设为首页 加入收藏

TOP

Clopidogrel TAD 75 mg film-coated tablets Clopidogrel Hydroc
2014-07-08 19:08:54 来源: 作者: 【 】 浏览:401次 评论:0

For doctors

 

What is it and how is it used?

Clopidogrel TAD 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 TAD 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 TAD 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 TAD

Take special care with Clopidogrel TAD
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel TAD:

While you are taking Clopidogrel TAD:

Clopidogrel TAD 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 TAD or vice versa.

You should specifically tell your doctor if you take

An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period), a substance present in many medicines used to relieve pain and lower fever, should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel TAD with food and drink
Clopidogrel TAD 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 TAD. If you become pregnant while taking Clopidogrel TAD, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

While taking Clopidogrel TAD, 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 TAD is unlikely to affect your ability to drive or to use machines.

Important information about some of the ingredients of Clopidogrel TAD
Clopidogrel TAD contains hydrogenated castor oil which may cause stomach upset and diarrhoea.

How is it used?

Always take Clopidogrel TAD 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 of Clopidogrel TAD per day to be taken orally with or without food, and at the same time each day.

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

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

If you stop taking Clopidogrel TAD:
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 TAD 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) 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 TAD
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 TAD’).

Other side effects reported 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 TAD 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.

↑ back to table of contents ↑

For doctors

What is it?

Clopidogrel TAD is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Clopidogrel TAD is a ‘generic medicine’. This means that Clopidogrel TAD 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 TAD is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Clopidogrel TAD can be given to the following groups of patients:

How is it used?

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

How does it work?

The active substance in Clopidogrel TAD, 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 TAD 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 TAD 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 TAD 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 TAD 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 TAD be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel TAD to Tad Pharma GmbH on 23 September 2009.

 

This summary was last updated in 07-2009.

↑ back to table of contents ↑
 

Name

 

Clopidogrel TAD 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!

 

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 Acino Pharma 75 mg .. 下一篇Clopidogrel Sandoz 75 mg film-c..

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