PATIENT INFORMATION LEAFLET

AGRELAN 75 mg film-coated tablets

Clopidogrel

AGRELAN belongs to a group of medications known as antiplatelet agents. Platelets are very small structures found in the blood, smaller than red or white blood cells, and aggregate when blood coagulates. Antiplatelet medications, by preventing this aggregation, reduce the likelihood of blood clots forming (a process known as thrombosis).

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

AGRELAN has been prescribed to help prevent blood clots from forming and reduce the risk of these severe events since:

• You suffer from a process that causes artery hardening (also known as atherosclerosis), or
• You have previously experienced a myocardial infarction, cerebral infarction, or suffer from a disease known as peripheral arterial disease, or
• You have experienced severe chest pain, known as unstable angina or myocardial infarction. For the treatment of this disease, your doctor may need to place a stent (a tiny tube) in the obstructed 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).

Do not take AGRELAN

• If you are allergic (hypersensitive) to clopidogrel or any of the other components of AGRELAN;
• If you have an active bleeding, such as a stomach ulcer or bleeding in the brain;
• 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 AGRELAN.

Be especially careful with AGRELAN

Before starting treatment with AGRELAN, 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 serious 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 are using another type of medication (see "Use of other medications").
• If you have liver or kidney diseases.

During treatment with AGRELAN:

• Inform your doctor if you have a scheduled surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder that includes fever and hematomas (bruises) under the skin that may appear as localized red spots, with or without inexplicable extreme fatigue, confusion, yellow color in the skin or eyes (jaundice) (see section 4 "Possible Adverse 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 concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 4 "Possible Adverse 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 "Possible Adverse Effects" of this prospectus or if you observe that some adverse effect worsens.

AGRELAN should not be administered to children or adolescents.

AGRELAN with other medications

Some medications may influence the use of AGRELAN or vice versa.

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

It is not recommended to administer AGRELAN with oral anticoagulants (medications used to reduce blood coagulation).

You must inform your doctor explicitly if you are taking:

• Ticlopidine, another antiplatelet agent; nonsteroidal anti-inflammatory drugs, medications used to treat muscle or joint pain and/or inflammation, or if you are taking heparin, or any other medication used to reduce blood coagulation, or if you are taking a proton pump inhibitor (e.g. omeprazole) for stomach discomfort.
• Antiretrovirals (medications to treat HIV infection).

If you have suffered severe chest pain (unstable angina or myocardial infarction), you may have been prescribed AGRELAN 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) should not cause any problems, but prolonged use in other circumstances should be consulted with your doctor.

AGRELAN with food and beverages

AGRELAN can be taken with and without food.

Pregnancy and breastfeeding

It is preferable not to use this medication during pregnancy and breastfeeding.

If you are pregnant or think you may be, inform your doctor or pharmacist before taking AGRELAN. If you become pregnant while taking AGRELAN, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

If you are breastfeeding, consult your doctor about breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It is unlikely that AGRELAN will affect your ability to drive or operate machinery.

Important information about some of the components of AGRELAN

AGRELAN contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for Agrelan as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you have experienced severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg of Agrelan (4 tablets of 75 mg) to be taken once at the beginning of treatment. Afterwards, the normal dose is one 75 mg Agrelan tablet per day, administered orally, with or without food, and at the same time each day.

You should take Agrelan for the time your doctor continues to prescribe it.

If you take more Agrelan than you should

Contact your doctor or go to the nearest hospital emergency service or call the Toxicological Information Service, phone 91 5620420 indicating the medication and the amount ingested, as there is a higher risk of hemorrhage.

If you forget to take an Agrelan dose, 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 Agrelan

Do not interrupt your treatment. 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, AGRELAN may have 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 “Be especially careful with AGRELAN”).
• 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 AGRELAN(which affects between 1 and 10 patients in every 100) is bleeding. Bleeding can appear 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 experience prolonged bleeding while taking AGRELAN

If you cut or get a wound, it is possible that bleeding may 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 usually does not matter. However, if you are concerned about your bleeding, consult your doctor immediately (see “Be especially careful with AGRELAN”)

Other side effects reported with AGRELAN are:

Frequent side effects (which affect between 1 and 10 patients in every 100): diarrhea, abdominal pain, indigestion, or heartburn.

Rare side effects (which affect between 1 and 10 patients in every 1,000): headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rashes, itching, dizziness, tingling, and numbness.

Rare side effects (which affect between 1 and 10 patients in every 10,000): dizziness.

Very rare side effects (which affect fewer than 1 patient in every 10,000): jaundice, severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions; 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; altered taste; eosinophilic pneumonia; acquired hemophilia A

Unknown frequency: hypersensitivity reactions.

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

Reporting of side effects

If you experience any type of side effect, consult your pharmacist or nurse, 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 the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

Do not use AGRELAN after the expiration date shown on the carton and blister pack.

This medication does not require special storage conditions.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of AGRELAN

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

The other components are: microcrystalline cellulose, mannitol (E421), hydroxypropyl cellulose, crospovidone, citric acid, polyethylene glycol 6000, stearic acid, talc, and as coating components: Hypromellose (E464), iron oxide red (E172), lactose monohydrate, triacetin (E1518), and titanium dioxide (E171).

Appearance of the product and contents of the package

AGRELAN 75 mg tablets are round, biconvex, pink, and film-coated. They are presented in carton packs of 28 tablets in PA/ALL/PVC-Aluminium (Aluminium-Aluminium) blisters or PVC/PE/PVDC aluminium blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

ESPECIALIDADES FARMACEUTICAS CENTRUM S.A.

C/ Sagitario, 14

03006 Alicante

Spain

Manufacturer:

Pharmathen, S.A.

6, Dervanakion street, Pallini 15351

Attiki

Greece

or

HARMATHEN INTERNATIONAL S.A.

Sapes Industrial Park, Block 5

Rodopi

Greece

This leaflet was revised in July 2019