Lecardi

Leaflet attached to the packaging: patient information

Lecardi 75 mg enteric-coated tablets
Acetylsalicylic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Lecardi and what is it used for
• 2. Important information before taking Lecardi
• 3. How to take Lecardi
• 4. Possible side effects
• 5. How to store Lecardi
• 6. Contents of the packaging and other information

1. What is Lecardi and what is it used for

Lecardi contains acetylsalicylic acid, which inhibits platelet aggregation.
The medicine is intended for long-term preventive use in diseases that may lead to the formation of blood clots and emboli in blood vessels.
Lecardi is used:

• to prevent heart attacks;
• to prevent cardiovascular diseases in patients with stable angina pectoris;
• in unstable angina pectoris, except during the acute phase;
• after surgical or interventional procedures on blood vessels, such as coronary artery bypass grafting or coronary angioplasty;
• to prevent transient ischemic attacks and ischemic strokes, as well as after they have occurred.

2. Important information before taking Lecardi

When not to take Lecardi:

• if the patient is allergic to the active substance, other salicylates, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has active gastric or duodenal ulcers;
• if the patient has an increased tendency to bleeding and coagulation disorders;
• if the patient has severe renal or hepatic impairment;
• if the patient has experienced asthma attacks after taking acetylsalicylic acid or other anti-inflammatory drugs (symptoms: shortness of breath, wheezing);
• if the patient is in the third trimester of pregnancy (the last three months);
• if the patient is taking methotrexate (a medicine used to treat cancer) in doses of 15 mg per week or higher;
• in children under 12 years of age with viral infections (e.g., flu, chickenpox) due to the risk of liver and brain damage (Reye's syndrome).

Warnings and precautions

Before starting to take Lecardi, the patient should discuss it with their doctor or pharmacist:

• if the patient is allergic to anti-inflammatory and anti-rheumatic drugs (e.g., naproxen) or other allergenic substances - see "When not to take Lecardi";
• if the patient has asthma, chronic respiratory diseases, or nasal polyps;
• if the patient has kidney or liver function disorders, as there is a risk of exacerbating the medicine's side effects;
• if the patient has severe heart failure;
• if the patient has a history of gastric or intestinal ulcers;
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase (a rare inherited disease);

Lecardi should not be taken for at least 5 days before a planned surgical procedure (including minor procedures, such as tooth extraction).
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

Lecardi and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Lecardi should not be taken at the same time as:

• methotrexate in doses of 15 mg per week or higher;
• ibuprofen (a medicine used to relieve pain and reduce fever).

Lecardi can be taken after prior consultation with a doctor:

• with anticoagulant medicines (e.g., acenocoumarol, warfarin, heparin);
• with other non-steroidal anti-inflammatory drugs, including salicylates;
• with medicines used to treat gout (e.g., probenecid, benzbromarone);
• with oral anti-diabetic medicines (e.g., tolbutamide, glibenclamide) and insulin;
• with medicines that inhibit platelet aggregation (e.g., ticlopidine);
• with medicines used to treat depression and anxiety (e.g., fluoxetine, paroxetine);
• with diuretics (medicines that increase urine production, such as furosemide);
• with systemic glucocorticosteroids (steroids used to treat, among other things, rheumatic diseases);
• with medicines used to treat hypertension (e.g., enalapril, captopril);
• with valproic acid (a medicine used to treat, among other things, epilepsy);
• with methotrexate in doses less than 15 mg per week;
• with digoxin (a medicine used to treat heart diseases);
• with metamizole (a medicine used to treat pain of various origins and fever, when other measures are contraindicated or ineffective).

Taking Lecardi with alcohol

Lecardi should not be taken with alcohol, as it may increase the risk of gastrointestinal side effects caused by acetylsalicylic acid.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Lecardi can be taken during the first 6 months of pregnancy only after consulting a doctor.
Taking the medicine during the last three months of pregnancy is contraindicated, as it may cause complications in the mother and child.
Short-term use of the medicine by a breastfeeding woman does not pose a significant risk to the breastfed child. However, breastfeeding is not recommended during long-term use of high doses of acetylsalicylic acid.

