PACKAGE LEAFLET: INFORMATION FOR THE USER

CLOPIDOGREL PENSA 75 mg film-coated tablets

Clopidogrel
Generic medicine
Please read this leaflet carefully before using 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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT IS CLOPIDOGREL PENSA AND WHAT IS IT USED FOR?

Clopidogrel Pensa belongs to a group of medicines called antiplatelet agents.
Platelets are very small components in the blood that clump together during blood clotting. Antiplatelet medicines reduce the chances of blood clots forming (a process called thrombosis), because they prevent this clumping.
Clopidogrel Pensa is used in adults to help prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, which may lead to atherothrombotic events (such as stroke, heart attack or death).
Clopidogrel Pensa has been prescribed to you to help prevent blood clots and thus reduce the risk of these serious events because:

you have a condition involving hardening of the arteries (atherosclerosis)
you have previously had a heart attack, stroke, or you suffer from a condition known as peripheral arterial disease
you have suffered from a severe type of chest pain known as “unstable angina” or “myocardial infarction” (heart attack). For the treatment of this condition, your doctor may have inserted a stent into the blocked or narrowed artery to restore blood flow. Your doctor should also have prescribed you acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, and also to prevent blood clotting).

2. WHAT YOU SHOULD KNOW BEFORE TAKING CLOPIDOGREL PENSA

Do not take Clopidogrel Pensa:

if you are allergic (hypersensitive) to clopidogrel or to any of the excipients of this medicine (listed in section 6);
if you have a medical condition causing you to bleed, such as a stomach ulcer or bleeding in the brain;
if you suffer from severe liver disease.

If you think any of these conditions apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel Pensa.
Warnings and precautions
If you have any of the conditions listed below, consult your doctor before taking Clopidogrel Pensa:

if you are at risk of bleeding, for example:
o a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer);
o a blood disorder that makes you prone to internal bleeding (bleeding within tissues, organs, or joints of the body);
o a recent severe injury;
o a recent surgical procedure (including dental surgery);
o a surgical procedure (including dental surgery) planned 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 any reaction to another medicine used to treat the same condition.

While taking Clopidogrel Pensa:

You must inform your doctor if you have scheduled a 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 bruising under the skin, which may appear as red spots, with or without unexplained extreme tiredness, 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 to stop the bleeding. This is related to how the medicine works, as it prevents the formation of blood clots. Minor cuts and injuries, such as shaving cuts, are generally not a concern. However, contact your doctor immediately if you are concerned about bleeding (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 as it is not effective.
Other medicines and Clopidogrel Pensa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may affect the use of Clopidogrel Pensa or vice versa.
You must precisely inform your doctor 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 pain and/or inflammation of muscles or joints,
heparin or any other injectable medicine used to reduce blood clotting,
ticlopidine or prasugrel, other antiplatelet agents,
selective serotonin reuptake inhibitors (including but not limited to fluoxetine or fluvoxamine),
medicines generally used to treat depression (moclobemide),
rifampicin (used to treat serious infections),
omeprazole, esomeprazole or cimetidine, medicines used to treat stomach disorders,
fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines used to treat bacterial and fungal infections,
efavirenz or other antiretroviral medicines (used to treat depression, treatment of HIV infection),
carbamazepine or oxcarbazepine, medicines used to treat certain forms of epilepsy,
paclitaxel, a medicine used to treat cancer,
opioids: while being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain). If you have had severe chest pain (unstable angina or heart attack), you may have been prescribed Clopidogrel Pensa in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain or reduce fever. Occasional use of acetylsalicylic acid (not more than 1000 mg within 24 hours) should generally not cause problems, but prolonged use in other circumstances should be discussed with your doctor.

Clopidogrel Pensa with food and drink
Clopidogrel Pensa can be taken regardless of meals.
Pregnancy and breastfeeding
It is preferable not to use this medicine during pregnancy.
If you are or think you may be pregnant, inform your doctor or pharmacist before taking Clopidogrel Pensa. If you find out you are pregnant while taking Clopidogrel Pensa, seek immediate advice from your doctor, as the use of clopidogrel is not recommended during pregnancy.
You must not breastfeed while taking this medicine.
If you are breastfeeding or planning 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 Pensa will affect your ability to drive or use machines.
Clopidogrel Pensa contains lactose monohydrate.
If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact him/her before taking this medicine.

3. HOW TO TAKE CLOPIDOGREL PENSA

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 75 mg Clopidogrel Pensa tablet daily, taken orally during or apart from meals, at the same time each day.
Additionally, if you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe an initial single dose of 300 mg Clopidogrel Pensa (4 tablets of 75 mg).
You must continue taking Clopidogrel Pensa for as long as prescribed by your doctor.
If you take more Clopidogrel Pensa than you should
Contact your doctor or go to the nearest emergency room immediately due to the increased risk of bleeding.
If you forget to take Clopidogrel Pensa
If you forget to take a dose of Clopidogrel Pensa but remember within 12 hours of your usual dosing time, take the tablet immediately and then take the next dose at your regular time.
If you forget to take a dose for more than 12 hours, take the next single dose at your usual time. Do not take a double dose to make up for the missed tablet.
If you stop taking Clopidogrel Pensa
Do not stop treatment unless instructed by your doctor. Consult your doctor or pharmacist before stopping treatment.
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 everyone will experience them.
Contact your doctor immediately if you notice any of the following:

fever, signs of infection, or extreme tiredness. These symptoms may be caused by a rare reduction in certain blood cells.
signs of liver problems such as yellowing of the skin or eyes (jaundice), which may or may not be associated with bleeding appearing under the skin as red spots and/or confusion (see section 2 “Warnings and precautions”).
swelling of the mouth or skin disorders, such as rash and itching, blisters on the skin. These may be signs of an allergic reaction.

The most commonly reported side effect with clopidogrel use is bleeding.
Bleeding may occur as gastrointestinal or intestinal bleeding, bruising, haematoma (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. In a limited number of cases, bleeding in the eyes, brain, lungs, or joints has also been reported.
If you experience prolonged bleeding while being treated with Clopidogrel Pensa
If you cut or injure yourself, it may take longer than usual to stop the bleeding. This is due to the way the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, for example those caused by shaving, this is generally not a cause for concern.
However, if you are concerned about any bleeding you experience, contact your doctor immediately (see section 2 “Warnings and precautions”).

Other side effects reported with clopidogrel use include:
Common side effects (may affect up to 1 in 10 people)
Diarrhoea, abdominal pain, indigestion, heartburn.

Uncommon side effects (may affect up to 1 in 100 people)
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, 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 and widespread discomfort up to fainting; mouth swelling; skin blisters; skin allergy; mouth pain (stomatitis); drop in blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste.

Side effects with unknown frequency (frequency cannot be estimated from available data):
hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar (hypoglycaemia).

In addition, your doctor may detect changes in blood or 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 the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CLOPIDOGREL PENSA

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the blisters and carton after EXP.
The expiry date refers to the last day of the stated month.
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 you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Clopidogrel Pensa contains
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as clopidogrel
besylate).
The excipients are:
Tablet core:
Corn starch, pregelatinized
Microcrystalline cellulose
Crospovidone Type A
Anhydrous colloidal silica
Stearic acid Type 50
Tablet film coating:
Carnauba wax
Lactose monohydrate
Hypromellose (E464)
Titanium dioxide (E171)
Triacetin (E1518)
Red iron oxide (E172)

Description of the appearance of Clopidogrel Pensa and pack sizes
Clopidogrel Pensa film-coated tablets are pink, round, biconvex, film-coated tablets with a diameter of approximately 8.3 mm.
Clopidogrel Pensa is available in blister packs containing:
14, 28, 30, 50, 84, 90, 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy

Manufacturer
Specifar S.A.
1, 28 Octovriou str., Ag. Varvara
12351 Athens
Greece
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.
Via Grignano, 43
24041 Brembate (BG)
Italy

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Clopidogrel Pensa