Polocard

Patient Information Leaflet

Polocard, 75 mg, enteric-coated tablets
Polocard, 150 mg, enteric-coated tablets
Acidum acetylsalicylicum
Please read this leaflet carefully before taking 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 a 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 Polocard is and what it is used for
2. Important information before taking Polocard
3. How to take Polocard
4. Possible side effects
5. How to store Polocard
6. Contents of the pack and other information

1. What Polocard is and what it is used for

Acetylsalicylic acid, the active substance in Polocard, when administered in low doses, inhibits platelet aggregation (clumping). Thus, it plays an important role in preventing the formation of blood clots.
Indications:

• Prevention of cardiovascular diseases associated with risk of thrombosis and embolism in blood vessels:
  • Myocardial infarction;
  • Unstable and stable ischaemic heart disease;
• Prevention of other diseases involving intravascular thrombosis.

Polocard is indicated for use in adult patients and adolescents above 16 years of age.
If your condition does not improve or worsens, contact your doctor.

2. Important information before using Polocard

When not to use Polocard:

• if the patient is allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity to acetylsalicylic acid occurs in 0.3% of the population, including 20% of patients with bronchial asthma or chronic urticaria. Symptoms of hypersensitivity: urticaria, and even shock, may occur within 3 hours after taking acetylsalicylic acid;
• if the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs), with symptoms such as bronchospasm, inflammation of the nasal mucosa, shock;
• if the patient has bronchial asthma, chronic respiratory disorders, hay fever, or nasal mucosal swelling, as patients with these conditions may react to non-steroidal anti-inflammatory drugs with asthma attacks, limited skin and mucosal swelling (angioedema), or urticaria more frequently than other patients;
• if the patient has active gastric and/or duodenal ulcer disease, or inflammatory conditions or bleeding from the gastrointestinal tract (gastrointestinal bleeding or exacerbation of ulcer disease may occur);
• if the patient has severe liver, kidney, or heart failure;
• if the patient has blood clotting disorders (e.g. haemophilia, thrombocytopenia), or if the patient is being treated simultaneously with anticoagulants (e.g. coumarin derivatives, heparin);
• if the patient has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disease);
• if the patient has gout;
• if the patient is concurrently receiving methotrexate at doses of 15 mg weekly or higher, due to its harmful effect on bone marrow;
• in children and adolescents under 16 years of age, especially during viral infections, due to the risk of Reye's syndrome, a rare but serious condition causing liver and brain damage (except in exceptional circumstances such as Kawasaki disease);
• during the third trimester of pregnancy, doses exceeding 100 mg per day must not be used (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Before starting to take Polocard, discuss it with your doctor.
Special caution is required when using Polocard:

• in patients with impaired kidney function or chronic kidney failure;
• if the patient is taking oral antidiabetic sulfonylurea drugs, due to the risk of enhanced hypoglycaemic (reducing blood glucose concentration) effect, and if the patient is taking anti-gout medications;
• in patients with juvenile rheumatoid arthritis and/or systemic lupus erythematosus, and in those with impaired liver function, as salicylate toxicity increases; liver function should be monitored in these patients;
• in cases of uterine bleeding, excessive menstrual bleeding, use of an intrauterine contraceptive device, arterial hypertension, or heart failure;
• when used concomitantly with methotrexate at doses less than 15 mg/week, due to increased risk of methotrexate-induced bone marrow toxicity. Concurrent use with methotrexate at doses greater than 15 mg/week is contraindicated;
• before planned surgical procedures. Due to the risk of prolonged bleeding time both during and after surgery, the medicine should be discontinued 5 to 7 days before the planned surgical procedure;
• caution should be exercised in patients with allergic conditions or dehydration;
• acetylsalicylic acid may cause bronchospasm or asthma attacks in susceptible patients;
• before initiating long-term treatment with acetylsalicylic acid for cardiovascular or cerebrovascular diseases, the patient should consult a doctor, who may advise on the benefits of using the product relative to the risks for the individual patient;
• during the first and second trimesters of pregnancy;
• during breastfeeding.

