POLOCARD 75 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: Patient information
2. Polocard, 75 mg, enteric-coated tablets
3. Polocard, 150 mg, enteric-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet
4. What is Polocard and what is it used for
   1. Indications:
5. Important information before taking Polocard
   1. When not to take Polocard:
   2. Warnings and precautions
   3. Polocard and other medicines
   4. Use in patients with liver or kidney impairment
   5. Use in the elderly
   6. Polocard with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Pregnancy – third trimester
   9. Pregnancy – first and second trimester
   10. Driving and using machines
   11. Polocard contains carmoisine, lake (E 124), and sodium
6. How to take Polocard
   1. Use in children and adolescents under 16 years of age
   2. Overdose of Polocard
   3. Missed dose of Polocard
7. Possible side effects
   1. Frequent side effects (may occur in up to 1 in 10 patients)
   2. Rare side effects (may occur in up to 1 in 1000 patients)
   3. Very rare side effects (may occur in up to 1 in 10,000 patients)
   4. Side effects with unknown frequency
   5. Reporting side effects
8. How to store Polocard
9. Contents of the pack and other information
   1. What Polocard contains
   2. What Polocard looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. For more information, please contact the local representative of the marketing authorization holder:

Leaflet attached to the packaging: Patient information

Polocard, 75 mg, enteric-coated tablets

Polocard, 150 mg, enteric-coated tablets

Acetylsalicylic acid

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
The medicine should always be taken exactly as described in the patient leaflet or as advised by the doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet

• 1. What is Polocard and what is it 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 is Polocard and what is it used for

Acetylsalicylic acid, the active substance in Polocard, when administered in low doses, inhibits platelet aggregation. This plays an important role in preventing the formation of blood clots.

Indications:

• prevention of cardiovascular diseases that may lead to the formation of blood clots and emboli in blood vessels:
• myocardial infarction;
• unstable and stable angina pectoris;
• prevention of other diseases involving blood clots in blood vessels.

Polocard is indicated for use in adult patients and adolescents over 16 years of age.
If there is no improvement or the patient feels worse, the doctor should be contacted.

2. Important information before taking Polocard

When not to take Polocard:

• if the patient is hypersensitive 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 asthma or chronic urticaria. Symptoms of hypersensitivity: urticaria, and even anaphylactic shock may occur within 3 hours of taking acetylsalicylic acid;
• if the patient is hypersensitive to other non-steroidal anti-inflammatory drugs, with symptoms such as: bronchospasm, nasal congestion, anaphylactic shock;
• if the patient has asthma, chronic respiratory diseases, hay fever, or nasal polyps, as patients with these diseases may react to non-steroidal anti-inflammatory drugs with asthma attacks, limited skin and mucous membrane edema (angioedema), or urticaria more frequently than other patients;
• if the patient has active peptic ulcer disease and/or gastrointestinal bleeding (gastrointestinal bleeding or exacerbation of peptic ulcer disease may occur);
• if the patient has severe liver, kidney, or heart failure;
• if the patient has bleeding disorders (e.g., hemophilia, thrombocytopenia) and is being treated with anticoagulants (e.g., coumarin derivatives, heparin);
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease);
• if the patient has gout;
• if the patient is taking methotrexate at doses of 15 mg/week or higher, due to the harmful effect on the bone marrow;
• in children and adolescents under 16 years of age, especially during viral infections, due to the risk of developing Reye's syndrome, a rare but serious disease that causes liver and brain damage (except in exceptional cases, such as Kawasaki disease);
• in the third trimester of pregnancy, doses greater than 100 mg/day should not be used (see section "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Before starting treatment with Polocard, the patient should discuss it with their doctor.
Particular caution should be exercised when taking Polocard:

