NASTILOX 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Nastilox 75 mg Film-Coated Tablets EFG

clopidogrel

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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

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

1. What is Nastilox and what is it used for

Nastilox contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells that clump together during blood clotting. By preventing this clumping, antiplatelet agents reduce the chances of blood clots (a process called thrombosis) forming.

Adults take clopidogrel to prevent blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can cause atherothrombotic events (such as stroke, heart attack, or death).

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

• you have a condition that causes hardening of the arteries (also known as atherosclerosis) and
• you have previously had a heart attack or stroke or have a condition known as peripheral arterial disease, or
• you have had a severe type of chest pain known as "unstable angina" or "myocardial infarction" (heart attack). 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 aspirin (a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clots);
• you have experienced symptoms of a stroke that disappear within a short period (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer aspirin to you within the first 24 hours;
• you have an irregular heartbeat, a condition called "atrial fibrillation", and you cannot take medications known as "oral anticoagulants" (vitamin K antagonists), which prevent the formation of new clots and prevent the growth of existing ones. You will have been told that "oral anticoagulants" are more effective than aspirin or the combined use of Nastilox and aspirin for this condition. Your doctor will have prescribed clopidogrel plus aspirin if you cannot take "oral anticoagulants" and do not have a risk of severe bleeding.

2. What you need to know before you take Nastilox

Do not take Nastilox:

• if you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
• if you have a condition that is causing bleeding, such as a stomach ulcer or bleeding in the brain;
• if you have a severe liver disease.

If you think you may have any of these conditions, or if you are in any doubt, consult your doctor before taking Nastilox.

Warnings and precautions

If any of the following situations apply to you, consult your doctor before taking Nastilox:

• if you have a risk of bleeding, such as:

• a condition that makes you prone to internal bleeding (such as a stomach ulcer);
• a blood disorder that makes you prone to internal bleeding (bleeding inside any of your body's tissues, organs, or joints);
• a recent severe injury;
• a recent surgery (including dental surgery);
• a planned 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 seven days;
• if you have liver or kidney disease;
• if you have had an allergy or reaction to any medication used to treat your condition;
• if you have a medical history of non-traumatic cerebral hemorrhage.

While taking Nastilox:

• Tell your doctor if you are scheduled to have surgery (including dental surgery);
• Also, you must immediately inform your doctor if you develop a disease (also known as thrombotic thrombocytopenic purpura or TTP) that includes fever and bruising under the skin that can appear as small red spots, with or without extreme unexplained fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or injure yourself, bleeding may take longer than usual to stop. This is related to the way the medicine works, as it prevents the formation of blood clots. In the case of minor cuts and injuries, e.g., when cutting or shaving, it is usually not a cause for concern. However, if you are concerned about bleeding, you should contact your doctor immediately (see section 2 "Warnings and precautions").
• Your doctor may ask you to have blood tests.

Children and adolescents

Do not give this medicine to children as it will not work.

Other medicines and Nastilox

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

Some other medicines may affect the use of Nastilox or vice versa.

In particular, you must tell your doctor if you are taking:

• medicines that may increase your risk of bleeding, such as:
• • oral anticoagulants, medicines used to reduce blood clot formation;
  • non-steroidal anti-inflammatory drugs, normally used to treat painful or inflammatory conditions of muscles or joints;
  • heparin or any other injectable medicine used to reduce blood clot formation;
  • ticlopidine or other antiplatelet agents;
  • a selective serotonin reuptake inhibitor (including, among others, fluoxetine or fluvoxamine), medicines commonly used to treat depression;
  • rifampicin (used to treat severe infections);
• omeprazole or esomeprazole, medicines to treat stomach upset;
• fluconazole or voriconazole, medicines to treat fungal infections;
• efavirenz or other antiretroviral medicines (used to treat HIV infections);
• moclobemide, a medicine to treat depression;
• carbamazepine, a medicine to treat some forms of epilepsy;

• repaglinide, a medicine to treat diabetes;
• paclitaxel, a medicine to treat cancer;
• opioids: while you are being treated with clopidogrel, you must inform your doctor before any opioid is prescribed to you (used to treat severe pain);
• rosuvastatin (used to lower cholesterol levels).

If you have had a severe chest pain (unstable angina or myocardial infarction), a transient ischemic attack, or a mild ischemic stroke, you may be prescribed Nastilox in combination with aspirin, a substance found in many medications used to relieve pain and reduce fever. In general, the occasional use of aspirin (no more than 1000 mg in a 24-hour period) should not cause problems, but prolonged use in other circumstances should be discussed with your doctor.

