CLOPIDOGREL ALTER 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Clopidogrel Alter 75 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Clopidogrel Alter and what is it used for
2. What you need to know before taking Clopidogrel Alter
3. How to take Clopidogrel Alter
4. Possible side effects
5. Storage of Clopidogrel Alter
6. Package Contents and Additional Information

1. What is Clopidogrel Alter and what is it used for

Clopidogrel Alter contains clopidogrel and belongs to a group of medications called antiplatelet agents. Platelets are very small cells found in the blood that clump together when the blood clots. Antiplatelet agents prevent this clumping, reducing the risk of blood clots (a process called thrombosis).

Clopidogrel is administered to adults to prevent the formation of blood clots (thrombi) in blood vessels (arteries) that have become hardened, a process known as atherothrombosis, which can cause atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed clopidogrel to help prevent the formation of blood clots and reduce the risk of these serious events because:

• You suffer from a process that causes hardening of the arteries (also known as arteriosclerosis), and
• You have previously suffered a myocardial infarction, stroke, or suffer from a disease called peripheral arterial disease, or
• You have suffered a severe type of chest pain, known as "unstable angina" or "myocardial infarction". For the treatment of this disease, your doctor may need to place a stent in the obstructed or narrowed artery to restore adequate blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clots)
• You have experienced symptoms of a stroke that disappear within a short period (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid within the first 24 hours
• You have an irregular heartbeat, a disease called 'atrial fibrillation', and you cannot take medications known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and prevent the growth of existing clots. You will have been told that "oral anticoagulants" are more effective than acetylsalicylic acid or the combined use of clopidogrel and acetylsalicylic acid for this disease. Your doctor will have prescribed clopidogrel plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a risk of severe bleeding.

2. What you need to know before taking Clopidogrel Alter

Do not take Clopidogrel Alter

• If you are allergic to clopidogrel or any of the other ingredients of this medication (listed in section 6)..
• If you have an active bleeding disorder, such as a stomach ulcer or bleeding in the brain;
• If you have a severe liver disease.

If you think any of these may apply to you, or if you are unsure, consult your doctor before taking Clopidogrel Alter.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication.

Before starting treatment with Clopidogrel Alter, inform your doctor if you are in any of the following situations:

• If you have a risk of bleeding (bleeding) because:

• You have a disease that involves a risk of internal bleeding (such as a stomach ulcer).
• You have a blood disorder that predisposes you to internal bleeding (bleeding in tissues, organs, or joints of the body).
• You have recently had a serious injury.
• You have recently undergone surgery (including dental surgery).
• You are scheduled to undergo surgery (including dental surgery) within the next seven days.

• If you have had a blood clot in an artery of the brain (ischemic stroke) in the last 7 days.
• If you have liver or kidney disease.
• If you have had an allergy or reaction to any medication used to treat your disease.
• If you have had a history of non-traumatic cerebral hemorrhage.

During treatment with Clopidogrel Alter:

• Inform your doctor if you are scheduled to undergo surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bruises) under the skin that may appear 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, bleeding may take longer than usual to stop. This is related to the way the medication works, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cuts while shaving, this is not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 4 "Possible side effects").
• Your doctor may ask you to have blood tests.

Children and Adolescents

This medication should not be given to children as it is not effective.

Other Medications and Clopidogrel Alter

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Some medications may affect the use of Clopidogrel Alter or vice versa

You must explicitly inform your doctor if you are taking:

• medications that may increase the risk of bleeding, such as:

• oral anticoagulants, medications used to decrease blood clotting,
• non-steroidal anti-inflammatory drugs, medications used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medication used to decrease blood clotting,
• ticlopidine, another antiplatelet agent,
• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medications of the same type), medications used to treat depression,
• rifampicin (used for severe infections),

• omeprazole or esomeprazole, medications to treat stomach discomfort,
• fluconazole or voriconazole, medications to treat fungal infections,
• efavirenz, or other antiretroviral medications (used to treat HIV infections),
• carbamazepine, a medication to treat some forms of epilepsy,
• moclobemide, a medication for depression,
• repaglinide, a medication for diabetes,
• paclitaxel, a medication for cancer,
• opioids: if you are being treated with clopidogrel, you should inform your doctor before being prescribed any opioid (used to treat severe pain),
• rosuvastatin (used to reduce cholesterol levels).

