pack sizes of 28 or 98 capsules are registered. Some pack sizes may not be marketed.

Marketing Authorisation Holder and Manufacturer
The product licence holder is: Novartis Pharmaceuticals UK Limited Trading as: Ciba Laboratories Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom. Diovan Capsules are released onto the market by: Novartis Pharmaceuticals UK Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom. If you would like any more information, or would like this leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370. This leaflet was last revised in January 2011. Copyright Novartis Pharmaceuticals UK Limited
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5. HOW TO STORE DIOVAN

4.POSSIBLE SIDE EFFECTS

Like all medicines, Diovan can cause side effects, although not everybody gets them. These side effects may occur with certain

eep your capsules in their original pack at a K temperature below 30C. Protect from moisture and heat. Keep out of the reach and sight of children. o not use Diovan after the expiry date which is D stated on the pack. The expiry date refers to the last day of that month. o not use Diovan if you notice that the pack is D damaged or shows signs of tampering. f your doctor tells you to stop taking Diovan I

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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