Polocard with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines you plan to take.
The use of acetylsalicylic acid is contraindicated with the following medicines:

• anticoagulants (heparin, coumarin derivatives);
• methotrexate at doses of 15 mg per week or higher.

Polocard may be used with the following medicines and foodstuffs only after consultation with a doctor:

• angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, captopril), as acetylsalicylic acid reduces the antihypertensive effect of these drugs;
• carbonic anhydrase inhibitors (e.g. acetazolamide), as acetylsalicylic acid may increase acetazolamide toxicity;
• drugs inhibiting platelet aggregation (e.g. ticlopidine), as there is an increased risk of bleeding;
• valproic acid, as acetylsalicylic acid increases the toxic effect of valproic acid, while valproic acid enhances the anti-aggregatory (preventing platelet clumping) effect of acetylsalicylic acid;
• diuretics, as acetylsalicylic acid may reduce their effectiveness and increase the ototoxicity (hearing-damaging effect) of furosemide. Acetylsalicylic acid exhibits antagonistic action towards spironolactone;
• methotrexate, as acetylsalicylic acid intensifies its toxic effect on bone marrow. Concurrent use of acetylsalicylic acid with methotrexate at doses of 15 mg per week or higher is contraindicated;
• non-steroidal anti-inflammatory drugs (including other salicylates), as there is an increased risk of gastrointestinal adverse effects;
• ibuprofen reduces the cardioprotective effect (heart-protective effect) of acetylsalicylic acid;
• systemic glucocorticosteroids (except hydrocortisone used as replacement therapy in Addison's disease), as they increase the risk of gastric and/or duodenal ulcer disease and gastrointestinal bleeding, and reduce salicylate plasma concentrations during treatment, while increasing the risk of salicylate overdose after treatment ends;
• antidiabetic drugs, as acetylsalicylic acid enhances their hypoglycaemic (reducing blood glucose concentration) effect;
• drugs increasing uric acid excretion (e.g. probenecid, benzbromarone), as salicylates reduce the effect of these drugs. Acetylsalicylic acid should not be used concomitantly with these drugs;
• acetylsalicylic acid may enhance the effect of phenytoin;
• drugs neutralizing gastric juice and adsorbents. Concurrent use of these drugs with acetylsalicylic acid should be avoided;
• acetylsalicylic acid may increase the toxicity of sulfonamides;
• acetylsalicylic acid increases zafirlukast (a drug used in bronchial asthma) concentration;
• digoxin, as acetylsalicylic acid may increase the effect of this drug;
• acetylsalicylic acid may affect thyroid function test results;
• concurrent use of metamizole with acetylsalicylic acid may reduce the antiplatelet aggregation effect of acetylsalicylic acid;
• thrombolytic drugs (clot-dissolving agents), such as streptokinase and alteplase, as acetylsalicylic acid may enhance the effect of these drugs (increased risk of bleeding).

Use in patients with impaired liver and/or kidney function
In patients with impaired liver and/or kidney function, there is a risk of increased adverse effects of the medicine; therefore, dose adjustment may be necessary depending on the severity of liver and/or kidney impairment.
The medicine is contraindicated in cases of severe liver and/or kidney failure.

Use in elderly patients
In elderly patients (over 65 years of age), the medicine should be used in lower doses and with longer intervals between doses, due to the increased risk of adverse effects in this patient group. Elderly patients may be more susceptible to the toxic effects of salicylates. Long-term use of acetylsalicylic acid should be avoided in elderly patients due to the risk of gastrointestinal bleeding.

Polocard with food, drink, and alcohol
The medicine should be taken during or after a meal.
Alcohol should not be consumed during treatment with acetylsalicylic acid, due to the increased risk of gastrointestinal mucosal damage.

Pregnancy, breastfeeding, and fertility
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.
If a pregnant patient continues or starts treatment with acetylsalicylic acid as advised by a doctor, she should follow the doctor's instructions and not exceed the recommended dose.

