Polopiryna max

Package leaflet: Information for the patient

Polopiryna MAX, 500 mg, enteric-coated tablets
Acidum acetylsalicylicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• 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 there is no improvement or if you feel worse after 3 days, consult your doctor.

Table of contents

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

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

Polopiryna Max contains acetylsalicylic acid, which has analgesic, anti-inflammatory,
and antipyretic properties.
The enteric-coated tablet dissolves only in the small intestine, thereby reducing the irritant effect
of acetylsalicylic acid on the gastric mucosa.
Indications:

• Mild to moderate pain of various origins, including: headache, toothache, muscle pain, joint pain;
• Symptoms associated with cold and flu accompanied by fever;
• Conditions requiring long-term, high-dose acetylsalicylic acid therapy, such as rheumatoid arthritis (only on prescription).

2. Important information before using Polopiryna Max

When not to use Polopiryna Max:

• 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 (urticaria, and even shock) may occur within 3 hours after taking acetylsalicylic acid;

• if the patient is allergic (hypersensitive) to other nonsteroidal anti-inflammatory drugs (NSAIDs), with symptoms such as bronchospasm, inflammation of the nasal mucosa, or shock;

• if the patient has bronchial asthma, chronic respiratory diseases, hay fever, or nasal mucosal edema, as patients with these conditions may react to nonsteroidal anti-inflammatory drugs with asthma attacks, limited skin and mucosal edema (angioedema), or urticaria more frequently than other patients;

• if the patient has active gastric or duodenal ulcer disease and/or gastrointestinal inflammation or bleeding (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 is being treated concomitantly with anticoagulant drugs (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 harmful effects on bone marrow;

• in children and adolescents under 16 years of age;

• if the patient is in the last three months of pregnancy, doses higher than 100 mg per day must not be used (see section "Pregnancy, breastfeeding and fertility");

• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Polopiryna Max, consult a doctor or pharmacist if:

• the patient has impaired kidney function or chronic kidney failure;
• the patient has juvenile rheumatoid arthritis and/or systemic lupus erythematosus or liver failure, as the toxicity of salicylates increases. In such patients, liver function should be monitored;
• the patient has uterine bleeding, excessive menstrual bleeding, or uses an intrauterine contraceptive device;
• the patient has hypertension or heart failure;
• the patient is taking 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 exceeding 15 mg per week is contraindicated;
• the patient is taking oral antidiabetic sulfonylureas due to the risk of enhanced hypoglycemic (reducing blood glucose concentration) effect, and if the patient is taking drugs for gout or has reduced uric acid excretion;
• the patient is in the first or second trimester of pregnancy (see section: Pregnancy, breastfeeding and fertility).

Serious allergic reactions, including chest pain and even myocardial infarction (Kounis syndrome), have occurred during treatment with acetylsalicylic acid (see section 4). Immediate medical attention is required if chest pain occurs together with allergic reactions (such as skin rash, shortness of breath).
Polopiryna Max should be discontinued 5 to 7 days before any planned surgical procedure due to the risk of prolonged bleeding, both during and after the procedure.
When acetylsalicylic acid is administered to children, there is a risk of Reye's syndrome. Reye's syndrome is a very rare condition affecting the brain and liver, which can be fatal.
Using the medicine at the lowest effective dose for the shortest necessary duration to relieve symptoms reduces the risk of adverse effects.
Long-term use of the medicine may be harmful and should therefore be under medical supervision.
Prolonged use of analgesics, especially those containing multiple active substances, may lead to severe kidney dysfunction and kidney failure.
Acetylsalicylic acid may impair fertility in women (see section: Pregnancy, breastfeeding and fertility).

