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Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets Clopi
2014-07-08 19:01:37 来源: 作者: 【 】 浏览:357次 评论:0

For doctors

 

What is it and how is it used?

Clopidogrel Teva Pharma B.V contains the active substance clopidogrel which belongs to a group of medicines called “platelet aggregation inhibitors.” It works by stopping certain particles in your blood (“platelets”) from sticking together to form blood clots which can block blood flow to important parts of your body including your heart and your brain.

If you suffer from hardening of the arteries (“atherosclerosis”) there is an increased risk of a blood clot forming in your blood vessels. Clopidogrel Teva Pharma B.V. reduces the risk of blood clots forming which in turn reduces the risk of serious conditions such as heart attack and stroke from occurring.

You have been prescribed Clopidogrel Teva Pharma B.V. because:

What do you have to consider before using it?

Do not take Clopidogrel Teva Pharma 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 Pharma B.V.

Take special care with Clopidogrel Teva Pharma B.V.
Tell your doctor before you start to take this medicine if:

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

Use in children
Clopidogrel Teva Pharma B.V. is not recommended for use in children or adolescents under 18 years of age.

Using 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.

Talk to your doctor if you are using or have recently used any of the following medicines:

Taking these medicines in combination with Clopidogrel Teva Pharma B.V. could result in an increased risk of bleeding.

If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed clopidogrel in combination with acetylsalicylic acid, a substance 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 Pharma B.V. with food and drink
You can take Clopidogrel Teva Pharma B.V. with or without food.

Pregnancy and breast-feeding
It is preferable not to use this medicine 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 Pharma B.V. If you become pregnant while taking Clopidogrel Teva Pharma B.V., consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

While taking Clopidogrel Teva Pharma B.V., consult your doctor about the breastfeeding of a baby.

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

Driving and using machines
Clopidogrel Teva Pharma B.V. is unlikely to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Clopidogrel Teva Pharma B.V. Your medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Your medicine also contains an ingredient called hydrogenated castor oil. This ingredient may cause stomach upset and diarrhoea.

How is it used?

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

The usual dose is one 75 mg tablet per day which should be swallowed with water or another liquid. You should take your medicine regularly at the same time each day. You can take it with or without food.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Pharma B.V. once at the start of treatment. Then, the usual dose is one 75-mg tablet of Clopidogrel Teva Pharma B.V. per day

You should continue taking Clopidogrel Teva Pharma B.V. for as long as your doctor has told you to take it.

If you take more Clopidogrel Teva Pharma B.V. than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause an increased risk of bleeding. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Clopidogrel Teva Pharma B.V.
If you forget to take a dose of Clopidogrel Teva Pharma B.V., but remember within 12 hours of the missed dose, take your tablet straight away and then take your next tablet at the usual time.

If you forget to take a dose of Clopidogrel Teva Pharma B.V., but don’t remember within 12 hours of the missed dose, skip the missed dose and take the next tablet at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clopidogrel Teva Pharma B.V.
Do not stop taking Clopidogrel Teva Pharma B.V. without discussing it with your doctor first.

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

What are possible side effects?

Like all medicines, Clopidogrel Teva Pharma B.V. can cause side effects, although not everybody gets them.

Some of the side effects may be serious. If you suffer from any of the following symptoms you should contact your doctor immediately:

Bleeding
The most common side effect (affects 1 to 10 users in 100) reported for medicines containing clopidogrel 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 abdomen, the lung and the joints have also been reported.

If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. This is linked to the way that your medicine works. For minor cuts and injuries (e.g. shaving cuts) you should not worry. However, if you are in any doubt, bleeding becomes serious or you experience unexpected bleeding from unusual parts of your body you should contact your doctor straight away.

The following side effects have been reported. They are listed according to frequency 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

Common side effects:

Uncommon side effects:

Rare side effects:

Very rare side effects:

If any of the side effects get 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 Pharma B.V. after the expiry date that is stated on the outer carton, bottle or blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package to protect from light.

30 tablets HDPE bottles:
Discard any remaining tablets 30 days after first opening of the bottle.

100 tablets HDPE bottles:
Discard any remaining tablets 100 days after first opening of the bottle.

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 Pharma B.V. is a medicine that contains the active substance clopidogrel. It is available as pink, capsule-shaped tablets (75 mg).

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

patients who have recently had a myocardial infarction heart attack. Clopidogrel Teva Pharma B.V. 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 Teva Pharma B.V. 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 Teva Pharma B.V. can be used in patients who are having a heart attack with ST segment elevation an abnormal reading on the ECG or electrocardiogram 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 it used?

The standard dose of Clopidogrel Teva Pharma B.V. is one 75-mg tablet once a day, taken with or without food. In acute coronary syndrome, Clopidogrel Teva Pharma 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 Pharma B.V. is converted into its active form in the body. For genetic reasons, some patients may not be able to convert Clopidogrel Teva Pharma 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 Pharma 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 Pharma 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 Pharma 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 Pharma 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 Pharma 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 Pharma B.V. be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Teva Pharma B.V. to Teva Pharma B.V. on 16 June 2011. 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 Pharma 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 Pharma B.V. 75 mg film-coated tablets

 

Composition

 

Each film-coated tablet contains 75 mg of clopidogrel (as hydrobromide).
Excipients: each tablet contains 62.16 mg lactose monohydrate and 10 mg hydrogenated castor oil.

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Film-coated tablet.
Light pink to pink, capsule-shaped film-coated tablets debossed with “C75” on one side and plain on the other side.

 

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

 

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