Pregnancy – third trimester
Acetylsalicylic acid should not be used in doses exceeding 100 mg per day during the third trimester of pregnancy, as it may harm the unborn child and cause complications in the perinatal period. It may cause kidney and heart problems in the unborn child. The medicine may affect the tendency of both mother and child to bleed and may cause delayed or prolonged labour.
When acetylsalicylic acid is used in low doses (up to 100 mg per day inclusive), strict obstetric monitoring is required, as advised by the doctor.

Pregnancy – first and second trimesters
Acetylsalicylic acid should not be taken during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration.
If the medicine has been used for more than a few days after the 20th week of pregnancy, acetylsalicylic acid may cause kidney problems in the unborn child, which may lead to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment lasts longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts; therefore, the medicinal product should not be used during breastfeeding due to the risk of Reye's syndrome in the infant. High doses of acetylsalicylic acid taken by the mother may cause platelet function disorders in the infant.

Effect on fertility
This medicine belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment. Such an effect may occur after administration of acetylsalicylic acid at a dose ≥ 500 mg/day.

Driving and operating machinery
The medicine has no influence on the ability to drive or operate machinery.

Polocard contains carmine, lacca (E 124), and sodium
The medicine contains carmine and may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Polocard

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally, preferably during or after a meal, with a small amount of water.
The lowest effective dose should be used to minimize the risk of adverse effects.

Recommended dose:
1–2 tablets of 75 mg or 1 tablet of 150 mg daily.

In acute myocardial infarction or in patients with suspected acute heart attack, the initial loading dose is:
225 mg (3 tablets of 75 mg) to 300 mg (2 tablets of 150 mg or 4 tablets of 75 mg) of acetylsalicylic acid once daily, to achieve rapid inhibition of platelet aggregation.
The tablets should be chewed to ensure rapid absorption.

Use in children and adolescents under 16 years of age
Polocard is contraindicated in children and adolescents under 16 years of age (see section "When not to use Polocard").

Taking more Polocard than recommended
If you take more than the recommended dose, contact your doctor immediately. In cases of severe poisoning, the patient should be taken to hospital immediately.
Overdose in elderly individuals and young children (taking higher than recommended doses or accidental poisoning) requires special attention, as it may lead to death in these patient groups.

Symptoms of acetylsalicylic acid overdose may include: nausea, vomiting, rapid breathing, tinnitus (ringing in the ears).
Other observed symptoms include: hearing loss, visual disturbances, headache, motor restlessness, drowsiness and coma, seizures, hyperthermia (body temperature above normal). In severe poisoning, acid-base and water-electrolyte imbalances occur (metabolic acidosis and dehydration).

Less frequently, following overdose, the following may occur: bloody vomiting, high fever, hypoglycemia, hypokalemia, thrombocytopenia, increased INR/PT, disseminated intravascular coagulation, renal failure, and non-cardiogenic pulmonary edema.

Central nervous system symptoms such as confusion, disorientation, coma, and seizures occur less frequently in adults than in children.

Management in case of overdose:
The patient should be taken to hospital.
There is no specific antidote.
Treatment of overdose includes:

• Induce vomiting or perform gastric lavage (to reduce drug absorption). This procedure is effective within 3–4 hours after ingestion, and in cases of very large doses, may still be effective up to 10 hours.
• Administer activated charcoal as an aqueous suspension (dose: 50–100 g in adults, 30–60 g in children) to reduce absorption of acetylsalicylic acid.
• In case of hyperthermia, reduce body temperature by maintaining a low ambient temperature and applying cool compresses.
• Carefully monitor water-electrolyte imbalances and correct them promptly.
• To accelerate renal excretion of acetylsalicylic acid and treat metabolic acidosis, administer intravenous sodium bicarbonate. Maintain urine pH between 7.0 and 7.5.
• In very severe cases, when acid-base disturbances cannot be corrected by conservative treatment, or when associated renal failure occurs, hemodialysis or peritoneal dialysis should be performed. Dialysis effectively removes acetylsalicylic acid from the body and helps correct acid-base and water-electrolyte imbalances.
• In cases of prolonged prothrombin time, administer vitamin K.
• Do not use central nervous system depressants such as barbiturates, due to the risk of respiratory acidosis and coma.
• Patients with respiratory disturbances should be provided with fresh air and oxygen. If necessary, perform endotracheal intubation and apply assisted ventilation.
• In case of shock, apply standard anti-shock measures.

