Clopidogrel Aurovitas 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Clopidogrel Aurovitas 75 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Clopidogrel Aurovitas is and what it is used for
2. What you need to know before taking Clopidogrel Aurovitas
3. How to take Clopidogrel Aurovitas
4. Possible side effects
5. How to store Clopidogrel Aurovitas
6. Contents of the pack and other information

1. What Clopidogrel Aurovitas is and what it is used for

Clopidogrel Aurovitas contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells that clump together when blood clots. Antiplatelet medicines prevent this clumping and thereby reduce the likelihood of blood clots (a process known as thrombosis).

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

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

• You have a condition causing hardening of the arteries (also called atherosclerosis), and
• You have previously had a myocardial infarction, stroke, or you have a condition called peripheral arterial disease, or
• You have experienced a severe type of chest pain known as “unstable angina” or “myocardial infarction.” For the treatment of this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clots).
• You have experienced symptoms of a stroke that resolve within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also administer acetylsalicylic acid during the first 24 hours.

You have an irregular heartbeat, a condition called “atrial fibrillation”, and you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists), which prevent the formation of new clots and stop existing clots from growing. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of clopidogrel and acetylsalicylic acid for this condition. Your doctor will have prescribed clopidogrel plus acetylsalicylic acid if you cannot take “oral anticoagulants” and you have no risk of serious bleeding.

2. What you need to know before taking Clopidogrel Aurovitas

Do not take Clopidogrel Aurovitas

• If you are allergic (hypersensitive) to clopidogrel or to any of the other ingredients of this medicine (listed in section 6).
• If you have active bleeding, such as a stomach ulcer or bleeding in the brain.
• If you have severe liver disease.

If you think any of these apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel Aurovitas.

Warnings and precautions

Before starting treatment with Clopidogrel Aurovitas, inform your doctor if you are in any of the following situations described below:

• If you are at risk of bleeding because:

• you have a condition that involves a risk of internal bleeding (such as a stomach ulcer),

• you have a blood disorder that predisposes you to internal bleeding (bleeding into tissues, organs, or joints),

• you have recently sustained a serious injury,

• you have recently undergone surgery (including dental surgery),

• you are scheduled to undergo surgery (including dental surgery) within the next 7 days.

• If you have had a blood clot in a brain artery (ischaemic stroke) within the last 7 days.

• If you have liver or kidney disease.

• If you have had an allergy or reaction to any medicine used to treat your condition.

• If you have a history of non-traumatic brain haemorrhage.

During treatment with Clopidogrel Aurovitas:

• Inform your doctor if you are scheduled for 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 bruising under the skin which may appear as localized red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• If you cut yourself or sustain an injury, bleeding may take longer than usual to stop. This is related to how the medicine works, as it prevents blood from forming clots. For minor cuts or injuries, such as shaving cuts, this is not usually a concern. However, if you are concerned about blood loss, consult your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may ask you to have blood tests.

Children and adolescents

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

Other medicines and Clopidogrel Aurovitas

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

Some medicines may affect the use of Clopidogrel Aurovitas or vice versa.

You must specifically inform your doctor if you are taking:

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

• oral anticoagulants, medicines used to reduce blood clotting,

• non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints,

• heparin, or any other injectable medicine used to reduce blood clotting,

• ticlopidine, another antiplatelet agent,

• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other drugs of this type), medicines commonly used to treat depression.

• rifampicin (used for serious infections),

• omeprazole or esomeprazole, medicines used to treat stomach discomfort,

• fluconazole or voriconazole, medicines used to treat fungal infections,

• efavirenz or other antiretroviral medicines (for treatment of HIV infections),

• carbamazepine, a medicine used to treat certain forms of epilepsy,

• moclobemide, a medicine for depression,

• repaglinide, a medicine for the treatment of diabetes,

• paclitaxel, a medicine for the treatment of cancer,

• opioids: if you are being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),

• rosuvastatin (used to reduce cholesterol levels).

If you have experienced severe chest pain (unstable angina or myocardial infarction), a transient ischaemic attack, or a mild ischaemic stroke, you may have been prescribed clopidogrel in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. A single dose of acetylsalicylic acid (not exceeding 1,000 mg within 24 hours) should not cause any problems, but prolonged use under other circumstances should be discussed with your doctor.