Polopiryna Max and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Medicines contraindicated for concomitant use with acetylsalicylic acid:

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

Use Polopiryna Max with caution when taking:

• angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, captopril), as acetylsalicylic acid reduces their antihypertensive effect;
• acetazolamide, as acetylsalicylic acid may increase its harmful effects;
• anticoagulants (heparin and warfarin), due to increased risk of bleeding;
• valproic acid, as acetylsalicylic acid enhances the toxic effect of valproic acid, and valproic acid enhances the antiplatelet (preventing platelet aggregation) effect of acetylsalicylic acid;
• diuretics, as acetylsalicylic acid may reduce their effectiveness and enhance the ototoxic (hearing-damaging) effect of furosemide;
• methotrexate at doses less than 15 mg per week, as acetylsalicylic acid intensifies its harmful effects on bone marrow;
• nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen), due to increased risk of gastrointestinal adverse effects;
• systemic glucocorticoids (except hydrocortisone used as replacement therapy in Addison's disease), as they increase the risk of peptic ulcer disease and gastrointestinal bleeding, reduce plasma salicylate concentrations during treatment, and increase the risk of salicylate overdose after treatment ends;
• antidiabetic drugs, as acetylsalicylic acid enhances their hypoglycemic (reducing blood glucose) effect;
• drugs increasing uric acid excretion (e.g. probenecid, sulfinpyrazone), as salicylates weaken the effect of these drugs. Concomitant use of acetylsalicylic acid with these drugs is not recommended;
• drugs neutralizing gastric juice, as increasing gastric pH may damage the tablet coating;
• digoxin, as acetylsalicylic acid may enhance the effect of this drug;
• selective serotonin reuptake inhibitors (SSRIs), e.g. fluoxetine, due to increased risk of upper gastrointestinal bleeding;
• ibuprofen, as it may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation;
• thrombolytic drugs (clot-dissolving agents) such as streptokinase and alteplase, as acetylsalicylic acid may enhance their effects.

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

Polopiryna Max with food, drink and alcohol
Tablets should be taken with a large amount of liquid.
Alcohol should not be consumed during treatment with acetylsalicylic acid due to increased risk of gastrointestinal mucosal damage.

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

Pregnancy
If the patient continues or starts treatment with Polopiryna Max during pregnancy as advised by a doctor, she should follow the recommendations and not exceed the recommended dose.

Pregnancy – third trimester
Acetylsalicylic acid should not be used in 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 Max may cause kidney and heart disorders in the unborn child. It may also affect the tendency to bleed in both the mother and the child and may delay or prolong labor.
If acetylsalicylic acid is taken in low doses (up to 100 mg per day inclusive), strict obstetric monitoring according to the doctor's recommendations is required.

Pregnancy – first and second trimester
Polopiryna Max 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 time should be used. Polopiryna Max taken for longer than a few days starting from week 20 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 prolonged treatment is required, the doctor may recommend additional monitoring.

Breastfeeding
This medicine must not be used during breastfeeding.

Effect 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
This medicine does not impair psychophysical performance.

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

3. How to use Polopiryna Max

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 during or after a meal. Tablets should be swallowed whole with a large amount of liquid.

For pain relief and antipyretic use, the usual dosage is:
Adults: single dose of 500 mg to 1000 mg (1 to 2 tablets). If necessary, the dose may be repeated 2 or 3 times daily.
Do not exceed 3000 mg of acetylsalicylic acid per day.

Adolescents over 16 years of age, only on medical advice: 500 mg to 1000 mg (1 to 2 tablets) per day.
The lowest effective dose should be used.
Self-treatment of symptoms without medical advice should not last longer than 3 days.

In rheumatic diseases, only on medical advice, the usual dosages are:
in rheumatic fever: 1000 mg (2 tablets) 4 times daily;
in rheumatoid arthritis: 500 mg (1 tablet) 3 or 4 times daily.

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 effects; therefore, dose adjustment may be necessary depending on the severity of liver and/or kidney impairment.
The medicine is contraindicated in severe liver and/or kidney failure.

Use of the medicine in elderly patients
In elderly patients (over 65 years of age), the medicine should be used at lower doses and with longer intervals due to an increased risk of adverse effects.

Use of a higher than recommended dose of Polopiryna Max
If a higher than recommended dose has been taken, seek immediate medical advice from a doctor or pharmacist.
After an overdose of acetylsalicylic acid, symptoms such as nausea, vomiting, rapid breathing, and tinnitus may occur.
Other observed symptoms include: hearing loss, visual disturbances, headache, motor agitation, drowsiness and coma, seizures, hyperthermia (body temperature above normal).
In severe poisoning, acid-base and water-electrolyte imbalances occur (metabolic acidosis and dehydration).