Missed dose of Polocard
If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur after administration of acetylsalicylic acid:

Common adverse effects (may occur in up to 1 in 10 patients)
Increased risk of bleeding; prolonged bleeding time; perioperative hemorrhage; bruising;
epistaxis (nosebleeds); bleeding from the genitourinary tract; gingival bleeding;
dyspeptic symptoms (heartburn, nausea, vomiting); abdominal pain; loss of appetite.

Uncommon adverse effects (may occur in up to 1 in 1,000 patients)
Thrombocytopenia (low platelet count); prolonged prothrombin time; hemorrhage may lead to acute or chronic anemia due to blood loss and (or) iron-deficiency anemia (e.g., due to occult microbleeding), with corresponding laboratory and clinical signs such as: asthenia (a nervous system condition characterized by fatigue, exhaustion, weakness), pallor, hypoperfusion; hemolytic anemia may occur in patients with glucose-6-phosphate dehydrogenase deficiency, as well as leukopenia (low white blood cell count), agranulocytosis (decreased number of blood cells which are the body's primary defense cells), or eosinopenia (low eosinophil count, a type of white blood cell); gastrointestinal bleeding; cerebral hemorrhage (especially in patients with uncontrolled hypertension and (or) when concomitantly administered with anticoagulant drugs, which in individual cases may potentially be life-threatening); inflammatory conditions of the gastric and intestinal mucosa; gastric and (or) duodenal ulcer disease; transient disturbances in liver function with increased activity of liver enzymes (aminotransferases, alkaline phosphatase) and increased bilirubin levels; hypersensitivity reactions (including: skin reactions, rash, urticaria, swelling, itching, disturbances in heart rhythm and respiration – including asthma); with long-term use of high doses of acetylsalicylic acid, necrosis of renal papillae and interstitial nephritis have been observed.

Very rare adverse effects (may occur in up to 1 in 10,000 patients)
Severe reactions including anaphylactic shock; gastrointestinal hemorrhage, gastric ulcer perforation, duodenal ulcer perforation.

The adverse effects listed below have been reported to the marketing authorization holder, but their frequency of occurrence is unknown
Dizziness; headache after prolonged use of medicines containing acetylsalicylic acid, which worsens with subsequent doses; tinnitus (usually a sign of overdose), hearing disturbances; heart failure; arterial hypertension; focal necrosis of liver cells, liver tenderness and enlargement (especially in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus (a chronic autoimmune disease in which the immune system attacks the body itself), rheumatic fever, or history of liver disease); proteinuria (presence of protein in urine), presence of leukocytes (white blood cells) and erythrocytes (red blood cells) in urine, formation of uric acid stones; severe disturbances in kidney function and kidney failure after prolonged use of analgesic medicines, particularly those containing multiple active substances.

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

5. How to store Polocard

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton after: EXP. 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 dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Polocard contains

• The active substance is acetylsalicylic acid. Each tablet contains 75 mg or 150 mg of acetylsalicylic acid.
• The other ingredients are: maize starch, powdered cellulose, sodium carboxymethyl starch, hypromellose, methacrylic acid copolymer, triethyl citrate, titanium dioxide (E 171), talc, sodium lauryl sulfate, carmine red, lac (E 214), colloidal anhydrous silica, sodium bicarbonate.

What Polocard looks like and contents of the pack
Enteric-coated tablets, pink in colour, round, biconvex, with a slightly rough surface.
Pack contains 30, 60 or 120 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Haleon Italy Manufacturing S.r.l.
Via Nettunense 90, 04011 Aprilia (LT)
Italy
LABORMED-PHARMA S.A.
44B Theodor Pallady Blvd., the 3rd district,
Bucharest, code 032266
Romania

For any further information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00