CLOPIDOGREL EG STADA

Package leaflet: Information for the user

Clopidogrel Laboratori Eurogenerici 75 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including 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 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

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

Clopidogrel Laboratori Eurogenerici contains clopidogrel and belongs to a group of medicines called
antiplatelet agents. Platelets are very small blood components that clump together during blood
clotting. By preventing this clumping, antiplatelet medicines reduce the likelihood of blood clots
forming (a process known as thrombosis).
What it is 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 lead to
atherothrombotic events (such as stroke, heart attack, or death).
Clopidogrel Laboratori Eurogenerici has been prescribed to you to help prevent blood clots 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 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 inserted a stent into the blocked or narrowed artery to restore blood flow. Your doctor may also have prescribed you acetylsalicylic acid (a substance found 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 you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists) that prevent the formation of new clots and the progression of existing ones. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Clopidogrel Laboratori Eurogenerici and acetylsalicylic acid in treating this condition. If you cannot take “oral anticoagulants” and do not have an increased risk of bleeding, your doctor may have prescribed you Clopidogrel Laboratori Eurogenerici plus acetylsalicylic acid.

2. What you should 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 severe liver disease.

If you think any of these apply to you, or if you are unsure, consult your doctor before
taking Clopidogrel Laboratori Eurogenerici.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clopidogrel Laboratori Eurogenerici

• if you have a 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 within any tissue, organ, or joint of the body),
  • a recent serious injury,
  • a recent surgical procedure (including dental surgery),
  • a surgical procedure (including dental surgery) scheduled within the next seven days;
• if you have had a blood clot in an artery of the brain (ischaemic stroke) within 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 taking Clopidogrel Laboratori Eurogenerici

• you must inform your doctor if you are due to undergo any surgical procedure (including dental surgery);
• you must inform your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) which includes fever and skin bruising appearing as small red spots, with or without unexplained extreme fatigue, confusion, or 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 the bleeding to stop. This is due to how the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, such as shaving or minor cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 4 “Possible side effects”);
• your doctor may prescribe blood tests for you.

Children and adolescents
This medicine must not be given to children because it is not effective.
Other medicines and Clopidogrel Laboratori Eurogenerici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
Some medicines can affect the use of Clopidogrel Laboratori Eurogenerici or vice versa.
You must inform your doctor precisely if you are taking:

• medicines that may increase your risk of bleeding such as:
  o oral anticoagulants, medicines used to reduce blood clotting,
  o a non-steroidal anti-inflammatory drug, generally used to treat painful and/or inflammatory conditions of muscles or joints,
  o heparin or any other injectable medicine used to reduce blood clotting,
  o ticlopidine, another antiplatelet agent,
  o 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 within 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, inform your doctor or
pharmacist before taking Clopidogrel Laboratori Eurogenerici. If you become pregnant while taking Clopidogrel Laboratori Eurogenerici,
contact your doctor immediately, as clopidogrel is not recommended during pregnancy.
You must not breastfeed while being treated with this medicine.
If you are breastfeeding or planning 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 or
use machines.
Clopidogrel Laboratori Eurogenerici contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
Clopidogrel Laboratori Eurogenerici contains hydrogenated castor oil
This may cause stomach upset or diarrhoea.

3. How to take Clopidogrel Laboratori Eurogenerici

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose, including for patients diagnosed with "atrial fibrillation" (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Laboratori Eurogenerici daily.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe a single 300 mg dose of Clopidogrel Laboratori Eurogenerici (4 tablets of 75 mg) at the beginning of treatment.
Afterwards, the recommended dose is one 75 mg tablet of Clopidogrel Laboratori Eurogenerici daily.
Method of administration
The tablet should be taken orally, with or without food, at the same time each day.
Duration of treatment
Clopidogrel Laboratori Eurogenerici should be taken for as long as your doctor considers it necessary.
If you take more Clopidogrel Laboratori Eurogenerici than you should
Contact your doctor or the nearest emergency department 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 dose at the regular time.
If more than 12 hours have passed, simply take the next dose at the usual time. Do not take a double dose to make up for the missed tablet.
If you stop treatment with Clopidogrel Laboratori Eurogenerici
Do not stop treatment unless your doctor advises you to do so. Before stopping, consult your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Consult your doctor immediately if you experience:

• fever, signs of infection, or severe tiredness. These effects may be due to a rare reduction in certain 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 spots and/or confusion (see section 2 "Warnings and precautions");
• swelling in the mouth or skin problems 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 present as bleeding in the stomach or intestines, bruising, haematomas (unusual bleeding or subcutaneous bruising), nosebleeds, blood in the urine. In rare cases, bleeding in the eye, intracranial bleeding, in the lungs, or in the joints has also been reported.
If you experience prolonged bleeding while taking Clopidogrel Laboratori Eurogenerici
If you get a cut or injury, 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 or injuries, such as shaving cuts, this usually does not cause problems. However, if you are concerned about 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):

• diarrhoea;
• abdominal pain;
• indigestion and stomach burning.

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

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

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

• vertigo;
• breast enlargement 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, difficulty breathing sometimes associated with cough;
• generalized allergic reactions (e.g., widespread feeling of warmth with sudden general malaise up to fainting);
• mouth swelling;
• skin blisters;
• skin allergy;
• mouth pain (stomatitis);
• decrease in blood pressure;
• confusion, hallucinations;
• joint pain, muscle pain;
• taste disturbances.

In addition, your doctor may have identified changes in blood and urine test results.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and blister after the words
EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Do not use this medicine if you notice any signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Clopidogrel Laboratori Eurogenerici contains
The active substance 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),
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 pack sizes
Clopidogrel Laboratori Eurogenerici is available as pink, round, biconvex, film-coated tablets with bevelled edges and a diameter of 9 mm.
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 Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel (Germany)
This medicinal product is authorized 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 compresse rivestite con film
NL: Clopidogrel STADA 75 mg, filmomhulde tabletten