CLOPIDOGREL 75 mg Фильм-Coated Таблетки

Содержание инструкции

1. CLOPIDOGREL ALTER 75 mg film-coated tablets
   1. WHAT IS CLOPIDOGREL ALTER 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
2. CLOPIDOGREL ALTER film-coated tablets are pink, round, biconvex.

CLOPIDOGREL ALTER 75 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start 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, talk to your doctor or pharmacist. This includes any possible side effects 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 you take 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 IS CLOPIDOGREL ALTER AND WHAT IT IS USED FOR

CLOPIDOGREL ALTER 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 decrease the possibility of blood clot formation (a phenomenon called 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 cause atherothrombotic events (such as stroke, heart attack,
or death).
CLOPIDOGREL ALTER 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, a 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 experienced symptoms of a stroke that disappear within a short period of time (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also prescribe acetylsalicylic acid starting within the first 24 hours.
• 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 have been told that “oral anticoagulants” are more effective than acetylsalicylic acid or the combined use of CLOPIDOGREL ALTER 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 ALTER plus acetylsalicylic acid.

2. WHAT YOU NEED TO KNOW BEFORE TAKING CLOPIDOGREL ALTER

Do not take CLOPIDOGREL ALTER:

• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
• if you have active bleeding, such as a gastric ulcer or a haemorrhage in the brain;
• if you suffer from a severe liver disease.

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

Warnings and precautions
If any of the situations mentioned below apply to you, inform your doctor before taking
CLOPIDOGREL ALTER:

• if you are at risk of bleeding such as:
• a medical condition that puts you at risk of internal bleeding (such as a gastric ulcer);
• a blood disorder that makes you prone to internal bleeding (bleeding inside any tissue, organ or joint of the body);
• a recent serious wound,
• a recent surgical intervention (including dental surgery);
• a surgical intervention (including dental surgery) planned in 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 diseases;
• if you have had an allergy or a reaction to any medicine used to treat your condition;
• if you have a history of non-traumatic brain haemorrhage.

While you are taking CLOPIDOGREL ALTER:

• you must inform your doctor if you need to undergo a surgical intervention (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 extreme fatigue
• unexplained, 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 injuries, 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 4 “Possible side effects”);
• the doctor may prescribe blood tests.

Children and adolescents
CLOPIDOGREL ALTER should not be used in children and adolescents.

Other medicines and CLOPIDOGREL ALTER
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 ALTER or vice versa.
You must inform your doctor accurately if you are taking:

• medicines that can increase the risk of bleeding, for example
• 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 drug used to reduce blood clotting,
• ticlopidine, or another antiplatelet agent,
• a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines normally 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 drugs (used to treat HIV infections),
• moclobemide, a medicine used to treat depression,
• carbamazepine, a medicine used to treat certain forms of epilepsy,
• repaglinide, a drug used to treat diabetes,
• paclitaxel, a drug used to treat cancer,
• opioids: while being treated with clopidogrel, you must inform your doctor before taking any opioid (used for the treatment of 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 (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 ALTER with food and drink
CLOPIDOGREL ALTER can be taken with or without food.

Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy and breastfeeding.
If you are pregnant, suspect you may be 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 ALTER,
consult your doctor immediately, as it is recommended not to take CLOPIDOGREL
ALTER 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 this medicine.

Driving and operating machinery
It is unlikely that CLOPIDOGREL ALTER will affect your ability to drive vehicles and
operate machinery.

CLOPIDOGREL ALTER contains lactose
If your doctor has told you that you have an intolerance to some sugars (e.g. lactose),
consult your doctor before taking this medicine.

3. HOW TO TAKE CLOPIDOGREL ALTER

Always take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
The recommended dose, including patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg tablet of CLOPIDOGREL ALTER per day
to be taken orally during or away from meals and at the same time each day.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you
300 mg or 600 mg of CLOPIDOGREL ALTER (4 or 8 tablets of 75 mg) once at the beginning
of treatment. Subsequently, the recommended dose is one 75 mg tablet of
CLOPIDOGREL ALTER per day as described above.
If you have experienced symptoms of a stroke that disappear within a short period of time (also known as a transient ischemic attack) or an ischemic stroke of mild severity, your doctor may
prescribe 300 mg of CLOPIDOGREL ALTER (4 tablets of 75 mg) once at the beginning
of treatment. Subsequently, the recommended dose is one 75 mg tablet of
CLOPIDOGREL ALTER per day as described above with acetylsalicylic acid for 3
weeks. Then your doctor may prescribe CLOPIDOGREL ALTER alone or acetylsalicylic acid alone.
CLOPIDOGREL ALTER should be taken for as long as your doctor considers necessary.

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

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 diseases such as skin rash, itching, blisters. These may be signs of an allergic reaction.

The most common side effectreported with CLOPIDOGREL ALTER is bleeding.Bleeding may manifest with bleeding in the stomach or intestine, the formation of bruises, hematomas (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. In rare cases, bleeding has also been reported in the eye, intracranial, in the lungs and in the joints.

If you experience prolonged bleeding while taking CLOPIDOGREL ALTER
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 create 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): diarrhea, 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, sensations of tingling and numbness.
Rare side effects (may affect up to 1 in 1,000 people): vertigo, enlargement of the breasts 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 (for example, a widespread feeling of 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 or loss of taste.
Side effects with unknown frequency (frequency cannot be estimated based on available data): hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar levels.
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:
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 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/aluminium blisters, store at
a temperature below 25°C.
If CLOPIDOGREL ALTER is supplied in aluminium/aluminium blisters, no particular
storage conditions are required.
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 to
protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

WhatCLOPIDOGREL ALTER 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
(E172), triacetin (E1518), titanium dioxide (E 171).

Description of the appearance of CLOPIDOGREL ALTER and contents of the pack

CLOPIDOGREL ALTER film-coated tablets are pink, round, biconvex.

They are available in PVC/PE/PVDC/aluminium blisters or PA/ALL/PVC – aluminium foil blisters (aluminium/aluminium) packaged in cardboard boxes containing
14, 28, 30, 50, 84, 90, 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan

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

Pharmathen International S.A.
Industrial Park, Sapes,
Rodopi Prefecture,
Block No5 Rodopi
69300
Greece

This medicinal product is authorised in the Member States of the European Economic
Area under the following denominations: