Package leaflet: Information for the user

CLOPIDOGREL DOC Generici 75 mg film-coated tablets

Equivalent Medicine
Please read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CLOPIDOGREL DOC Generici is and what it is used for
What you need to know before taking CLOPIDOGREL DOC Generici
How to take CLOPIDOGREL DOC Generici
Possible side effects
How to store CLOPIDOGREL DOC Generici
Contents of the pack and other information

1. What CLOPIDOGREL DOC Generici is and what it is used for

CLOPIDOGREL DOC Generici contains clopidogrel and belongs to a group of medicines
called antiplatelet agents. Platelets are microscopic components of the blood
that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the likelihood of blood clots forming (a process known as thrombosis).
CLOPIDOGREL DOC Generici is taken by adults 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 DOC Generici has been prescribed to you to help prevent the formation of 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 severe 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 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) which prevent the formation of new clots and the growth of existing ones. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of CLOPIDOGREL DOC Generici 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 CLOPIDOGREL DOC Generici plus acetylsalicylic acid.

2. What you need to know before taking CLOPIDOGREL DOC Generici

Do not take CLOPIDOGREL DOC Generici:

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 situations apply to you, or if you are unsure, consult your doctor before
using CLOPIDOGREL DOC Generici.
Warnings and precautions
If any of the conditions listed below apply to you, speak to your doctor before taking
CLOPIDOGREL DOC Generici:

if you are at risk of bleeding, such as:
a medical condition that puts you at risk of internal bleeding (e.g. 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 severe injury
a recent surgical procedure (including dental surgery)
a planned surgical procedure (including dental surgery) within the next 7 days
if you have had a blood clot in an artery of the brain (ischaemic stroke) that occurred within the last 7 days
if you have kidney or liver disease
if you have had an allergic reaction or adverse reaction to any medicine used to treat your condition.

While taking CLOPIDOGREL DOC Generici:

You must inform your doctor if you are scheduled for surgery (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 red spots, with or without unexplained extreme fatigue, 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 due to the way the medicine works, as it prevents blood clots from forming. 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 4 “Possible side effects”).
Your doctor may prescribe blood tests for you.

Children and adolescents
Do not give this medicine to children, as it is not effective.
Other medicines and CLOPIDOGREL DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take
any other medicines, including those not requiring a prescription.
Some medicines may affect how CLOPIDOGREL DOC Generici works, or vice versa.
You must inform your doctor accurately if you are taking:

medicines that may increase your risk of bleeding such as: oral anticoagulants, medicines used to reduce blood clotting,
a non-steroidal anti-inflammatory drug, generally used to treat painful and/or inflammatory conditions of muscles or joints,
heparin or any other injectable medicine used to reduce blood clotting,
ticlopidine, other antiplatelet agents.
a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines normally used to treat depression, or omeprazole or esomeprazole, medicines used to treat stomach problems, or fluconazole or voriconazole, medicines used to treat fungal infections, or efavirenz, a medicine used to treat HIV (human immunodeficiency virus) infection, or carbamazepine, a medicine used to treat certain forms of epilepsy, or moclobemide, a medicine used to treat depression, or repaglinide, a medicine used to treat diabetes, or paclitaxel, a medicine used to treat cancer. If you have experienced severe chest pain (unstable angina or heart attack), you may have been prescribed CLOPIDOGREL DOC Generici in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (not exceeding 1,000 mg within 24 hours) is generally not expected to cause problems, but prolonged use in other circumstances should be discussed with your doctor.

CLOPIDOGREL DOC Generici with food and drink
CLOPIDOGREL DOC Generici can be taken with or without food.
Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine. If you become
pregnant while taking CLOPIDOGREL DOC Generici, contact your doctor immediately, as it is
recommended not to take CLOPIDOGREL DOC Generici during pregnancy.
You must not breastfeed while taking this medicine.
If you are breastfeeding or intend to breastfeed, consult your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that CLOPIDOGREL DOC Generici will affect your ability to drive or operate
machinery.
CLOPIDOGREL DOC Generici contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.

