Clopidogrel Almus 75 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel Almus 75 mg film-coated tablets EFG

Clopidogrel

Read the entire leaflet carefully before you start taking this medicine:

• 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Clopidogrel Almus 75 mg is and what it is used for
2. Before you take Clopidogrel Almus 75 mg
3. How to take Clopidogrel Almus 75 mg
4. Possible side effects
5. How to store Clopidogrel Almus 75 mg
6. Contents of the pack and other information

1. What is Clopidogrel Almus 75 mg and what is it used for?

Clopidogrel Almus belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells that clump together when blood clots. Antiplatelet medicines reduce the chance of blood clots (a process known as thrombosis) by preventing platelets from sticking together.

Clopidogrel is administered 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 you have 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 adequate 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 disappeared within a short period of time (also known as a transient ischaemic attack) or a mild stroke. Your doctor may also administer acetylsalicylic acid during the first 24 hours.
• you have an irregular heartbeat, a condition called “atrial fibrillation”, and you 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 you have no risk of serious bleeding.

2. What you need to know before taking Clopidogrel Almus 75 mg

Do not take Clopidogrel Almus 75 mg:

• If you are allergic (hypersensitive) to clopidogrel or to any of the other components of Clopidogrel Almus 75 mg (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 may apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel Almus 75 mg.

Warnings and precautions:

Before starting treatment with Clopidogrel Almus, 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 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 seven days.

• If you have had an allergy or reaction to any medicine used to treat your condition.

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

• If you have liver or kidney disease.

During treatment with Clopidogrel Almus:

• 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 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.

Inform your doctor or pharmacist if you notice any adverse effects not listed in section 4 “Possible side effects” or if you notice that any adverse effect worsens.

Children and adolescents

Clopidogrel Almus 75 mg must not be given to children or adolescents.

Taking clopidogrel with other medicines:

Some medicines may affect the use of Clopidogrel Almus 75 mg or vice versa.

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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 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 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) should not cause any problems, but prolonged use in other circumstances should be discussed with your doctor.

Taking clopidogrel with food and drink:

Clopidogrel Almus 75 mg 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 must inform your doctor or pharmacist before taking Clopidogrel Almus. If you become pregnant while taking Clopidogrel Almus, 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 Almus will affect your ability to drive or operate machinery.

Clopidogrel Almus 75 mg 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 Almus 75 mg

Follow exactly the instructions provided by your doctor for taking this medicine. If in doubt, 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 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 or 600 mg of clopidogrel (4 or 8 tablets of 75 mg) as a single dose at the beginning of treatment. Afterwards, the recommended dose is one 75 mg clopidogrel tablet daily, as described above.

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

You should continue taking clopidogrel for as long as your doctor prescribes it.

If you take more Clopidogrel Almus 75 mg 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: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Clopidogrel Almus 75 mg:

If you forget to take a dose of clopidogrel but remember within 12 hours of the scheduled time, take the tablet immediately and then 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 Almus 75 mg:

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 how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Clopidogrel Almus 75 mg can have adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

??Fever, signs of infection, or severe fatigue. These symptoms may be due to a rare decrease 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 Almus 75 mg 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 joint bleeding.

If you experience prolonged bleeding while taking Clopidogrel Almus 75 mg

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 prevents blood from forming clots. For minor cuts or wounds, such as those occurring 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 Almus 75 mg 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, gastric 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 coughing; generalized allergic reactions (for example, a sensation of generalized warmth with sudden malaise up 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;

Adverse effects with unknown frequency (cannot be estimated from 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, pharmacist, or nurse, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Almus 75 mg

Keep this medicine out of the reach and sight 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.

Do not use Clopidogrel Almus 75 mg if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel Almus 75 mg:

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).

The other components are:

• Core: anhydrous lactose, pregelatinized corn starch, polyethylene glycol (PEG 6000), microcrystalline cellulose, hydrogenated cottonseed vegetable oil.
• Coating (Opadry II Pink 33G34629): hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol, triacetin, red iron oxide (E172).

Appearance of the product and contents of the pack:

Clopidogrel Almus 75 mg are pink, round, film-coated tablets.

They are available in cardboard packs containing 28 and 50 tablets in PCTFE+PE+PVC/Alu blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer responsible:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710-228

Portugal

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

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