Clopidogrel Hexal

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  • Clopidogrel Hexal
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Meðferðarupplýsingar

  • Meðferðarhópur:
  • Antithrombotic agents,
  • Lækningarsvæði:
  • Peripheral Vascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke
  • Ábendingar:
  • Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease;patients suffering from acute coronary syndrome:- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA);- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.For further information please refer to section 5.1.
  • Vörulýsing:
  • Revision: 2

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Withdrawn
  • Leyfisnúmer:
  • EMEA/H/C/001139
  • Leyfisdagur:
  • 27-07-2009
  • EMEA númer:
  • EMEA/H/C/001139
  • Síðasta uppfærsla:
  • 31-03-2019

Opinber matsskýrsla

European Medicines Agency

7 Westferry Circus, Canary Wharf, London E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16

E-mail: mail@emea.europa.eu http://www.emea.europa.eu

European Medicines Agency, 2009. Reproduction is authorised provided the source is acknowledged.

Doc. Ref.: EMEA/405817/2009

EMEA/H/C/1139

Clopidogrel Hexal

clopidogrel

EPAR summary for the public

This document is a summary of the European Public Assessment Report (EPAR). It explains how

the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to

reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package

Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more

information on the basis for the CHMP recommendations, read the Scientific Discussion (also

part of the EPAR).

What is Clopidogrel Hexal?

Clopidogrel Hexal is a medicine that contains the active substance clopidogrel. It is available as white,

round tablets (75 mg).

Clopidogrel Hexal is a ‘generic medicine’. This means that Clopidogrel Hexal is similar to a

‘reference medicine’ already authorised in the European Union (EU) called Plavix. For more

information on generic medicines, see the question-and-answer document here

What is Clopidogrel Hexal used for?

Clopidogrel Hexal is used in adults to prevent atherothrombotic events (problems caused by blood

clots and hardening of the arteries). Clopidogrel Hexal can be given to the following groups of

patients:

patients who have recently had a myocardial infarction (heart attack). Clopidogrel Hexal can be

started between a few days and 35 days after the attack;

patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to

part of the brain). Clopidogrel Hexal can be started between seven days and six months after the

stroke;

patients with peripheral arterial disease (problems with blood flow in the arteries);

patients who have a condition known as ‘acute coronary syndrome’, when it should be given with

aspirin (another medicine that prevents blood clots), including patients who have had a stent

inserted (a short tube placed in an artery to prevent it closing up). Clopidogrel Hexal can be used

in patients who are having myocardial infarction with ‘ST segment elevation’ (an abnormal

reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the

treatment. It can also be used in patients who do not have this abnormal reading on the ECG, if

they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave’ myocardial

infarction.

The medicine can only be obtained with a prescription.

How is Clopidogrel Hexal used?

The standard dose of Clopidogrel Hexal is one 75 mg tablet once a day, taken with or without food. In

acute coronary syndrome, Clopidogrel Hexal is used together with aspirin and treatment generally

starts with a loading dose of four 75 mg tablets. This is then followed by the standard 75 mg dose once

Medicinal product no longer authorised

a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months

(in non-ST segment elevation syndrome).

How does Clopidogrel Hexal work?

The active substance in Clopidogrel Hexal, clopidogrel, is an inhibitor of platelet aggregation. This

means that it helps to prevent blood clots from forming. When the blood clots, this is due to special

cells in the blood called platelets aggregating (sticking together). Clopidogrel stops the platelets

aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.

This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to

prevent another heart attack or stroke.

How has Clopidogrel Hexal been studied?

Because Clopidogrel Hexal is a generic medicine, studies have been limited to tests to determine that

it is bioequivalent to the reference medicine, Plavix. Two medicines are bioequivalent when they

produce the same levels of the active substance in the body.

What are the benefit and risk of Clopidogrel Hexal?

Because Clopidogrel Hexal is a generic medicine and is bioequivalent to the reference medicine, its

benefit and risk are taken as being the same as those of the reference medicine.

Why has Clopidogrel Hexal been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with

EU requirements, Clopidogrel Hexal has been shown to have comparable quality and to be

bioequivalent to Plavix. Therefore, the CHMP’s view was that, as for Plavix, the benefit outweighs the

identified risk. The Committee recommended that Clopidogrel Hexal be given marketing

authorisation.

Other information about Clopidogrel Hexal:

The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel

Hexal to Acino Pharma GmbH on 28 July 2009.

The full EPAR for Clopidogrel Hexal can be found here

This summary was last updated in 06-2009.