Taking Nastilox with food and drinks

Nastilox can be taken with or without food.

Pregnancy and breast-feeding

It is preferable not to take this product during pregnancy.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking Nastilox, consult your doctor immediately, as it is recommended not to take clopidogrel during pregnancy.

You should not breast-feed while taking this medicine.

If you are breast-feeding or plan to breast-feed, talk to your doctor before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Nastilox is unlikely to affect your ability to drive or use machines.

Nastilox contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Nastilox contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Nastilox

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose, even in patients with a condition called "atrial fibrillation" (irregular heartbeat), is one 75 mg Nastilox tablet per day, to be taken orally with or without food and at the same time each day.

If you have had a severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg or 600 mg of Nastilox (4 or 8 tablets of 75 mg) once at the start of treatment. After that, the recommended dose is one 75 mg Nastilox tablet per day, as described above.

If you have experienced symptoms of a stroke that disappear within a short period (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may give you 300 mg of Nastilox (4 tablets of 75 mg) once at the start of treatment. After that, the recommended dose is one 75 mg Nastilox tablet per day, as described above, with aspirin for 3 weeks. Then, your doctor will prescribe Nastilox alone or aspirin alone.

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

If you take more Nastilox than you should

Contact your doctor or the nearest hospital emergency department immediately because of an increased risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Nastilox

If you forget to take a dose of Nastilox, but remember within 12 hours of the time you should have taken it, take the tablet immediately and then take the next tablet at the usual time.

If you forget for more than 12 hours, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Nastilox

Do not stop treatment unless your doctor tells you to.Contact your doctor or pharmacist before stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Consult your doctor immediately if you experience:

• fever, signs of infection, or extreme fatigue. These could be due to a rare decrease in some blood cells;
• signs of liver problems such as yellowing of the skin or eyes (jaundice), associated or not with bleeding that appears under the skin in the form of small red spots or confusion (see section 2 "Warnings and precautions");
• swelling of the mouth or skin disorders such as rash and itching, blisters on the skin. These could be signs of an allergic reaction.

The most common side effect reported with Nastilox is bleeding.Bleeding may appear as stomach or intestine bleeding, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. In a small number of cases, bleeding has also been reported in the eye, inside the head, in the lung, or in the joints.

If you experience prolonged bleeding while taking Nastilox

If you cut or injure yourself, bleeding may take longer than usual to stop. This is related to the way the medicine works, as it prevents the formation of blood clots. In the case of minor cuts and injuries, e.g., when cutting or shaving, it is usually not a cause for concern. However, if you are concerned about bleeding, you should contact 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):

stomach pain, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, 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, breathing difficulties sometimes associated with cough, generalized allergic reactions (e.g., general feeling of heat with sudden general discomfort leading to fainting), swelling of the mouth, blisters on the skin, skin allergy, painful mouth (stomatitis), low blood pressure, confusion, hallucinations, joint pain, muscle pain, changes in taste or loss of taste for food.

Side effects with unknown frequency(frequency cannot be estimated from the available data):

hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nastilox

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

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP.". The expiry date refers to the last day of the month shown.

Do not store above 25°C.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Nastilox

• The active substance is clopidogrel.

Each film-coated tablet contains 75 mg of clopidogrel (as besylate).

• The other ingredients are (see section 2 "Nastilox contains lactose"):

Core of the tablet:microcrystalline cellulose (type PH-102), mannitol (E-421), hydroxypropylcellulose, crospovidone type A, citric acid monohydrate, macrogol 6000, stearic acid 50, fumaric acid, and sodium.

Coating of the tablet:hypromellose, lactose monohydrate, red iron oxide (E-172), triacetin, titanium dioxide (E-171).

Appearance of the product and contents of the pack

Nastilox film-coated tablets are pink, round, biconvex, with a diameter of 9.1 mm ± 0.1 mm and a thickness of 4.2 mm ± 0.2 mm. They are presented in white PVC/PE/PVDC/aluminum blisters packaged in cardboard boxes containing 28, 50, or 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Pharmathen S.A.

6, Dervenakion street

Pallini 15351, Attiki

Greece

or

Pharmathen International S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain - Nastilox 75 mg film-coated tablets EFG

Portugal - Nastilox 75 mg film-coated tablets

Date of last revision of this leaflet:December 2024

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