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Clopidogrel Teva Generics B.V. (clopidogrel hydrochloride) – Package leaflet - B01AC04

Updated on site: 06-Oct-2017

Medication nameClopidogrel Teva Generics B.V.
ATC CodeB01AC04
Substanceclopidogrel hydrochloride
ManufacturerTeva Pharma B.V.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel Teva Generics B.V. 75 mg film-coated tablets

Clopidogrel

Read all of this leaflet carefully before you start taking this medicine.

-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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-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.

In this leaflet:

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1.

What Clopidogrel Teva Generics B.V. is and what it is used for

2.

Before you take Clopidogrel Teva Generics B.V.

 

3.

How to take Clopidogrel Teva Generics B.V.

 

4.

Possible side effects

 

5.

How to store Clopidogrel Teva Generics B.V.

 

6.

Further information

 

1.

WHAT CLOPIDOGREL TEVA GENERICS B.V. IS AND WHAT IT IS USED FOR

Clopidogrel Teva Generics B.V. belongs to a group of medici es called antiplatelet medicinal

products. Platelets are very small structures in the blo d, which clump together during blood clotting.

 

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By preventing this clumping, antiplatelet medicinal pr longerducts reduce the chances of blood clots

forming (a process called thrombosis).

 

product

 

Clopidogrel Teva Generics B.V. is taken to prevent blood clots (thrombi) forming in hardened blood

vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed C o idogrel Teva Generics B.V. to help prevent blood clots and reduce the risk of these severe events bec use:

-You have a cond t on of hardening of arteries (also known as atherosclerosis), and

-You have prev ously experienced a heart attack, stroke or have a condition known as peripheral

 

in theMedicinalblocked or narrowed artery to restore effective blood flow. You should also be given

-

arterial disease, or

You have xperienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial

 

infarction’ (heart attack). For the treatment of this condition your doctor may have placed a stent

 

acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever

 

as well as to prevent blood clotting) by your doctor.

2.BEFORE YOU TAKE CLOPIDOGREL TEVA GENERICS B.V.

Do not take Clopidogrel Teva Generics B.V.

if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Teva Generics B.V.

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 think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva Generics B.V..

Take special care with Clopidogrel Teva Generics B.V.

If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva Generics B.V.:

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 within the last seven days

if you have kidney or liver disease.

While you are taking Clopidogrel Teva Generics B.V.:

You should tell your doctor if a surgery (including dental) is planned

You should also tell your doctor immediately if you develop a medical c ndition (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 unexpl ined 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 y ur doctor straightaway (see section 4 ‘Possible side effects’)

Your doctor may order blood tests no authorised

Clopidogrel Teva Generics B.V.productis not intended for use in children or adolescents.

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.

Some other medicines may inf uence the use of Clopidogrel Teva Generics B.V. or vice versa. You should specifically tell your doctor if you take

-oral anticoagulants, medicines used to reduce blood clotting,

-a non-st roi al anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints,

-heparin, or any other medicine used to reduce blood clotting.

-a proton pump inhibitor (e.g, omeprazole) for upset stomach,

-fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections,

-cimetidine, medicine to treat upset stomach,

-fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression,

-carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy,

-ticlopidine, other antiplatelet agent.Medicinal

If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed clopidogrel in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Teva Generics B.V. with food and drink

Clopidogrel Teva Generics B.V. may be taken with or without food.

Pregnancy and breast-feeding

It is preferable not to use this product during pregnancy and breast-feeding.

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

While taking Clopidogrel Teva Generics B.V., consult your doctor about the breast-feeding of a baby.

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

Driving and using machines

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Clopidogrel Teva Generics B.V. is unlikely to affect your ability to drive or to use machines.

Important information about some of the ingredients of Clopidogrel Teva Generics B.V.

Clopidogrel Teva Generics B.V. contains hydrogenated castor oil which may cause stomach upset and diarrhoea.

Always take Clopidogrel Teva Generics B.V. exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

3. HOW TO TAKE CLOPIDOGREL TEVA GENERICSlongerB.V.

or without food, and at the same time each day.

If you have experienced severe chest pain (unstablenoangina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva GenericsproductB.V. (4 ablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75 mg tablet of Clopidogrel Teva Generics B.V. per day to be taken orally with

You should take Clopidogrel Teva Generics B.V. for as long as your doctor continues to prescribe it.

If you takeMedicinalmore Clopidogrel Teva Generics B.V. than you should

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

If you forget to take Clopidogrel Teva Generics B.V.

If you forget to take a dose of Clopidogrel Teva Generics B.V., but remember within 12 hours of your usual time, take your tablet straightaway 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 dose.

For the 28x1 tablets pack size, you can check the day on which you last took the tablet by referring to the calendar printed on the blister.

If you stop taking Clopidogrel Teva Generics B.V.