3. How to take CLOPIDOGREL DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose, including for patients diagnosed with "atrial fibrillation" (an irregular heartbeat), is one 75 mg tablet of CLOPIDOGREL DOC Generici daily, taken orally during or regardless of meals, and at the same time each day.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe an initial dose of 300 mg of CLOPIDOGREL DOC Generici (4 tablets of 75 mg) as a single dose at the beginning of treatment.
Afterwards, the recommended dose is one 75 mg tablet of CLOPIDOGREL DOC Generici daily, as described above.
CLOPIDOGREL DOC Generici should be taken for as long as your doctor considers it necessary.
If you take more CLOPIDOGREL DOC Generici than you should
Contact your doctor or go to the nearest hospital emergency department immediately, due to the risk of increased bleeding.
If you forget to take CLOPIDOGREL DOC Generici
If you forget a dose but remember within 12 hours of your usual time, take one tablet immediately and then continue with your next dose at the regular time.
If more than 12 hours have passed, simply take your next dose at the usual time. Do not take a double dose to make up for the forgotten tablet.
If you stop treatment with CLOPIDOGREL DOC Generici:
Do not stop treatment unless your doctor has told you to do so. Before stopping, consult your doctor or pharmacist.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

fever, signs of infection, or severe weakness. 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, itching, or skin blisters. These may be signs of an allergic reaction.

The most common side effect reported with CLOPIDOGREL DOC Generici is bleeding.
Bleeding may occur as gastrointestinal bleeding (in the stomach or intestines), bruising, haematomas (unusual or subcutaneous bleeding or bruising), nosebleeds, or 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 DOC Generici
If you cut yourself or are 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 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 2 “Warnings and precautions”).
Other side effects include:
Common side effects (may affect up to 1 in 10 people): Diarrhoea, abdominal pain, indigestion or stomach burning.
Uncommon side effects (may affect up to 1 in 100 people): Headache, gastric ulcer, vomiting, nausea, constipation, excessive 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): Dizziness, breast enlargement in males.
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 (for example, a general feeling of warmth with sudden general malaise up to fainting); swelling in the mouth; skin blisters; skin allergy; mouth pain (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
hypersensitivity reactions with chest or abdominal pain.
Additionally, your doctor may have detected changes in blood and urine test results.

Reporting of side effects
If you experience any side effects, 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 the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CLOPIDOGREL DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the
blister, after Exp.
The expiry date refers to the last day of that month.
Refer to the storage conditions indicated on the outer packaging.
If CLOPIDOGREL DOC Generici is supplied in PVC/PE/PVDC/aluminium blisters, store below 25°C.
If CLOPIDOGREL DOC Generici is supplied in aluminium/aluminium blisters, the medicine does not require
any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CLOPIDOGREL DOC Generici contains
The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel.
The other components are:
Tablet core: microcrystalline cellulose, mannitol,
hydroxypropylcellulose, crospovidone (Type A), citric acid monohydrate, macrogol 6000, stearic acid, talc
Tablet coating: hypromellose (E464), lactose monohydrate, iron oxide red (E 172),
triacetin (E1518), titanium dioxide (E 171).

Description of the appearance of CLOPIDOGREL DOC Generici and package contents
CLOPIDOGREL DOC Generici film-coated tablets are pink, round, biconvex tablets.
CLOPIDOGREL DOC Generici is supplied in boxes containing 14, 28, 30, 50, 56, 84, 90, 98, 100
film-coated tablets in PVC/PE/PVDC/aluminum blisters or PA/Al/PVC-aluminum foil blisters (aluminum/aluminum).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer
Pharmathen S.A.
Dervenakion 6
15351 Pallini, Attiki
Greece

Alternative manufacturer
Pharmathen International S.A.
Industrial Park Sapes Rodopi Prefecture
Block No 5
69300 Rodopi
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Clopidogrel Pharmathen
Spain: Clopidogrel Viso Pharmaceutica 75 mg Film-coated tablets EFG
Italy: CLOPIDOGREL DOC Generici 75 mg film-coated tablets
United Kingdom: Clopidogrel 75mg Film-coated tablets