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Clopidogrel Teva Pharma 75 mg film-coated tablets Clopidogre
2014-07-08 19:03:22 来源: 作者: 【 】 浏览:361次 评论:0

For doctors

 

What is it and how is it used?

Clopidogrel Teva Pharma 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 Pharma 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 Pharma 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 Pharma

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.

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

While you are taking Clopidogrel Teva Pharma:

Clopidogrel Teva Pharma 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 Pharma or vice versa.

You should specifically tell your doctor if you take

Taking Clopidogrel Teva Pharma with food and drink
Clopidogrel Teva Pharma may be taken with or without food.

Pregnancy and breast-feeding
It is preferable not to take this product during pregnancy.

If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Teva Pharma. If you become pregnant while taking Clopidogrel Teva Pharma, 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 Pharma is unlikely to affect your ability to drive or to use machines.

Important information about some of the ingredients of Clopidogrel Teva Pharma Clopidogrel Teva Pharma contains hydrogenated castor oil which may cause stomach upset or diarrhoea.

How is it used?

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

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

If you take more Clopidogrel Teva Pharma 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 Pharma:
If you forget to take a dose of Clopidogrel Teva Pharma, 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 the forgotten individual doses.

If you stop taking Clopidogrel Teva Pharma:
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 Pharma can cause side effects, although not everybody gets them.

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

Contact your doctor immediately if you experience:

The most common side effect reported with Clopidogrel Teva Pharma 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 Pharma
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 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 Teva Pharma’).

Other side effects reported with Clopidogrel Teva Pharma 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?

Keep out of the reach and sight of children.
Do not use Clopidogrel Teva Pharma 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.

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 Pharma is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).

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

1 Previously known as Clopidogrel HCS.

The medicine can only be obtained with a prescription.

How is it used?

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

How does it work?

The active substance in Clopidogrel Teva Pharma, 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 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 Pharma 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 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 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 be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel HCS on 21 September 2009. The name of the medicine was changed to Clopidogrel Teva Pharma on 20 October 2009. The marketing authorisation holder is Teva Pharma B.V. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Clopidogrel Teva Pharma, read the Package Leaflet (also part of the EPAR).

This summary was last updated in 05-2010.

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Name

 

Clopidogrel Teva Pharma 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 of 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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