• in patients with renal impairment and/or chronic renal failure;
• if the patient is taking oral hypoglycemic agents from the sulfonylurea group, due to the risk of enhancing the hypoglycemic effect (reducing blood glucose levels), and if the patient is taking anti-gout agents;
• in patients with juvenile rheumatoid arthritis and/or systemic lupus erythematosus and impaired liver function, as the toxicity of salicylates increases; in these patients, liver function should be monitored;
• in cases of menstrual bleeding, excessive menstrual bleeding, use of an intrauterine contraceptive device, hypertension, heart failure;
• when taking methotrexate at doses less than 15 mg/week, due to the enhancement of methotrexate's toxic effect on the bone marrow. Concurrent use with methotrexate at doses greater than 15 mg/week is contraindicated;
• before planned surgery. 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 surgery;
• caution should be exercised in patients with allergic diseases and dehydration;
• acetylsalicylic acid may cause bronchospasm or asthma attacks in susceptible patients;
• before starting long-term treatment with acetylsalicylic acid for cardiovascular or cerebrovascular diseases, the patient should consult a doctor who can advise on the benefits of using the product in relation to the risk for the individual patient;
• in the first and second trimester of pregnancy;
• during breastfeeding.

Polocard and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Acetylsalicylic acid is contraindicated with the following medicines:

• anticoagulant medicines (heparin, coumarin derivatives);
• methotrexate at doses of 15 mg/week or higher.

Polocard can be used with the following medicines and food only after consulting a doctor:

• angiotensin-converting enzyme inhibitors (e.g., enalapril, captopril), as acetylsalicylic acid reduces the antihypertensive effect of these medicines;
• carbonic anhydrase inhibitors (e.g., acetazolamide), as acetylsalicylic acid may increase the toxicity of acetazolamide;
• platelet aggregation inhibitors (e.g., ticlopidine), as there is an increased risk of bleeding;
• valproic acid, as acetylsalicylic acid increases the toxic effect of valproic acid, and valproic acid, in turn, enhances the anti-aggregatory effect of acetylsalicylic acid;
• diuretics, as acetylsalicylic acid may reduce the effectiveness of these medicines and increase the ototoxicity (hearing damage) of furosemide. Acetylsalicylic acid has an antagonistic effect on spironolactone;
• methotrexate, as acetylsalicylic acid enhances its toxic effect on the bone marrow. Concurrent use with methotrexate at doses of 15 mg/week or higher is contraindicated;
• non-steroidal anti-inflammatory drugs (including other salicylates), as there is an increased risk of gastrointestinal side effects;
• ibuprofen reduces the cardioprotective effect of acetylsalicylic acid;
• systemic corticosteroids (except for hydrocortisone used as replacement therapy in Addison's disease), as they increase the risk of peptic ulcer disease and gastrointestinal bleeding, and reduce salicylate levels in the blood during treatment, and after its completion, increase the risk of salicylate overdose;
• antidiabetic medicines, as acetylsalicylic acid enhances the hypoglycemic effect of these medicines;
• medicines that increase uric acid excretion (e.g., probenecid, benzbromarone), as salicylates reduce the effect of these medicines. Salicylates should not be used concurrently with these medicines;
• acetylsalicylic acid may enhance the effect of phenytoin;
• antacids and adsorbents. Concurrent use of these medicines with acetylsalicylic acid should be avoided;
• acetylsalicylic acid may increase the toxicity of sulfonamides;
• acetylsalicylic acid increases the levels of zafirlukast (a medicine used in asthma);
• digoxin, as acetylsalicylic acid may increase the effect of this medicine;
• acetylsalicylic acid may affect the results of thyroid function tests;
• concomitant use of metamizole with acetylsalicylic acid may reduce the anti-aggregatory effect of acetylsalicylic acid on platelets.
• thrombolytic medicines (such as streptokinase and alteplase), as acetylsalicylic acid may increase the effect of these medicines (increased risk of bleeding).

Use in patients with liver or kidney impairment

In patients with liver or kidney impairment, there is a risk of enhanced side effects of the medicine, so dose adjustment may be necessary depending on the severity of liver or kidney impairment.
The medicine is contraindicated in cases of severe liver or kidney impairment.

