Polopiryna s

Package leaflet: Information for the patient

Polopiryna S, 300 mg, tablets
Acidum acetylsalicylicum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, consult your doctor.

Table of contents

1. What Polopiryna S is and what it is 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 pack and other information

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

Polopiryna S contains acetylsalicylic acid, which has analgesic, anti-inflammatory, and antipyretic properties.
Indications:

• Mild to moderate pain of various origins, including headache, toothache, muscle pain, joint pain;
• Symptoms associated with cold and influenza accompanied by fever;
• Medical conditions requiring long-term, high-dose acetylsalicylic acid therapy, such as rheumatoid arthritis (only on prescription);
• Myocardial infarction and prevention of recurrent myocardial infarction.

2. Important information before using Polopiryna S

When not to use Polopiryna S

• if the patient is allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6). Allergy to acetylsalicylic acid occurs in 0.3% of the population, including 20% of patients with bronchial asthma or chronic urticaria. Hypersensitivity reactions (such as urticaria, or 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, nasal mucosal inflammation, or shock;
• if the patient has bronchial asthma, chronic respiratory diseases, hay fever, or nasal mucosal edema, as patients with these conditions may react more frequently than others to non-steroidal anti-inflammatory drugs with asthma attacks, limited skin and mucosal swelling (angioedema), or urticaria;
• if the patient has active peptic ulcer disease of the stomach and/or duodenum, or inflammatory conditions or bleeding from the gastrointestinal tract (this may lead to gastrointestinal bleeding or exacerbation of peptic ulcer disease);
• if the patient has severe liver, kidney, or heart failure;
• if the patient has blood coagulation disorders (e.g. hemophilia, thrombocytopenia), or is being treated concomitantly with anticoagulant agents (e.g. coumarin derivatives, heparin);
• if the patient has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder);
• if the patient is concurrently receiving methotrexate at doses of 15 mg per week 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;
• if the patient is in the last three months of pregnancy, doses exceeding 100 mg per day must not be used (see section “Pregnancy, breastfeeding and effects on fertility”);
• during breastfeeding.

Warnings and precautions
Before starting treatment with Polopiryna S, consult your doctor in the following situations:

• 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 hypoglycemic (blood glucose-lowering) effect, or if the patient is taking antihypertensive drugs;
• in patients with juvenile rheumatoid arthritis and/or systemic lupus erythematosus, and those with impaired liver function, as the toxicity of salicylates increases. Liver function should be monitored in these patients;
• in cases of uterine bleeding, excessive menstrual bleeding, use of intrauterine contraceptive devices, arterial hypertension, or heart failure;
• when used concomitantly with methotrexate at doses less than 15 mg per week, due to increased risk of methotrexate-induced bone marrow toxicity. Concurrent use with methotrexate at doses greater than 15 mg per week is contraindicated;
• during the first and second trimesters of pregnancy;
• 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 scheduled surgical procedure;
• acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Patients with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps, or those exhibiting allergic reactions (e.g. skin reactions, itching, urticaria) to other substances are particularly at risk.

Serious allergic reactions have occurred during treatment with acetylsalicylic acid, which may include chest pain and even myocardial infarction (Kounis syndrome) (see section 4). Seek immediate medical attention if chest pain occurs along with allergic reactions (such as skin rash, shortness of breath).

Use of the medicine in patients with impaired liver and/or kidney function
In patients with impaired liver and/or kidney function, there is an increased risk of adverse drug reactions; 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 at lower doses and with longer intervals between doses, due to the increased risk of adverse reactions in this patient group.

Polopiryna S and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Medicines contraindicated for concomitant use with acetylsalicylic acid:

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

Use with caution when used concomitantly with:

• methotrexate at doses less than 15 mg per week, due to its toxic effect on bone marrow;
• anticoagulant medicines, e.g. coumarin derivatives, heparin, and thrombolytic agents such as streptokinase and alteplase, or other medicines inhibiting platelet aggregation, e.g. ticlopidine. Concomitant use of acetylsalicylic acid with anticoagulants may enhance the anticoagulant effect, thereby increasing the risk of bleeding;
• other non-steroidal anti-inflammatory drugs (NSAIDs), as there is an increased risk of gastrointestinal adverse effects;
• selective serotonin reuptake inhibitors (SSRIs), due to increased risk of upper gastrointestinal bleeding resulting from synergistic effects of these medicines;
• ibuprofen, as it may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation;
• medicines that increase urinary excretion of uric acid, e.g. benzbromarone, probenecid, as salicylates reduce the effectiveness of these medicines. Concomitant use of acetylsalicylic acid with these medicines is not recommended;
• digoxin, as acetylsalicylic acid may enhance the effect of this medicine;
• antidiabetic medicines, e.g. insulin, sulfonylurea derivatives, as acetylsalicylic acid enhances the hypoglycemic (blood glucose-lowering) effect of antidiabetic medicines;
• diuretics, as acetylsalicylic acid may reduce the effectiveness of these medicines and enhance the ototoxic (hearing-damaging) effects of furosemide;
• systemic glucocorticoids, except hydrocortisone used as replacement therapy in Addison’s disease, as their concomitant use with salicylates increases the risk of peptic ulcer disease and gastrointestinal bleeding, reduces salicylate plasma concentrations during treatment, and increases the risk of salicylate overdose after treatment discontinuation;
• angiotensin-converting enzyme (ACE) inhibitors used concomitantly with high-dose acetylsalicylic acid (e.g. enalapril, captopril), as acetylsalicylic acid reduces the antihypertensive effect of these medicines;
• valproic acid, as it enhances the antiplatelet effect of acetylsalicylic acid due to synergistic antiplatelet action of both medicines;
• acetazolamide, as acetylsalicylic acid may significantly increase its concentration and thus its toxicity;
• metamizole (a substance with analgesic and antipyretic effects), as it may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and clot formation) when used concomitantly. Therefore, caution should be exercised when using 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).
Alcohol should not be consumed during treatment with acetylsalicylic acid, due to the increased risk of gastrointestinal mucosal damage.

