Clopidogrel Qualigen 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clopidogrel Qualigen 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Clopidogrel is used in 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 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 found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clot formation).
• you have experienced symptoms of a stroke that resolve within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also administer acetylsalicylic acid during 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) that prevent the formation of new clots and stop existing clots from growing. You have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of clopidogrel and acetylsalicylic acid for this condition. Your doctor has prescribed clopidogrel if you cannot take “oral anticoagulants” and do not have a high risk of severe bleeding.

2. What you need to know before taking Clopidogrel Qualigen

Do not take Clopidogrel Qualigen:

• If you are allergic (hypersensitive) to clopidogrel or to any of the other components of this medicine (listed in section 6).

• If you have active bleeding, such as a stomach ulcer or bleeding in the brain.

• If you have severe liver disease.

If you think any of these apply to you, or if you have any doubts, consult your doctor before starting to take Clopidogrel Qualigen.

Warnings and precautions

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

• If you are at risk of bleeding (haemorrhage) 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 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 allergy or reaction to any medicine used to treat your condition.

• If you have a history of non-traumatic brain haemorrhage.

During treatment with clopidogrel:

• Inform your doctor if you have surgery scheduled (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 prevents blood from forming 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 Qualigen with other medicines

Inform 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 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, 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 or other antiplatelet agents.

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

• moclobemide, a medicine for depression,

• repaglinide, a medicine for the treatment of diabetes,

• paclitaxel, a medicine for the treatment of 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 experienced severe chest pain (unstable angina or myocardial infarction), transient ischaemic attack, or mild to moderate ischaemic stroke, you may have been prescribed this medicine 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 under other circumstances should be discussed with your doctor.

Taking Clopidogrel Qualigen with food and drinks

This medicine can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or think you may be, you must inform your doctor or pharmacist before taking this medicine.

If you become pregnant while taking this medicine, 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 will affect your ability to drive or operate machinery.

Clopidogrel Qualigen contains isomalt and sucrose

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

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

3. How to take Clopidogrel Qualigen

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

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg clopidogrel tablet per day, 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 (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) to be taken once at the beginning of treatment. Afterwards, 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 of time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe 300 mg of clopidogrel (1 tablet of 300 mg or 4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg clopidogrel tablet per day, 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 take clopidogrel for as long as your doctor continues to prescribe it.

If you take more Clopidogrel Qualigen 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, telephone: 91 5620420 (indicating the medicine and the amount ingested).

If you forget to take Clopidogrel Qualigen

If you forget to take a dose of this medicine but remember within 12 hours of the time you should have taken it, take the tablet immediately and take the next dose 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 dose.

With the 28- and 84-tablet pack sizes, you can check the last day you took a Clopidogrel Qualigen tablet by looking at the calendar printed on the blister pack.

If you stop taking Clopidogrel Qualigen

Do not stop your treatment unless instructed by your doctor. Contact your doctor or pharmacist before stopping this medicine.

If you have any further questions about using 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.

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 skin and/or eyes (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 is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, blood in 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

If you cut yourself or sustain an injury, bleeding may take slightly longer than normal to stop. This is related to the medicine's mechanism of action, as it prevents blood from forming clots. For minor cuts or injuries, 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 side effects include:

Common side effects (may affect up to 1 in 10 people):

Diarrhoea, 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 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 (for example, generalized feeling of warmth with sudden general discomfort up to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mucous membrane of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste.

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

5. Storage of Clopidogrel Qualigen

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions. Store in the original packaging.

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

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

6. Contents of the pack and other information

Composition of Clopidogrel Qualigen

• The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
• The other components are isomalt (E 953), hydroxypropylcellulose (E 463), low-substituted hydroxypropylcellulose (E 463a) in the tablet core, and hypromellose (E 464), macrogol 400, titanium dioxide (E 171), and iron oxide red (E 172) in the tablet coating.

Appearance of the medicinal product and contents of the pack

Clopidogrel Qualigen 75 mg tablets are round, biconvex-faced, and pink in colour.

They are available in cardboard boxes containing 28, 50, and 84 tablets in aluminium/aluminium blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Date of the most recent review of this leaflet: November 2023