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Clopidogrel Teva Generics B.V. 75 mg film-coated tablets Clo
2014-07-08 19:12:33 来源: 作者: 【 】 浏览:413次 评论:0

For doctors

 

What is it and how is it used?

Clopidogrel Teva Generics B.V. 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 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 Clopidogrel Teva Generics B.V. 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 Teva Generics B.V.

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.:

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

Clopidogrel Teva Generics B.V. 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 Teva Generics B.V. 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 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
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.

How is it used?

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.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Generics B.V. (4 tablets 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 or without food, and at the same time each day.

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

If you take more Clopidogrel Teva Generics B.V. 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 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.

What are 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:

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, 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 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 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:

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

Uncommon side effects (affects 1 to 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.

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

Very rare side effects (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); 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?

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.

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For doctors

What is it?

Clopidogrel Teva Generics B.V. is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).

Clopidogrel Teva Generics B.V. is a ‘generic medicine’. This means that Clopidogrel Teva Generics B.V. 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 Teva Generics B.V. is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Clopidogrel Teva Generics B.V. can be given to the following groups of patients:

The medicine can only be obtained with a prescription.

How is it used?

The standard dose of Clopidogrel Teva Generics B.V. is one 75-mg tablet once a day, taken with or without food. In acute coronary syndrome, Clopidogrel Teva Generics B.V. is used together with aspirin and treatment generally starts with a loading dose of four 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).

Clopidogrel Teva Generics B.V. is converted into its active form in the body. For genetic reasons, some patients may not be able to convert Clopidogrel Teva Generics B.V. as effectively as others, which could reduce their response to the medicine. The best dose to use in these patients has not yet been determined.

How does it work?

The active substance in Clopidogrel Teva Generics B.V., 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 Teva Generics B.V. is a generic medicine, studies in patients 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 Teva Generics B.V. 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 Teva Generics B.V. 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 CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Generics B.V. 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 Teva Generics B.V. be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Teva Generics B.V. to Teva Generics B.V. on 28 October 2010. The marketing authorisation is valid for five years, after which it can be renewed.

V. can be found on the Agency’s website under EMA website/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Clopidogrel Teva Generics B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2010.

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Name

 

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

 

Composition

 

Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).

Excipient:
Each film-coated tablet contains 13 mg hydrogenated castor oil.

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Film-coated tablet.
Pink, round and slightly convex film-coated tablets.

 

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

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