Taking Clopidogrel Aurovitas with food and drink

Clopidogrel Aurovitas may be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

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

You must not breastfeed while taking this medicine.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Clopidogrel Aurovitas contains lactose

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

Clopidogrel Aurovitas contains hydrogenated castor oil

Clopidogrel Aurovitas may cause stomach discomfort and diarrhoea.

3. How to take Clopidogrel Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose, including for patients with a condition called “atrial fibrillation” (an irregular heartbeat), is one 75 mg clopidogrel tablet daily, taken orally, with or without food, at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe you 300 mg or 600 mg of clopidogrel (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) to be taken once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg clopidogrel tablet daily, as described above.

If you have experienced symptoms of a stroke that disappear within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe you 300 mg of clopidogrel (1 tablet of 300 mg or 4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg clopidogrel tablet daily as described above, together with acetylsalicylic acid for 3 weeks. After this, your doctor will prescribe either clopidogrel alone or acetylsalicylic acid alone.

You should take clopidogrel for as long as your doctor continues to prescribe it.If you take more Clopidogrel Aurovitas than you should In case of overdose or accidental ingestion, contact your doctor or pharmacist or go to the nearest hospital emergency department, as there is an increased risk of bleeding. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Clopidogrel Aurovitas

If you forget to take a dose of clopidogrel but remember within 12 hours of the time you were supposed to take it, take the tablet immediately and take the next dose at your usual time.

If you forget for more than 12 hours, simply take the next dose at your usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Clopidogrel Aurovitas

Do not stop your treatment unless your doctor tells you to do so.

Contact your doctor or pharmacist before stopping this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 certain blood cells.
• Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing 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 may be signs of an allergic reaction.

The most frequently reported adverse effect with Clopidogrel Aurovitas is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases have also been reported of: bleeding from blood vessels in the eyes, intracranial bleeding, pulmonary bleeding, or bleeding into joints.

If you experience prolonged bleeding while taking Clopidogrel Aurovitas:

If you cut yourself or sustain a wound, it may take slightly longer than normal for the bleeding to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or wounds, such as those occurring during shaving, this is usually not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Warnings and precautions”).

Other adverse effects include:

Common adverse effects (may affect up to 1 in 10 people): diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon adverse effects (may affect up to 1 in 100 people): headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, skin rash, itching, dizziness, tingling and numbness sensations.

Rare adverse effects (may affect up to 1 in 1,000 people): vertigo, breast enlargement in males.

Very rare adverse 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 (for example, a sensation of warmth with sudden general discomfort up to fainting); swelling of the mouth; blisters on the skin, skin allergy; inflammation of the mouth mucosa (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste.

Adverse effects with unknown frequency (cannot be estimated from available data): hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

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

Reporting of adverse effects

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

5. Storage of Clopidogrel Aurovitas

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

Do not use this medicine after the expiry date stated on the carton, the blister pack, and the label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

Store below 30 °C.

Bottle: use within 6 months after first opening the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel Aurovitas

• The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel bisulfate).
• The other components are: microcrystalline cellulose (Grade 133), mannitol, low-substituted hydroxypropylcellulose, crospovidone (type A), macrogol 6000, hydrogenated castor oil, lactose monohydrate (see section 2 “Clopidogrel Aurovitas contains lactose”), hypromellose (15 cp), titanium dioxide (E171), triacetin, and red iron oxide (E172).

Appearance of the product and contents of the pack

Film-coated tablet.

Pink, biconvex, bevel-edged, round film-coated tablets, marked with “E” on one side and “34” on the other.

Clopidogrel Aurovitas is available in blisters containing 14, 28, 30, 50, 56, 84, 100 and 500 film-coated tablets, and in perforated transparent unit-dose blisters made of PVC/PE/PVdC-Al containing 28 film-coated tablets.

Bottles containing 30, 100 and 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Germany: Clopidogrel Aurobindo 75 mg Filmtabletten
Spain: Clopidogrel Aurovitas 75 mg film-coated tablets EFG
France: CLOPIDOGREL ARROW 75 mg, comprimé pelliculé
Italy: Clopidogrel Aurobindo
Malta: Clopidogrel Aurobindo 75 mg film-coated tablets
Netherlands: Clopidogrel Aurobindo 75 mg filmomhulde tabletten

Date of the most recent review of this leaflet: August 2022

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