ZYLLT 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Zyllt 75 mg Film-Coated Tablets EFG

clopidogrel

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Zyllt and what is it used for
2. What you need to know before taking Zyllt
3. How to take Zyllt
4. Possible side effects
5. 5 Storage of Zyllt
6. Package Contents and Additional Information

1. What is Zyllt and what is it used for

Zyllt contains clopidogrel and belongs to a group of medications called antiplatelet agents. Platelets are very small cells found in the blood, and they aggregate when the blood clots. Antiplatelet agents, by preventing this aggregation, reduce the likelihood of blood clots (a process called thrombosis) forming.

Zyllt is administered to adults to prevent the formation of blood clots (thrombi) in blood vessels (arteries) that have become hardened, a process known as atherothrombosis, which can cause atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed Zyllt to help prevent the formation of blood clots and reduce the risk of these serious events, as you:

• suffer from a process that causes the hardening of the arteries (also known as atherosclerosis), and
• have previously suffered a myocardial infarction, a stroke, or suffer from a disease called peripheral arterial disease, or
• 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 obstructed or narrowed artery to restore adequate blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and lower fever, as well as to prevent blood clots).

have an irregular heartbeat, a disease called "atrial fibrillation", and you 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 will have been told that "oral anticoagulants" are more effective than acetylsalicylic acid or the combined use of Zyllt and acetylsalicylic acid for this disease. Your doctor will have prescribed Zyllt plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a risk of severe bleeding.

2. What you need to know before taking Zyllt

Do not take Zyllt

• 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 disorder, such as a stomach ulcer or bleeding in the brain;
• If you have a severe liver disease.

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

Warnings and Precautions

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

• If you are at 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 had a severe 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 an artery of the brain (ischemic stroke) in the last 7 days.
• If you have liver or kidney disease.
• If you have had an allergy or reaction to any medication used to treat your disease.

During treatment with Zyllt:

• Tell your doctor if you are scheduled to undergo 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 (bleeding under the skin that can appear as red spots), accompanied or not 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 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 injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and Precautions").
• Your doctor may ask you to have blood tests.

Children and Adolescents

This medication should not be given to children as it is not effective.

Other Medications and Zyllt

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those obtained without a prescription.

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

You must explicitly inform your doctor if you are taking:

• medications that may increase the risk of bleeding, such as:
• • oral anticoagulants, medications used to decrease blood clotting,
  • non-steroidal anti-inflammatory drugs, medications used to treat pain and/or inflammation of muscles or joints,
  • heparin, or any other injectable medication used to decrease blood clotting,
  • 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, a medication to treat HIV (human immunodeficiency virus) infections,
• carbamazepine, a medication to treat some forms of epilepsy,
• moclobemide, a medication for depression,
• repaglinide, a medication to treat diabetes,
• paclitaxel, a medication to treat cancer,
• antiretrovirals (medications to treat HIV infection).

If you have suffered severe chest pain (unstable angina or myocardial infarction), you may have been prescribed Zyllt in combination with acetylsalicylic acid, a substance found in many medications used to relieve pain and lower 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 Zyllt with Food and Drinks

Zyllt can be taken with or without food.

Pregnancy and Breastfeeding

It is preferable not to take this medication during pregnancy.

If you are pregnant or think you may be pregnant, you should inform your doctor or pharmacist before taking Zyllt. If you become pregnant while taking Zyllt, 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 breastfeed, inform your doctor before taking this medication.

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

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

Zyllt contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Zyllt

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose, even for patients with a disease called "atrial fibrillation" (an irregular heartbeat), is one 75 mg Zyllt tablet per day, administered orally with or without food and at the same time each day.

If you have suffered severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg of Zyllt (4 tablets of 75 mg) to be taken once at the start of treatment. Afterward, the recommended dose is one 75 mg Zyllt tablet per day as described above.

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

If you take more Zyllt than you should

Contact your doctor or go to the emergency department of the nearest hospital, as there is a greater risk of bleeding.

If you forget to take Zyllt

If you forget to take a dose of Zyllt, 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 a forgotten tablet.

If you interrupt treatment with Zyllt

Do not interrupt your 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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone 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 rashes and itching, blisters on the skin. These can be signs of an allergic reaction.

The most common side effect reported with Zyllt 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 from the blood vessels of the eyes, intracranial bleeding, pulmonary or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Zyllt

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's ability to form clots. For minor cuts or injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and Precautions").

Other side effects include:

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

Diarrhea, abdominal pain, indigestion, or heartburn.

Uncommon side effects (may affect up to 1 in 100 people):

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, rash, itching, dizziness, tingling sensation, 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 (such as a feeling of heat with sudden general discomfort up to fainting); 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 or loss of taste of food.

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

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Zyllt

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

Do not use this medication after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Zyllt Composition

• The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
• The other ingredients are: lactose (see section "Zyllt contains lactose"), microcrystalline cellulose, pregelatinized corn starch, macrogol 6000, and hydrogenated castor oil in the tablet, and hypromellose (E464), titanium dioxide (E171), red iron oxide (E172), talc, and propylene glycol in the film coating.

Appearance of Zyllt and Package Contents

Film-coated tablets are pink, round, and slightly convex.

Boxes of 7, 14, 28, 30, 50, 56, 60, 84, 90, and 100 film-coated tablets in blisters.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

KRKA-POLSKA Sp. z o.o., ul. Równolegla 5, 02-235 Warszawa, Poland

KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Prospectus:

Detailed information about this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu/.