Use in the elderly

In elderly patients (over 65 years), the medicine should be used in lower doses and at longer intervals, due to the increased risk of side effects in this group of patients. 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.
During treatment with acetylsalicylic acid, alcohol should not be consumed, due to the increased risk of gastrointestinal mucosa damage.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
If a pregnant patient continues or starts treatment with acetylsalicylic acid according to the doctor's advice, she should follow the doctor's instructions and not exceed the recommended dose.

Pregnancy – third trimester

Acetylsalicylic acid should not be used in the third trimester of pregnancy in doses greater than 100 mg/day, as it may harm the unborn child and cause complications during delivery. This may cause kidney and heart problems in the unborn child. The medicine may affect the mother's and child's tendency to bleed and may cause prolonged or delayed delivery.
When using acetylsalicylic acid in low doses (up to 100 mg/day), close obstetric monitoring is necessary, according to the doctor's advice.

Pregnancy – first and second trimester

Acetylsalicylic acid should not be taken during the first 6 months of pregnancy, unless absolutely necessary and advised by a doctor. If treatment is needed during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.
If the medicine was used for more than a few days after the 20th week of pregnancy, acetylsalicylic acid may cause kidney problems in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) 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, so the medicine should not be used during breastfeeding due to the risk of Reye's syndrome in the child. The mother's use of high doses of acetylsalicylic acid may cause platelet function disorders in the child.
Fertility
This medicine belongs to the group of non-steroidal anti-inflammatory drugs, which may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment. Such an effect may occur after administration of acetylsalicylic acid at a dose of ≥ 500 mg/day.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

Polocard contains carmoisine, lake (E 124), and sodium

The medicine contains carmoisine and may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Polocard

This medicine should always be taken exactly as described in the patient leaflet or as advised by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
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 side effects.
The recommended dose is:

• 1-2 tablets of 75 mg or 1 tablet of 150 mg per day. In acute myocardial infarction or suspected acute myocardial infarction, 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 a day to achieve rapid inhibition of platelet aggregation. The tablets should be chewed to achieve rapid absorption.

Use in children and adolescents under 16 years of age

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

Overdose of Polocard

In case of overdose, the doctor should be consulted immediately, and in case of severe poisoning, the patient should be taken to the hospital immediately.
Overdose in elderly patients and young children (taking higher-than-recommended doses or accidental poisoning) requires special attention, as it can lead to death in these patient groups.
After an overdose of acetylsalicylic acid, the following symptoms may occur: nausea, vomiting, rapid breathing, tinnitus.
Other symptoms, such as hearing loss, vision disturbances, headaches, restlessness, drowsiness, and coma, seizures, hyperthermia (body temperature above normal), have also been observed. In severe poisonings, metabolic acidosis and electrolyte disturbances (metabolic acidosis and dehydration) may occur. Less frequently, overdose may cause gastrointestinal bleeding, high fever, hypoglycemia, hypokalemia, thrombocytopenia, increased INR/PT, disseminated intravascular coagulation, renal failure, and pulmonary edema.
Symptoms from the central nervous system, such as confusion, disorientation, coma, and seizures, occur less frequently in adults than in children.
Procedure after overdose:
The patient should be taken to the hospital.
There is no specific antidote.
Treatment of overdose:

• Induce vomiting or perform gastric lavage (to reduce absorption of the medicine). Such treatment is effective within 3-4 hours after taking the medicine, and in case of poisoning with a very large dose of the medicine, even up to 10 hours.
• Administer activated charcoal in the form of a water suspension (at a dose of 50-100 g in adults and 30-60 g in children) to reduce the absorption of acetylsalicylic acid.
• In case of hyperthermia, the body temperature should be reduced by maintaining a low ambient temperature and applying cool compresses.
• Electrolyte and water balance disturbances should be closely monitored and quickly corrected.
• To accelerate the elimination of acetylsalicylic acid by the kidneys and to treat acidosis, sodium bicarbonate should be administered intravenously. The urine pH should be maintained at 7.0-7.5.
• In very severe poisonings, when it is not possible to correct electrolyte and water balance disturbances with conservative treatment, and in cases of concurrent renal failure, hemodialysis or peritoneal dialysis should be used. Dialysis effectively removes acetylsalicylic acid from the body and helps to correct electrolyte and water balance disturbances.
• In cases of prolonged prothrombin time, vitamin K should be administered.
• Medicines that depress the central nervous system, such as barbiturates, should not be used due to the risk of respiratory acidosis and coma.
• Patients with respiratory disorders should be provided with fresh air, and oxygen should be administered if necessary. If necessary, endotracheal intubation and assisted ventilation should be performed.
• In case of shock, standard anti-shock treatment should be used.

