Package Leaflet: Information for the User

Clopidogrel Tarbis 75 mg Film-Coated Tablets

Clopidogrel, besilate

Read this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist

Clopidogrel Tarbis belongs to a group of medications known as antiplatelet agents. Platelets are very small cells found in the blood, smaller than red or white blood cells, and aggregate when blood clots. Antiplatelet agents, by preventing this aggregation, reduce the likelihood of blood clots (a process known as thrombosis) forming.

Clopidogrel Tarbis is administered to prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can cause atherothrombotic effects (such as cerebral infarction, myocardial infarction, or death).

Clopidogrel Tarbis has been prescribed to help prevent blood clots from forming and reduce the risk of these serious events because:

• You suffer from a process that causes artery hardening (also known as atherosclerosis), and
• You have previously experienced a myocardial infarction, cerebral infarction, or suffer from a disease known as peripheral artery disease.

Do not take Clopidogrel Tarbis

• If you are allergic (hypersensitive) to clopidogrel or any of the other components of Clopidogrel;
• 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 Clopidogrel.

Be especially careful with Clopidogrel Tarbis

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

• If you have a risk of bleeding (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 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.
• If you have had a blood clot in a cerebral artery (ischemic cerebral infarction) in the last 7 days.
• If you are using another type of medication (see "Use of other medications").
• If you have liver or kidney diseases.

During treatment with Clopidogrel Tarbis:

• Inform your doctor if you have a scheduled surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder that includes fever and hematomas (bruises) under the skin that may appear as localized red spots, accompanied or not by extreme fatigue, confusion, yellow color in the skin or eyes (jaundice) (see section 4 "Possible Adverse Effects").
• If you cut or get a wound, bleeding may take longer to stop. This is related to the way the medication works, as it prevents the blood from forming clots. For minor cuts or wounds, such as cutting during shaving, this is not a problem. However, if you are concerned about your bleeding, 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 observe any adverse effect not mentioned in section 4 "Possible Adverse Effects" or if you observe that some adverse effect worsens.

Clopidogrel Tarbis should not be administered to children or adolescents

Use of other medications

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

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

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

You should inform your doctor explicitly if you are taking nonsteroidal anti-inflammatory drugs, medications used to treat muscle or joint pain and inflammation, or if you are taking heparin, or any other medication used to reduce blood coagulation, or if you are taking a proton pump inhibitor (e.g. omeprazole) for stomach discomfort, or if you are taking antiretrovirals (medications to treat HIV infection).

You should inform your doctor explicitly 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 consulted with your doctor.

Taking Clopidogrel Tarbis with food and drinks

Clopidogrel Tarbis can be taken with and 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, 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 operating machinery

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

Important information about some of the components of Clopidogrel

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

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

If you have experienced 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 beginning of treatment. After that, the usual dose is one 75 mg Clopidogrel Tarbis tablet per day, taken orally, with or without food, and at the same time every 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 service, 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 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 missed 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 interrupt treatment with Clopidogrel Tarbis

Do not interrupt 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.

Like all medications, Clopidogrel Tarbis may have side effects, although not everyone will experience 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.
• Symptoms 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 especially careful with Clopidogrel”).
• 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 Clopidogrel(which affect between 1 and 10 patients in every 100) is bleeding. Bleeding can appear in the stomach or intestines, 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 bleeding, pulmonary or joint bleeding have been reported.

If you experience prolonged bleeding while taking Clopidogrel Tarbis

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 “Be especially careful with Clopidogrel”)

Other side effects reported with Clopidogrel are:

Frequent side effects (which affect between 1 and 10 patients in every 100): Diarrhea, abdominal pain, indigestion, or heartburn.

• Rare side effects (which affect between 1 and 10 patients in every 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rashes, itching, dizziness, tingling, and numbness.
• Very rare side effects (which affect between 1 and 10 patients in every 10,000): Dizziness.
• Very rare side effects (which affect fewer 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 mucous membrane of the mouth (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in the taste of things; eosinophilic pneumonia; acquired hemophilia A.
• Unknown frequency: Hypersensitivity reactions.

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

If you experience any type of side effect, consult your doctor or pharmacist or nurse, 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 Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use Clopidogrel Tarbis after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Do not use Clopidogrel Tarbis if you observe any visible sign of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Clopidogrel Tarbis Composition

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

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

Product Appearance and Packaging Content

Clopidogrel Tarbis tablets are round, biconvex, pink, and coated with a film

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible 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

Last reviewed date of this leaflet: August 2019

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/