Polopirina S

Leaflet attached to the packaging: patient information

Polopiryna S, 300 mg, tablets

Acetylsalicylic acid

Read the 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 you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Polopiryna S and what is it used for
• 2. Important information before taking Polopiryna S
• 3. How to take Polopiryna S
• 4. Possible side effects
• 5. How to store Polopiryna S
• 6. Contents of the packaging and other information

1. What is Polopiryna S and what is it used for

Polopiryna S contains acetylsalicylic acid, which has analgesic, anti-inflammatory, and antipyretic effects.

Indications:

• pain of various origins with mild and moderate intensity, including: headaches, toothaches, muscle pains, joint pains;
• symptoms accompanying colds and flu with fever;
• conditions requiring long-term use of acetylsalicylic acid in high doses, such as rheumatoid arthritis (only on a doctor's prescription);
• myocardial infarction and prevention of repeated myocardial infarction.

2. Important information before taking Polopiryna S

When not to take Polopiryna S:

• 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 disease that causes liver and brain damage;
• during breastfeeding.

Warnings and precautions

Before starting treatment with Polopiryna S, the patient should discuss it with their doctor in the following situations:

• in patients with kidney function disorders and chronic kidney failure;
• in patients with juvenile rheumatoid arthritis and systemic lupus erythematosus, as well as 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 in doses less than 15 mg per week, due to the toxic effect on the bone marrow; methotrexate should not be taken concurrently with doses higher than 15 mg per week;
• during the first and second trimesters of pregnancy;
• before scheduled 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 scheduled surgery;
• acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Patients with asthma, chronic respiratory diseases, hay fever, or nasal polyps are particularly at risk.

Use in patients with liver and kidney function disorders

In patients with liver and kidney function disorders, there is a risk of increased side effects of the medicine, so dose adjustment may be necessary depending on the severity of liver and kidney failure. The medicine is contraindicated in cases of severe liver and kidney failure.

Use in elderly patients

In elderly patients (over 65 years), the medicine should be taken in smaller doses and at longer intervals, due to the increased risk of side effects in this patient group.

Polopiryna S and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Medicines that are contraindicated for concurrent use with acetylsalicylic acid:

• methotrexate in doses of 15 mg per week or higher, due to its toxic effect on the bone marrow.

Caution should be exercised when taking:

• methotrexate in doses less than 15 mg per week, due to its toxic effect on the bone marrow;
• anticoagulant medications, such as coumarin derivatives, heparin, and thrombolytic agents, such as streptokinase and alteplase, or other medications that inhibit platelet aggregation, such as ticlopidine. Concurrent use of acetylsalicylic acid with anticoagulant medications may increase the risk of bleeding;
• other nonsteroidal anti-inflammatory drugs, as there is an increased risk of side effects from the gastrointestinal tract;
• selective serotonin reuptake inhibitors (SSRIs), due to the increased risk of bleeding from the upper gastrointestinal tract due to the synergistic effect of these medications;
• ibuprofen, as it may inhibit the effect of acetylsalicylic acid on platelet aggregation;
• medications that increase uric acid excretion in the urine, such as benzbromarone, probenecid, as salicylates weaken the effect of these medications. Acetylsalicylic acid should not be taken concurrently with these medications;
• digoxin, as acetylsalicylic acid may enhance its effect;
• antidiabetic medications, such as insulin, sulfonylurea derivatives, as acetylsalicylic acid enhances the hypoglycemic effect (reducing blood glucose levels) of antidiabetic medications;
• diuretic medications, as acetylsalicylic acid may reduce their effectiveness and enhance the ototoxic (hearing-damaging) effect of furosemide;
• glucocorticosteroids administered systemically, except for hydrocortisone used as replacement therapy in Addison's disease, as they increase the risk of gastrointestinal ulcers and bleeding when taken with salicylates, and reduce salicylate levels in the blood during treatment, and increase the risk of salicylate overdose after treatment;
• angiotensin-converting enzyme (ACE) inhibitors taken concurrently with acetylsalicylic acid in high doses (e.g., enalapril, captopril), as acetylsalicylic acid reduces the antihypertensive effect of these medications;
• valproic acid, as it enhances the anti-aggregatory effect of acetylsalicylic acid due to the synergistic effect of both medications;
• acetazolamide, as acetylsalicylic acid may significantly increase its levels and toxicity;
• metamizole (a medication with analgesic and antipyretic effects), as it may reduce the effect of acetylsalicylic acid on platelet aggregation, so caution should be exercised when taking metamizole in patients receiving acetylsalicylic acid.

Omeprazole and ascorbic acid (vitamin C) do not affect the absorption of acetylsalicylic acid.

