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Clopidogrel Qualimed 75 mg film-coated tablets Clopidogrel H
2014-07-08 19:16:24 来源: 作者: 【 】 浏览:397次 评论:0

For doctors

 

What is it and how is it used?

Clopidogrel Qualimed belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, smaller than red or white blood cells, 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 Qualimed 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 Qualimed 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 Qualimed

If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Qualimed.

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

While you are taking Clopidogrel Qualimed:

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

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

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

How is it used?

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

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

If you take more Clopidogrel Qualimed 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 Qualimed:
If you forget to take a dose of Clopidogrel Qualimed, 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 Qualimed:
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 Qualimed 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 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 Qualimed
If you cut or injure yourself, it may take 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 Qualimed’).

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

How is it used?

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

How does it work?

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

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Qualimed to Qualimed on 23 September 2009.

 

This summary was last updated in 07-2009.

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Name

 

Clopidogrel Qualimed 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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