Pregnancy, breastfeeding, and effects on fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
If the patient continues or starts treatment with Polopiryna S during pregnancy as advised by her doctor, she should use Polopiryna S according to the doctor’s instructions and should not take a higher dose than recommended.

Pregnancy – third trimester
Acetylsalicylic acid should not be used at doses exceeding 100 mg per day during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Polopiryna S may cause kidney and heart problems in the unborn child. It may also affect the tendency to bleeding in both the mother and the child and may delay or prolong labor.

If the patient takes acetylsalicylic acid at low doses (up to and including 100 mg per day), strict obstetric monitoring is required as advised by the doctor.

Pregnancy – first and second trimesters
Polopiryna S should not be taken 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 for the shortest possible duration should be used. Use of Polopiryna S for longer than a few days starting from the 20th week of pregnancy may cause kidney dysfunction 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 longer-term treatment is necessary, the doctor may recommend additional monitoring.

Breastfeeding
The medicine is contraindicated during breastfeeding.

Effects on fertility
This medicine belongs to a group of medicines that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
The medicine does not impair psychomotor performance.

3. How to use Polopiryna S

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken orally, preferably during or after a meal, with a large amount of liquid. The tablet may also be dissolved in ½ glass of water or milk before use.
Symptomatic treatment without medical advice should not last longer than 3 days.
The lowest effective dose should be used.
The usual dosage recommendations are as follows:
For pain relief and fever reduction:
Adults: 300 mg to 600 mg (1 to 2 tablets) every 4 hours. Do not exceed 3 g (10 tablets) per day.
Adolescents over 16 years of age: 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 daily;
in rheumatoid arthritis: 600 mg (2 tablets) 3 to 4 times daily.
Myocardial infarction, prevention of myocardial infarction:
150 mg to 300 mg (½ to 1 tablet) per day.
Use in children and adolescents under 16 years of age
This medicine is contraindicated in children and adolescents under 16 years of age (see section "When not to use Polopiryna S").
Taking more Polopiryna S than recommended
If you take more than the recommended dose, contact a doctor or pharmacist immediately.
Overdose of acetylsalicylic acid may cause: nausea, vomiting, rapid breathing, tinnitus (ringing in the ears).
Other symptoms may also occur, such as: hearing loss, visual disturbances, headache, restlessness, drowsiness and coma, seizures, hyperthermia (body temperature above normal). In severe poisoning, disturbances in acid-base and water-electrolyte balance occur (metabolic acidosis and dehydration).
Mild or moderately severe toxic effects occur after acetylsalicylic acid doses of 150–300 mg/kg body weight. Severe poisoning symptoms occur after ingestion of 300–500 mg/kg body weight. A potentially lethal dose of acetylsalicylic acid is greater than 500 mg/kg body weight.
Treatment of overdose
There is no specific antidote for acetylsalicylic acid. The patient should be taken to hospital immediately.
Management in case of acetylsalicylic acid poisoning:

• induce vomiting and perform gastric lavage (to reduce drug absorption). This is effective within 3–4 hours after ingestion, and in cases of very large overdose, even up to 10 hours;
• administer activated charcoal as an aqueous suspension (50–100 g for adults, 30–60 g for children) to reduce absorption of acetylsalicylic acid;
• in case of hyperthermia, reduce body temperature by maintaining a low ambient temperature and applying cold compresses.

In severe poisoning, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.
Missed dose of Polopiryna S
If a dose is missed, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
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 experiences them.
After administration of acetylsalicylic acid, the following adverse effects may occur:
Blood and lymphatic system disorders
Thrombocytopenia (decrease in platelet count), anemia due to microbleeding from the gastrointestinal tract, hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency, leukopenia (decrease in white blood cell count), agranulocytosis (absence of granulocytes in blood), eosinopenia (decrease in 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, shock. If any of these occur, a doctor should be informed immediately.
Nervous system disorders
tinnitus (usually as a symptom of overdose), hearing disturbances, dizziness.
Cardiac disorders
heart failure,
acute myocardial ischemia (painful heart disease caused by inadequate blood supply to the heart), with or without myocardial infarction (heart attack), occurring as part of an allergic reaction (Kounis syndrome) (frequency unknown – frequency cannot be estimated from available data).
Vascular disorders
hypertension.
Gastrointestinal disorders
dyspepsia, heartburn, feeling of fullness in the epigastrium, nausea, vomiting, loss of appetite, abdominal pain, gastrointestinal bleeding, damage to gastric mucosa, exacerbation of peptic ulcer disease, perforations.
Gastric ulceration occurs in 15% of patients on long-term acetylsalicylic acid therapy.
Hepatobiliary disorders
focal necrosis of hepatocytes, tenderness and enlargement of the liver, particularly in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, rheumatic fever or history of liver disease, transient increases in serum aminotransferase activity, alkaline phosphatase and bilirubin concentration.
Renal and urinary disorders
proteinuria, presence of leukocytes and erythrocytes in urine, renal papillary necrosis, interstitial nephritis.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps increase the knowledge about the medicine's safety.

5. How to store Polopiryna S

Do not store above 25°C. Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Polopiryna S contains

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

What Polopiryna S looks like and contents of the pack
White, flat-faced tablets, biconvex, with a break line on one side.
The pack contains 6, 10, 12, 20, 30 or 40 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
POLPHARMA S.A. Pharmaceutical Works
Production Branch in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba