PATIENT INFORMATION LEAFLET

Clopidogrel Almus 75 mg Film-Coated Tablets

Clopidogrel

Read this leaflet carefully before you start to take 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

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

You have been prescribed clopidogrel to help prevent blood clots from forming and reduce the risk of these serious events because:

• you have a process that produces the hardening of the arteries (also known as atherosclerosis), and
• you have previously had a myocardial infarction, a cerebral infarction, or suffer from a disease known as peripheral arterial disease, or
• you have had a severe chest pain, known as “unstable angina” or “myocardial infarction”. Your doctor may have to place a stent in the blocked or narrowed artery to restore adequate blood flow. It is possible that your doctor has also prescribed acetylsalicylic acid (a substance found 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 stroke that disappear in a short period of time (also known as a transient ischemic attack) or a mild 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 and acetylsalicylic acid for this disease. Your doctor has prescribed clopidogrel plus acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have a high risk of severe bleeding.

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 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 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 (bleeding) because:

• Patient with a disease that involves a risk of internal bleeding (such as a stomach ulcer).
• Patient with a blood disorder that predisposes them to internal bleeding (bleeding in tissues, organs, or joints of the body).
• Recently suffered a serious injury.
• Recently underwent surgery (including dental surgery).
• Must 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 seven days.

• 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.

• If you have liver or kidney diseases.

During treatment with Clopidogrel Almus:

• 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 color in the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• If you cut or get a wound, bleeding may take longer to stop. This is related to the way the medication works, as it prevents the blood's ability to form clots. For minor cuts or wounds, such as cutting during shaving, this is not a problem. 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.

Inform your doctor or pharmacist if you observe any adverse effect not mentioned in section 4 of “Possible side effects” or if you observe that some adverse effect worsens.

Children and adolescents

Clopidogrel Almus 75 mg should not be administered to children or adolescents.

Clopidogrel use with other medications:

Some medications 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 other medications, including those purchased without a prescription.

You must inform your doctor specifically if you are taking:

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

• oral anticoagulants, medications used to reduce blood coagulation,

• nonsteroidal anti-inflammatory drugs, medications used generally 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 normally to treat depression,
• rifampicin (used for severe 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,

- moclobemide, a medication for depression,

- repaglinide, a medication to treat diabetes,

- paclitaxel, a medication to treat cancer,

- opioids: if you are taking clopidogrel, inform your doctor before they prescribe any opioid (used to treat intense pain),

- rosuvastatin (used to reduce cholesterol levels).

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

Clopidogrel use with food and beverages:

Clopidogrel Almus 75 mg can 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 taking Clopidogrel Almus. If you become pregnant while taking Clopidogrel Almus, consult your doctor immediately since clopidogrel is not recommended 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 Almus is unlikely to affect your ability to drive or operate machinery.

Clopidogrel Almus 75 mg contains lactose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication

Follow exactly the administration instructions for this medication as indicated by your doctor. 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 rhythm),is one 75 mg clopidogrel tablet per day, taken 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 or 600 mg of clopidogrel (4 or 8 75 mg tablets) to be taken once at the beginning of treatment. After that, the recommended dose is one 75 mg clopidogrel 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 stroke, your doctor may prescribe 300 mg of clopidogrel (4 tablets of 75 mg) once at the beginning of treatment. After that, the recommended dose is one 75 mg clopidogrel 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 for the time your doctor continues to prescribe 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 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 Almus 75 mg:

If you forget to take a dose of clopidogrel 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 dose.

If you interrupt treatment with Clopidogrel Almus 75 mg:

Do not stop 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, pharmacist, or nurse.

Like all medicines, Clopidogrel Almus 75 mg may cause side 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 some blood cells.

Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), associated or not with bleeding that appears under the skin as red spots and/or confusion (see section 2 “Warnings and precautions”).

Swelling of the mouth or skin disorders such as hives and itching, blisters on the skin. These may be signs of an allergic reaction.

The most frequent side effect reported with Clopidogrel Almus 75 mgis bleeding. Bleeding can occur in the stomach or intestine, 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 Almus 75 mg

If you cut or get a wound, it is possible that bleeding will take a little longer than normal to stop. This is related to the mechanism of action of the medication, as it prevents the blood's ability to form clots. For minor cuts or wounds, such as cutting during shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Warnings and precautions”)

Other side effects reported with Clopidogrel Almus 75 mg 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 intestine, rashes, itching, dizziness, numbness, and tingling.

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 until 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.

Additionally, your doctor may observe changes in your blood or urine test results.

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions..

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment..

Composition of Clopidogrel Almus 75 mg:

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

The other components are:

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

Appearance of the product and content of the packaging:

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

They are presented in carton packaging of 28 and 50 tablets in PCTFE+PE+PVC/Alu blisters.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holderof the marketing authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira

2710-089 Sintra

Portugal

Last review date of this leaflet: May 2023

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