VATOUD 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Vatoud 75 mg Film-Coated Tablets EFG

clopidogrel

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Vatoud and what is it used for
2. What you need to know before you take Vatoud
3. How to take Vatoud
4. Possible side effects
5. Storage of Vatoud

Contents of the pack and further information

1. What is Vatoud and what is it used for

Vatoud contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that help the blood to clot. Antiplatelet agents prevent platelet clumping, reducing the risk of blood clots (a process called thrombosis).

Vatoud is given to adults to prevent 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 Vatoud to help prevent blood clots and reduce the risk of these serious events because:

• you have a condition that causes hardening of the arteries (also known as arteriosclerosis), and
• you have previously had a heart attack, 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 need to place a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed aspirin (a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clots).
• you have an irregular heartbeat, a disease called "atrial fibrillation", and you 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 will have been told that "oral anticoagulants" are more effective than aspirin or the combined use of Vatoud and aspirin for this disease. Your doctor will have prescribed Vatoud plus aspirin if you cannot take "oral anticoagulants" and do not have a risk of severe bleeding.

2. What you need to know before you take Vatoud

Do not take Vatoud

• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• 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 Vatoud.

Warnings and precautions

Consult your doctor or pharmacist before starting this medication.

Before starting treatment with Vatoud, 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 in tissues, organs, or joints of the body).
• you have recently had 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 an artery of the brain (ischemic stroke) in the last 7 days.
• If you have liver or kidney disease.
• If you have had an allergy or reaction to any medication used to treat your disease.

During treatment with Vatoud:

• Tell your doctor if you are scheduled to have surgery (including dental surgery).
• Tell 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 that can appear as red spots, accompanied or not by unexplained extreme fatigue, confusion, yellow color of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or injure yourself, bleeding may take longer than usual to stop. This is related to the way the medicine works, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cuts while 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").
• Your doctor may ask you to have blood tests.

Children and adolescents

This medicine should not be given to children as it is not effective.

Taking Vatoud with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect the use of Vatoud or vice versa.

You must explicitly tell your doctor if you are taking:

• medicines that may increase the risk of bleeding, such as:

• oral anticoagulants, medicines used to decrease blood clotting,
• non-steroidal anti-inflammatory drugs, medicines used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medicine used to decrease blood clotting,
• ticlopidine, another antiplatelet agent,
• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other drugs of the same type), medicines used to treat depression,
• • omeprazole or esomeprazole, medicines to treat stomach discomfort,
  • fluconazole or voriconazole, medicines to treat fungal infections,
  • efavirenz, or other antiretroviral medicines (used to treat HIV infections),
  • carbamazepine, a medicine to treat some forms of epilepsy,
  • moclobemide, a medicine for depression,
  • repaglinide, a medicine for diabetes,
  • paclitaxel, a medicine for cancer,
  • opioids: if you are being treated with clopidogrel, you should tell your doctor before they prescribe you any opioid (used to treat severe pain).

If you have had severe chest pain (unstable angina or myocardial infarction), you may have been prescribed Vatoud in combination with aspirin, a substance found in many medications used to relieve pain and reduce fever. A dose of aspirin given occasionally (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 Vatoud with food and drinks

Vatoud can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is preferable not to take this medicine during pregnancy and breastfeeding.

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

You should not breastfeed while taking this medicine.

If you are breastfeeding or planning to breastfeed, tell your doctor before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Vatoud is unlikely to affect your ability to drive or use machines.

Vatoud contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Vatoud

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

The recommended dose, even for patients with a disease called "atrial fibrillation" (an irregular heartbeat), is one 75 mg Vatoud tablet per day, taken orally with or without food and at the same time every day.

If you have had severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg of Vatoud (4 tablets of 75 mg) to be taken once at the start of treatment. After that, the recommended dose is one 75 mg Vatoud tablet per day as described above.

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

If you take more Vatoud than you should

Contact your doctor or go to the nearest hospital emergency department, as there is a greater risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Vatoud

If you forget to take a dose of Vatoud, but remember before 12 hours have passed since 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 forgotten doses.

If you stop taking Vatoud

Do not stop your treatment unless your doctor tells you to.Consult your doctor or pharmacist before stopping this medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Consult 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 rashes and itching, blisters on the skin. These can be signs of an allergic reaction.

The most common side effect reported with Vatoud is bleeding. Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases of bleeding from the blood vessels of the eyes, intracranial, pulmonary, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Vatoud

If you cut or injure yourself, bleeding may take a little longer than usual to stop. This is related to the mechanism of action of the medicine, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cuts while 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 effectsinclude:

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

• Diarrhea, abdominal pain, indigestion, or heartburn.

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

• Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, eruptions, itching, dizziness, sensation of tingling and numbness.

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., general feeling of heat with sudden general discomfort leading to fainting); 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; changes in taste or loss of taste of food.

Side effects with unknown frequency (cannot be estimated from the available data):

• Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

Your doctor may also observe changes in the results of your blood or urine tests.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vatoud

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

Do not use this medicine after the expiry date which is stated on the carton and blister, after EXP. The expiry date is the last day of the month shown.

Consult the storage conditions in the carton.

If Vatoud is supplied in PVC/PE/PVDC/aluminum blisters, store below 25°C.

If Vatoud is supplied in PA/ALL/PVC/aluminum blisters, no special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Vatoud

• The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel besylate).
• The other ingredients are:

• Core of the tablet: microcrystalline cellulose, mannitol (E421), hydroxypropylcellulose, crospovidone, citric acid monohydrate, macrogol 6000, stearic acid, talc.
• Coating of the tablet: hypromellose, lactose monohydrate, red iron oxide (E172), triacetin, titanium dioxide (E171).

Appearance of the product and contents of the pack

Film-coated tablets are pink, round, and biconvex.

They are packaged in PVC/PE/PVDC/aluminum blisters or in PA/ALL/PVC-aluminum (Alu-Alu) cartons containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 500, 50 x 1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Pharmathen S.A.

6 Dervenakion str.

Pallini Attiki

15351 Greece

or

Pharmathen International S.A.

Industrial Park Sapes

Rodopi Prefecture

Block No 5, Rodopi

69300 Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark Vatoud

Bulgaria Vatoud

Spain Vatoud

Date of last revision of this leaflet: September 2020.

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

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