Polopirina Max Hot

Leaflet attached to the packaging: patient information

Polopiryna Max Hot

500 mg + 300 mg + 50 mg

powder for oral solution
Acidum acetylsalicylicum + Acidum ascorbicum + Coffeinum

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.

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

Table of contents of the leaflet

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

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

The medicine is recommended for use in the following indications:

• fever and pain associated with colds and flu;
• mild to moderate pain (throat pain, muscle and bone pain, headaches).

2. Important information before taking Polopiryna Max Hot

When not to take Polopiryna Max Hot:

• if the patient is allergic to acetylsalicylic acid, ascorbic acid, caffeine, 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: hives, and even anaphylactic shock may occur within 3 hours of taking acetylsalicylic acid;
• if the patient is allergic to other non-steroidal anti-inflammatory drugs, with symptoms such as: bronchospasm, hay fever, anaphylactic shock;
• if the patient has asthma, chronic respiratory diseases, hay fever, or nasal polyps, as patients with these conditions may react to non-steroidal anti-inflammatory drugs with asthma attacks, skin and mucous membrane swelling (angioedema) or hives more frequently than other patients;
• if the patient has active gastric or duodenal ulcers and/or gastrointestinal bleeding (gastrointestinal bleeding or ulcer exacerbation 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 anticoagulant medications (e.g., vitamin K antagonists, heparin);
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease);
• if the patient is taking methotrexate in doses of 15 mg per week or higher, due to its toxic effect on the bone marrow;
• in children and adolescents under 16 years of age, especially during viral infections, due to the risk of Reye's syndrome (see below);
• if the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Before starting treatment with Polopiryna Max Hot, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when taking Polopiryna Max Hot:

• in patients with renal impairment and chronic renal failure;
• in patients with juvenile rheumatoid arthritis and/or systemic lupus erythematosus and liver failure, 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 increased risk of toxic effects on the bone marrow; concomitant use with methotrexate in doses higher than 15 mg per week is contraindicated;
• if the patient is taking oral hypoglycemic agents from the sulfonylurea group, due to the risk of increased hypoglycemic effect (reduced blood glucose levels), and if the patient is taking diuretics;
• in patients who are psychomotorically excited and suffer from insomnia;
• 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 .

Medicines containing acetylsalicylic acid should not be used in women in the first and second trimester of pregnancy, unless absolutely necessary.
When administering acetylsalicylic acid to children and adolescents, there is a risk of Reye's syndrome. Reye's syndrome is a very rare disease in which pathological changes occur in many organs, mainly in the brain and liver. For this reason, in children and adolescents under 16 years of age, medicines containing acetylsalicylic acid should not be used.
Acetylsalicylic acid, even in small doses, reduces uric acid excretion.
In predisposed patients, the medicine may cause gout attacks.
Long-term use of the medicine may be harmful, so it should be done under medical supervision.

Children and adolescents

The medicine is contraindicated in children and adolescents under 16 years of age.

Use in patients with liver and/or kidney impairment

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

Use in elderly patients

In elderly patients, the medicine should be used in smaller doses and at longer intervals, due to the increased risk of side effects in this patient group.

Polopiryna Max Hot 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 contraindicated for concomitant 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 Polopiryna Max Hot with:

• methotrexate in doses less than 15 mg per week, due to its toxic effect on the bone marrow;
• anticoagulant medications, e.g., vitamin K antagonists, heparin, and thrombolytic agents, e.g., streptokinase and alteplase, or other medications that inhibit platelet aggregation, e.g., ticlopidine. Concomitant use of acetylsalicylic acid with anticoagulant medications may increase the risk of bleeding;
• other non-steroidal anti-inflammatory drugs, as there is an increased risk of gastrointestinal side effects;
• selective serotonin reuptake inhibitors (SSRIs), due to the increased risk of gastrointestinal bleeding due to the synergistic effect of these medications;
• medicines that increase uric acid excretion in the urine, e.g., benzbromarone, probenecid, as salicylates weaken the effect of these medications. Acetylsalicylic acid should not be used concomitantly with these medications;
• digoxin, as acetylsalicylic acid may increase the effect of this medication;
• oral hypoglycemic agents, e.g., insulin, sulfonylurea derivatives, as acetylsalicylic acid increases the hypoglycemic effect (reduces blood glucose levels) of oral hypoglycemic agents;
• diuretics, as acetylsalicylic acid may reduce the effectiveness of these medications and increase 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 used concomitantly with salicylates, and reduce salicylate levels in plasma during treatment, and after its completion, increase the risk of salicylate overdose;
• angiotensin-converting enzyme (ACE) inhibitors, e.g., enalapril, captopril. Acetylsalicylic acid in high doses, used concomitantly with ACE inhibitors, reduces the antihypertensive effect of these medications;
• valproic acid, as it increases the anti-aggregatory effect of acetylsalicylic acid due to the synergistic anti-aggregatory effect of both medications;
• acetazolamide, as acetylsalicylic acid may significantly increase the concentration and toxicity of acetazolamide;
• ibuprofen, which may increase side effects, may reduce the inhibitory effect of low doses of acetylsalicylic acid on platelet aggregation;
• analeptics and ergotamine. The medicine may increase the effect of other analeptics and ergotamine;
• oral contraceptives, cimetidine, and disulfiram, as they may slow down the metabolism and excretion of caffeine;
• barbiturates, as they may accelerate caffeine metabolism;
• adrenergic receptor agonists, as they may cause additional central nervous system stimulation and other toxic effects when used concomitantly with caffeine;
• mexiletine, as it may reduce caffeine elimination and increase its side effects;
• monoamine oxidase inhibitors (MAOIs), as high doses of caffeine may increase the side effects of MAOIs;
• antihistamines and benzodiazepines, as caffeine may counteract the sedative effects of these medications;
• sympathomimetics and other medications that increase cardiac contractility,

as caffeine, acting synergistically with these medications, may cause tachycardia;

• caffeine, which increases dependence on ephedrine-like substances;
• methylxanthines, as caffeine may reduce the excretion of theophylline and other methylxanthines;
• beta-blockers, as their therapeutic effect and the effect of caffeine may be mutually neutralized;
• lithium, as concomitant use with caffeine may lead to increased lithium excretion in the urine and reduced therapeutic effect;
• calcium, as high doses of caffeine may reduce calcium absorption.
• quinolones, erythromycin, as they may slow down caffeine metabolism in the liver; Caffeine metabolism in the liver is accelerated by smoking or administration of anticonvulsant medications of the hydantoin type;
• oral contraceptives, as 1 g of ascorbic acid per day may increase the bioavailability of oral contraceptives;
• corticosteroids, as they may increase ascorbic acid oxidation;
• tetracyclines, as they may increase ascorbic acid excretion in the urine;
• oral anticoagulant medications, there are reports that ascorbic acid in doses higher than 10 g per day may reduce the effect of oral anticoagulant medications by reducing their absorption;
• deferoxamine, as concomitant use of ascorbic acid with deferoxamine may increase the toxic effect of iron, mainly on the heart and especially in the elderly;
• disulfiram, as chronic use of high doses of ascorbic acid may disrupt the interaction between disulfiram and alcohol.

Ascorbic acid lowers urine pH, which may affect the excretion of other medications, e.g., mexiletine.
Omeprazole does not affect the absorption of acetylsalicylic acid.

Diagnostic tests

Acetylsalicylic acid may change the values of the following parameters in analytical tests:
Blood: increased activity of transaminases (ALAT or AspAT), alkaline phosphatase, increased levels of ammonia, bilirubin, cholesterol, creatine kinase, digoxin, free thyroxine, dehydrogenase (DHO), thyroxine-binding globulin, triglycerides, uric acid, and valproic acid, increased glucose levels (test result disturbance), paracetamol, total protein, decreased levels of free thyroxine, glucose, phenytoin, TSH, TSH-RH, triglycerides, triiodothyronine, uric acid, and creatinine clearance, decreased activity of transaminase (ALAT), albumin, alkaline phosphatase, cholesterol, creatine kinase, and lactate dehydrogenase (LDH) and total protein.
Urine: decreased levels of estriol, 5-hydroxyindoleacetic acid, 4-hydroxy-3-methoxyphenylacetic acid, total estrogens, and glucose.

Polopiryna Max Hot with food, drinks, and alcohol

The medicine should be taken 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 they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The medicine may be used in the first and second trimester of pregnancy only if, in the doctor's opinion, it is absolutely necessary.
The medicine should not be used in the third trimester of pregnancy.
The medicine should not be used during breastfeeding.
This medicine belongs to a group of non-steroidal anti-inflammatory drugs that may adversely affect female fertility. This effect is transient and reverses after treatment is stopped.

Driving and using machines

The medicine does not affect psychophysical abilities.

Polopiryna Max Hot contains sucrose, sulfites, and sodium

The medicine contains 1921 mg of sucrose in each sachet. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This should be taken into account in patients with diabetes.
The medicine, due to its sulfite content, may rarely cause severe hypersensitivity reactions and bronchospasm.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

3. How to take Polopiryna Max Hot

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Adults and adolescents over 16 years of age:
1 sachet every 6-8 hours as needed.
The dose of 4 g of acetylsalicylic acid per day (8 sachets) should not be exceeded.
The medicine should not be given to children and adolescents under 16 years of age.
The contents of one sachet should be dissolved in a glass of hot water, mixed, and drunk.
Take orally in the form of a hot drink.

