Package leaflet: Information for the patient

Lecardi 75 mg enteric-coated tablets
Acidum acetylsalicylicum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient information leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your condition does not improve or if you feel worse, you should consult your doctor.

Table of contents of the leaflet

What Lecardi is and what it is used for
Important information before taking Lecardi
How to take Lecardi
Possible side effects
How to store Lecardi
Contents of the pack and other information

1. What Lecardi is and what it is used for

Lecardi contains acetylsalicylic acid, which inhibits platelet aggregation (clumping).
The medicine is intended for long-term prophylactic use in diseases associated with risk of thrombus and embolus formation in blood vessels.
Lecardi is used:

for prevention of myocardial infarction;
for prevention of cardiovascular diseases in patients with stable angina pectoris;
in patients with a history of unstable angina pectoris, except during the acute phase;
following surgical or interventional procedures on blood vessels, e.g. after coronary artery bypass grafting, coronary angioplasty;
for prevention of transient ischaemic attacks and ischaemic stroke, as well as after such events have occurred.

2. Important information before using Lecardi

When not to use Lecardi:

if the patient is allergic to the active substance, other salicylates, or to any of the other ingredients of this medicine (listed in section 6);
if the patient has active peptic ulcer of the stomach and (or) duodenum;
if the patient has an increased tendency to bleeding or blood clotting disorders;
if the patient has severe renal impairment or severe hepatic impairment;
if the patient has previously experienced asthma attacks after taking acetylsalicylic acid or other anti-inflammatory drugs (manifested by shortness of breath, wheezing);
if the patient is in the third trimester of pregnancy (last three months);
if the patient is taking methotrexate (a drug used in cancer treatment) at doses of 15 mg per week or higher;
in children under 12 years of age during viral infections (e.g. influenza, varicella) due to the risk of liver and brain damage (Reye's syndrome).

Warnings and precautions
Before starting treatment with Lecardi, discuss this with a doctor or pharmacist:

if the patient is allergic to anti-inflammatory and anti-rheumatic drugs (e.g. naproxen) or other allergenic substances – see section "When not to use Lecardi";
if the patient suffers from asthma, chronic respiratory diseases, or has nasal polyps;
if the patient has impaired kidney and (or) liver function, as there is a risk of increased adverse effects of the drug;
if the patient has been diagnosed with severe heart failure;
if the patient has a history of peptic ulcers of the stomach or intestines;
if the patient has congenital glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder).

Do not use Lecardi for at least 5 days before any planned surgical procedure
(including minor procedures, e.g. tooth extraction).
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".
Lecardi and other medicines
Inform your doctor or pharmacist about all medicines currently taken,
recently taken, or planned to be taken.
Do not use Lecardi simultaneously with:

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

Lecardi may be used after prior consultation with a doctor together with:

anticoagulants (e.g. acenocoumarol, warfarin, heparin);
other non-steroidal anti-inflammatory drugs, including salicylates;
medicines used in gout (e.g. probenecid, benzbromarone);
oral antidiabetic medicines (e.g. tolbutamide, glibenclamide) and insulin;
antiplatelet agents (e.g. ticlopidine);
medicines used to treat depression and anxiety (e.g. fluoxetine, paroxetine);
diuretics (medicines that increase urine production, such as furosemide);
systemic glucocorticosteroids (steroids used, among others, in the treatment of rheumatic disease);
medicines used to treat hypertension (e.g. enalapril, captopril);
valproic acid (a medicine used, among others, in epilepsy treatment);
methotrexate at doses lower than 15 mg per week;
digoxin (a medicine used in heart diseases);
metamizole (a medicine used to treat severe pain of various origins and fever when other agents are contraindicated or ineffective).

Use of Lecardi with alcohol
Do not take Lecardi with alcohol, as alcohol may increase the risk of gastrointestinal adverse effects caused by acetylsalicylic acid.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Lecardi may be used during the first 6 months of pregnancy only after consultation with a doctor.
Use of the medicine during the last three months of pregnancy is contraindicated, as it may cause complications in both mother and child.
Short-term use of the medicine by a breastfeeding woman does not pose a major risk to the breastfed infant. 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 or operate machinery.

3. How to use Lecardi

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

For prevention of transient ischaemic attacks and ischaemic stroke, as well as after such events: 1 to 4 enteric-coated tablets (75 mg to 300 mg) once daily.

Enteric-coated tablets should be taken after a meal – swallowed whole, without chewing.
The Lecardi enteric-coated tablet has a coating and does not disintegrate in the stomach, thereby reducing the irritating effect of acetylsalicylic acid on the gastric mucosa.
Use of a higher than recommended dose of Lecardi
In case of overdose, consult a physician immediately. In cases of severe poisoning, the patient should be taken to hospital immediately.
Initial symptoms of poisoning include: tinnitus, increased respiration, fever, nausea, vomiting, visual disturbances, headache and dizziness, confusion, and skin rashes.
In more severe cases, the following may occur: delirium, tremor, dyspnoea, excessive sweating, agitation, coma.
Missed dose of Lecardi
Do not take a double dose to make up for a missed dose. Take the next dose as scheduled.
If you have any further doubts concerning the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
Treatment should be discontinued and immediate contact with a doctor is required if the patient develops
first signs of hypersensitivity (e.g. swelling of the face, lips, tongue, throat, causing difficulty
in breathing or swallowing) or if bleeding occurs, e.g. gastrointestinal bleeding (symptoms: black stools) or hemorrhage. The physician will then assess the severity of symptoms and decide on further management.
After administration of acetylsalicylic acid, the following occurred:

Common (in 1 to 10 out of 100 people):

gastrointestinal discomfort (heartburn, nausea, vomiting) and abdominal pain.

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

inflammation of the stomach and intestines, gastric and (or) duodenal ulcer disease;
transient disturbances in liver function.

Uncommon or rare:

serious bleeding such as gastrointestinal hemorrhage (symptoms: black stools), cerebral hemorrhage (especially in patients with uncontrolled arterial hypertension and (or) during concomitant administration of drugs inhibiting blood clotting). Hemorrhage may lead to acute or chronic anemia due to blood loss and (or) iron deficiency anemia (symptoms: weakness, pallor).

Rare (less than 1 in 10,000 people):

severe allergic reactions, including anaphylactic shock (symptoms: swelling of the face, eyelids, tongue and larynx, significant drop in blood pressure, and disturbances in heart rhythm and breathing);
disturbances in kidney function;
decreased blood glucose concentration.

Additionally reported:

dizziness and tinnitus (symptoms of overdose);
hypersensitivity reactions: rash, urticaria, edema, pruritus, cardiac and respiratory disorders (including asthma);
increased risk of bleeding, prolonged bleeding time;
perioperative hemorrhage, bruising, bleeding (from nose, urogenital tract, gums).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. How to store Lecardi

Keep this medicine out of the sight and reach of children.
Store below 25ºC.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Lecardi contains

The active substance is acetylsalicylic acid. One enteric-coated tablet contains 75 mg of acetylsalicylic acid.
Other components are:
Core: microcrystalline cellulose, talc, pregelatinized corn starch.
Coating Aqua Polish D clear 094.18 MS containing: hypromellose, hydroxypropylcellulose, talc, hydrogenated cottonseed oil, medium-chain triglycerides.
Coating Aqua Polish P white 712.01 E containing: methacrylic acid – ethyl acrylate copolymer (1:1), sodium carmellose, Macrogol 6000, talc, colloidal anhydrous silica, titanium dioxide (E 171), triethyl citrate.

What Lecardi looks like and contents of the pack
Lecardi enteric-coated tablets are white, round, biconvex tablets.
The pack contains 60 enteric-coated tablets.
Marketing Authorisation Holder and Manufacturer
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208
30-133 Kraków
Tel.: +48 12 639 27 27
Information for blind and partially sighted people: 800-007-777
19.04.2023