Leaflet: information for the user

Clopidogrel Normon 75 mg film-coated tablets

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

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

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

2. What you need to know before taking Clopidogrel Normon

3. How to take Clopidogrel Normon

4. Possible side effects

5. Storage of Clopidogrel Normon

6. Contents of the pack and additional information

Clopidogrel Normonbelongs to a group of medications called antiplatelet agents. Platelets are very small cells found in the blood that aggregate when the blood clots. Antiplatelet agents, by preventing this aggregation, reduce the likelihood of blood clots (a process known as thrombosis) forming.

Clopidogrel Normonis administered to adults to prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can cause atherothrombotic effects (such as cerebral infarction, myocardial infarction, or death).

You have been prescribed Clopidogrel Normonto help prevent blood clots from forming and reduce the risk of these severe events because:

• you have a process that produces the hardening of the arteries (also known as atherosclerosis), and
• you have previously experienced a myocardial infarction, a cerebral infarction, or suffer from a disease known as peripheral arterial disease or
• you have experienced a severe 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. It is possible that your doctor has also prescribed acetylsalicylic acid (a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clots from forming).
• you have experienced symptoms of a transient ischemic attack that disappear in a short period of time (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 known as “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 have been told that “oral anticoagulants” are more effective than acetylsalicylic acid or the combined use of Clopidogrel Normonand acetylsalicylic acid for this disease. Your doctor has prescribed Clopidogrel Normonmore acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have a high risk of severe bleeding.

Do not take Clopidogrel Normon.

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

If you think this may affect you, or if you have any doubts, consult your doctor before taking Clopidogrel Normon.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Clopidogrel Normon

Before starting treatment with Clopidogrel Normoninform 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 an increased 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 suffered a serious injury.
  • You have recently undergone surgery (including dental surgery).
  • You are scheduled to undergo surgery (including dental surgery) in the next seven days.
• If you have had a blood clot in a cerebral artery (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 a history of non-traumatic cerebral hemorrhage.

During treatment with Clopidogrel Normon:

• Inform your doctor if you have a scheduled 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 hematomas (bruises) under the skin that may appear as localized red spots, with or without extreme fatigue, confusion, yellow discoloration of the skin or eyes (jaundice) (see section 4. "Possible side effects").
• If you cut or injure yourself, bleeding may take longer to stop than usual. This is related to the way the medication works, as it prevents the blood from forming clots. For minor cuts or injuries, such as cutting during shaving, this is not a concern. 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 administered to children because it is not effective.

Use of Clopidogrel Normonwith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may affect the use of Clopidogrel Normon or vice versa.

You must inform your doctor explicitly if you are taking:

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

• oral anticoagulants, medications used to reduce blood coagulation,

• 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 reduce blood coagulation,
• ticlopidine, another antiplatelet agent,
• an inhibitor of serotonin reuptake (such as fluoxetine or fluvoxamine and other medications of the same type),
• medications used to treat depression,
• rifampicin (used to treat serious 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,
• repaglinide, a medication to treat diabetes,
• paclitaxel, a medication to treat cancer,

• moclobemide, a medication to treat depression,
• opioids: if you are taking clopidogrel, inform your doctor before they prescribe any other opioid (used to treat pain).

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

Taking Clopidogrel Normonwith food and drinks

Clopidogrel Normoncan be taken with and without food.

Pregnancy and breastfeeding

It is preferable not to use this medication during pregnancy.

If you are pregnant or think you may be, inform your doctor or pharmacist before using this medication. 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 medication.

If you are breastfeeding or plan to do so, inform your doctor before taking this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Clopidogrel Normonis unlikely to affect your ability to drive or operate machinery.

Clopidogrel Normoncontains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heart beat), is one 75 mg Clopidogrel Normon tablet per day, administered orally with or without food and at the same time every day.

If you have experienced 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 beginning of treatment. After that, the recommended dose is one 75 mg Clopidogrel Normon tablet per day as described above.

If you have experienced symptoms of a stroke that disappear in a short period of time (also known as transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe 300 mg of Clopidogrel Normon (4 tablets) once a day at the beginning of treatment. After that, the recommended dose is one 75 mg Clopidogrel Normon tablet 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 the time your doctor continues to prescribe it.

If you take more Clopidogrel Normon than you should

Contact your doctor or go to the nearest hospital emergency service, as there is a higher 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 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 compensate for the missed doses.

If you interrupt treatment with Clopidogrel Normon

Do not interrupt 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 or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

The most frequent side effect reported with Clopidogrel Normonis bleeding. Bleeding can occur in the stomach or intestines, bruises, hematomas (abnormal bleeding or bruises under the skin), nasal bleeding, blood in urine. Also, a reduced number of cases of: bleeding of the blood vessels of the eyes, intracranial, pulmonary, or joint bleeding have been reported.

If you experience prolonged bleeding while taking Clopidogrel Normon

If you cut or get a wound, it is possible that bleeding will 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 wounds, such as cutting during shaving, this usually does not matter. 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:

Frequent side effects (may affect up to 1 in 10 people): diarrhea, abdominal pain, indigestion, or heartburn.

Rare side effects (may affect up to 1 in 100 people): headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rashes, 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 general heat with sudden general discomfort to fainting), swelling of the mouth, blisters on the skin, skin allergy, inflammation of the mucous membrane of the mouth (stomatitis), decreased blood pressure, confusion, hallucinations, joint pain, muscle pain, changes in taste or loss of taste of food.

Side effects of unknown frequency (cannot be estimated from available data): hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar levels.

Your doctor may also observe changes in your blood or urine test results.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging afterExp.The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Clopidogrel Normon Composition

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

Appearance of the product and contents of the packaging

Clopidogrel Normon 75 mg are pink film-coated, round, biconvex tablets that are presented 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)

Last review date of this leaflet:February 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/