AGRELAN 75 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

AGRELAN 75 mg film-coated tablets EFG

Clopidogrel

Contents of the pack:

1. What Agrelan is and what it is used for.
2. Before you take Agrelan.
3. How to take Agrelan.
4. Possible side effects.
5. Storing Agrelan.
6. Further information.

1. What Agrelan is and what it is used for

AGRELAN belongs to a group of medicines called antiplatelet agents. Platelets are very small structures in the blood that are smaller than red or white blood cells and clump together when the blood clots. Antiplatelet agents prevent this clumping, reducing the risk of blood clots (a process called thrombosis) forming.

AGRELAN is given to prevent the formation of blood clots (thrombi) in blood vessels (arteries) that have become hardened, a process known as atherothrombosis, which can cause atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed AGRELAN to help prevent the formation of blood clots and reduce the risk of these serious events because:

• You have a process that causes hardening of the arteries (also called atherosclerosis), or
• You have previously had a myocardial infarction, a stroke, or suffer from a disease called peripheral arterial disease, or
• You have had a severe type of chest pain, known as "unstable angina" or "myocardial infarction". For the treatment of this disease, your doctor may have prescribed AGRELAN in combination with acetylsalicylic acid, a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clots.

2. Before you take Agrelan

Do not take Agrelan

• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients 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 any of these apply to you, or if you are unsure, consult your doctor before taking Agrelan.

Be cautious when taking Agrelan

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

• If you are at 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 had 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 (ischemic stroke) in the last 7 days.
• If you are taking other medications (see "Using other medications").
• If you have liver or kidney disease.

During treatment with Agrelan:

• Tell your doctor if you are scheduled to undergo surgery (including dental surgery).
• Tell your doctor immediately if you develop a disorder that includes fever and bruising (bruises) under the skin that can appear as 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 or injure yourself, the bleeding may take longer than usual 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 yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see "Be cautious when taking Agrelan").
• Your doctor may ask you to have blood tests.
• Tell your doctor or pharmacist if you notice any side effects not mentioned in this leaflet or if you notice that any side effect worsens.

Agrelan should not be given to children or adolescents.

Taking Agrelan with other medications

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

Tell your doctor or pharmacist if you are taking or have recently taken other medications, including those obtained without a prescription.

Concomitant administration of Agrelan with oral anticoagulants (medications used to decrease blood clotting) is not recommended.

You must explicitly inform your doctor if you are taking:

• Ticlopidine, another antiplatelet agent; non-steroidal anti-inflammatory drugs, medications commonly used to treat pain and/or inflammation of muscles or joints, or if you are taking heparin, or any other medication used to decrease blood clotting, or if you are taking a proton pump inhibitor (e.g., omeprazole) for stomach discomfort.
• Antiretrovirals (medications for treating HIV infection).

If you have had 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. An occasional 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 Agrelan with food and drinks

Agrelan can be taken with or 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 pregnant, you must inform your doctor or pharmacist before taking Agrelan. If you become pregnant while taking Agrelan, consult your doctor immediately, as it is not recommended to take clopidogrel during pregnancy.

If you are taking Agrelan, consult your doctor about breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Important information about some of the ingredients of Agrelan

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

3. How to take Agrelan

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

If you have had 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 start of treatment. Afterward, the usual dose is one 75 mg tablet of Agrelan per day, taken orally, with or without food, and at the same time each day.

You should take Agrelan for as long as your doctor continues to prescribe it.

If you take more Agrelan than you should

Contact your doctor or go to the nearest hospital emergency department or call the Toxicology Information Service, phone 91 5620420, indicating the medication and the amount ingested, as there is an increased risk of bleeding.

If you forget to take a dose of Agrelan, 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 make up for the missed dose.

If you stop taking Agrelan

Do not stop your treatment. Contact your doctor or pharmacist before stopping this medication.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Agrelan can have side effects, although not everyone gets 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 cautious when taking Agrelan").
• Swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin.

These can be signs of an allergic reaction.

The most common side effect reported with Agrelan(affecting between 1 and 10 patients in 100) is bleeding. Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A reduced number of cases of bleeding in the blood vessels of the eyes, intracranial bleeding, pulmonary or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Agrelan

If you cut or injure yourself, it is possible that the 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 injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see "Be cautious when taking Agrelan").

Other side effects reported with Agrelan are:

Common side effects (affecting between 1 and 10 patients in 100): Diarrhea, abdominal pain, indigestion, or heartburn.

Uncommon side effects (affecting between 1 and 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, rash, itching, dizziness, tingling sensation, and numbness.

Rare side effects (affecting between 1 and 10 patients in 10,000): Vertigo.

Very rare side effects (affecting less than 1 patient in 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 mouth mucosa (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; altered taste; eosinophilic pneumonia; acquired hemophilia A.

Frequency unknown: hypersensitivity reactions.

In addition, your doctor may observe changes in the results of your blood or urine tests.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storing Agrelan

Keep out of the reach and sight of children.

Do not use Agrelan after the expiration date stated on the carton and blister.

This medication does not require special storage conditions.

Do not use Agrelan if you notice any visible signs of deterioration.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications and packaging you no longer need. This will help protect the environment.

6. Further information

Composition of Agrelan

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

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

Appearance of the product and pack contents

The Agrelan 75 mg tablets are round, biconvex, pink, and film-coated. They are available in cardboard boxes of 28 tablets in PA/ALL/PVC-Aluminum (Aluminum-Aluminum) or PVC/PE/PVDC aluminum 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 last revised in July 2019