Prospect: information for the patient

Clopidogrel Stada 75 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isClopidogrel Stadaand for what it is used

2. What you need to know before starting to takeClopidogrel Stada

3. How to takeClopidogrel Stada

4. Possible adverse effects

5. Storage ofClopidogrel Stada

6. Contents of the package and additional information

Clopidogrel belongs to a group of medications 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 may cause atherothrombotic effects (such as cerebral infarction, myocardial infarction, or death).

Clopidogrel has been prescribed to help prevent blood clots from forming and reduce the risk of these serious events because:

• you suffer from a process that produces the hardening of the arteries (also known as atherosclerosis),

and

• you have previously suffered a myocardial infarction, a cerebral infarction, or suffer from a disease known as peripheral arterial disease, or

• you have suffered a severe chest pain, known as “unstable angina” or “myocardial infarction”. Your doctor may need 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 ischemic 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 any risk of severe bleeding

.

Do not take Clopidogrel Stada:

•If you are allergic (hypersensitive) to clopidogrel or to any of the other components of this medication (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 Stada.

Warnings and precautions

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

•If you have a risk of bleeding (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 in tissues, organs, or joints of the body).

-You have recently suffered a severe injury.

-You have recently undergone surgery (including dental surgery).

-You are scheduled to undergo surgery (including dental surgery) in the next seven days.

•If you have had a blood clot in a cerebral artery (ischemic cerebral infarction) in the last 7 days.

•If you have liver or kidney diseases.

•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

During treatment with clopidogrel:

•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 discoloration of the skin or eyes (jaundice) (see section 4 "Possible side effects").

•If you cut or injure yourself, 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 injuries, such as cutting during shaving, this is not a concern. 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.

Children and adolescents

This medication should not be administered to children because it is not effective.

Taking Clopidogrel Stada with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may affect the use of clopidogrel or vice versa.

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,
• non-steroidal anti-inflammatory drugs, medications used 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 to treat depression,
• rifampicin (used to treat 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 certain 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 ischemic 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 dose of acetylsalicylic acid administered sporadically (not exceeding 1,000 mg in 24 hours) generally should not cause any problems, but prolonged use in other circumstances should be consulted with your doctor.

Taking Clopidogrel Stada with food and drinks

Clopidogrel can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medication during pregnancy.

If you are pregnant or think you may be, inform your doctor or pharmacist before taking this medication. If you become pregnant while taking this medication, consult your doctor immediately, as it is not recommended to take clopidogrel 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 is unlikely to affect your ability to drive or operate machinery.

Clopidogrel Stada contains isomalt and sucrose.

If your doctor has indicated that you have a sensitivity to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 and at the same time every day.

If you have experienced severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg or 600 mg of clopidogrel (1 or 2 300 mg tablets or 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 a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe 300 mg of clopidogrel (1 300 mg tablet or 4 75 mg tablets) 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 Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested) or go to the nearest hospital emergency service, as there is a higher risk of bleeding.

If you forget to take Clopidogrel Stada

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 Stada

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 or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

•fever, signs of infection, or extreme 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 clopidogrelis bleeding. Bleeding can occur in the stomach or intestines, 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 suffer a prolonged bleeding while taking Clopidogrel Stada

If you cut or get a wound, it is possible that the bleeding will take a little longer than usual 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 include:

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

Diarrhea, abdominal pain, indigestion, or heartburn.

Less frequent side effects (may affect up to 1 in 100 people):

Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, 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 coughing; 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.

Your doctor may also observe changes in your blood or urine test results.

Reporting side effects

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

Keep this medication out of the sight and reach 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.

Store in the original packaging to protect it from moisture.

Do not use Clopidogrel Stada if you observe any visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Clopidogrel Stada Composition

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

- The other components are isomalta, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, saccharose stearate in the tablet core and hypromellose (E464), macrogol 400, titanium dioxide (E171), iron oxide red (E172) in the tablet coating.

Product appearance and packaging contents

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

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet:September 2023

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