CLOPIDOGREL 75 mg Film-Coated Tablets

Зміст інструкції

1. Clopidogrel Laboratori Eurogenerici 75 mg film-coated tablets
   1. What is Clopidogrel Laboratori Eurogenerici and what is it used for?
   2. What you need to know before taking Clopidogrel Laboratori Eurogenerici
   3. How to take Clopidogrel Laboratori Eurogenerici
   4. Possible side effects
   5. How to store Clopidogrel Laboratori Eurogenerici
   6. Contents of the pack and other information

Clopidogrel Laboratori Eurogenerici 75 mg film-coated tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Clopidogrel Laboratori Eurogenerici is and what it is used for
• 2. What you need to know before you take Clopidogrel Laboratori Eurogenerici
• 3. How to take Clopidogrel Laboratori Eurogenerici
• 4. Possible side effects
• 5. How to store Clopidogrel Laboratori Eurogenerici
• 6. Contents of the pack and other information

1. What is Clopidogrel Laboratori Eurogenerici and what is it used for?

Clopidogrel Laboratori Eurogenerici contains clopidogrel and belongs to a group of medicines called
antiplatelet agents. Platelets are very small elements of the blood that clump together during blood clotting. By preventing this clumping, antiplatelet agents decrease the possibility of blood clot formation (a phenomenon
called thrombosis).

What is it used for
Clopidogrel Laboratori Eurogenerici is taken by adult patients to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can
cause atherothrombotic events (such as stroke, heart attack, or death).
Clopidogrel Laboratori Eurogenerici has been prescribed to help prevent blood clot formation and to reduce the risk of these serious events because:

• you have a condition known as hardening of the arteries (also called atherosclerosis) and
• you have previously had a heart attack, stroke, or a condition known as peripheral obliterating arterial disease, or
• you have previously suffered from a severe type of chest pain known as “unstable angina” or “myocardial infarction” (heart attack). To treat this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore blood flow. Your doctor may have also prescribed acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting);
• you have an irregular heartbeat, a condition called “atrial fibrillation”, and cannot take medicines known as “oral anticoagulants” (vitamin K antagonists) that prevent the formation of new clots and the development of existing ones. You will have been told that “oral anticoagulants” are more effective than acetylsalicylic acid or the combined use of Clopidogrel Laboratori Eurogenerici and acetylsalicylic acid in the treatment of this condition. If you cannot take “oral anticoagulants” and do not have a higher risk of bleeding, your doctor may have prescribed Clopidogrel Laboratori Eurogenerici plus acetylsalicylic acid.

2. What you need to know before taking Clopidogrel Laboratori Eurogenerici

DO NOT take Clopidogrel Laboratori Eurogenerici

• if you are allergic to clopidogrel or to any of the other ingredients of this medicine (listed in section 6);
• if you have active bleeding, such as a stomach ulcer or bleeding in the brain;
• if you suffer from a severe liver disease.

If you believe that any of these situations apply to you, or if you have any doubts, consult your doctor before
taking Clopidogrel Laboratori Eurogenerici.

Warnings and precautions
Talk to your doctor or pharmacist before taking Clopidogrel Laboratori Eurogenerici

• if you are at risk of bleeding such as:
• a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer),
• a blood disorder that makes you prone to internal bleeding (bleeding inside any tissue, organ or joint of the body),
• a recent serious injury,
• recent surgery (including dental surgery),
• surgery (including dental surgery) scheduled in the next seven days;
• if you have had a blood clot in an artery in the brain (ischemic stroke) that occurred in the last seven days;
• if you have kidney or liver disease;
• if you have had an allergy or reaction to any medicine used to treat your condition.

While you are taking Clopidogrel Laboratori Eurogenerici

• you must inform your doctor if you need to have surgery (including dental surgery);
• you must immediately inform your doctor if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruises under the skin that appear as red dots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”);
• if you cut yourself or get injured, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works as it prevents the formation of blood clots. For minor cuts and wounds, such as cutting yourself or shaving, this usually does not cause problems. However, if you are concerned about the bleeding, contact your doctor immediately (see section 4 “Possible side effects”);
• your doctor may prescribe blood tests for you.

Children and adolescents
This medicine should not be given to children because it is not effective.

Other medicines and Clopidogrel Laboratori Eurogenerici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can affect the use of Clopidogrel Laboratori Eurogenerici or vice versa.
You must tell your doctor precisely if you are taking:

• medicines that can increase your risk of bleeding such as: oral anticoagulants, medicines used to reduce blood clotting, or a non-steroidal anti-inflammatory drug, usually used to treat pain and/or inflammation of muscles or joints, or heparin or any other injectable medicine used to reduce blood clotting, or ticlopidine, another antiplatelet agent, or a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines usually used to treat depression;
• omeprazole or esomeprazole, medicines used to treat stomach problems;
• fluconazole or voriconazole, medicines used to treat fungal infections;
• efavirenz, a medicine used to treat HIV (human immunodeficiency virus) infection;
• carbamazepine, a medicine used to treat certain forms of epilepsy;
• moclobemide, a medicine used to treat depression;
• repaglinide, a medicine used to treat diabetes;
• paclitaxel, a medicine used to treat cancer.

If you have had severe chest pain (unstable angina or heart attack), you may have been
prescribed Clopidogrel Laboratori Eurogenerici in combination with acetylsalicylic acid, a substance
present in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic
acid (no more than 1,000 mg in 24 hours) should generally not cause problems, but prolonged use in other
circumstances should be discussed with your doctor.

