CLOPIDOGREL TARBIS 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Clopidogrel Tarbis 75 mg Film-Coated Tablets EFG

Clopidogrel, besylate

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience 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 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. Storing Clopidogrel Tarbis.
6. Further information.

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

Clopidogrel Tarbis belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that help the blood to clot when a vessel is injured, which can sometimes cause serious problems. Antiplatelet agents reduce the ability of platelets to clump together and form clots, thereby preventing clots from forming in the blood vessels (a process known as thrombosis).

Clopidogrel Tarbis is used to prevent the formation of blood clots (thrombi) in blood vessels (arteries) that have become hardened (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 the formation of blood clots and reduce the risk of these serious events, because:

• You have a condition that causes the hardening of the arteries (also known as atherosclerosis), and
• You have previously suffered a myocardial infarction, a stroke, or suffer from a disease known as peripheral arteriopathy.

2. Before you take Clopidogrel Tarbis

Do not take Clopidogrel Tarbis

• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Tarbis;
• If you have an active bleeding condition, 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 Clopidogrel Tarbis.

Be cautious when taking 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 (haemorrhage) 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 serious 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 are taking other medications (see "Using other medications").
• If you have liver or kidney disease.

During treatment with Clopidogrel Tarbis:

• Inform your doctor if you are scheduled to undergo surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder that includes fever and bruising (bleeding under the skin that can appear as red spots), which may be accompanied by 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 medicine works, as it prevents the blood from forming clots. For minor cuts or injuries, such as those that occur while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Be cautious when taking Clopidogrel Tarbis").
• Your doctor may ask you to have blood tests.
• Inform your doctor or pharmacist if you notice any side effects not mentioned in this leaflet or if you notice that any side effect becomes worse.

Clopidogrel Tarbis should not be given to children or adolescents.

Using other medications

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

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

It is not recommended to take Clopidogrel with oral anticoagulants (medications used to decrease blood clotting).

You must explicitly inform your doctor if you are taking non-steroidal anti-inflammatory drugs, medications commonly used to treat pain and/or muscle or joint inflammation, 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, or if you are taking antiretrovirals (medications for treating HIV infection).

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

If you have suffered severe chest pain (unstable angina or myocardial infarction), you may have been prescribed Clopidogrel in combination with acetylsalicylic acid, a substance present in many medications used to relieve pain and reduce fever. A dose of acetylsalicylic acid administered 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 Clopidogrel Tarbis with food and drinks

Clopidogrel Tarbis 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 Clopidogrel Tarbis. If you become pregnant while taking Clopidogrel, consult your doctor immediately, as it is not recommended to take Clopidogrel during pregnancy.

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

Consult your doctor or pharmacist before using any medication.

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 told you that you have an intolerance to certain sugars (e.g., lactose), consult with them before taking this medication.

3. How to take Clopidogrel Tarbis

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

If you have suffered severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg of Clopidogrel Tarbis (1 tablet of 300 mg or 4 tablets of 75 mg) to be taken once at the start of treatment. After that, the usual dose is one 75 mg tablet of Clopidogrel Tarbis per day, taken orally, with or without food, and at the same time each day.

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

If you take more Clopidogrel Tarbis 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 Toxicology Information Service, phone 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 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 forgotten dose.

In the 7, 14, 28, and 84 tablet formats, 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 stopping this medication.

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

4. Possible side effects

Like all medications, Clopidogrel Tarbis can cause 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 section 2 "Be cautious when taking Clopidogrel Tarbis").
• 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 Clopidogrel(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 small number of cases of bleeding in the blood vessels of the eyes, intracranial bleeding, pulmonary bleeding, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Tarbis

If you cut or injure yourself, 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 from forming clots. For minor cuts or injuries, such as those that occur while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Be cautious when taking Clopidogrel Tarbis").

Other side effects reported with Clopidogrel 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; changes in 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.

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storing Clopidogrel Tarbis

Keep out of the reach and sight of children.

Do not use Clopidogrel Tarbis after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Store below 25°C.

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

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Further information

Composition of Clopidogrel Tarbis

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

The other ingredients are: microcrystalline cellulose, spray-dried mannitol, 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 product and packaging contents

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

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

Not all 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 last revision of this leaflet: August 2019

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