设为首页 加入收藏

TOP

Clopidogrel Teva 75 mg film-coated tablets Clopidogrel Hydro
2014-07-08 19:15:58 来源: 作者: 【 】 浏览:394次 评论:0

For doctors

 

What is it and how is it used?

Clopidogrel 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 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 because:

Or:

If you have unstable angina or symptoms of a developing heart attack your doctor may also have inserted a device called a “stent” into the blocked or narrowed blood vessel to hold it open and to restore blood flow.

What do you have to consider before using it?

Do not take Clopidogrel Teva

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

While you are taking Clopidogrel Teva:

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

Using other medicines
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 could result in an increased risk of bleeding.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Clopidogrel Teva with food and drink
You can take Clopidogrel Teva with or without food.

Pregnancy and breastfeeding
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 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 Teva is unlikely to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Clopidogrel Teva
Your medicine 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 medicinal product.

How is it used?

Always take Clopidogrel Teva 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.

In addition, if you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva (4 tablets of 75 mg) once at the start of treatment.

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

If you take more Clopidogrel Teva 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
If you forget to take a dose of Clopidogrel Teva, 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, 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
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.

What are possible side effects?

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

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

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

The most common side effect 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.

Other side effects reported with clopidogrel are:

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 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.

This medicinal product does not require any special storage conditions.

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.

↑ back to table of contents ↑

For doctors

What is it?

Clopidogrel Teva is a medicine that contains the active substance clopidogrel. It is available as pink tablets (75 mg).
Clopidogrel Teva is a ‘generic medicine’. This means that Clopidogrel Teva 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 is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Clopidogrel Teva can be given to the following groups of patients: - patients who have recently had a myocardial infarction (heart attack). Clopidogrel Teva 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 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 can be used in patients who are having myocardial infarction 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 ‘non-Q-wave’ myocardial infarction. The medicine can only be obtained with a prescription.

How is it used?

The standard dose of Clopidogrel Teva is one 75 mg tablet once a day, taken with or without food. In acute coronary syndrome, Clopidogrel Teva 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 Teva, 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 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 Teva 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 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 Teva 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 be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Teva to Teva Pharma B.V. on 28 July 2009.

This summary was last updated in 06-2009.

↑ back to table of contents ↑
 

Name

 

Clopidogrel Teva 75 mg film-coated tablets

 

Composition

 

Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
Excipients: each film-coated tablet contains 62.16 mg of lactose monohydrate.
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 “93” on one side and “7314” on the other side.

 

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

 

以下是“全球医药”详细资料
Tags: 责任编辑:admin
】【打印繁体】【投稿】【收藏】 【推荐】【举报】【评论】 【关闭】 【返回顶部
分享到QQ空间
分享到: 
上一篇Clopidogrel Qualimed 75 mg film.. 下一篇Clopidogrel Winthrop 300 mg fil..

相关栏目

最新文章

图片主题

热门文章

推荐文章

相关文章

广告位