Package leaflet: Information for the patient

Acard PRO, 100 mg, enteric-coated tablets
Acetylsalicylic acid
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Acard PRO is and what it is used for

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

for prevention of myocardial infarction in individuals at high risk;
in acute myocardial infarction or suspected acute myocardial infarction;
after an episode of unstable angina;
for prevention of recurrent myocardial infarction;
after surgical or interventional procedures on blood vessels, e.g. coronary artery bypass grafting, coronary angioplasty;
for prevention of transient ischaemic attacks and ischaemic stroke, as well as after such events;
in patients with peripheral arterial atherosclerosis;
for prevention of coronary thrombosis in patients with multiple risk factors;
for prevention of venous thrombosis and pulmonary embolism in long-term immobilized patients, e.g. after major surgical procedures, as an addition to other prophylactic measures.

The decision to initiate treatment with acetylsalicylic acid and the dosage to be used should be made by a physician.

2. Important information before using Acard PRO

When not to use Acard PRO

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 peptic ulcer of the stomach and/or duodenum;
if the patient has severe kidney, liver, or heart disease (severe renal, hepatic, or cardiac 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 last three months of pregnancy, doses higher than 100 mg per day must not be used (see section "Pregnancy and breastfeeding");
if the patient has gout;
if the patient has congenital glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder);
if the patient is taking methotrexate (a medicine used in cancer treatment) at doses of 15 mg per week or higher;
in children and adolescents under 16 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 take Acard PRO, 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 PRO";
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 impaired kidney and/or liver function, as there is a risk of worsening adverse effects of the medicine.

Do not use Acard PRO for at least 5 days before a planned surgical procedure (including minor procedures such as tooth extraction).
Children and adolescents
Do not use in children and adolescents under 16 years of age.
Acard PRO 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 PRO simultaneously with:
- methotrexate at doses of 15 mg per week or higher.
Acard PRO may be used together with the following medicines, but only 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;
- antiplatelet agents (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);
- medicines used to prevent transplant rejection after transplantation (e.g. cyclosporine and tacrolimus);
- methotrexate at doses lower than 15 mg per week (used in oncological or rheumatoid diseases);
- ibuprofen;
- 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 simultaneously. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.

Acard PRO with food, drink, and alcohol
Take the medicine after a meal – swallow whole.
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.
Pregnancy
If the patient continues or starts treatment with Acard PRO during pregnancy as recommended by a doctor, she should take Acard PRO according to the doctor's instructions and should not take a higher dose than recommended.
Pregnancy – third trimester
Do not use acetylsalicylic acid in doses higher than 100 mg per day during the last three months of pregnancy, as this may harm the unborn child or cause complications during delivery. Use of Acard PRO may cause kidney and heart problems in the unborn child. It may also affect the bleeding tendency in both the mother and her child and may cause delayed or prolonged labour.
If the patient takes acetylsalicylic acid in low doses (up to 100 mg per day inclusive), strict obstetric monitoring according to the doctor's recommendations is required.
Pregnancy – first and second trimester
Do not take Acard PRO during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible time. Acard PRO taken for longer than a few days starting from week 20 of pregnancy may cause kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment longer than a few days is necessary, the doctor may recommend additional monitoring.
Breastfeeding
Acetylsalicylic acid passes into breast milk in small concentrations; therefore, the medicine should not be used during breastfeeding due to the risk of Reye's syndrome in the child. In cases where high doses of acetylsalicylic acid are used in a breastfeeding woman, disturbances in platelet function in the child may occur.
Driving and operating machinery
Acard PRO has no effect on the ability to drive or operate machinery.
Acard PRO 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 PRO

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
Oral administration.

Recommended dosage:

1 enteric-coated tablet (100 mg) daily.
Enteric-coated tablets should be taken after a meal – swallowed whole.
The enteric-coated tablet of Acard PRO has a coating and does not disintegrate in the stomach, thus reducing the irritant effect of acetylsalicylic acid on the gastric mucosa.

**In acute myocardial infarction or suspected acute myocardial infar游戏副本

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment should be discontinued and immediate medical advice sought if the patient
develops first signs 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 haemorrhage. The physician will then assess the severity of
symptoms and decide on further management.
The following adverse effects have been reported with acetylsalicylic acid:
Common (in 1 to 10 out of 100 people):

gastrointestinal symptoms (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 ulceration;
transient disturbances in liver function.

Uncommon or rare:

serious bleeding such as gastrointestinal haemorrhage (symptoms: black stools), cerebral haemorrhage (particularly in patients with uncontrolled arterial hypertension and (or) when administered concomitantly with anticoagulant drugs). Haemorrhage may lead to acute or chronic anaemia due to blood loss and (or) iron deficiency anaemia (symptoms: weakness, pallor).

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

severe allergic reactions, including anaphylactic shock (symptoms: facial, eyelid, tongue and laryngeal oedema, marked drop in blood pressure, and disturbances in heart rhythm and respiration);
disturbances in kidney function;
decreased blood glucose concentration.

Additionally reported:

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects may also be reported to the Marketing Authorisation Holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Acard PRO

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 this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The marking on the package following "EXP" indicates the expiry date, and following "Lot" or "LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Acard PRO contains

The active substance is acetylsalicylic acid. Each enteric-coated tablet contains 100 mg of acetylsarylic acid.
The other ingredients are: powdered cellulose, maize starch, sodium carboxymethyl starch (type C); coating: hypromellose, Acryl-Eze White (methacrylic acid and ethyl acrylate copolymer (1:1), talc, titanium dioxide (E 171), colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate), triethyl citrate, simethicone emulsion.

What Acard PRO looks like and contents of the pack
Acard PRO is a white, oval, film-coated tablet.
Aluminium/PVC/PVDC blister in a cardboard carton.
The pack contains 30, 60, 90 or 120 enteric-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański, Poland
tel. + 48 22 364 61 01