Acard

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
ACARD (AKARD), 75 mg, enteric-coated tablets
Acetylsalicylic acid
ACARD and AKARD are different trade names of the same medicinal product written in Polish
and Bulgarian.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

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

Table of contents

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

1. What Acard is and what it is used for

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

• to prevent myocardial infarction in high-risk individuals;
• in acute myocardial infarction or suspected acute myocardial infarction;
• in unstable angina pectoris;
• to prevent recurrent myocardial infarction;
• after surgical or interventional procedures on blood vessels, e.g. coronary artery bypass grafting, coronary angioplasty;
• to prevent transient ischaemic attacks and ischaemic stroke, as well as after such events;
• in patients with atherosclerotic peripheral arterial disease;
• to prevent coronary thrombosis in patients with multiple risk factors;
• to prevent venous thrombosis and pulmonary embolism in patients who are immobilised for prolonged periods.

2. Important information before using Acard

When not to use Acard

• if the patient is allergic to acetylsalicylic acid, other salicylates, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an increased tendency to bleeding or blood clotting disorders;
• if the patient has a peptic ulcer of the stomach and/or duodenum;
• if the patient has severe kidney or liver problems (severe renal or hepatic insufficiency);
• if the patient has previously 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 (last three months of pregnancy);
• if the patient is taking methotrexate (a medicine used in cancer treatment) at doses of 15 mg per week or higher;
• in children under 12 years of age with viral infections (e.g. influenza or varicella), due to the risk of liver and brain damage (Reye's syndrome).

Warnings and precautions
Before starting to use Acard, discuss this with your doctor or pharmacist:

• if the patient is allergic to anti-inflammatory and anti-rheumatic medicines (e.g. naproxen) or other allergenic substances – see section "When not to use Acard";
• if the patient suffers from asthma, chronic respiratory diseases, or has nasal polyps;
• 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);
• if the patient has been diagnosed with severe heart failure;
• if the patient has impaired kidney and/or liver function, as there is a risk of worsening adverse effects of the medicine.
• Do not use Acard for at least 5 days before a planned surgical procedure (including minor procedures, e.g. tooth extraction).

Acard with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

• Do not use Acard simultaneously with:
• methotrexate at doses of 15 mg per week or higher;
• ibuprofen.
• Acard may be used together with the following medicines after prior consultation with a doctor:
• anticoagulants (e.g. acenocoumarol, warfarin, heparin);
• other non-steroidal anti-inflammatory drugs, including salicylates;
• medicines used in gout (e.g. probenecid, benzbromarone);
• antidiabetic medicines – oral (e.g. tolbutamide, glibenclamide) and insulin;
• medicines that inhibit platelet aggregation (e.g. ticlopidine);
• medicines used to treat depression and anxiety (e.g. fluoxetine, paroxetine);
• diuretics (e.g. furosemide);
• systemic glucocorticoids;
• antihypertensive medicines (e.g. enalapril, captopril);
• valproic acid (an antiepileptic medicine);
• methotrexate at doses lower than 15 mg per week;
• digoxin (a cardiac medicine).
• Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and clot formation) when both medicines are used simultaneously. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.
• 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 or pharmacist before using this medicine.
Acard may be used during the first 6 months of pregnancy only after consultation with a doctor.
Use during the last three months of pregnancy is contraindicated, as it may cause complications in both mother and child.
Short-term use of Acard by a breastfeeding woman does not pose a significant risk to the breastfed infant. However, breastfeeding is not recommended during long-term use of high doses of acetylsalicylic acid.

Driving and operating machinery
Acard has no effect on the ability to drive or operate machinery.

Acard 75 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Acard

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist.
Consult a doctor before starting to take Acard.
Acard is available in two strengths: 75 mg and 150 mg. The doctor will recommend the appropriate dose for the individual patient and determine the duration of treatment.
Administer orally.

• The usual recommended dosage is:

1 tablet (75 mg) daily.
Enteric-coated tablets should be taken after a meal – swallowed whole with a small amount of water.
The enteric-coated tablet of Acard has a coating and does not disintegrate in the stomach, thereby reducing the irritating effect of acetylsalicylic acid on the gastric mucosa.

• In acute myocardial infarction or suspected acute myocardial infarction:

a single dose of 4 enteric-coated tablets (300 mg). The tablets should be thoroughly chewed to accelerate absorption.
Note: In acute myocardial infarction or suspected acute myocardial infarction, enteric-coated tablets may be used only when uncoated acetylsalicylic acid tablets are not available.

Taking more Acard than recommended
In case of overdose, contact a doctor immediately. In the event of severe poisoning, the patient should be taken to hospital without delay.
Early signs of poisoning include: tinnitus, increased respiratory rate, fever, nausea, vomiting, visual disturbances, headache, dizziness, confusion, and skin rashes.
In more severe cases, symptoms may include: delirium, tremor, shortness of breath, excessive sweating, restlessness, and coma.

Missing a dose of Acard
Do not take a double dose to make up for a missed dose. Take the next dose as usual.

Stopping Acard
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can 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 symptoms of hypersensitivity (e.g. swelling of the face, lips, tongue, throat causing
difficulty in breathing or swallowing) or 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.
Following administration of acetylsalicylic acid, the following have been reported:
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, peptic ulcer disease of the stomach and (or) duodenum;
• transient disturbances in liver function.

Uncommon or rare:

• serious bleeding events such as gastrointestinal hemorrhage (symptoms: black stools), cerebral hemorrhage (particularly in patients with uncontrolled arterial hypertension and (or) when administered concomitantly with anticoagulant drugs). Hemorrhage may lead to acute or chronic blood loss anemia 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, swelling of the tongue and larynx, marked drop in blood pressure, cardiac arrhythmias, and breathing difficulties);
• disturbances in kidney function;
• decreased blood glucose concentration.

Additionally reported:

• dizziness and tinnitus (symptoms of overdose);
• hypersensitivity reactions: rash, urticaria, angioedema, 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 adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 .
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Acard

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from moisture.
Do not use Acard after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the packaging and other information

What Acard contains

• The active substance is acetylsalicylic acid. Each enteric-coated tablet contains 75 mg of acetylsalicylic acid.
• Other components: microcrystalline cellulose, corn starch, sodium carboxymethyl starch (type C); coating: hypromellose, triethyl citrate, simethicone emulsion, Acryl Eze-White: copolymer of methacrylic acid and ethyl acrylate (1:1), talc, titanium dioxide (E 171), colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate.

What Acard looks like and contents of the pack
Acard tablets are white or almost white, heart-shaped, biconvex, with a smooth surface.
Pack sizes: 30, 60, 90 or 120 enteric-coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Bulgaria, country of export:
POLPHARMA SA Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer:
POLPHARMA SA Pharmaceutical Works
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
POLPHARMA SA Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing Authorisation Number in Bulgaria, country of export: 20170037
Parallel Import Licence Number: 19/22