Medicinal product no longer authorised

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel HEXAL 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

What Clopidogrel HEXAL is and what it is used for

Before you take Clopidogrel HEXAL

How to take Clopidogrel HEXAL

Possible side effects

How to store Clopidogrel HEXAL

Further information

1.

WHAT CLOPIDOGREL HEXAL IS AND WHAT IT IS USED FOR

Clopidogrel HEXAL contains the active ingredient Clopidogrel which belongs to a group of medicines

called antiplatelet medicinal products. Platelets (so-called thrombocytes) are very small structures,

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 HEXAL 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 Clopidogrel HEXAL 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 (disturbed blood flow in arms or legs caused by vascular

occlusions) 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.

2.

BEFORE YOU TAKE CLOPIDOGREL HEXAL

Do not take Clopidogrel HEXAL:

If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of

Clopidogrel HEXAL;

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 HEXAL.

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Take special care with Clopidogrel HEXAL:

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

Clopidogrel HEXAL:

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 HEXAL:

You should tell your doctor if a 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

Clopidogrel HEXAL is 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 influence the use of Clopidogrel HEXAL or vice versa.

You should specifically tell your doctor if you take

oral anticoagulants, medicines used to reduce blood clotting,

a 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

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.

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

Clopidogrel HEXAL 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.

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Taking Clopidogrel HEXAL with food and drink

Clopidogrel HEXAL may be taken with or without food.

Pregnancy and breast-feeding

It is preferable not to take this product during pregnancy.

If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist

before taking Clopidogrel HEXAL. If you become pregnant while taking Clopidogrel HEXAL,

consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

You should not breastfeed while taking this medicine.

If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine.

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

Driving and using machines

Clopidogrel HEXAL is unlikely to affect your ability to drive or to use machines.

Important information about some of the ingredients of Clopidogrel HEXAL:

Clopidogrel HEXAL contains hydrogenated castor oil which

may cause stomach upset or diarrhoea.

3.

HOW TO TAKE CLOPIDOGREL HEXAL

Always take Clopidogrel HEXAL exactly as your doctor has told you. You should check with your

doctor or pharmacist if you are not sure.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you

300 mg of Clopidogrel HEXAL (4 tablets of 75 mg) once at the start of treatment. Then, the usual

dose is one 75 mg tablet of Clopidogrel HEXAL per day to be taken orally with or without food, and

at the same time each day.

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

If you take more Clopidogrel HEXAL 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 HEXAL

If you forget to take a dose of Clopidogrel HEXAL, 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 the forgotten individual doses.

If you stop taking Clopidogrel HEXAL

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 product, ask your doctor or pharmacist.

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4.

POSSIBLE SIDE EFFECTS

Like all medicines, Clopidogrel HEXAL can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10)

common (affects 1 to 10 users in 100)

uncommon (affects 1 to 10 users in 1,000)

rare (affects 1 to 10 users in 10,000)

very rare (affects less than 1 user in 10,000)

not known (frequency cannot be estimated from the available data)

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 HEXAL’).

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 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, bleeding in the eye, inside the head, the lung or

the joints has also been reported.

If you experience prolonged bleeding when taking Clopidogrel HEXAL.

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 ‘Take special care with

Clopidogrel HEXAL’).

Other side effects reported with Clopidogrel HEXAL are

-Common side effects:

Diarrhoea, abdominal pain, indigestion or heartburn.

-Uncommon side effects:

Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines,

rashes, itching, dizziness, sensation of tingling and numbness.

-Rare side effect:

Vertigo.

-Very rare side effects:

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); decrease 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.

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5.

HOW TO STORE CLOPIDOGREL HEXAL

Store in the original blister in order to protect from moisture.

Keep out of the reach and sight of children.

Do not use Clopidogrel HEXAL after the expiry date which is stated on the carton and on the blister

after EXP. The expiry date refers to the last day of that month.

Do not use Clopidogrel HEXAL if you notice any visible sign of damage of blister or film-coated

tablets.

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 HEXAL contains

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as besilate).

The other ingredients are:

Tablet core:

Macrogol 6000

Cellulose, microcrystalline (E460)

Crospovidone type A

Castor oil, hydrogenated

Film-coating:

Macrogol 6000

Ethylcellulose (E462)

Titanium dioxide (E 171)

What Clopidogrel HEXAL looks like and contents of the pack

Clopidogrel HEXAL 75 mg film-coated tablets are white to off-white, marbled, round and biconvex.

