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Clopidogrel Stada

Document: Clopidogrel STADA film-coated tablet ENG PL change

Package leaflet: Information for the user


Clopidogrel STADA 75 mg film-coated tablets


Clopidogrel


Read all of this leaflet carefully before you start taking this medicinebecause it contains important information for you.



What is in this leaflet

1. What Clopidogrel STADA is and what it is used for

2. What you need to know before you take Clopidogrel STADA

3. How to take Clopidogrel STADA

4. Possible side effects

5. How to store Clopidogrel STADA

6. Contents of the pack and other information


1. What Clopidogrel STADA is and what it is used for


Clopidogrel STADA contains clopidogrel and 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 STADA is taken by adults 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 STADA to help prevent blood clots and reduce the risk of these severe events because:



2. What you need to know before you take Clopidogrel STADA


DO NOT take Clopidogrel STADA:


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


Warnings and precautions

Talk to your doctor or pharmacist before taking Clopidogrel STADA, especially:


if you have a risk of bleeding such as


While you are taking Clopidogrel STADA:


Children and adolescents

Do not give this medicine to children because it does not work.


Other medicines and Clopidogrel STADA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some other medicines may influence the use of Clopidogrel STADA 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 STADA 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.


Clopidogrel STADA with food and drink

Clopidogrel STADA 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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


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


You should not breast-feed while taking this medicine.

If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.


Ask your doctor or pharmacist for advice before taking any medicine.


Driving and using machines

Clopidogrel STADA is unlikely to affect your ability to drive or to use machines.


Clopidogrel STADA 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.


3. How to take Clopidogrel STADA


Always take this medicine exactly as your doctor or pharmacist has told you. 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 (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel STADA per day to be taken orally with or without food, and at the same time each day.


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


If you take more Clopidogrel STADA 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 STADA:

If you forget to take a dose of Clopidogrel STADA, 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.


If you stop taking Clopidogrel STADA:

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 medicine, ask your doctor or pharmacist.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


Contact your doctor immediately if you experience:


The most common side effect reported with clopidogrel 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 STADA

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 ‘Warnings and precautions’).


Other side effects include:

Common side effects (may affect up to 1 in 10 people):

Diarrhoea, abdominal pain, indigestion or heartburn.


Uncommon side effects (may affect up to 1 in 100 people):

Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.


Rare side effect (may affect up to 1 in 1,000 people):

Vertigo.


Very rare side effects (may affect up to 1 in 10,000 people):

Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste of food.


In addition, your doctor may identify changes in your blood or urine test results.


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via {to be completed nationally: the national reporting system listed in Appendix V}. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Clopidogrel STADA


Keep this medicine out of the sight and reach of children.

Do not store above 30 °C.


Store in the original package in order to protect from moisture.


Do not use Clopidogrel STADA after the expiry date which is stated on the blisters and the carton after EXP. The expiry date refers to the last day of that month.


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


Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information


What Clopidogrel STADA contains

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as clopidogrel besilate).


The other ingredients are:

Tablet core:

Maize Starch, Pregelatinised

Cellulose, Microcrystalline

Crospovidone Type A

Silica, Colloidal Anhydrous

Stearic Acid Type 50


Film-coating:

Carnauba wax

Lactose monohydrate

Hypromellose (E464)

Titanium dioxide (E171)

Triacetin (E1518)

Iron oxide red (E172)


What Clopidogrel STADA looks like and contents of the pack

Clopidogrel STADA film-coated tablets are pink, round, biconvex, film-coated tablets with ‘75’ embossed on one side and a diameter of approximately 8.3 mm.


Clopidogrel STADA is available in blister packs of:

14, 28, 30, 50, 56, 84, 90, 98 100 film-coated tablets


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer:


STADA Arzneimittel AG

Stadastrasse 2-18

DE-61118 Bad Vilbel

Germany


Manufacturer:
Specifar S.A.

1, 28 Octovriou str., Ag. Varvara, 12351 Athens

Greece

0030 210 54 01 500

0030 210 54 01 600


STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel

Germany


Aliud Pharma GmbH

Gottlieb-Daimler-Strasse 19, 89150 Laichingen

Germany


This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden: Clopidogrel STADA

Belgium: Clopidogrel EG 75 mg filmomhulde tabletter

Germany: Clopidogrel AL 75 mg Filmtabletten

Italy: Clopidogrel EG - 75 mg compresse rivestite con film

Luxembourg: Clopidogrel EG 75 mg comprimés pelliculés

The Netherlands: Clopidogrel CF 75 mg, filmomhulde tabletten


This leaflet was last revised in 2014-09-05.