CLOPIDOGREL 75 mg Tabletki Powlekane

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1. CLOPIDOGREL DOC Generici 75 mg film-coated tablets
   1. What is CLOPIDOGREL DOC Generici and what it is used for
   2. What you need to know before taking CLOPIDOGREL DOC Generici
   3. How to take CLOPIDOGREL DOC Generici
   4. Possible side effects
   5. How to store CLOPIDOGREL DOC Generici
   6. Package Contents and Other Information

CLOPIDOGREL DOC Generici 75 mg film-coated tablets

Equivalent 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 DOC Generici is and what it is used for
• 2. What you need to know before you take CLOPIDOGREL DOC Generici
• 3. How to take CLOPIDOGREL DOC Generici
• 4. Possible side effects
• 5. How to store CLOPIDOGREL DOC Generici
• 6. Contents of the pack and other information

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

CLOPIDOGREL DOC Generici contains clopidogrel and belongs to a group of medicines
called antiplatelet agents. Platelets are microscopic elements of the blood that clump together during blood coagulation. By preventing this aggregation, antiplatelet agents reduce the possibility of blood clot formation (a phenomenon called 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 cause atherothrombotic events (such as stroke, heart attack, or death).
CLOPIDOGREL DOC Generici has been prescribed to you 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 severe 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 DOC Generici 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 DOC Generici plus acetylsalicylic acid.

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

Donottake 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 ongoing bleeding, such as a stomach ulcer or a haemorrhage in the brain;
• if you suffer from a severe liver disease.

If you believe any of these apply to you, or if you have any doubts, consult your doctor before
using CLOPIDOGREL DOC Generici.

Warnings and precautions
In the presence of any of the situations mentioned below, consult 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 (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) planned for the next 7 days
• if you have had a blood clot in an artery in the brain (ischaemic stroke) that occurred in the last 7 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 DOC Generici:

• You must inform your doctor if you need to undergo 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 or injure yourself, 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 4 “Possible side effects”).
• Your doctor may prescribe blood tests.

Children and adolescents
Do not give this medicine to children because it is not effective.

Other medicines and CLOPIDOGREL DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
Some medicines can affect the use of CLOPIDOGREL DOC Generici or vice versa.
You must inform your doctor accurately if you are taking:

• medicines that can increase your risk of bleeding such as: oral anticoagulants, medicines used to reduce blood clotting,
• a non-steroidal anti-inflammatory drug, usually used to treat pain and/or inflammation of muscles or joints,
• heparin or any other injectable drug 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 had 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 (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 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 are pregnant or are planning a pregnancy, or if you 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, consult your doctor immediately
as it is recommended not to take CLOPIDOGREL DOC Generici during
pregnancy.
You should 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 operating machinery
It is unlikely that CLOPIDOGREL DOC Generici will affect your ability to drive vehicles and
operate machinery.

CLOPIDOGREL DOC Generici contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take CLOPIDOGREL DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose, also for patients diagnosed with “atrial fibrillation” (an irregular heartbeat), is one 75 mg tablet of CLOPIDOGREL DOC Generici per day to be taken orally during or away from meals, and at the same time each day.
If you have had severe chest pain (unstable angina or heart attack), your doctor may give you 300
mg of CLOPIDOGREL DOC Generici (4 tablets of 75 mg) once at the beginning of treatment.
Subsequently, the recommended dose is one 75 mg tablet of CLOPIDOGREL DOC Generici
per day as described above.
CLOPIDOGREL DOC Generici must 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 the emergency room of the nearest hospital due to the risk of increased
bleeding.

If you forget to take CLOPIDOGREL DOC Generici
If you forget to take a dose, but remember within 12 hours of your usual time, take one
tablet immediately and then take the next one at your usual time.
If more than 12 hours have passed, simply take your normal dose at the usual time. Do not
take a double dose to make up for a missed tablet.

If you stop taking CLOPIDOGREL DOC Generici:
Do not stop treatment unless your doctor has told you to. Before
stopping it, contact your doctor or pharmacist.
If you have any questions about using 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.
li manifestino.

Contact your doctor immediately if you experience:

• fever, signs of infection or a severe feeling of weakness. These effects may be due to a rare decrease 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 disorders such as skin rash, itching, blisters. These may be signs of an allergic reaction.

The most common side effectreported with CLOPIDOGREL DOC Generici is
bleeding.Bleeding may manifest as bleeding in the stomach or intestines,
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 DOC Generici
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 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, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, skin rash,
itching, dizziness, tingling and numbness.
Rare side effects (may affect up to 1 in 1000 people): Dizziness, increased volume
of the breasts 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, shortness of breath sometimes associated with cough;
generalised allergic reactions (for example, a feeling of general warmth with sudden
general malaise up to fainting); swelling in the mouth; blisters; skin allergy;
mouth pain (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain;
muscle pain; changes in the taste of food.
Side effects with unknown frequency (frequency cannot be estimated based on available data):
hypersensitivity reactions with chest or abdominal pain.
In addition, your doctor may have identified changes in blood and urine tests.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at 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 which is reported 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/aluminum blisters, store at a
temperature below 25°C.
If CLOPIDOGREL DOC Generici is supplied in aluminum/aluminum blisters, the medicine does not require
any particular storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine in 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 DOC Generici contains
The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel.
The other ingredients are: Tablet core: microcrystalline cellulose, mannitol,
hydroxypropylcellulose, crospovidone (Type A), citric acid monohydrate, macrogol 6000, stearic acid, talc
Tablet coating: hypromellose (E464), lactose monohydrate, red iron oxide (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.
CLOPIDOGREL DOC Generici is supplied in cartons containing 14, 28, 30, 50, 56, 84, 90, 98, 100
film-coated tablets in PVC/PE/PVDC/aluminum blisters or PA/Al/PVC blisters with an aluminum foil
(aluminum/aluminum).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
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 authorised in the Member States of the European Economic Area under the
following denominations:
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