Clopidogrel/Acetylsalicylic acid Teva - patient leaflet, side effects, dosage

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4..

What is in this leaflet

What Clopidogrel/A­cetylsalicylic acid Teva is and what it is used for What you need to know before you take Clopidogrel/A­cetylsalicylic aci How to take Clopidogrel/A­cetylsalicylic acid Teva Possible side effects

it is used for

How to store Clopidogrel/A­cetylsalicylic acid Teva Contents of the pack and other information

What Clopidogrel/A­cetylsalicylic acid Teva is a

Clopidogrel/A­cetylsalicylic acid Teva contains clopidogrel and acetylsalicylic acid (ASA) and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping in some types of blood vessels (called arteries), antiplatelet medicinal products reduce the chances of blood clots forming (a process called atherothrombosis).

Clopidogrel/A­cetylsalicylic acid Teva is taken by adults to prevent blood clots forming in hardened arteries which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed Clopidogrel/A­cetylsalicylic acid Teva in place of the two separate medicines, clopidogrel and ASA, to help prevent blood clots because you have experienced a severe type of chest pain known as ‘unstable angina’ or heart attack (myocardial infarction). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.

2. What you need to know before you take Clopidogrel/Acetylsalicylic acid Teva

Do not take Clopidogrel/A­cetylsalicylic acid Teva

• If you are allergic to clopidogrel, acetylsalicylic acid (ASA) or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other products called non-steroidal anti-inflammatory products usually used to treat painful and/or inflammatory conditions of muscles or joints.
• If you have a medical condition that include the combination of asthma, nasal discharge (runny nose) and polyps (a type of growth in the nose).
• If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
• If you suffer from severe liver disease.
• If you suffer from severe kidney disease.
• If you are in your last trimester of pregnancy

Warnings and precautions

If any of the situations mentioned below apply to you, you should tell your doctor before taking

Clopidogrel/A­cetylsalicylic acid Teva:

if you have a risk of bleeding such as:

a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer). a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).

a recent serious injury.

a recent surgery (including dental).

a planned surgery (including dental) in the next seven days.

if you have had a clot in an artery of your brain (ischaemic stroke) which occurred in the last seven days.

if you have kidney or liver disease.

if you have a history of asthma or allergic reactions including allergy to any medicine used to treat your disease.

if you have gout.

While you are taking Clopidogrel/A­cetylsalicylic acid Teva:

You should tell your doctor

• – if a surgery (including dental) is planned.

• – if you have any stomach or abdominal pain or bleeding in the stomach or bowels (red stools or black stools).

You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects’).

If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects’).

Your doctor may order blood tests.

Children and adolescents

Clopidogrel/A­cetylsalicylic acid Teva is not intended for use in children or adolescents less than

• 18 years of age. There is a possible association between acetylsalicylic acid (ASA) and Reye’s Syndrome when products containing ASA are given to children or adolescents with a viral infection. Reye’s Syndrome is a very rare disease which can be fatal.

Other medicines and Clopidogrel/A­cetylsalicylic acid Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Some other medicines may influence the use of Clopidogrel/A­cetylsalicylic acid Teva or vice versa.

You should specifically tell your doctor if you take

• oral anticoagulants, medicines used to reduce blood clotting,
• ASA or another non-steroidal anti-inflammatory medicine usually used to treat painful and/or inflammatory conditions of muscle or joints,
• heparin or any other injectable medicine used to reduce blood clotting,
• omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach,
• methotrexate, a medicine used to treat severe joint disease (rheumatoid arthritis) or skin disease (psoriasis),
• probenecid, benzbromarone, or sulfinpyrazone, medicines used to treat gout,
• fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections,
• fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression,
• carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy,
• ticlopidine, other antiplatelet agent.

You should stop other clopidogrel treatment while you are taking Clopidogrel/A­cetylsalicylic acid Teva.

An occasional use of ASA (no more than 1,000 mg in any 24-hour period) should generally not cause a problem, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist.

Pregnancy and breast-feeding

Do NOT take Clopidogrel/A­cetylsalicylic acid Teva during third trimester of pregnancy.

It is preferable not to take this product during first and second trimesters of pregnancy.

If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel/A­cetylsalicylic acid Teva. If you become pregnant while taking Clopidogrel/A­cetylsalicylic acid Teva, consult your doctor immediately as it is recommended not to take Clopidogrel/A­cetylsalicylic acid Teva while you are pregnant.

You should not breast-feed while using this medicine.

If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.

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

Driving and using machines

Clopidogrel/A­cetylsalicylic acid Teva should not affect your ability to drive or to use machines.

Clopidogrel/A­cetylsalicylic acid Teva contains lactose

If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

3. How to take Clopidogrel/Acetylsalicylic acid Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet of Clopidogrel/A­cetylsalicylic acid Teva per day, to be taken orally with a glass of water, with or without food.

ur medicine at the same time each day.

Depending on your condition, your doctor will determine the length of time for which you need to take Clopidogrel/A­cetylsalicylic acid Teva. If you have had a heart attack, it should be prescribed for at least four weeks. In any case, you should take it for as long as your doctor continues to prescribe it.

If you take more Clopidogrel/A­cetylsalicylic acid Teva than you should

Contact your doctor or the nearest hospital emergency department immediately because of the increased risk of bleeding.

If you forget to take Clopidogrel/A­cetylsalicylic acid Teva

If you forget to take a dose of Clopidogrel/A­cetylsalicylic acid Teva, but remember within 12 hours of your usual time, take your tablet straight away and then take your next tablet at the usual time.

If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clopidogrel/A­cetylsalicylic acid Teva

Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping.