Clopidogrel Laboratori Eurogenerici with food and drink
Clopidogrel Laboratori Eurogenerici can be taken with or without food.

Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy.
If you are pregnant or think you may be pregnant, tell your doctor or
pharmacist before taking Clopidogrel Laboratori Eurogenerici. If you become pregnant while taking Clopidogrel Laboratori Eurogenerici,
consult your doctor immediately, as it is recommended not to take clopidogrel during pregnancy.
Do not breastfeed your baby while taking this medicine.
If you are breastfeeding or plan to breastfeed, consult your doctor before taking this medicine.
Talk to your doctor or pharmacist before taking any medicine.

Driving and using machines
It is unlikely that Clopidogrel Laboratori Eurogenerici will impair your ability to drive vehicles or
use machines.

Clopidogrel Laboratori Eurogenerici contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

Clopidogrel Laboratori Eurogenerici contains hydrogenated castor oil
This may cause stomach upset or diarrhea.

3. How to take Clopidogrel Laboratori Eurogenerici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose, also for patients diagnosed with “atrial fibrillation” (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Laboratori Eurogenerici per day.
If you have had severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of
Clopidogrel Laboratori Eurogenerici (4 tablets of 75 mg) once at the beginning of treatment.
Subsequently, the recommended dose is one 75 mg tablet of Clopidogrel Laboratori Eurogenerici.

Method of administration
The tablet must be taken orally with or without food and at the same time each day.

Duration of treatment
Clopidogrel Laboratori Eurogenerici must be taken for as long as your doctor deems necessary.

If you take more Clopidogrel Laboratori Eurogenerici than you should
Contact your doctor or the nearest Emergency Room due to the risk of increased bleeding.

If you forget to take Clopidogrel Laboratori Eurogenerici
If you forget to take a dose of Clopidogrel Laboratori Eurogenerici, but remember within 12 hours
of the usual time, take one tablet immediately and then take the next one at the usual time.
If, however, more than 12 hours have passed, simply take the normal dose at the usual time. Do not take
a double dose to make up for the forgotten tablet.

If you stop taking Clopidogrel Laboratori Eurogenerici
Do not stop treatment unless your doctor advises you to do so.Before
stopping it, contact your doctor or pharmacist.
If you have any doubts about 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.
manifest.

Consult your doctor immediately if you experience:

• fever, signs of infection or severe feeling of tiredness. These effects may be due to a rare decrease in some blood cells;
• signs of liver problems such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red dots and/or confusion (see section 2 “Warnings and precautions”);
• swelling in the mouth or skin disorders such as rash and itching, skin blisters. These may be signs of an allergic reaction.

The most common side effect reported with clopidogrel is bleeding. Bleeding may
manifest as bleeding in the stomach or intestine, bruising, hematomas
(unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. In rare cases, bleeding in the
eye, intracranial, in the lungs and joints has also been reported.

If you experience prolonged bleeding while taking Clopidogrel Laboratori Eurogenerici
If you cut yourself or get hurt, it may take longer than usual for the
bleeding to stop. This is due to the way the medicine works as it prevents the formation
of blood clots. For minor cuts and wounds, such as cutting yourself or shaving, this usually does not
create problems. However, if you are concerned about the bleeding, contact your doctor immediately (see section 2
“Warnings and precautions”).

Other side effects include:

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

• diarrhea;
• abdominal pain;
• indigestion and heartburn.

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

• headache;
• gastric ulcer;
• vomiting, nausea;
• constipation;
• excess gas in the stomach or intestines;
• rash, itching;
• dizziness;
• sensation of tingling and numbness.

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

• vertigo;
• enlargement of the breasts in men.

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

• jaundice;
• severe abdominal pain with or without back pain;
• fever, shortness of breath sometimes associated with cough;
• generalized allergic reactions (for example, widespread feeling of warmth with sudden general malaise up to fainting);
• swelling in the mouth;
• skin blisters;
• skin allergy;
• mouth pain (stomatitis);
• decreased blood pressure;
• confusion, hallucinations;
• joint pain, muscle pain;
• altered taste.

In addition, your doctor may have identified changes in blood and urine tests.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Clopidogrel Laboratori Eurogenerici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister pack after the words
EXP. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not use this medicine if you notice any signs of deterioration.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Clopidogrel Laboratori Eurogenerici contains
The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as
hydrogen sulfate).
The other components in the tablet core are mannitol (E421), microcrystalline cellulose (E460), and
hydroxypropylcellulose (E463), macrogol 6000 (E1521), crospovidone (E1202), hydrogenated castor oil.
The other components in the tablet coating are lactose monohydrate, hypromellose (E464), titanium
dioxide (E171), triacetin (E1518), red iron oxide (E172).

Description of the appearance of Clopidogrel Laboratori Eurogenerici and contents of the pack
Clopidogrel Laboratori Eurogenerici is available in the form of film-coated tablets of pink
colour, round, biconvex, with bevelled edges and a diameter of 9 mm.
They are available in cardboard boxes containing 14, 28, 30, 50, 56, 98 and 100 film-coated tablets in
blister packs made of PVC/Aclar-Al or PVC/Aclar/PVC-Al.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan

Manufacturer
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel (Germany)

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
DE: Clopidogrel STADApharm 75 mg Filmtabletten
IT: Clopidogrel Laboratori Eurogenerici 75 mg film-coated tablets
NL: Clopidogrel STADA 75 mg, filmomhulde tabletten