They are supplied in cardboard cartons containing 14, 28, 30, 50, 84, 90 and 100 tablets in aluminium

blisters. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Acino Pharma GmbH

Am Windfeld 35

83714 Miesbach

Germany

Manufacturer

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Medicinal product no longer authorised

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

Authorisation Holder:

België/Belgique/Belgien

Sandoz N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

België

Tel: +32 (0)2 722 97 97

Luxembourg/Luxemburg

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Allemagne/Deutschland

Tél/Tel: + 49 8024 908 0

България

Representative office Sandoz d.d.

Business Park Sofia, buil. 8B, fl. 6

1766 Sofia

Teл.: + 359 2 970 47 47

Magyarország

Sandoz Hungária Kft.

Tímár u. 20.

H-1034 Budapest

Tel.: +36 1 430 2890

Email : info.hungary@sandoz.com

Česká republika

Sandoz s.r.o.

Jeseniova 30

13000 Praha 3

Tel: +420 221 421 611

Email: office.cz@sandoz.com

Malta

V.J.Salomone Pharma Limited

Marsa HMR 14

Tel: + 356 21220174

Danmark

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

info.sandoz-dk@sandoz.com

Nederland

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

Tel: +31 36 5241600

Email info.sandoz-nl@sandoz.com

Deutschland

HEXAL AG

Industriestraße 25

D-83607 Holzkirchen

Tel: + 49 8024 908 0

Email: service@hexal.com

Norge

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danmark

info.sandoz-dk@sandoz.com

Eesti

Sandoz d.d. Eesti filiaal,

Pärnu mnt 105,

EE-11312 Tallinn,

Tel: +372 6652400

Österreich

HEXAL Pharma GmbH

Carlbergergasse 44

A-1235 Wien

Tel: + 43 (0)53382000

Medicinal product no longer authorised

Ελλάδα

Sambrook Pharmaceutical

4, KAZANTZAKI & AG. PANTELEIMONOS

GR- 13561 AG. ANARGYROI

Τηλ: + 30 210 8323 372

Polska

Lek Polska Sp.z o.o.

ul. Domaniewska 50 C

PL - 02-672 Warszawa

Tel: +48 22 549 15 00

España

Bexal Farmaceutica S.A.

Av/Osa Mayor no 4, Area B

E-28023 Aravaca / Madrid

sandoz.responde@sandoz.com

Portugal

Sandoz Farmacêutica Lda.

Alameda da Beloura

Edifício 1, 2º andar - Escritório 15

2710-693 Sintra

Tel: +351 21 0008781

France

Sandoz SAS

49, avenue Georges Pompidou

92593 Levallois-Perret Cedex

Tél: +33 1 4964 4800

România

Sandoz Pharma Services S.R.L.

Victoria Business Park

Soseaua Bucuresti-Ploiesti 73-81

Corp 2, etaj 2, Sector 1

Tel: +40 21 4075183

Ireland

Rowex Ltd.

Newtown

IRL - Bantry Co. Cork

Tel: + 353 27 50077

Slovenija

Lek Pharmaceuticals d.d.

Verovśkova 57

1526 Ljubljana

Tel: +386 1 5802111

info.lek@sandoz.com

Ísland

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danmörk

info.sandoz-dk@sandoz.com

Slovenská republika

Sandoz d.d. - organizačná zložka

Galvaniho 15/C

SK-821 04 Bratislava

Tel: +421 2 48 200 600

Italia

HEXAL S.p.A. c/o Sandoz S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio / VA

Tel: + 39-02-96 541

Suomi/Finland

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Tanska/Danmark

info.sandoz-dk@sandoz.com

Κύπρος

Panicos Hadjigeorgiou

For P. T. Hadjigeorgiou co ltd

Postal address: P.O. Box 53158-3301 Limassol,

Cyprus

Office address: Yildiz 31-3042 Limassol Cyprus

Τηλ: 00357 25372425

Fax: 00357 25376400

e-mail: hapanicos@cytanet.com.cy

Sverige

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danmark

info.sandoz-dk@sandoz.com

Latvija

Sandoz d.d. Representative Office in Latvia

Meza Str. 4

LV-1048 Riga

Tel: +371 67892006

United Kingdom

United Kingdom

Sandoz Ltd

37 Woolmer Way

Bordon GU35 9QE – UK

Tel: +44 1420 478301

uk.drugsafety@sandoz.com

Medicinal product no longer authorised

Lietuva

Sandoz Pharmaceuticals d.d.,

Branch Office Lithuania

Seimyniskiu Str. 3A

LT-09312 Vilnius

Tel: +370 5 2636037

This leaflet was last approved in.

Detailed information on this medicinal product is available on the European Medicines Agency

website: http://www.ema.europa.eu/

Medicinal product no longer authorised