Driving and operating machinery

Lecardi does not affect the ability to drive and operate machinery.

3. How to take Lecardi

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
The usual recommended daily dose is 1 to 2 enteric-coated tablets (75 mg to 150 mg).

• To prevent transient ischemic attacks and ischemic strokes, as well as after they have occurred: 1 to 4 enteric-coated tablets (75 mg to 300 mg) once a day.

The enteric-coated tablets should be taken after a meal - swallowed whole, not chewed.
The Lecardi enteric-coated tablet has a coating and does not dissolve in the stomach, which reduces the irritating effect of acetylsalicylic acid on the gastric mucosa.

Taking a higher dose of Lecardi than recommended

In case of overdose, the patient should contact their doctor, and in case of severe poisoning, the patient should be taken to the hospital immediately.
The first symptoms of poisoning are: tinnitus, rapid breathing, fever, nausea, vomiting, vision disturbances, headaches, and dizziness.
In more severe cases, the following may occur: hallucinations, tremors, shortness of breath, excessive sweating, agitation, coma.

Missing a dose of Lecardi

The patient should not take a double dose to make up for a missed dose, but instead take the next dose as usual.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lecardi can cause side effects, although not everybody gets them.
The patient should stop taking the medicine and contact their doctor immediately if they experience the first symptoms of hypersensitivity (e.g., facial swelling, lip swelling, tongue swelling, throat swelling, causing difficulty breathing or swallowing) or if they experience bleeding, e.g., from the gastrointestinal tract (symptoms: black stools) or hemorrhages. The doctor will then assess the severity of the symptoms and decide on further action.
After taking acetylsalicylic acid, the following have been reported:

• Frequent (in 1 to 10 out of 100 people):
• symptoms of indigestion (heartburn, nausea, vomiting) and abdominal pain.

Rare (in 1 to 10 out of 10,000 people):

• inflammatory diseases of the stomach and intestines, gastric and duodenal ulcers;
• transient liver function disorders.

Rare or very rare:

• serious bleeding, such as gastrointestinal bleeding (symptoms: black stools), cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or during concomitant administration of bleeding-inhibiting medicines). Bleeding can lead to acute or chronic anemia due to blood loss and/or iron deficiency anemia (symptoms: weakness, pallor).

Very rare (less than 1 in 10,000 people):

• severe allergic reactions, including anaphylactic shock (symptoms: facial swelling, eyelid swelling, tongue swelling, and throat swelling, significant decrease in blood pressure, and disturbances in heart rhythm and breathing);
• kidney function disorders;
• decreased blood glucose levels.

Additionally, the following have been reported:

• dizziness and tinnitus (symptoms of overdose);
• hypersensitivity reactions: rash, urticaria, edema, itching, heart and respiratory disorders (including asthma);
• increased risk of bleeding, prolonged bleeding time;
• peroperative bleeding, hematomas, bleeding (from the nose, genitourinary tract, gums).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lecardi

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lecardi contains

• The active substance of the medicine is acetylsalicylic acid. One enteric-coated tablet contains 75 mg of acetylsalicylic acid.
• The other ingredients are: Core: microcrystalline cellulose, talc, maize starch paste Otoczka Aqua Polish D clear 094.18 MS with the composition: hypromellose, hydroxypropylcellulose, talc, hydrogenated cottonseed oil, medium-chain triglycerides. Otoczka Aqua Polish P white 712.01 E with the composition: methacrylic acid and ethyl acrylate copolymer (1:1), sodium carmellose, Macrogol 6000, talc, hydrated silica, titanium dioxide (E 171), triethyl citrate.

What Lecardi looks like and what the packaging contains

Lecardi enteric-coated tablets are round, white, and biconvex.
The packaging contains 60 enteric-coated tablets.

Marketing authorization holder and manufacturer

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208
30-133 Kraków
Phone: +48 12 639 27 27

Information for the blind and visually impaired: 800-007-777

Date of the last update of the leaflet:

• 19.04.2023