Mild to moderate toxicity symptoms 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.
Death due to acetylsalicylic acid poisoning has been reported after a single oral dose of 10–30 g in adults.

Treatment of overdose
The patient should be taken immediately to a hospital emergency department. There is no specific antidote. Management in case of acetylsalicylic acid poisoning includes:

• Induce vomiting and perform gastric lavage (to reduce drug absorption). This procedure is effective within 3–4 hours after ingestion, and in cases of very large overdoses, may still be effective 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 cool environment and applying cold compresses;
• Continuously monitor water and electrolyte balance and correct any disturbances;
• To accelerate renal excretion of acetylsalicylic acid and treat acidosis, administer sodium bicarbonate intravenously;
• In patients with normal kidney function, alkaline diuresis may be used until urine pH reaches 7.5–8. In severe poisoning, hemodialysis or peritoneal dialysis may be applied. 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 depression;
• Administer oxygen to patients with respiratory disturbances. If necessary, perform endotracheal intubation and apply mechanical ventilation;
• In case of shock, apply standard anti-shock measures;
• Replenish fluids and provide general symptomatic treatment.

Missed dose of Polopiryna Max
If a dose is missed, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If there are any further doubts about the use of this medicine, consult a 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,
with unknown frequency (frequency cannot be estimated from available data).

Blood and lymphatic system disorders
Decreased platelet count, anaemia due to gastrointestinal microbleeding, haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), decreased white blood cell count, neutrophils, acidophilic granulocytes, increased risk of bleeding, prolonged bleeding time, prolonged blood coagulation time, iron deficiency anaemia with laboratory and clinical manifestations, haemolysis (destruction of red blood cells).

Immune system disorders
Hypersensitivity, drug hypersensitivity, bronchospasm, allergic oedema and angioedema, anaphylactic reactions, anaphylactic shock confirmed by appropriate laboratory tests and clinical symptoms.

Nervous system disorders
Tinnitus (usually as a symptom of overdose), hearing disturbances, dizziness, cerebral haemorrhage and intracranial haemorrhage.
Long-term use of medicines containing acetylsalicylic acid may cause headaches which may worsen with each subsequent dose.

Cardiac disorders
Heart failure, acute myocardial ischaemia (painful heart disease caused by insufficient blood supply to the heart) with or without myocardial infarction (heart attack), occurring as part of an allergic reaction (Kounis syndrome).

Vascular disorders
Hypertension, haemorrhage, surgical bleeding, haematomas, muscular haemorrhages.

Respiratory, thoracic and mediastinal disorders
Epistaxis (nosebleeds), analgesic-induced asthma, nasal mucosa inflammation, nasal mucosa congestion.

Gastrointestinal disorders
Dyspepsia, heartburn, feeling of fullness in the epigastrium, nausea, vomiting, loss of appetite, abdominal pain, gastrointestinal bleeding, gastric mucosal damage, exacerbation of peptic ulcer disease, perforations, gingival bleeding, inflammatory conditions of the gastrointestinal tract.
Gastric ulceration occurs in 15% of patients on long-term acetylsalicylic acid therapy.

Hepatobiliary disorders
Focal hepatic necrosis, liver tenderness and enlargement, particularly in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, rheumatic fever, or history of liver disease, transient increases in serum aminotransferase and alkaline phosphatase activity, and bilirubin concentration.

Skin and subcutaneous tissue disorders
Rash, urticaria, pruritus.

Renal and urinary disorders
Proteinuria, presence of leukocytes and erythrocytes in urine, renal papillary necrosis, interstitial nephritis, haemorrhage within the urogenital system, renal dysfunction, acute renal failure.

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

5. How to store Polopiryna Max

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 label. 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 packaging and other information

What Polopiryna Max contains

• The active substance is acetylsalicylic acid. Each enteric-coated tablet contains 500 mg of acetylsalicylic acid.
• Other ingredients are: maize starch; modified maize starch; hypromellose; methacrylic acid copolymer; talc; titanium dioxide (E 171); triethyl citrate; carmine red lake (E 124); colloidal anhydrous silica; sodium bicarbonate; sodium lauryl sulfate.

What Polopiryna Max looks like and contents of the pack
Pink, round, biconvex tablets.
The pack contains 6, 10, 12 or 20 enteric-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01