Acard 150 mg

Package leaflet: Information for the patient

ACARD 150 mg, 150 mg, enteric-coated tablets
Acidum acetylsalicylicum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the 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 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 150 mg is and what it is used for
2. Important information before taking Acard 150 mg
3. How to take Acard 150 mg
4. Possible side effects
5. How to store Acard 150 mg
6. Contents of the pack and other information

1. What Acard 150 mg is and what it is used for

Acard 150 mg 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.
Acard 150 mg is used:

• for prevention of myocardial infarction in high-risk individuals;
• in acute myocardial infarction or suspected acute myocardial infarction;
• following 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 following such events;
• in patients with obstructive peripheral arterial disease;
• for prevention of coronary thrombosis in patients with multiple risk factors;
• for prevention of venous thrombosis and pulmonary embolism in patients who are immobilised for prolonged periods.

The decision to initiate treatment and the dosage used are made by the physician.

2. Important information before using Acard 150 mg

When not to use Acard 150 mg

• 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 exceeding 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 drug 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 use Acard 150 mg, discuss with your 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 Acard 150 mg";
• 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 impaired kidney and/or liver function, as there is a risk of worsening adverse effects of the drug.

Serious allergic reactions, including chest pain and even myocardial infarction (Kounis syndrome), have occurred during acetylsalicylic acid treatment (see section 4). Seek immediate medical attention if chest pain occurs together with allergic reactions (such as skin rash, shortness of breath).
Do not use Acard 150 mg for at least 5 days before a planned surgical procedure (including minor procedures, e.g. tooth extraction).

Children and adolescents
Do not use in children and adolescents under 16 years of age.

Acard 150 mg and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.

• Do not use Acard 150 mg simultaneously with:
  • methotrexate at doses of 15 mg per week or higher.
• Acard 150 mg may be used, after prior consultation with a doctor, together with the following medicines:
  • 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);
  • cyclosporine and tacrolimus;
  • methotrexate at doses less than 15 mg per week;
• ibuprofen;
• digoxin (a cardiac medicine).

Metamizole (a substance with analgesic and antipyretic properties) 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 150 mg 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 a doctor or pharmacist before using this medicine.

Pregnancy
If the patient continues or starts treatment with Acard 150 mg during pregnancy as advised by a doctor, she should use Acard 150 mg 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 exceeding 100 mg per day during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Acard 150 mg may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and her child and may delay or prolong labour.
If the patient takes acetylsalicylic acid in low doses (up to 100 mg per day inclusive), close obstetric monitoring is required as advised by the doctor.

Pregnancy – first and second trimesters
Do not take Acard 150 mg 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. Use of Acard 150 mg for longer than a few days starting from week 20 of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts; therefore, the medicine should not be used during breastfeeding due to the risk of Reye's syndrome in the infant. When high doses of acetylsalicylic acid are used in a breastfeeding woman, it may cause impaired platelet function in the infant.

Driving and using machines
Acard 150 mg has no influence on the ability to drive or operate machinery.

Acard 150 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 150 mg

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist.
You should consult your doctor before starting to take Acard 150 mg.
Your doctor will recommend the appropriate dose for you and determine the duration of treatment.
Oral use.

• The usual recommended dosage is:

1 enteric-coated tablet (150 mg) daily.
Enteric-coated tablets should be taken after a meal – swallowed whole.
The enteric-coated tablet of Acard 150 mg has a coating that prevents it from dissolving 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 2 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 150 mg than recommended
In case of overdose, contact your doctor immediately. In cases of severe poisoning, the patient must be taken to hospital without delay.
Early signs of poisoning include: tinnitus, rapid breathing, fever, nausea, vomiting, visual disturbances, headache and dizziness, confusion, skin rashes.
In more severe cases, the following may occur: delirium, tremor, shortness of breath, excessive sweating, agitation, coma.

If you forget to take Acard 150 mg
Do not take a double dose to make up for the missed dose. Take the next dose as usual.

Stopping Acard 150 mg
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 must 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 hemorrhages. The doctor will then assess the severity of
the symptoms and decide on further management.

After administration of acetylsalicylic acid, the following occurred:

Common (in no more than 1 in 10 people):

• gastrointestinal discomfort (dyspepsia, nausea, vomiting) and abdominal pain.

Uncommon (in no more than 1 in 1,000 people):

• inflammation of the stomach and intestines, peptic ulcer of the stomach and/or duodenum;
• transient disturbances in liver function.

Uncommon or rare:

• major bleeding events such as gastrointestinal hemorrhage (symptoms: black stools), cerebral hemorrhage (especially in patients with uncontrolled arterial hypertension and/or when concomitantly administered with anticoagulant drugs). Bleeding may lead to acute or chronic anemia due to blood loss and/or iron deficiency anemia (symptoms: weakness, pallor).

Rare (in no more than 1 in 10,000 people):

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

Frequency not known (frequency cannot be estimated from available data):

• acute myocardial ischemia (painful heart condition caused by lack of blood supply to the heart) with or without myocardial infarction (heart attack), occurring as part of an allergic reaction (Kounis syndrome).

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, genitourinary tract, gums).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your 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 enables better assessment of the benefit-risk profile of the medicine.

5. How to store Acard 150 mg

Do not store above 25°C. Keep in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
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 should not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Acard 150 mg contains

• The active substance is acetylsalicylic acid. Each enteric-coated tablet contains 150 mg of acetylsalicylic acid.
• Other ingredients are: powdered cellulose, corn starch, sodium carboxymethyl starch; coating: hypromellose, Acryl Eze-White (methacrylic acid and ethyl acrylate copolymer (1:1), talc, titanium dioxide (E 171), anhydrous colloidal silica, sodium bicarbonate, sodium lauryl sulfate), triethyl citrate, simethicone emulsion.

What Acard 150 mg looks like and contents of the pack
Acard 150 mg tablets are white or almost white, round, biconvex, with a smooth surface.
Aluminium/PVC/PVDC blister in a cardboard box.
The pack contains 30, 60, 90 or 120 enteric-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański