Acard

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
ACARD (Acard)
75 mg, enteric-coated tablets
Acetylsalicylic acid
ACARD and Acard are trade names of the same medicinal product written in Polish and Bulgarian.
Please read the entire leaflet carefully before using this 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 a physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, please consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse, consult a physician.

Table of contents of the leaflet

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 package and other information

1. What ACARD is and what it is used for

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

• for prevention of myocardial infarction in individuals at high risk;
• in acute myocardial infarction or suspected acute myocardial infarction;
• in unstable angina pectoris;
• for prevention of recurrent myocardial infarction;
• following surgical or interventional procedures on blood vessels, e.g. coronary artery bypass grafting, coronary angioplasty;
• for prevention of transient ischemic attacks and ischemic stroke, as well as after such events;
• in patients with atherosclerosis of peripheral arteries;
• for prevention of coronary thrombosis in patients with multiple risk factors;
• for prevention of venous thrombosis and pulmonary embolism in patients who are immobilized 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 gastric or duodenal ulcer disease;
• 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 antirheumatic drugs (e.g. naproxen) or other allergenic substances – see the 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 ulcer disease of the stomach or intestines;
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary 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 and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken,
as well as any medicines the patient intends to take.

• Do not use ACARD simultaneously with:
  • methotrexate at doses of 15 mg per week or higher;
  • ibuprofen.
• ACARD may be used 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 the treatment of gout (e.g. probenecid, benzbromarone);
  • antidiabetic medicines – oral (e.g. tolbutamide, glibenclamide) and insulin;
  • antiplatelet agents (e.g. ticlopidine);
  • medicines used in the treatment of depression and anxiety (e.g. fluoxetine, paroxetine);
  • diuretics (e.g. furosemide);
  • systemic glucocorticosteroids;
  • antihypertensive medicines (e.g. enalapril, captopril);
• valproic acid (an antiepileptic medicine);
• methotrexate at doses less 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 these medicines are used together. Therefore, caution is advised 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 have a child, she should consult her 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 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 treatment with high doses of acetylsalicylic acid.

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

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

3. How to take ACARD

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. You should consult your doctor before starting to take ACARD.

ACARD is available in two strengths: 75 mg and 150 mg. Your doctor will recommend the appropriate dose for you and determine the duration of treatment.
Take orally.

• The usual recommended dosage is:

1 tablet (75 mg) daily.
Enteric-coated tablets should be taken after a meal – swallow whole with a small amount of water.
The enteric-coated ACARD tablet 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:

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
If an overdose occurs, contact a doctor immediately. In case of severe poisoning, the patient should be taken to hospital without delay.
Early signs of poisoning include: tinnitus, rapid breathing, fever, nausea, vomiting, visual disturbances, headache, dizziness, confusion, and skin rashes.
In more severe cases, the following may occur: delirium, tremor, shortness of breath, excessive sweating, agitation, and coma.

If you forget to take ACARD
Do not take a double dose to make up for the 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 will experience them.
Treatment should be discontinued and immediate contact with a doctor is required if the patient
experiences 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 doctor will then assess the severity of
the symptoms and decide on further management.
Following administration of acetylsalicylic acid, the following have been observed:
Common (in 1 to 10 out of 100 people):

• gastrointestinal discomfort (dyspepsia, 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 events such as gastrointestinal hemorrhage (symptoms: black stools), cerebral hemorrhage (particularly in patients with uncontrolled hypertension and/or when used concomitantly with anticoagulant drugs). Hemorrhage may lead to acute or chronic blood loss anemia 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, marked 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 disturbances (including asthma);
• increased risk of bleeding, prolonged bleeding time;
• perioperative hemorrhage, bruising, bleeding (from nose, genitourinary 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 of Adverse Drug Reactions, 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
Reporting adverse reactions helps to provide more information on the safety of this 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 container. 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What ACARD contains

• The active substance is acetylsalicylic acid. Each enteric-coated tablet contains 75 mg of acetylsalicylic acid.
• The other ingredients are: cellulose microcrystalline, corn starch, sodium carboxymethyl starch (type C); coating: hypromellose, triethyl citrate, simethicone emulsion, Acryl-Eze

White: methacrylic acid-ethyl acrylate copolymer (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.
The pack contains 30, 60, 90 or 120 enteric-coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
Polpharma S.A. Pharmaceutical Works
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Manufacturer:
Polpharma S.A. Pharmaceutical Works
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Polpharma S.A. Pharmaceutical Works
Production Branch in Nowa Dęba
ul. Metalowca 2
39-460 Nowa Dęba
Poland
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing Authorisation number in Bulgaria, country of export: 20170037
Parallel import licence number: 198/23