Clopidogrel Stada 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Clopidogrel Stada 75 mg film-coated tablets EFG

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

1. What is Clopidogrel Stada and what is it used for?

Clopidogrel 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 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 to help prevent the formation of 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 acetylsalicylic acid (a substance found in many medicines used to relieve pain, reduce fever, and prevent blood clot formation).

  • you have experienced symptoms of a stroke that disappear within a short period of time (also known as a 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) that 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 and acetylsalicylic acid for this condition. Your doctor will have prescribed clopidogrel plus acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have a high risk of serious bleeding.

2. What you need to know before taking Clopidogrel Stada

Do not take Clopidogrel Stada:

• 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 taking Clopidogrel Stada.

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 because:
  • You have a condition that increases the 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 an artery of the brain (ischaemic stroke) within 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 condition.
  • If you have a history of non-traumatic intracranial haemorrhage

During treatment with clopidogrel:

• Inform your doctor if you have 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 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 an injury, bleeding may take longer than normal to stop. This is related to how the medicine works, as it prevents blood from forming clots. For minor cuts or injuries, such as during 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 Stada 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 (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 the same type), medicines usually 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 used to treat diabetes,
  • Paclitaxel, a medicine used to treat 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 ischaemic stroke, you may have been prescribed clopidogrel 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 Stada with food and drink

Clopidogrel may 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 pregnant, 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 planning 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 Stada contains isomalt and sucrose.

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Clopidogrel Stada

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, 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 stroke that disappear within a short period of time (also known as transient ischemic attack) or a mild ischemic 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, taken together with acetylsalicylic acid for 3 weeks. After this, 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 Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone: 91 562 04 20 (indicating the medicine and amount ingested), or go to the nearest hospital emergency department, as there is an increased risk of bleeding.

If you forget to take Clopidogrel Stada

If you forget to take a dose of clopidogrel 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.

If you stop taking Clopidogrel Stada

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 the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 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 Stada

If you cut yourself or sustain a wound, it may take longer than usual for the bleeding to stop. This is related to the mechanism of action of the medicine, as it reduces the blood's ability to form clots. For minor cuts or wounds, such as those occurring during shaving, this is usually not a concern. However, if you are worried about your bleeding, consult your doctor immediately (see section 2 “Warnings and precautions”).

Other adverse effects include:

Common 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 and numbness.

Rare adverse effects (may affect up to 1 in 1,000 people):

Dizziness, breast enlargement in males.

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 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 adverse effects

If you experience any 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Stada

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 outer packaging and on the blister after EXP.. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Do not use Clopidogrel Stada 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 in your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Clopidogrel Stada

• The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
• The other components are isomalt, hydroxypropylcellulose, low-substituted hydroxypropylcellulose in the tablet core, and hypromellose (E464), macrogol 400, titanium dioxide (E171), and red iron oxide (E172) in the tablet coating.

Appearance of the medicinal product and contents of the pack

Clopidogrel Stada 75 mg film-coated tablets are pink-colored, round, and biconvex-faced.

They are presented in cardboard packs containing blisters (calendar or non-calendar) of 28, 50, and 84 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona)
Spain

Date of the most recent revision of this leaflet: September 2023

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