If you have suffered severe chest pain (unstable angina or myocardial infarction), transient ischemic attack, or mild ischemic stroke, you may have been prescribed Clopidogrel Alter in combination with acetylsalicylic acid, a substance found in many medications used to relieve pain and reduce fever. A dose of acetylsalicylic acid administered occasionally (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Alter with Food and Drinks

Clopidogrel Alter can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is preferable not to take this medication during pregnancy and breastfeeding.

If you are pregnant or think you may be pregnant, you should inform your doctor or pharmacist before taking Clopidogrel Alter. If you become pregnant while taking Clopidogrel Alter, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

You should not breastfeed while taking this medication.

If you are breastfeeding or plan to breastfeed, inform your doctor before taking this medication

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

It is unlikely that Clopidogrel Alter will affect your ability to drive or operate machinery.

Clopidogrel Altercontains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Clopidogrel Alter

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose, even for patients with a disease called "atrial fibrillation" (an irregular heartbeat), is one 75 mg clopidogrel tablet per day, administered orally with or without food and at the same time each day.

If you have suffered severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg or 600 mg of clopidogrel (4 or 8 tablets of 75 mg) to be taken once at the start of treatment. Afterward, the recommended dose is one 75 mg clopidogrel tablet per day, as described above.

If you have experienced symptoms of a stroke that disappear within a short period (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe 300 mg of clopidogrel (4 tablets of 75 mg) once at the start of treatment. Afterward, the recommended dose is one 75 mg clopidogrel tablet per day, as described above, with acetylsalicylic acid for 3 weeks. Afterward, the doctor will prescribe either clopidogrel alone or acetylsalicylic acid alone.

You should take clopidogrel for as long as your doctor continues to prescribe it.

If you take more Clopidogrel Alter than you should

Contact your doctor or go to the emergency department of the nearest hospital, as there is a greater risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Clopidogrel Alter

If you forget to take a dose of clopidogrel, but remember before 12 hours have passed since the time you should have taken the medication, take the tablet immediately and the next one at the usual time.

If you forget for more than 12 hours, simply take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you stop taking Clopidogrel Alter

Do not stop your treatment unless your doctor tells you to.Consult your doctor or pharmacist before stopping this medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

• Fever, signs of infection, or extreme fatigue. These symptoms may be due to a rare decrease in some blood cells.
• Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), associated or not with bleeding that appears under the skin as red spots and/or confusion (see section 2 "Warnings and Precautions").
• Swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin. These can be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Alter is bleeding.

Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases of bleeding in the blood vessels of the eyes, intracranial bleeding, pulmonary bleeding, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Alter

If you cut or injure yourself, it is possible that bleeding may take a little longer than usual to stop. This is related to the mechanism of action of the medication, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cuts while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and Precautions").

Other side effectsinclude:

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, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, rash, itching, dizziness, tingling, and numbness.

Rare side effects (may affect up to 1 in 1,000 people):

Dizziness, breast enlargement 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 (e.g., feeling of heat with sudden general discomfort leading to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mouth mucosa (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

Side effects with unknown frequency (cannot be estimated from available data):

Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

In addition, your doctor may observe changes in the results of your blood or urine tests.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Clopidogrel Alter

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging and blister, after EXP. The expiration date is the last day of the month indicated.

Consult the storage conditions in the packaging.

If Clopidogrel Alter is supplied in a PVC/PE/PVDC/aluminum blister, store below 25°C.

If Clopidogrel Alter is supplied in a PA/ALL/PVC/aluminum blister, no special storage conditions are required.

Do not use this medication if you notice any visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Clopidogrel Alter Composition

• The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel besylate).
• 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, red iron oxide (E172), triacetin (E1518), titanium dioxide (E171).

Product Appearance and Package Contents

Film-coated tablets are pink, round, and biconvex. They are packaged in PVC/PE/PVDC/aluminum or PA/ALL/PVC-aluminum (Alu-Alu) blisters in cardboard boxes containing 14, 28, 30, 50, 84, 90, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Pharmathen S.A.

6 Dervenakion str.

Pallini Attiki

15351 Greece

Or

Pharmathen International S.A.

Industrial Park Sapes

Rodopi Prefecture

Block No 5, Rodopi

69300 Greece

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

Denmark Clopimar

Ireland Clopidogrel Bluefish

Greece Clopidogrel Genepharm

Portugal Clopidogrel Bluepharma

Italy Clopidogrel Alter

Spain Clopidogrel Alter

Date of the last revision of this leaflet:January 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/