Clopidogrel Alter

PATIENT INFORMATION LEAFLET

CLOPIDOGREL ALTER 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 may be harmful.
• If you experience any adverse reaction, contact your doctor or pharmacist. This includes any possible adverse reaction not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. WHAT CLOPIDOGREL ALTER IS AND WHAT IT IS USED FOR

CLOPIDOGREL ALTER 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 ALTER 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 ALTER has been prescribed to you to help prevent blood clots
and 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 experienced 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 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 experienced symptoms of a stroke that disappeared within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also prescribe you acetylsalicylic acid starting within the first 24 hours.
• 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 ALTER 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 ALTER plus acetylsalicylic acid.

2. WHAT YOU SHOULD KNOW BEFORE TAKING CLOPIDOGREL ALTER

Do not take CLOPIDOGREL ALTER:

• if you are allergic (hypersensitive) 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 using CLOPIDOGREL ALTER.

Warnings and precautions

Tell your doctor before taking CLOPIDOGREL ALTER if you have any of the following conditions:

• 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 within 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 a brain artery (ischaemic stroke) that occurred within 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;
• if you have a history of non-traumatic brain haemorrhage.

While taking CLOPIDOGREL ALTER:

• inform your doctor if you are scheduled to undergo surgery (including dental surgery);
• inform your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and skin bruising appearing as small 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 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

CLOPIDOGREL ALTER must not be used in children and adolescents.

Other medicines and CLOPIDOGREL ALTER

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Some medicines may affect the use of CLOPIDOGREL ALTER or vice versa. You must inform your doctor precisely if you are taking:

• medicines that may increase the risk of bleeding, for example:
• oral anticoagulants, medicines used to reduce blood clotting;
• a non-steroidal anti-inflammatory medicine, 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, or another antiplatelet agent;
• a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines usually used to treat depression;
• rifampicin (used for severe infections);
• omeprazole or esomeprazole, medicines used to treat stomach problems, fluconazole or voriconazole, medicines used to treat fungal infections, efavirenz, or other antiretroviral medicines (used to treat HIV infections);
• moclobemide, a medicine used to treat depression;
• carbamazepine, a medicine used to treat certain forms of epilepsy;
• repaglinide, a medicine used to treat diabetes;
• paclitaxel, a medicine used to treat cancer;
• opioids: while being treated with clopidogrel, you must inform your doctor before taking any opioid (used to treat severe pain);
• rosuvastatin (used to lower cholesterol levels).

If you have had severe chest pain (unstable angina or heart attack), transient ischaemic attack, or mild ischaemic stroke, you may have been prescribed CLOPIDOGREL ALTER 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) should generally not cause problems, but prolonged use in other circumstances should be discussed with your doctor.

CLOPIDOGREL ALTER with food and drink

CLOPIDOGREL ALTER may be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy or breastfeeding.

If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking CLOPIDOGREL ALTER, consult your doctor immediately, as it is recommended not to take CLOPIDOGREL ALTER 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 this medicine.

Driving and using machines

It is unlikely that CLOPIDOGREL ALTER will affect your ability to drive or use machinery.

CLOPIDOGREL ALTER contains lactose

If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), consult your doctor before taking this medicine.

3. HOW TO TAKE CLOPIDOGREL ALTER

Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, you should consult your doctor or pharmacist.

The recommended dose, including for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg tablet of CLOPIDOGREL ALTER daily, taken orally, with or without food, at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you an initial dose of 300 mg or 600 mg of CLOPIDOGREL ALTER (4 or 8 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg tablet of CLOPIDOGREL ALTER daily, as described above.

If you have experienced symptoms of a stroke that disappear within a short time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe an initial dose of 300 mg of CLOPIDOGREL ALTER (4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg tablet of CLOPIDOGREL ALTER daily, as described above, taken together with acetylsalicylic acid for 3 weeks. After this period, your doctor may prescribe either CLOPIDOGREL ALTER alone or acetylsalicylic acid alone.

CLOPIDOGREL ALTER should be taken for as long as your doctor considers it necessary.

If you take more CLOPIDOGREL ALTER 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 ALTER
If you forget to take a dose of CLOPIDOGREL ALTER but remember within 12 hours of your usual time, take one tablet immediately and then take the next dose at your usual 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 missed tablet.

If you stop taking CLOPIDOGREL ALTER
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 the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Contact your doctor immediately if you experience:

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

The most common adverse reaction reported with CLOPIDOGREL ALTER is bleeding.
Bleeding may present as gastrointestinal bleeding, bruising, haematomas (unusual or excessive bruising under the skin), 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 ALTER
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 blood clots from forming. For minor cuts or injuries, such as self-inflicted cuts or shaving, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 2 “Warnings and precautions”).
Other adverse reactions include:
Common adverse reactions (may occur in up to 1 in 10 patients): diarrhoea, abdominal pain, indigestion or stomach burning.
Uncommon adverse reactions (may occur in up to 1 in 100 patients): headache, gastric ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rash, itching, dizziness, sensations of tingling and numbness.
Rare adverse reactions (may occur in up to 1 in 1,000 patients): vertigo, breast enlargement in men.
Very rare adverse reactions (may occur in up to 1 in 10,000 patients): jaundice, severe abdominal pain with or without back pain, fever, difficulty breathing sometimes associated with cough, generalized allergic reactions (for example, a 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, changes or loss of taste.
Adverse reactions with unknown frequency (frequency cannot be estimated from the available data): hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar levels.
Additionally, your doctor may identify changes in blood and urine test results.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CLOPIDOGREL ALTER

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 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 ALTER is supplied in PVC/PE/PVDC/aluminum blisters, store below 25°C.
If CLOPIDOGREL ALTER is supplied in aluminum/aluminum blisters, no special storage conditions are required.
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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What CLOPIDOGREL ALTER 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 (E172), triacetin (E1518), titanium dioxide (E171).
Description of the appearance of CLOPIDOGREL ALTER and contents of the pack
CLOPIDOGREL ALTER film-coated tablets are pink, round, biconvex tablets.
They are available in PVC/PE/PVDC/aluminum blisters or PA/Al/PVC blisters – aluminum-aluminum foil packs, packed in cardboard boxes containing
14, 28, 30, 50, 84, 90, 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milano
Manufacturers
Pharmathen S.A.
Dervenakion 6
Pallini, Attiki
15351 Greece
Pharmathen International S.A.
Industrial Park, Sapes,
Rodopi Prefecture,
Block No5 Rodopi
Greece
This medicinal product is authorized in the Member States of the European Economic Area under the following names:

This patient information leaflet was last approved on