Missed dose of Polocard

In case of a missed dose, the next dose should be taken at the scheduled time. A double dose should not be taken to make up for the missed dose.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After taking acetylsalicylic acid, the following side effects may occur:

Frequent side effects (may occur in up to 1 in 10 patients)

Increased risk of bleeding; prolonged bleeding time; perioperative bleeding; hematomas; nosebleeds; bleeding from the urinary and reproductive tracts; gum bleeding; symptoms of indigestion (heartburn, nausea, vomiting); abdominal pain; loss of appetite.

Rare side effects (may occur in up to 1 in 1000 patients)

Thrombocytopenia (low platelet count); prolonged prothrombin time; bleeding may lead to acute or chronic anemia due to bleeding and/or iron deficiency anemia (e.g., due to hidden microbleeds) with corresponding laboratory and clinical symptoms, such as: asthenia (a condition of the nervous system characterized by fatigue, exhaustion, weakness), pallor, hypoperfusion; hemolytic anemia may occur in patients with glucose-6-phosphate dehydrogenase deficiency, and leukopenia (low white blood cell count), agranulocytosis (decrease in the number of granulocytes, which are the main defensive cells of the body), or eosinopenia (low eosinophil count); gastrointestinal bleeding; cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concomitant use of bleeding-inhibiting medicines, which may potentially be life-threatening); inflammatory conditions of the gastric and intestinal mucosa; peptic ulcer disease; transient liver function disorders with increased liver enzyme activity (transaminases, alkaline phosphatase) and increased bilirubin levels; hypersensitivity reactions (including skin reactions, rash, urticaria, angioedema, pruritus, cardiac and respiratory disorders – including asthma); after long-term use of high doses of acetylsalicylic acid, necrosis of the renal papillae and interstitial nephritis have been reported.

Very rare side effects (may occur in up to 1 in 10,000 patients)

Severe reactions, including anaphylactic shock; gastrointestinal bleeding, perforation of gastric or duodenal ulcers.

Side effects with unknown frequency

Dizziness; headache after long-term use of acetylsalicylic acid, which worsens with subsequent doses; tinnitus (usually a sign of overdose), hearing disturbances; heart failure; hypertension; focal necrosis of liver cells, liver tenderness, and liver enlargement (especially in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, rheumatic fever, or liver disease in their medical history); proteinuria (presence of protein in the urine), presence of leukocytes (white blood cells) and erythrocytes (red blood cells) in the urine, formation of uric acid stones; severe kidney function disorders and kidney failure after long-term use of painkillers, especially those containing multiple active substances.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Polocard

The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Polocard contains

• The active substance of the medicine is acetylsalicylic acid. One tablet contains 75 mg or 150 mg of acetylsalicylic acid.
• The other ingredients are: cornstarch, cellulose powder, sodium carboxymethylcellulose, hypromellose, methacrylic acid copolymer, triethyl citrate, titanium dioxide (E 171), talc, sodium lauryl sulfate, carmoisine, lake (E 124), colloidal silica, anhydrous sodium bicarbonate.

What Polocard looks like and contents of the pack

Enteric-coated tablets, pink, round, biconvex, with a slightly rough surface.
The pack contains 30, 60, or 120 tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 more information, please contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z.o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00
Date of last revision of the leaflet:May 2025