Clopidogrel Tarbis 75 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Clopidogrel Tarbis 75 mg film-coated tablets EFG

Clopidogrel besilate

Read all of this leaflet carefully before you start taking this medicine

• 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 personally. Do not pass it on to others, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience are serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Contents of the leaflet:

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

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

Clopidogrel Tarbis belongs to a group of medicines known as antiplatelet agents. Platelets are very small cells found in the blood, smaller than red or white blood cells, which clump together when blood clots. Antiplatelet medicines prevent this clumping and thereby reduce the likelihood of blood clots forming (a process known as thrombosis).

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

• You have a condition causing hardening of the arteries (also known as atherosclerosis), and
• You have previously had a myocardial infarction, a stroke, or you have a disease called peripheral arterial disease.

2. Before taking Clopidogrel Tarbis

Do not take Clopidogrel Tarbis

• If you are allergic (hypersensitive) to clopidogrel or to any of the other components of this medicine;
• If you have 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 conditions may apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel.

Take special care with Clopidogrel Tarbis

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

• 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 suffered 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 a brain artery (ischaemic stroke) within the last 7 days.
• If you are taking other types of medicines (see "Use of other medicines").
• If you have liver or kidney disease.

During treatment with Clopidogrel Tarbis:

• Inform your doctor if you have scheduled surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder involving fever and bruising (bruises) 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 ADVERSE EFFECTS”).
• If you cut yourself or sustain a wound, bleeding may take longer than usual to stop. This is related to the way the medicine works, as it reduces the blood’s ability to form clots. For minor cuts or wounds, such as those occurring during shaving, this is not significant. However, if you are concerned about blood loss, 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 notice any adverse effects not mentioned in section 4 “POSSIBLE ADVERSE EFFECTS”, or if you notice that any adverse effect worsens.

Clopidogrel Tarbis must not be given to children or adolescents.

Use of other medicines

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

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.

The concomitant administration of Clopidogrel with oral anticoagulants (medicines used to reduce blood clotting) is not recommended.

You must explicitly inform your doctor if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints, or if you are taking heparin, or any other medicine used to reduce blood clotting, or if you are taking a proton pump inhibitor (e.g., omeprazole) for stomach discomfort, or if you are taking antiretrovirals (medicines to treat HIV infection).

You must also explicitly inform your doctor if you are taking ticlopidine, another antiplatelet agent.

If you have experienced severe chest pain (unstable angina or myocardial infarction), 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 occasional dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use under other circumstances should be discussed with your doctor.

Taking Clopidogrel Tarbis with food and drink

Clopidogrel Tarbis may be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to use this medicine during pregnancy or breastfeeding.

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Important information about some of the ingredients of Clopidogrel

Clopidogrel contains lactose. If your doctor has informed you that you have an intolerance to certain sugars (e.g., lactose), consult with him before taking this medicine.

3. How to take Clopidogrel Tarbis

Follow exactly the instructions for use of Clopidogrel Tarbis provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe you a single initial dose of 300 mg of Clopidogrel Tarbis (one 300 mg tablet or four 75 mg tablets). After this, the usual dose is one 75 mg Clopidogrel Tarbis tablet daily, taken orally, with or without food, and at the same time each day.

You should continue taking Clopidogrel Tarbis for as long as your doctor prescribes it.

If you take more Clopidogrel Tarbis than you should

Contact your doctor or go to the nearest hospital emergency department, as there is an increased risk of bleeding. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Clopidogrel Tarbis

If you forget to take a dose of Clopidogrel Tarbis but remember within 12 hours of the scheduled time, take the tablet immediately and then take the next dose at the usual time.

If more than 12 hours have passed, simply take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

With the pack sizes of 7, 14, 28, and 84 tablets, you can check the last day you took a Clopidogrel tablet by looking at the calendar printed on the blister pack.

If you stop taking Clopidogrel Tarbis

Do not stop your treatment. Contact your doctor or pharmacist before discontinuing 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, Clopidogrel Tarbis may have 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 “Take special care with Clopidogrel”).
• 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 (affecting between 1 and 10 patients in every 100) 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 or joint bleeding.

If you experience prolonged bleeding while taking Clopidogrel Tarbis

If you cut yourself or sustain a wound, bleeding may take slightly longer than normal to stop. This is related to the medicine's mechanism of action, since it prevents blood from forming clots. For minor cuts or wounds, such as cutting yourself while shaving, this is usually not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Take special care with Clopidogrel”).

Other adverse effects reported with Clopidogrel include:

Frequent adverse effects (affecting between 1 and 10 patients in every 100): Diarrhoea, abdominal pain, indigestion or heartburn.

• Uncommon adverse effects (affecting between 1 and 10 patients in every 1,000): headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rashes, burning sensation, dizziness, tingling and numbness.
• Rare adverse effects (affecting between 1 and 10 patients in every 10,000): vertigo.
• Very rare adverse effects (affecting less 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 mouth lining (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste; eosinophilic pneumonia; acquired haemophilia A.
• Frequency not known: hypersensitivity reactions.

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

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

5. Storage of Clopidogrel Tarbis

Keep out of the reach and sight of children.

Do not use Clopidogrel Tarbis after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of Clopidogrel Tarbis

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

The other components are: microcrystalline cellulose, spray-dried manitol, hydroxypropylcellulose, crospovidone, citric acid, PEG 6,000, stearic acid, talc, hypromellose, lactose monohydrate, red iron oxide (E172), triacetin and titanium dioxide (E171).

Appearance of the medicinal product and contents of the pack

Clopidogrel Tarbis tablets are round, biconvex, pink in colour and film-coated.

They are packaged in packs of 28, 50, 84 or 100 tablets in PVC/PE/PVDC-Aluminium or Aluminium/Aluminium blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

TARBIS FARMA, S.L.
Gran Vía Carlos III, 94
08028 Barcelona (Spain)

Manufacturer

PHARMATHEN, S.A.
6, Dervenakion Str (Pallini Attikis)
16351 Greece

or

PHARMATHEN INTERNATIONAL S.A.
Industrial Park Sapes,
Rodopi Prefecture, Block No 5
Rodopi 69300, Greece

or

FARMALIDER S.A.
C/Aragoneses, 15
28108 Alcobendas, Madrid
Spain

Date of the most recent review of this leaflet: August 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/