Clopidogrel/Acetylsalicylic acid Teva
clopidogrel, acetylsalicylic acid
clopidogrel/acetylsalicylic acid
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 only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
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 Clopidogrel/Acetylsalicylic acid Teva is and what it is used for
What you need to know before you take Clopidogrel/Acetylsalicylic acid Teva
How to take Clopidogrel/Acetylsalicylic acid Teva
Possible side effects
How to store Clopidogrel/Acetylsalicylic acid Teva
Contents of the pack and other information
Medicinal product no longer authorised
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.
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
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).
Medicinal product no longer authorised
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.
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.
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.
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.
Medicinal product no longer authorised
Clopidogrel/Acetylsalicylic acid Teva should not affect your ability to drive or to use machines.
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.
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.
You should take your 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 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 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood 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.
Medicinal product no longer authorised
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’).
diarrhoea
abdominal pain
indigestion or heartburn.
headache
stomach ulcer
vomiting (being sick)
nausea (feeling sick)
constipation
excessive gas in stomach or intestines
rashes
itching
dizziness
sensation of tingling and numbness.
vertigo.
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.
ulcer perforation
ringing in the ears
hearing loss
sudden life-threatening allergic reactions
kidney disease
low blood sugar
Medicinal product no longer authorised
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.
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 thenationalreportingsystem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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, 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.
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).
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: Teva Pharma B.V.
Swensweg 5
Medicinal product no longer authorised
2031 GA Haarlem The Netherlands
Manufacturers:
TEVA Pharmaceutical Works Private Limited Company Pallagi út 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:
Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
UAB “Sicor Biotech” Tel: +370 5 266 02 03
Тева Фармасютикълс България ЕООД Teл: +359 2 489 95 82
Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111
Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
Medicinal product no longer authorised
Teva Denmark A/S Tlf: +45 44 98 55 11
Teva Pharmaceuticals Ireland Tel: +353 51 321740
Teva GmbH
Tel: +49 731 402 08
Teva Nederland B.V. Tel: +31 800 0228 400
Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Tel: +372 661 0801
Teva Norway AS Tlf: +47 6677 55 90
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099
ratiopharm Arzneimittel Vertriebs GmbH Tel: +43 1 97007 0
Teva Pharma S.L.U. Tél: +34 91 387 32 80
Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00
Teva Santé
Tél: +33 1 55 91 7800
Teva Pharma - Produtos Farmacêuticos Lda Tel: +351 21 476 75 50
Pliva Hrvatska d.o.o Tel: + 385 1 37 20 000
Teva Pharmaceuticals S.R.L Tel: +4021 230 6524
Teva Pharmaceuticals Ireland Tel: +353 51 321 740
Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
ratiopharm Oy
Sími: +358 20 180 5900
Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 2 5726 7911
Teva Italia S.r.l.
Tel: +39 028 917 981
ratiopharm Oy
Puh/Tel: +358 20 180 5900
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099
Teva Sweden AB Tel: +46 42 12 11 00
UAB Sicor Biotech filiāle Latvijā Tel: +371 67 323 666
Teva UK Limited
Tel: +44 1977 628 500
Medicinal product no longer authorised