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Zyllt 75 mg film-coated tablets Clopidogrel Hydrogen Sulphat
2014-07-08 19:10:00 来源: 作者: 【 】 浏览:790次 评论:0

For doctors

 

What is it and how is it used?

Zyllt 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).

Zyllt 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 Zyllt 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 Zyllt:

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

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

While you are taking Zyllt:

Zyllt 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 Zyllt 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 Zyllt 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 Zyllt with food and drink
Zyllt 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 Zyllt. If you become pregnant while taking Zyllt, 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
Zyllt is unlikely to affect your ability to drive or to use machines.

Important information about some of the ingredients of Zyllt
Zyllt contains lactose and hydrogenated castor oil.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Hydrogenated castor oil may cause stomach upset and diarrhoea.

How is it used?

Always take Zyllt 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 Zyllt (4 tablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75 mg tablet of Zyllt per day to be taken orally with or without food, and at the same time each day.

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

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

If you forget to take Zyllt:
If you forget to take a dose of Zyllt, 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 Zyllt:
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, Zyllt 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 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 Zyllt
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 Zyllt’).

Other side effects reported 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 Zyllt 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?

Zyllt is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Zyllt is a ‘generic medicine’. This means that Zyllt 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?

Zyllt is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Zyllt can be given to the following groups of patients:

How is it used?

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

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Zyllt to Krka, d.d., Novo mesto on 28 September 2009.

This summary was last updated in 07-2009.

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Name

 

Zyllt 75 mg film-coated tablets

 

Composition

 

Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).

Excipients:
Each film-coated tablet contains 108.125 mg lactose and 4 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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