Clopidogrel Winthrop 300 mg film-coated tablets Clopidogrel - United Kingdom[英国药品]

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Clopidogrel Winthrop 300 mg film-coated tablets Clopidogrel

2014-07-08 19:15:27 来源: 作者: 【大中小】浏览:319次评论:0条

For doctors

What is it and how is it used?

IS USED FOR

Clopidogrel Winthrop 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 Winthrop 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 Winthrop 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 Winthrop:

If you are allergic hypersensitive to clopidogrel or any of the other ingredients of Clopidogrel Winthrop If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain If you suffer from severe liver disease.

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

Take special care with Clopidogrel Winthrop:
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Winthrop:
- if you have a risk of bleeding such as

While you are taking Clopidogrel Winthrop:
- You should tell your doctor if a surgery (including dental) is planned.
- You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE EFFECTS’). - 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 usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘POSSIBLE SIDE EFFECTS’).
- Your doctor may order blood tests.

Clopidogrel Winthrop 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 Winthrop or vice versa.

You should specifically tell your doctor if you take

If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Winthrop in combination with acetylsalicylic acid, a substance present in many medicines 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 Winthrop with food and drink
Clopidogrel Winthrop may be taken with or without food.

Pregnancy and breastfeeding
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 Winthrop. If you become pregnant while taking Clopidogrel Winthrop, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

While taking Clopidogrel Winthrop, consult your doctor about the breast-feeding of a baby. 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 Winthrop is unlikely to affect your ability to drive or to use machines.

Important information about some of the ingredients of Clopidogrel Winthrop: Clopidogrel Winthrop 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 medicine.

Clopidogrel Winthrop also contains hydrogenated castor oil which may cause stomach upset or diarrhoea.

How is it used?

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

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Winthrop (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75 mg tablet of Clopidogrel Winthrop per day to be taken orally with or without food, and at the same time each day.

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

If you take more Clopidogrel Winthrop than you should:
Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.

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 Winthrop can cause side effects, although not everybody gets them.

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

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

Contact your doctor immediately if you experience:

The most common side effect reported with Clopidogrel Winthrop 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 Winthrop
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 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 Winthrop’).

Other side effects reported with Clopidogrel Winthrop 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 Winthrop after the expiry date which is stated on the carton and on the blister, after EXP.
This medicinal product does not require any special storage conditions.

Do not use Clopidogrel Winthrop if you notice any visible sign of deterioration.

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 Winthrop is a medicine that contains the active substance clopidogrel. It is available as pink tablets (round: 75 mg; oblong: 300 mg).

What is it used for?

Clopidogrel Winthrop is used to prevent problems caused by blood clots in adults who have:

recently had a myocardial infarction heart attack. Clopidogrel Winthrop can be started between a few days and 35 days after the attack

recently had an ischaemic stroke stroke caused by failure of the blood supply to part of the brain. Clopidogrel Winthrop can be started between seven days and six months after the stroke

peripheral arterial disease problems with blood flow in the arteries

a condition known as acute coronary syndrome, when it should be given with aspirin another medicine that prevents blood clots. Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina a severe type of chest pain. Some of these patients have had a stent inserted a short tube placed in an artery to prevent it from closing up.

atrial fibrillation irregular rapid contractions of the upper chambers of the heart, when it should be given with aspirin. It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.

The medicine can only be obtained with a prescription.

How is it used?

The standard dose of Clopidogrel Winthrop is one 75-mg tablet once a day. In acute coronary syndrome, treatment generally starts with a loading dose of one 300-mg tablet or 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 unstable angina or ‘non-Q-wave’ myocardial infarction). In acute coronary syndrome and atrial fibrillation, Clopidogrel Winthrop is used together with aspirin, the dose of which should not be higher than 100 mg.

Clopidogrel Winthrop is converted into its active form in the body. For genetic reasons, some patients may not be able to convert Clopidogrel Winthrop 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 Winthrop, 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?

Clopidogrel Winthrop has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or ischaemic stroke, or who had established peripheral arterial disease. The main measure of effectiveness was how many patients experienced a new ‘ischaemic event’ (heart attack, ischaemic stroke or death) over one to three years.

In acute coronary syndrome, Clopidogrel Winthrop has been compared with placebo (a dummy treatment) in one study involving over 12,000 patients with non-ST segment elevation, 2,172 of whom had a stent inserted during the study (CURE study, lasting up to a year). Clopidogrel Winthrop has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted for up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Clopidogrel Winthrop with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks. In the studies of acute coronary syndrome, all of the patients also took aspirin and the main measure of effectiveness was the number of patients who experienced an ‘event’ such as a blocked artery, another heart attack or death during the study.

In atrial fibrillation, Clopidogrel Winthrop has been compared with placebo (both taken together with aspirin) in one main study involving around 7,500 patients who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy. The patients were treated for an average of three years, and the main measure of effectiveness was the number of patients who experienced an ‘event’ such as a heart attack, ischaemic stroke or death.

What benefits has it shown during the studies?

Clopidogrel Winthrop was more effective than aspirin at preventing new ischaemic events. In CAPRIE, there were 939 events in the Clopidogrel Winthrop group, and 1,020 in the aspirin group. This corresponds to a relative reduction in risk of 9% compared with aspirin. This means that fewer patients will have new ischaemic events if they receive Clopidogrel Winthrop than if they receive aspirin. In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Clopidogrel Winthrop instead of aspirin.

In non-ST segment elevation acute coronary syndrome, the overall relative reduction in the risk of an event compared with placebo was 20%. There was also a reduction in the patients who had a stent inserted. In ST segment elevation myocardial infarction, fewer patients on Clopidogrel Winthrop had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study). This showed that Clopidogrel Winthrop reduces the risk of an event.

In the study in atrial fibrillation patients, Clopidogrel Winthrop taken together with aspirin reduced the risk of new events by 11% compared with placebo taken with aspirin, with the largest reduction (28%) seen for stroke.

What is the risk associated?

The most common side effects with Clopidogrel Winthrop (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured. For the full list of all side effects reported with Clopidogrel Winthrop, see the Package Leaflet.

Clopidogrel Winthrop should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients. It must not be used in patients who have severe liver disease or a disease that may cause bleeding such as a stomach ulcer or bleeding in the brain.

Why has it been approved?

The CHMP decided that Clopidogrel Winthrop’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Winthrop on 16 July 2008. This authorisation was based on the authorisation granted to Plavix in 1998 (‘informed consent’). The marketing authorisation holder is Sanofi-Aventis. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Clopidogrel Winthrop, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist..

This summary was last updated in 12-2010.

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Name

Clopidogrel Winthrop 300 mg film-coated tablets

Composition

Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen sulphate).
Excipients: each film-coated tablet contains 12 mg of lactose and 13.2 mg of hydrogenated castor oil.

For a full list of excipients, see section 6.1.