Do not stop the treatment. Contact your doctor or pharmacist before stopping.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Clopidogrel Teva Generics B.V. 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 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 ‘Take special care with Clopidogrel Teva Generics B.V.’).

-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 (affects 1 to 10 patients in 100) reported with Clopidogrel Teva

Generics B.V. is bleeding.

Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bl ding in the eye, inside the head, the lung or the joints has also been reported.

If you experience prolonged bleeding when taking Clopidogrel Teva Generics B.V.

If you cut or injure yourself, it may take slightly 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 of no concern. However, if you are concerned by your

 

 

 

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bleeding, you should contact your doctor straightaway (see section 2 ‘Take special care with

Clopidogrel Teva Generics B.V.’).

 

 

 

Other side effects reported with Clopidogrel Teva Generics B.V. are:

 

 

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Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or

heartburn.

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Uncommon side effects (affects product1 to 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea,

constipation, excessive gas in stomach r intestines, rashes, itching, dizziness, sensation of tingling and numbness.

Rare side effect (affects 1 to 10 patients in 10,000): Vertigo.

Very rare sideMedicinaleffects (affects less than 1 patient in 10,000): Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic

reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); d cr ase in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste.

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

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.

5. HOW TO STORE CLOPIDOGREL TEVA GENERICS B.V.

Keep out of the reach and sight of children.

Do not use Clopidogrel Teva Generics B.V. after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture and light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Clopidogrel Teva Generics B.V. contains

-The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).

-The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil in the tablet core and hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol in the film- coating.

What Clopidogrel Teva Generics B.V. looks like and contents of the pack

The film-coated tablets are pink, round and slightly convex.

Boxes of 28, 30, 50, 56, 84, 90 or 100 film-coated tablets in blisters or boxes of 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in perforated unit dose blisters are available.

Not all pack sizes may be marketed.

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Marketing Authorisation Holder

 

Teva Generics B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands

Manufacturer

 

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 N volongermesto, Slovenia

Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

 

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

België/Belgique/Belgien

 

Luxembourg/Luxemburg

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

Teva Pharma Belgium S.A.

Tél/Tél: +32 3 820 73 73

product

 

Tél/Tel: +32 3 820 73 73

България

Magyarország

Тева Фармасютикълс България ЕООД

Teva Magyarország Zrt

Teл: +359 2 489 95 82

Tel.: +36 1 288 64 00

Česká republika

Malta

Medicinal

Teva Ελλάς Α.Ε.

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Τel: +30 210 72 79 099

Danmark

Nederland

Teva Denmark A.S.

Teva Nederland B.V.

Tlf: +45 44 98 55 11

Tel: +31 (0) 800 0228400

Deutschland

Norge

Teva Generics GmbH

Teva Sweden AB

Tel: (49) 351 834 0

Tlf: (46) 42 12 11 00

Eesti

Österreich

Teva Eesti esindus UAB Sicor Biotech

Teva Generics GmbH

Eesti filiaal

Tel: (49) 351 834 0

 

Tel: +372 611 2409

Ελλάδα

 

Polska

 

 

Teva Ελλάς Α.Ε.

 

Teva Pharmaceuticals Polska Sp. z o.o.

Τηλ: +30 210 72 79 099

 

Tel.: +(48) 22 345 93 00

España

 

Portugal

 

TEVA PHARMA, S.L.U.

 

Teva Pharma - Produtos Farmacêuticos Lda

Tél: +(34) 91 387 32 80

 

Tel: (351) 214 235 910

France

 

România

 

Teva Santé

 

Teva Pharmaceuticals S.R.L

Tél: +(33) 1 55 91 7800

 

Tel: +4021 230 65 24

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Ireland

 

Slovenija

 

 

Teva Pharmaceuticals Ireland

 

Pliva Ljubljana d.o.o.

 

Tel: +353 (0)42 9395 892

 

Tel: +386 1 58 90 390

Ísland

 

Slovenská republika

 

Teva UK Limited

 

Teva Pharmaceuticals Slovakia s.r.o.

Sími: +(44) 1323 501 111.

 

Tel: +(421) 2 5726 7911

Italia

 

 

 

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Suomi/Finland

 

Teva Italia S.r.l.

 

Teva Sweden AB

 

Tel: +(39) 0289179805

 

Puh/Te : +(46) 42 12 11 00

Κύπρος

 

 

no

 

 

 

Sverige

 

 

Teva Ελλάς Α.Ε.

 

Teva Sweden AB

 

Τηλ: +30 210 72 79 099

product

 

 

 

 

Tel: +(46) 42 12 11 00

Latvija

 

United Kingdom

 

UAB Sicor Biotech filiāle Latvijā

Teva UK Limited

 

Tel: +371 67 784 980

 

Tel: +(44) 1323 501 111

Medicinal

 

 

 

 

 

Lietuva

UAB “Sicor Biotech”

Tel: +370 5 266 02 03

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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