Polopiryna S with food, drink, and alcohol

The medicine should be taken during or after a meal (see section 3). During treatment with acetylsalicylic acid, alcohol should not be consumed, due to the increased risk of gastrointestinal mucosal damage.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or is planning to have a child, they should consult their doctor or pharmacist before taking this medicine. Pregnancy If the patient continues or starts treatment with Polopiryna S during pregnancy according to the doctor's recommendations, they should take the medicine according to the doctor's instructions and not exceed the recommended dose. Pregnancy - third trimester Acetylsalicylic acid should not be taken in doses higher than 100 mg per day in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Polopiryna S may cause kidney and heart disorders in the unborn child. This may affect the patient's and child's tendency to bleed and cause delayed or prolonged delivery. If the patient takes acetylsalicylic acid in low doses (up to 100 mg per day), close obstetric monitoring is necessary according to the doctor's instructions. Pregnancy - first and second trimesters Polopiryna S should not be taken during the first six months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period or during attempts to conceive, the smallest effective dose of the medicine should be used for the shortest possible time. Polopiryna S taken for a period longer than a few days, starting from the 20th week of pregnancy, may cause kidney disorders in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct in the child's heart. If treatment is necessary for longer than a few days, the doctor may recommend additional monitoring. Breastfeeding The medicine is contraindicated during breastfeeding. Fertility This medicine belongs to a group of medicines that may adversely affect fertility in women. This effect is temporary and disappears after the end of treatment.

Driving and operating machinery

The medicine does not affect psychophysical abilities.

3. How to take Polopiryna S

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The medicine should be taken orally, preferably during or after a meal, with a large amount of liquid. The tablet can also be dissolved in 1/2 cup of water or milk before use. Symptomatic treatment without medical consultation should not be continued for more than 3 days. The patient should use the smallest effective dose of the medicine. The following dosages are usually recommended:

For analgesic and antipyretic effects:

Adults: 300 mg to 600 mg (1 to 2 tablets) every 4 hours. Do not take more than 3 g (10 tablets) per day. Adolescents over 16 years: 600 mg to 900 mg (2 to 3 tablets) per day.

In rheumatic diseases, only on a doctor's prescription:

in rheumatic fever: 900 mg (3 tablets) 4 times a day; in rheumatoid arthritis: 600 mg (2 tablets) 3 to 4 times a day.

Myocardial infarction, prevention of myocardial infarction:

150 mg to 300 mg (1/2 to 1 tablet) per day.

Use in children and adolescents under 16 years of age

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

Taking a higher dose of Polopiryna S than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist. 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, there are disorders of acid-base balance and water-electrolyte balance (metabolic acidosis and dehydration). Mild or moderate symptoms of toxic effects occur after taking acetylsalicylic acid in doses of 150-300 mg/kg body weight. Severe symptoms of poisoning occur after taking doses of 300-500 mg/kg body weight. The potentially lethal dose of acetylsalicylic acid is higher than 500 mg/kg body weight.

Treatment of overdose

There is no specific antidote for acetylsalicylic acid. The patient should be taken to the hospital. Procedure in case of acetylsalicylic acid poisoning:

• induce vomiting and perform gastric lavage (to reduce absorption of the medicine). This procedure 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 (in a dose of 50-100 g in adults and 30-60 g in children) to reduce absorption of acetylsalicylic acid;
• in case of hyperthermia, lower the body temperature by maintaining a low ambient temperature and using cold compresses.

In severe poisonings, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.

Missing a dose of Polopiryna S

In case of missing a dose, the patient should take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

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:

Blood and lymphatic system disorders

thrombocytopenia (reduced platelet count), anemia due to microbleeding from the gastrointestinal tract, hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency, leukopenia (reduced white blood cell count), agranulocytosis (absence of granulocytes), eosinopenia (reduced eosinophil count), increased risk of bleeding, prolonged bleeding time, and (or) prolonged prothrombin time.

Immune system disorders

hypersensitivity reactions: rash, urticaria, angioedema (swelling of the face, tongue, and trachea, causing breathing difficulties), bronchospasm, anaphylaxis. If these occur, the patient should immediately inform their doctor.

Nervous system disorders

tinnitus (usually as a symptom of overdose), hearing disturbances, dizziness.

Cardiac disorders

heart failure.

Vascular disorders

hypertension.

Gastrointestinal disorders

indigestion, heartburn, feeling of fullness in the upper abdomen, nausea, vomiting, loss of appetite, abdominal pain, gastrointestinal bleeding, mucosal damage, exacerbation of ulcers, perforations. Gastric ulcers occur in 15% of patients taking acetylsalicylic acid long-term.

Hepatobiliary disorders

focal liver cell necrosis, liver tenderness and enlargement, especially in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, rheumatic fever, or liver disease in their medical history, transient increase in serum aminotransferase activity, alkaline phosphatase, and bilirubin levels.

Renal and urinary disorders

proteinuria, presence of leukocytes and erythrocytes in the urine, renal papillary necrosis, interstitial nephritis.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Polopiryna S

Do not store above 25°C. Store in the original packaging to protect from light and 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 month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Polopiryna S contains

• The active substance of the medicine is acetylsalicylic acid. Each tablet contains 300 mg of acetylsalicylic acid.
• The other ingredients of the medicine are: cornstarch, powdered cellulose, microcrystalline cellulose.

What Polopiryna S looks like and contents of the packaging

White, flat, tablets with a dividing line on one side. The packaging contains 6, 10, 12, 20, 30, or 40 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: