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Clopidogrel HEXAL 75 mg film-coated tablets Clopidogrel
2014-07-08 18:58:48 来源: 作者: 【 】 浏览:377次 评论:0

For doctors

 

What is it and how is it used?

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:

What do you have to consider before using it?

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.

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

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

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.

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 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 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.

While taking Clopidogrel HEXAL, 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
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.

How is it used?

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. Contact your doctor or pharmacist before stopping.

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

What are possible side effects?

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

Contact your doctor immediately if you experience:

The most common side effect (affects 1 to 10 patients in 100) 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’).

Side effects may occur with certain frequencies, which are defined as follows 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.

Other side effects reported with clopidogrel 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.

How should it be stored?

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.

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For doctors

What is it?

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 it 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:

How is it 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 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 it 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 it 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 benefits has it shown during the studies?

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.

What is the risk associated?

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 it 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.

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Hexal to Acino Pharma GmbH on 28 July 2009.

This summary was last updated in 06-2009.

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Name

 

Clopidogrel HEXAL 75 mg film-coated tablets

 

Composition

 

Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Excipients: each tablet contains 3.80 mg hydrogenated castor oil.

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Film-coated tablet.

White to off-white, marbled, round and biconvex film-coated tablets.

 

Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

 

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