CLOPIDOGREL NORMON 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Clopidogrel Normon 75 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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. It may harm them, even if their signs of illness are the same as yours.
• 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 the Package Leaflet

1. What is Clopidogrel Normon and what is it used for
2. What you need to know before you take Clopidogrel Normon
3. How to take Clopidogrel Normon
4. Possible side effects
5. Storage of Clopidogrel Normon
6. Contents of the pack and further information

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

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

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

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

• you have a condition that leads to hardening of the arteries (also known as atherosclerosis), 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 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 ischemic stroke. Your doctor may also administer acetylsalicylic acid during the first 24 hours.
• you have an irregular heartbeat, a disease called "atrial fibrillation", and 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 Normon and acetylsalicylic acid for this disease. Your doctor will have prescribed Clopidogrel Normon 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 you take Clopidogrel Normon

Do not take Clopidogrel Normon:

• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (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 Normon.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Clopidogrel Normon.

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

• If you are at 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 going to undergo surgery (including dental surgery) in 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 Normon:

• 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, with or without 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 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").
• Your doctor may ask you to have blood tests.

Children and adolescents

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

Use of Clopidogrel Normon with other medicines

Tell 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 Normon or vice versa.

You must explicitly tell your doctor if you are taking:

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

• oral anticoagulants, medicines used to decrease blood clotting,

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

• omeprazole or esomeprazole, medicines to treat stomach discomfort,
• fluconazole or voriconazole, medicines to treat fungal infections,
• efavirenz, or other antiretroviral medicines (used to treat HIV infections),
• carbamazepine, a medicine to treat some forms of epilepsy,
• repaglinide, a medicine to treat diabetes,
• paclitaxel, a medicine to treat cancer,

• moclobemide, a medicine for depression,
• opioids: if you are being treated with clopidogrel, you should tell your doctor before any other opioid is prescribed (used to treat pain).

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 Normon in combination with acetylsalicylic acid, a substance found in many medications used to relieve pain and lower fever. A dose of acetylsalicylic acid given occasionally (not exceeding 1,000 mg in 24 hours) is generally not a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Normon with food and drinks

Clopidogrel Normon can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to use this medicine during pregnancy.

If you are pregnant or think you may be pregnant, you should tell your doctor or pharmacist before using this medicine. If you become pregnant while taking Clopidogrel Normon, consult your doctor immediately, as it is not recommended to take clopidogrel during pregnancy.

You should not breastfeed while taking this medicine.

If you are breastfeeding or plan to breastfeed, tell your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Clopidogrel Normon contains lactose

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

3. How to take Clopidogrel Normon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of 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 tablet of Clopidogrel Normon per day, taken 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 Normon (4 or 8 tablets) to be taken once at the start of treatment. After that, the recommended dose is one 75 mg tablet of Clopidogrel Normon 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 Normon (4 tablets) once a day at the start of treatment. After that, the recommended dose is one 75 mg tablet of Clopidogrel Normon per day as described above, with acetylsalicylic acid for 3 weeks. After that, your doctor will prescribe either clopidogrel alone or acetylsalicylic acid alone.

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

If you take more Clopidogrel Normon 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 medicine and the amount ingested.

If you forget to take Clopidogrel Normon

If you forget to take a dose of Clopidogrel Normon, 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 forgotten doses.

If you stop taking Clopidogrel Normon

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

If you have any further questions on the use of 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.

Consult 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 eyes and/or skin (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 Normonis 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 from the blood vessels of the eyes, intracranial, pulmonary, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Normon

If you cut or injure yourself, bleeding may take a little longer than usual to stop. This is related to the mechanism of action of the medicine, 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 effects reported with Clopidogrel Normon are:

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, eruptions, itching, dizziness, sensation of tingling and numbness.

Rare side effects (may affect up to 1 in 1,000 people): vertigo, 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., general 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 the 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, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Normon

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 carton after Exp. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Clopidogrel Normon

• The active substance is clopidogrel as besilate. Each tablet contains 75 mg of clopidogrel.
• The other ingredients are: Core:Microcrystalline cellulose, mannitol, hydroxypropylcellulose, crospovidone, citric acid monohydrate, polyethylene glycol 6000, stearic acid, talc. Coating:Hypromellose (E-421), red iron oxide (E-172), lactose monohydrate, triacetin (E-1518), titanium dioxide (E-171).

Appearance of the product and pack contents

Clopidogrel Normon 75 mg are film-coated tablets of pink color, round, biconvex, and are available in packs of 28, 50, and 84 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this leaflet:February 2022

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