Package Insert: Information for the Patient

Vatoud 75 mg Film-Coated Tablets

Clopidogrel

Read this entire package insert carefully before starting to take this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonlyfor you, and you should not give it to others even if they have the same symptomsas 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 package insert. See section 4.

Contents of the package and additional information

Vatoudcontains clopidogrel andbelongs 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 likelihood of blood clots forming (a process known as thrombosis).

Vatoudis administeredto adultsto prevent the formation of blood clots (thrombi) 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 prescribedVatoudto help prevent the formation of blood clots and reduce the risk of these serious events because:

• you suffer from a process that produces the hardening of the arteries (also known as arteriosclerosis), 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 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 adequate blood flow. It is possible that your doctor has also prescribed acetylsalicylic acid (a substance present in many medications used to relieve pain and reduce fever, as well as to prevent the formation of blood clots).
• 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 Vatoud and acetylsalicylic acid for this disease. Your doctor has prescribed Vatoud plus acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have a high risk of severe bleeding.

Do not take Vatoud

• If you are allergic to clopidogrel or 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 Vatoud.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

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

• If you have a risk of bleeding (hemorrhage) 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.

• You have had a blood clot in a cerebral artery (ischemic cerebral infarction) in the last 7 days.
• You have liver or kidney diseases.
• You have had an allergy or reaction to any medication used to treat your disease.

During treatment with Vatoud:

• 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, accompanied or not by 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 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 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 Vatoud with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

You must inform your doctor explicitly 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 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,
• A serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medications of the same type), medications used to treat depression,
• • 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 being prescribed any opioid (used to treat intense pain).

If you have had severe chest pain (unstable angina or myocardial infarction), you may have been prescribed Vatoud 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.

Taking Vatoud with food and drinks

Vatoud can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

It is recommended not to take this medication during pregnancy and breastfeeding.

If you are pregnant or think you may be, inform your doctor or pharmacist before taking Vatoud. If you become pregnant while taking Vatoud, 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

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

Vatoud contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, 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 heart rhythm), is one 75 mg Vatoud 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 of Vatoud (four 75 mg tablets) for you to take once at the beginning 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 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 Vatoud

If you forget to take a Vatoud 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 make up for the missed doses.

If you interrupt treatment with Vatoud

Do not stop 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 medicinecanproduceside effects, although not all people 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 Vatoud is bleeding. Bleeding can appear 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 Vatoud

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 section 2 “Warnings and precautions”).

Other side effectsinclude:

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

• Diarrhea, abdominal pain, indigestion, or heartburn.

Infrequent 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, 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., 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 levels.

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 of Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do notuse this medicationafter the expiration date that appears on thepack andthe blister pack, after CAD. The expiration date is the last day of the month indicated.

Consult the storage conditions in the pack.

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 notuse this medicationif 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 pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Vatoud

• The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel besilate).
• The other components are:

• Tablet core: microcrystalline cellulose, mannitol (E421), hydroxypropyl cellulose, crospovidone, citric acid monohydrate, macrogol 6000, stearic acid, talc.
• Tablet coating: hypromellose, lactose monohydrate, iron oxide red (E172), triacetin, titanium dioxide (E171).

Appearance of the product and contents of the packaging

Film-coated tablets of pink color, round, and biconvex.

They are packaged in blister PVC/PE/PVDC/aluminum or in blister PA/ALU/PVC-aluminum (Alu-Alu) in cardboard containers that contain 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 500, 50 x 1 tablets.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Pharmathen S.A.

6 Dervenakionstr.

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 with the following names:

DenmarkVatoud

BulgariaVatoud

SpainVatoud

Last review date of this leaflet: September 2020.

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/.

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