Clopidogrel Normon 75 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Clopidogrel Normon 75 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Clopidogrel Normon belongs to a group of medicines called antiplatelet agents. Platelets are very small cells found in the blood that clump together when blood clots. Antiplatelet medicines prevent this clumping, thereby reducing the likelihood of blood clots forming (a process known as thrombosis).

Clopidogrel Normon is administered to adults to prevent the formation of blood clots (thrombi) 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 causing hardening of the arteries (also known as atherosclerosis), and
• you have previously had a myocardial infarction, stroke, or suffer from a condition called peripheral arterial disease, or
• you have experienced a severe type of chest pain known as “unstable angina” or “myocardial infarction.” For the treatment of this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed you acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clot formation).
• you have experienced stroke symptoms that disappear within a short period of time (also known as 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 condition called “atrial fibrillation,” and cannot take medicines known as “oral anticoagulants” (vitamin K antagonists), which prevent the formation of new clots and stop existing clots from growing. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Clopidogrel Normon and acetylsalicylic acid for this condition. Your doctor will have prescribed Clopidogrel Normon plus acetylsalicylic acid if you cannot take “oral anticoagulants” and you have no risk of serious bleeding.

2. What you need to know before taking Clopidogrel Normon

Do not take Clopidogrel Normon:

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

If you think any of these may apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel Normon.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take 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 because:
  • you have a disease that involves a risk of internal bleeding (such as a stomach ulcer).
  • you have a blood disorder that makes you prone to internal bleeding (bleeding into tissues, organs, or joints).
  • you have recently suffered 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 a brain artery (ischaemic stroke) within the last 7 days.
• If you have liver or kidney disease.
• If you have had an allergic reaction or adverse reaction to any medication used to treat your condition.
• If you have a history of non-traumatic brain haemorrhage.

During treatment with Clopidogrel Normon:

• Inform your doctor if you are scheduled for 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 which may appear as localized 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 yourself or sustain a wound, bleeding may take longer than usual to stop. This is related to how the medicine works, as it reduces the blood’s ability to form clots. For minor cuts or wounds, such as those from shaving, this is not significant. However, if you are concerned about blood loss, consult your doctor immediately (see section 4. “Possible side effects”).
• Your doctor may ask you to have blood tests.

Children and adolescents

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

Taking Clopidogrel Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

You must specifically inform your doctor if you are taking:

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

• oral anticoagulants, medicines used to reduce blood clotting,

• non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints,

• heparin, or any other injectable medicine used to reduce blood clotting,

• ticlopidine, another antiplatelet agent,

• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other drugs of this type),

• medicines commonly used to treat depression,

• rifampicin (used for serious infections),

• omeprazole or esomeprazole, medicines used to treat stomach discomfort,

• fluconazole or voriconazole, medicines used to treat fungal infections,

• efavirenz, or other antiretroviral medicines (used to treat HIV infections),

• carbamazepine, a medicine used to treat certain forms of epilepsy,

• repaglinide, a medicine used to treat diabetes,

• paclitaxel, a medicine used to treat cancer,

• moclobemide, a medicine for depression,

• opioids: if you are being treated with clopidogrel, you must inform your doctor before being prescribed any other opioid (used to treat pain).

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

Taking Clopidogrel Normon with food and drink

Clopidogrel Normon may 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, inform your doctor or pharmacist before using this medicine. If you become pregnant while taking Clopidogrel Normon, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

You must not breastfeed while taking this medicine.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Clopidogrel Normon contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Clopidogrel Normon

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, please consult your doctor or pharmacist again.

The recommended dose, including for patients with a condition called “atrial fibrillation” (an irregular heartbeat), is one 75 mg Clopidogrel Normon tablet daily, taken orally with or without food, at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe 300 mg or 600 mg of Clopidogrel Normon (4 or 8 tablets) as a single dose at the beginning of treatment. Afterwards, the recommended dose is one 75 mg Clopidogrel Normon tablet daily, as described above.

If you have experienced stroke symptoms that disappear within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe 300 mg of Clopidogrel Normon (4 tablets) once daily at the beginning of treatment. Afterwards, the recommended dose is one 75 mg Clopidogrel Normon tablet daily as described above, together with acetylsalicylic acid for 3 weeks. After this period, your doctor will prescribe either clopidogrel alone or acetylsalicylic acid alone.

You should continue taking 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 nearest hospital emergency department, as there is an increased risk of bleeding.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 within 12 hours of the scheduled time, take the tablet immediately and take the next one at your usual time.

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

If you stop taking Clopidogrel Normon

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

If you have any further questions about 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 everyone will experience them.

Contact your doctor immediately if you experience:

• fever, signs of infection, or extreme tiredness. These symptoms may be due to a rare reduction in certain blood cells.
• signs of liver problems, such as yellowing of the eyes and/or skin (jaundice), with or without bleeding appearing 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 may be signs of an allergic reaction.

The most frequently reported adverse effect with Clopidogrel Normon is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, or blood in the urine. A small number of cases have also been reported of bleeding from blood vessels in the eyes, intracranial bleeding, pulmonary bleeding, or bleeding into joints.

If you experience prolonged bleeding while taking Clopidogrel Normon

If you cut yourself or sustain a wound, it may take slightly longer than normal for the bleeding to stop. This is related to the medicine's mechanism of action, as it prevents blood from forming clots. For minor cuts or wounds, such as during shaving, this is usually not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2, "Warnings and precautions").

Other adverse effects reported with Clopidogrel Normon include:

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

Uncommon adverse effects (may affect up to 1 in 100 people): headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, skin rashes, itching, dizziness, tingling sensation, and numbness.

Rare adverse effects (may affect up to 1 in 1,000 people): dizziness, breast enlargement in men.

Very rare adverse 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 sensation of warmth with sudden general discomfort up 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.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel Normon

• The active substance is clopidogrel as besilate. Each tablet contains 75 mg of clopidogrel.
• The other components 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 medicine and contents of the pack

Clopidogrel Normon 75 mg are pink, film-coated, round, biconvex tablets 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 the most recent revision of this leaflet: February 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/