Exforge 5 mg/80 mg film-coated tablets

Exforge tablets contain two substances called amlodipine and valsartan. Both of these substances help to control high blood pressure.

• Amlodipine belongs to a group of substances called ?calcium channel blockers?. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening.
• Valsartan belongs to a group of substances called ?angiotensin-II receptor antagonists?. Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II. This means that both of these substances help to stop the blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered.

Exforge is used to treat high blood pressure in patients whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.

Do not take Exforge

• if you are allergic (hypersensitive) to amlodipine or other medicines of the dihydropyridine type,
• if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Exforge. If you think you may be allergic, talk to your doctor before taking Exforge.
• if you have severe liver problems, such as biliary cirrhosis or cholestasis.
• if you have severe kidney problems or if you are having dialysis.
• if you are more than 3 months pregnant. (It is also better to avoid Exforge in early pregnancy ? , see Pregnancy section). If any of the above applies to you, do not take Exforge and talk to your doctor.

Take special care with Exforge

• if you have been sick (vomiting or diarrhoea).
• if you are taking diuretics (a type of medicine also called ?water tablets? which increases the amount of urine you produce).
• if you are taking other medicines or substances that increase the level of potassium in your blood (e.g. some types of diuretics, potassium supplements or salt substitutes containing potassium).
• if you have liver or kidney problems.
• if you have a condition affecting the renal glands called ?primary hyperaldosteronism?.
• if you have had heart failure.
• if your doctor has told you that you have a narrowing of the valves in your heart (called ?aortic or mitral stenosis?) or that the thickness of your heart muscle is abnormally increased (called ?obstructive hypertrophic cardiomyopathy?). If any of these apply to you, tell your doctor before taking Exforge.

You must tell your doctor if you think that you are ( or might become) pregnant. Exforge 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 section Pregnancy).

The use of Exforge in children and adolescents is not recommended.

Also tell your doctor if you have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.

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. Your doctor may need to change the dose or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below:

• lithium (a medicine used to treat some types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels;
• anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, St. John?s wort;
• nitroglycerin and other nitrates, or other substances called ?vasodilators?;
• medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. ketoconazole).

Taking Exforge with food and drink
You can take Exforge with or without food.

Exforge and older people

Caution is required when increasing the dosage.

Pregnancy and breast-feeding

Pregnancy
You must tell your doctor if you think you are ( or might become) pregnant. Your doctor will normally advise you to stop taking Exforge before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Exforge. Exforge 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 used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Exforge 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine may make you feel dizzy. This can affect how well you can concentrate. So, if you are not sure how this medicine will affect you, do not drive, use machinery, or do other activities that you need to concentrate on.

Always take this medicine exactly as your doctor has told you. You should check with your doctor if you are not sure. This will help you get the best results and lower the risk of side effects.

The usual dose of Exforge is one tablet per day.

• It is advisable to take your medicine at the same time each day, preferably in the morning.
• Swallow the tablets with a glass of water.
• You can take Exforge with or without food.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you take more Exforge than you should
If you have taken too many tablets of Exforge, or if someone else has taken your tablets, consult a doctor immediately.

If you forget to take Exforge
If you forget to take this medicine, take it as soon as you remember. Then take your next dose at its usual time. 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 tablet.

Like all medicines, Exforge can cause side effects, although not everybody gets them.

Some side effects can be serious:

A few patients have experienced these serious side effects (affecting less than 1 in 1,000 patients). If any of the following happen,tell your doctor straight away:
Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, light-headedness).

Other possible side effects:

Common (affecting less than 1 in 10 patients): Influenza; blocked nose, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; tiredness; redness and warm feeling of the face and/or neck.
Uncommon (affecting less than 1 in 100 patients): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
Rare (affecting less than 1 in 1,000 patients): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, light-headedness; excessive sweating; skin rash all over your body; itching; muscle spasm. If any of these affect you severely, tell your doctor.

Side effects with amlodipine or valsartan alone which can be serious:

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

AmlodipineCommon: Vomiting.
Uncommon: Hair loss; change in bowel habits, feeling bloated, indigestion, stomach discomfort after meal; stomach pain, nausea; bleeding, tender or enlarged gums; breathlessness; breast enlargement in men; runny or stuffy nose, sneezing; yellow skin and eyes, nausea, loss of appetite, light-coloured urine; high level of sugar in the blood; inability to achieve or maintain an erection; increased need to pass urine; fever, sore throat or mouth ulcers due to infections; mood swings; muscle pain; sensation of numbness or tingling in fingers and toes; severe upper stomach pain; spontaneous bleeding or bruising; rash, purplish-red spots, fever, itching; swelling mainly of the face and throat; skin reddening, blistering of lips, eyes or mouth, skin peeling.
Rare: Crushing chest pain, irregular heart beat, angina pain.
Very rare: Yellowing of the skin and eyes, changes in the results of some liver function tests; purple skin patches, rash and itching, stiff limbs, trembling hands

ValsartanNot known: Decrease in red blood cells, fever, sore throat or mouth sores due to infections, spontaneous bleeding or bruising, high level of potassium in the blood, abnormal liver test results, decreased renal functions and severely decreased renal functions, swelling mainly of the face and the throat, muscle pain, rash, purplish-red spots, fever, itching, allergic reaction.

If you experience any of these, tell your doctor straight away.

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.

Keep out of the reach and sight of children.
Do not use Exforge after the expiry date stated on the carton and blister.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not use any Exforge pack that is damaged or shows signs of tampering.

What Exforge contains

• The active substances of Exforge are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 5 mg amlodipine and 80 mg valsartan.
• The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).

What Exforge looks like and contents of the pack

Exforge 5 mg/80 mg tablets are round and dark yellow with ?NVR? on one side and ?NV? on the other side.

Exforge is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH TélTel 49 911 273 0

Novartis Pharma Services Inc. . 359 2 976 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 60 62 400 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 77

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 9 61 33 22 11

357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 7 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva

Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

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