If you have been told by your doctor to stop treatment temporarily, ask your doctor when to restart the treatment.

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

4. Possible side effects

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

Contact your doctor immediately if you experience:

fever, signs of infection or extreme tiredness. These may be due to rare decrease cells.

signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion

(see section 2 ‘Warnings and precautions’).

• swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be the signs of an allergic reaction.

The most common side effect which has been seen with Clopidogrel/A­cetylsalicylic acid Teva is bleeding. Bleeding may occur as bleeding in the stomach or bleeding or bruising under the skin), nose bleed, blood in the bleeding in the eye, inside the head, the lung or the joints ha

If you experience prolonged bleeding when taking Clopidogrel/A­cetylsalicylic acid Teva

If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions’).

Other side effects include:

Common side effects (may affect up to 1 in 10 people):

• diarrhoea
• abdominal pain
• indigestion or heartburn.

♦

Uncommon side effects (may affect up to 1 in 100 people):

• headache
• stomach ulcer
• vomiting (being sick)
• nausea (feeling sick)
• constipation
• excessive gas in stomach or intestines
• rashes
• itching
• dizziness
• sensation of tingling and numbness.

Rare side effect (may affect up to 1 in 1000 people):

• vertigo.

Very rare side effects (may affect up to 1 in 10,000 people):

• jaundice
• burning in stomach and/or oesophagus
• severe abdominal pain with or without back pain
• fever
• breathing difficulties sometimes associated with cough
• generalised allergic reactions (for example, overall sensation of heat with sudden general

discomfort until fainting)

• swelling in the mouth
• blisters of the skin
• skin allergy
• sore mouth (stomatitis)
• decrease in blood pressure
• confusion
• hallucinations
• joint pain
• muscular pain
• changes in taste of foods
• inflammation of small vessels.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• ulcer perforation
• ringing in the ears
• hearing loss
• sudden life-threatening allergic reactions
• kidney disease
• low blood sugar
• gout (a condition of painful, swollen joints caused by uric acid crystals)
• worsening of food allergies.

In addition, your doctor may identify changes in your blood or urine tests.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Clopidogrel/Acetylsalicylic acid Teva

Keep this

Do not use this medicine after the expiry date which is stated on the carton, bottle and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from light and moisture.

After first opening the bottle use within 30 days.

Do not use this medicine if you notice any visible signs of deterioration

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Clopidogrel/A­cetylsalicylic acid Teva contains

• The active substances are clopidogrel and acetylsalicylic a­cid.

Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic a­cid.

• The other ingredients are:

• – Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropyl­cellulose 100 cP, crospovidone (type A), stearic acid, croscarmellose sodium, hydrogenated vegetable oil and sodium lauril sulfate.

• – Tablet coating: hypromellose, polydextrose, titanium dioxide (E171), quinoline yellow aluminium lake (E104), talc, maltodextrin, medium chain triglycerides and iron oxide yellow (E172).

What Clopidogrel/Acetylsalicylic acid Teva looks like and contents of the pack

Clopidogrel/A­cetylsalicylic acid Teva 75 mg/75 mg film-coated tablets are yellow, film-coated capsule shaped tablets. The tablets have a length of 14.0 mm and a width of 6.8 mm.

Clopidogrel/A­cetylsalicylic acid Teva is supplied in blisters in pack sizes of 14, 28 and 30 film-coated tablets or in bottles in a pack size of 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturers:

TEVA Pharmaceutical Works Private Limited Company

Pallagi ut 13

4042 Debrecen

Hungary

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne

East Sussex, BN22 9AG

United Kingdom

Teva Pharma B.V.

Swensweg 5 2031 GA Haarlem The Netherlands

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305 74770 Opava-Komarov

Czech Republic

Teva Operations Poland Sp. z.o.o. ul. Mogilska 80 31–546 Krakow

Poland

Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Germany

Pliva Croatia Ltd

Prilaz baruna Filipovica 25

10 000 Zagreb

Croatia

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

Authorisation Holder:

België/Belgiqu­e/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tel/Tél: +32 3 820 73 73

Efcnrapua

TeBa OapMacromuKMC Etnrapua EOOfl

Ten: +359 2 489 95 82

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Danmark

Teva Denmark A/S

Tlf: +45 44 98 55 11

Deutschland

Teva GmbH

Tel: +49 731 402 08

Eesti

Teva Eesti esindus UAB Sicor Biotech Eesti filiaal

Tel: +372 661 0801

EXXáSa

Teva EUáq A.H.J

Tql: +30 2i0 72 79 099

España

Teva Pharma S.L.U.

Tél: +34 91 387 32 80

Lietuva

UAB “Sicor Biotech”

Tel: +370 5 266 02 03

Luxembourg/Lu­xemburg

Teva Pharma Belgium N.V./S.A./AG

Tel/Tel: +32 3 820' 73 73

Magyarorszag

Teva Gy jgyszergyar Zrt

Tel.: +36 1 288 64 00

Malta

Teva Pharmaceuticals Ireland

Tel: +353 51 321740

Nederland

Teva Nederland B.V.

Tel: +31 800 0228 400

Norge

Teva Norway AS

Tlf: +47 6677 55 90

Österreich

ratiopharm Arzneimittel Vertriebs GmbH

Tel: +43 1 97007 0

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel.: +48 22 345 93 00

Portugal

Teva Pharma – Produtos Farmacêuticos Lda

Tel: +351 21 476 75 50

România

Teva Pharmaceuticals S.R.L

Tel: +4021 230 6524

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Slovenská republika

Teva Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 5726 7911