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Clopidogrel Teva (hydrogen sulphate) (clopidogrel hydrogen sulphate) – Package leaflet - B01AC04

Updated on site: 06-Oct-2017

Medication nameClopidogrel Teva (hydrogen sulphate)
ATC CodeB01AC04
Substanceclopidogrel hydrogen sulphate
ManufacturerTeva Pharma B.V.

Package leaflet: Information for the user

Clopidogrel Teva 75 mg film-coated tablets clopidogrel

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

-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 have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

What is in this leaflet

1.What Clopidogrel Teva is and what it is used for

2.What you need to know before you take Clopidogrel Teva

3.How to take Clopidogrel Teva

4.Possible side effects

5.How to store Clopidogrel Teva

6.Contents of the pack and other information

1.What Clopidogrel Teva is and what it is used for

Clopidogrel Teva contains clopidogrel 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, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).

Clopidogrel Teva is taken by adults 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 Clopidogrel Teva to help prevent blood clots and reduce the risk of these severe events because:

-You have a condition of hardening of arteries (also known as atherosclerosis), and

-You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or

-You have experienced 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 in the blocked or narrowed artery to restore effective blood flow. You should also be given 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.

-You have an irregular heartbeat, a condition called ‘atrial fibrillation’, and you cannot take medicines known as ‘oral anticoagulants’ (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing. You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid or the combined use of Clopidogrel Teva and acetylsalicylic acid for this condition. Your doctor should have prescribed Clopidogrel Teva and acetylsalicylic acid if you cannot take ‘oral anticoagulants’ and you do not have a risk of major bleeding.

2. What you need to know before you take Clopidogrel Teva

Do not take Clopidogrel Teva

If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).

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.

Warnings and precautions

If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel 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 within the last seven days

if you have kidney or liver disease.

if you have had an allergy or reaction to any medicine used to treat your disease.

While you are taking Clopidogrel Teva:

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

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

Do not give this medicine to children because it does not work.

Other medicines and Clopidogrel 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 Teva or vice versa.

You should specifically tell your doctor if you take

-medicines that may increase your risk of bleeding such as:

o oral anticoagulants, medicines used to reduce blood clotting,

o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints,

o heparin or any other injectable medicine used to reduce blood clotting,

o ticlopidine, other antiplatelet agent,

oa selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,

-omeprazole or esomeprazole, medicines to treat upset stomach,

-fluconazole or voriconazole, medicines to treat fungal infections,

-efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,

-carbamazepine, a medicine to treat some forms of epilepsy,

-moclobemide, medicine to treat depression,

-repaglinide, medicine to treat diabetes,

-paclitaxel, medicine to treat cancer.

If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Teva 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.

Pregnancy and breast-feeding

It is preferable not to take this medicine during pregnancy.

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

You should not breast-feed while taking 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 Teva is unlikely to affect your ability to drive or to use machines.

Clopidogrel 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 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, including for patients with a condition called ‘atrial fibrillation’ (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Teva per day to be taken orally with or without food, and at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75-mg tablet of Clopidogrel Teva per day as described above.

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

If you take more Clopidogrel Teva than you should

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

If you forget to take Clopidogrel Teva

If you forget to take a dose of Clopidogrel Teva, but remember within 12 hours of 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

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

If you stop taking Clopidogrel Teva

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

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 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.

The most common side effect reported with Clopidogrel Teva is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleeds or blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.

If you experience prolonged bleeding when taking Clopidogrel 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, nausea, 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, enlarged breasts in males.

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

Jaundice; 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 food.

Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain.

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

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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Clopidogrel Teva

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 outer carton, bottle or blister, after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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

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

6. Contents of the pack and other information

What Clopidogrel Teva contains

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

The other ingredients are (see section 2 ‘Clopidogrel Teva contains lactose’):

Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated vegetable oil and sodium laurilsulfate.

Tablet coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172) and indigo carmine aluminium lake (E132).

What Clopidogrel Teva looks like and contents of the pack

The film-coated tablets are light pink to pink, film coated, capsule shaped tablets. One side of the tablet is debossed with the number “93”. The other side of the tablet is debossed with the number “7314”.

Clopidogrel Teva is supplied in:

Peelable perforated blisters of aluminium/aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablets

Perforated blisters of aluminium/aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablets

HDPE bottles with polypropylene closures or child resistant polypropylene closures and silica gel desiccant containing 30 or 100 tablets.

Calendar pack of perforated blisters of aluminium/aluminium containing 28x1 tablets

Not all pack sizes may be marketed.

Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva B.V.,

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturer:

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

GALIEN LPS 98 rue Bellocier 89100 Sens France

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

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

België/Belgique/Belgien

Lietuva

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

UAB “Sicor Biotech”

Tel/Tél: +32 3 820 73 73

Tel: +370 5 266 02 03

България

Luxembourg/Luxemburg

Тева Фармасютикълс България ЕООД

ratiopharm GmbH

Teл: +359 2 489 95 82

Allemagne/Deutschland

 

Tél/Tel: +49 731 402 02

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt.

Tel: +420 251 007 111

Tel.: +36 1 288 64 00

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland

Tlf: +45 44 98 55 11

L-Irlanda

 

Tel: +353 51 321740

Deutschland

Nederland

TEVA GmbH

Teva Nederland B.V.

Tel: (49) 731 402 08

Tel: +31 (0) 800 0228400

Eesti

Norge

Teva Eesti esindus UAB Sicor Biotech

Teva Norway AS

Eesti filiaal

Tlf: (+47) 66 77 55 90

Tel: +372 661 0801

 

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

Tel: +431 97007 0

España

Polska

TEVA PHARMA, S.L.U

Teva Pharmaceuticals Polska Sp. z o.o.

Tél: +(34) 91 387 32 80

Tel.: +(48) 22 345 93 00

France

Portugal

Teva Santé

Teva Pharma - Produtos Farmacêuticos Lda

Tél: +(33) 1 55 91 78 00

Tel: (351) 21 4767550

Hrvatska

România

Pliva Hrvatska d.o.o

Teva Pharmaceuticals S.R.L

Tel: + 385 1 37 20 000

Tel: +4021 230 65 24

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Tel: +353 (0)51 321 740

Tel: +386 1 58 90 390

Ísland

Slovenská republika

ratiopharm Oy

Teva Pharmaceuticals Slovakia s.r.o.

Finnland

Tel: +(421) 2 5726 7911

Sími: +358 20 180 5900

 

Italia

Suomi/Finland

Teva Italia S.r.l.

ratiopharm Oy

Tel: +(39) 028917981

Puh/Tel: +358 20 180 5900

Κύπρος

Sverige

Teva Ελλάς Α.Ε.

Teva Sweden AB

 

Ελλάδα

Tel: +(46) 42 12 11 00

Τηλ: +30 210 72 79 099

 

Latvija

United Kingdom

UAB Sicor Biotech filiāle Latvijā

Teva UK Limited

Tel: +371 67 323666

Tel: +(44) 1977628500

This leaflet was last approved in

 

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

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