CLOPIDOGREL ALMUS 75 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel Almus 75 mg film-coated tablets EFG

Clopidogrel

Read all of this leaflet carefully before you start taking this medicine:

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Clopidogrel Almus 75 mg is and what it is used for
2. Before you take Clopidogrel Almus 75 mg
3. How to take Clopidogrel Almus 75 mg
4. Possible side effects
5. Storing Clopidogrel Almus 75 mg
6. Contents of the pack and further information

1. What Clopidogrel Almus 75 mg is and what it is used for

Clopidogrel Almus belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that help it to clot. Antiplatelet agents prevent platelet clumping, reducing the risk of blood clots (a process called thrombosis).

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

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

• You have a condition that causes hardening of the arteries (also known as atherosclerosis), and
• You have previously had a myocardial infarction, stroke, or suffer from a disease called peripheral arterial disease, or
• You have had 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 proper blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and lower 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 stroke. Your doctor may also administer acetylsalicylic acid during 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 Almus 75 mg

Do not take Clopidogrel Almus 75 mg:

• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Almus 75 mg (listed in section 6);
• If you have an active bleeding, such as a stomach ulcer or bleeding in the brain;
• If you have a severe liver disease;

If you think any of these apply to you, or if you are unsure, consult your doctor before taking Clopidogrel Almus 75 mg.

Warnings and precautions:

Before starting treatment with Clopidogrel Almus, 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 severe 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 seven days.

• If you have had an allergy or reaction to any medication used to treat your disease.

• If you have a history of non-traumatic cerebral hemorrhage.

• If you have liver or kidney disease.

During treatment with Clopidogrel Almus:

• Tell your doctor if you are scheduled to have surgery (including dental surgery).
• Tell 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 can appear as red spots, accompanied or not by unexplained extreme fatigue, confusion, yellow color in 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 medicine works, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cutting yourself 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").
• Your doctor may ask you to have blood tests.

Tell your doctor or pharmacist if you notice any side effects not mentioned in section 4 of "Possible side effects" or if you notice that any side effect worsens.

Children and adolescents

Clopidogrel Almus 75 mg should not be given to children or adolescents.

Taking clopidogrel with other medicines:

Some medicines may affect the use of Clopidogrel Almus 75 mg or vice versa.

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

You must explicitly tell your doctor if you are taking:

• medicines 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 muscle or joint inflammation,
• 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 must inform your doctor before being prescribed any opioid (used to treat severe pain),
• rosuvastatin (used to reduce cholesterol levels).

If you have had severe chest pain (unstable angina or myocardial infarction), a transient ischemic attack, or a mild stroke, you may have been prescribed clopidogrel in combination with acetylsalicylic acid, a substance found in many medications used to relieve pain and lower 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 with food and drinks:

Clopidogrel Almus 75 mg can be taken with or without food.

Pregnancy and breastfeeding:

It is preferable not to use this medication during pregnancy.

If you are pregnant or think you may be pregnant, you must inform your doctor or pharmacist before taking Clopidogrel Almus. If you become pregnant while taking Clopidogrel Almus, consult your doctor immediately, as it is not recommended to take clopidogrel 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:

Clopidogrel Almus is unlikely to affect your ability to drive or use machines.

Clopidogrel Almus 75 mg contains lactose.

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

3. How to take Clopidogrel Almus 75 mg

Follow the instructions for administration of this medication exactly as indicated by your doctor. 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 had severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe you 300 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 stroke, your doctor may prescribe you 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 Almus 75 mg 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 Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Clopidogrel Almus 75 mg:

If you forget to take a dose of clopidogrel but remember before 12 hours have passed since 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 forgotten dose.

If you stop taking Clopidogrel Almus 75 mg:

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

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

4. Possible side effects

Like all medicines, Clopidogrel Almus 75 mg can have side effects, although not everyone gets them.

Contact your doctor immediately if you experience:

Fever, signs of infection, or severe 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 Almus 75 mg is bleeding.Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. There have also been reports of a small number of cases of: bleeding from the blood vessels of the eyes, intracranial hemorrhage, pulmonary or joint bleeding.

If you experience prolonged bleeding while taking Clopidogrel Almus 75 mg

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 cutting yourself 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 effects reported with Clopidogrel Almus 75 mg are:

Frequent 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 sensation, 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); decrease in 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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System. Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storing Clopidogrel Almus 75 mg

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

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

This medication does not require special storage conditions.

Do not use Clopidogrel Almus 75 mg if you observe any visible signs of deterioration.

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

6. Contents of the pack and further information

Composition of Clopidogrel Almus 75 mg:

The active ingredient is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).

The other ingredients are:

• Core: anhydrous lactose, pregelatinized corn starch, polyethylene glycol (PEG 6000), microcrystalline cellulose, hydrogenated cottonseed oil.
• Coating(Opadry II Pink 33G34629): hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol, triacetin, red iron oxide (E172).

Appearance of the product and pack contents:

Clopidogrel Almus 75 mg are film-coated tablets, round, and pink in color.

They are available in cardboard boxes of 28 and 50 tablets in PCTFE+PE+PVC/Alu blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710-228

Portugal

Date of last revision of this leaflet: May 2023

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