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AstraZeneca

Exforge
amlodipine, valsartan

Package leaflet: Information for the user


Exforge 5 mg/80 mg film-coated tablets Exforge 5 mg/160 mg film-coated tablets Exforge 10 mg/160 mg film-coated tablets amlodipine/valsartan


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


The following side effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.

Common (may affect up to 1 in 10 people): Dizziness, sleepiness; palpitations (awareness of your heart

beat); flushing, ankle swelling (oedema); abdominal pain, feeling sick (nausea).

Uncommon (may affect up to 1 in 100 people): Mood changes, anxiety, depression, sleeplessness, trembling, taste abnormalities, fainting, loss of pain sensation; visual disturbances, visual impairment,

ringing in the ears; low blood pressure; sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis); indigestion, vomiting (being sick); hair loss, increased sweating, itchy skin, skin

discolouration; disorder in passing urine, increased need to urinate at night, increased number of times of passing urine; inability to obtain an erection, discomfort or enlargement of the breasts in men, pain,

feeling unwell, muscle pain, muscle cramps; weight increase or decrease.

Rare (may affect up to 1 in 1,000 people): Confusion.

Very rare (may affect up to 1 in 10,000 people): Decreased number of white blood cells, decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage); excess

sugar in blood (hyperglycaemia); swelling of the gums, abdominal bloating (gastritis); abnormal liver

function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests; increased muscle tension; inflammation of blood vessels often with skin rash, sensitivity to light; disorders combining rigidity, tremor and/or movement disorders.


Valsartan

Not known (frequency cannot be estimated from the available data): 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; blistering skin (sign of a condition called dermatitis bullous).


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


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

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not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Exforge


    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 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.


  2. Contents of the pack and other information What Exforge contains

Exforge 5 mg/80 mg film-coated tablets

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 (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).


Exforge 5 mg/160 mg film-coated tablets

The active substances of Exforge are amlodipine (as amlodipine besylate) and valsartan. Each tablet

contains 5 mg amlodipine and 160 mg valsartan.


The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).


Exforge 10 mg/160 mg film-coated tablets

The active substances of Exforge are amlodipine (as amlodipine besylate) and valsartan. Each tablet

contains 10 mg amlodipine and 160 mg valsartan.


The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (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. Approximate size: diameter 8.20 mm.


Exforge 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side. Approximate size: 14.2 mm (length) x 5.7 mm (width).


Exforge 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side. Approximate size: 14.2 mm (length) x 5.7 mm (width).


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. All packs are available with standard blisters; the 56, 98 and 280 tablet packs are additionally available with perforated unit dose blisters.


Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road Dublin 4

Ireland


Manufacturer

Novartis Farma S.p.A.

Via Provinciale Schito 131 80058 Torre Annunziata (NA) Italy


Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764 08013 Barcelona

Spain


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Novartis Pharma GmbH Roonstraße 25

D-90429 Nuremberg Germany


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


België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11

Lietuva

SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50


България

Novartis Bulgaria EOOD Тел.: +359 2 976 98 28

Luxembourg/Luxemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11


Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00


Danmark

Novartis Healthcare A/S Tlf: +45 39 16 84 00

Malta

Novartis Pharma Services Inc. Tel: +356 2122 2872


Deutschland

Novartis Pharma GmbH Tel: +49 911 273 0

Nederland

Novartis Pharma B.V. Tel: +31 88 04 52 111


Eesti

SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810

Norge

Novartis Norge AS Tlf: +47 23 05 20 00


Ελλάδα

Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12

Österreich

Novartis Pharma GmbH Tel: +43 1 86 6570

España

Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00

Polska

Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888


France

Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600


Hrvatska

Novartis Hrvatska d.o.o. Tel. +385 1 6274 220

România

Novartis Pharma Services Romania SRL 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 50


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

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200


Κύπρος

Novartis Pharma Services Inc. Τηλ: +357 22 690 690

Sverige

Novartis Sverige AB Tel: +46 8 732 32 00


Latvija

SIA Novartis Baltics Tel: +371 67 887 070

United Kingdom (Northern Ireland)

Novartis Ireland Limited

Tel: +44 1276 698370


This leaflet was last revised in