Overdose of Polopiryna Max Hot

In case of overdose, the patient should immediately contact their doctor or pharmacist.
Symptoms of overdose:
The first symptoms of acetylsalicylic acid poisoning are nausea, vomiting, tinnitus, and rapid breathing.
Other symptoms have also been observed, such as: hearing loss, vision disturbances, headaches, psychomotor agitation, drowsiness, and coma, seizures, hyperthermia. In severe poisonings, serious acid-base and electrolyte disorders (metabolic acidosis and dehydration) occur.
Mild or moderate toxic symptoms occur after taking acetylsalicylic acid in a dose of 150-300 mg/kg body weight. Severe poisoning symptoms occur after a dose of 300-500 mg/kg body weight.
The potentially fatal 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 emergency department.
In case of acetylsalicylic acid poisoning, the following should be done:

• Vomiting should be induced and the stomach should be rinsed (to reduce drug absorption). This procedure is effective within 3-4 hours after taking the medicine, and in case of very high doses, even up to 10 hours.
• Activated charcoal should be administered in the form of a water suspension (in a dose of 50-100 g in adults and 30-60 g in children) to reduce acetylsalicylic acid absorption.
• In case of hyperthermia, the body temperature should be lowered by maintaining a low ambient temperature and using cool compresses.

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

• Symptoms of caffeine overdose are: insomnia, fatigue, tremors, hallucinations, tachycardia, extra beats, seizures. There is no specific antidote. In case of overdose, symptomatic treatment should be used.

Missed dose of Polopiryna Max Hot

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 patient 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:

• Decreased platelet count, decreased red blood cell count due to gastrointestinal microbleeding, decreased red blood cell count in patients with a congenital deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease), decreased white blood cell count, decreased granulocyte count, increased risk of bleeding, prolonged blood clotting time, prolonged bleeding time, iron deficiency anemia confirmed by laboratory tests and clinical symptoms, hemolysis.
• Hypersensitivity reactions with clinical symptoms and abnormal laboratory test results, such as: asthma, mild to moderate skin reactions, respiratory system, cardiovascular system, allergic edema, angioedema (swelling of the face, tongue, and larynx, causing breathing difficulties), anaphylactic reactions, anaphylactic shock confirmed by laboratory tests. Hypersensitivity to acetylsalicylic acid occurs in 0.3% of the population and in 20% of patients with asthma or chronic urticaria. Symptoms of hypersensitivity: hives, and even anaphylactic shock may occur within 3 hours of taking the medicine. If they occur, the doctor should be informed immediately.
• Dizziness and tinnitus, usually symptoms of overdose, cerebral and intracranial hemorrhage (especially in patients with uncontrolled hypertension and/or concomitantly taking other anticoagulant medications). Long-term use of acetylsalicylic acid may cause headache, which worsens with subsequent doses.
• Visual disturbances.
• Tinnitus, reversible hearing loss. Ringing in the ears is the first symptom of salicylate poisoning.
• Heart failure.
• Bleeding, perioperative bleeding, hematomas, muscle bleeding.
• Non-cardiogenic pulmonary edema (occurring mainly in chronic or acute poisoning), asthma, nosebleeds, aspirin-induced asthma syndrome, nasal mucositis, nasal congestion.
• Nausea, heartburn, feeling of fullness in the upper abdomen, nausea, vomiting, loss of appetite, abdominal pain, gastrointestinal bleeding, gastric mucosa damage, gastric or duodenal ulcers, perforations, gum bleeding, gastrointestinal inflammation.
• Gastric ulcers occur in 15% of patients taking acetylsalicylic acid long-term.
• Focal liver cell necrosis, liver tenderness and enlargement, especially in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, or a history of liver disease, transient increased activity of aminotransferases, alkaline phosphatase, and bilirubin levels.
• Hypersensitivity reactions: rash, urticaria, itching; skin rashes of various types, rarely blisters or purpura.
• Presence of protein in the urine, presence of red and/or white blood cells in the urine, renal papillary necrosis, interstitial nephritis.
• Fever.
• Long-term use of painkillers, especially those containing multiple active substances, may lead to severe kidney dysfunction and kidney failure.

After taking ascorbic acid, the following side effects may occur:

• Fatigue, insomnia, or drowsiness.
• Burning sensation behind the breastbone.
• Ascorbic acid lowers urine pH, which facilitates the precipitation of uric acid, cystine, or oxalates.
• Ascorbic acid may falsify the results of some tests performed using oxidation-reduction methods (e.g., glucose or creatinine measurement in blood and urine, stool test for occult blood).

After taking caffeine, the following side effects may occur:

• Headache, insomnia, difficulty concentrating, hand tremors.
• Gastrointestinal disorders (diarrhea, nausea, vomiting).
• Disturbances in coronary blood flow test results with dipyridamole.
• False-positive test results for pheochromocytoma or neuroblastoma, by increasing the levels of catecholamines and their metabolites in the urine.
• Increased blood glucose levels. Caffeine may cause dependence.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient 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
Phone: +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 Max Hot

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
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 Max Hot contains:

• The active substances of the medicine are: acetylsalicylic acid, ascorbic acid (vitamin C), caffeine. Each sachet contains 500 mg of acetylsalicylic acid (Acidum acetylsalicylicum), 300 mg of ascorbic acid (Acidum ascorbicum), 50 mg of caffeine (Coffeinum).
• Other ingredients are: colloidal silica, sucrose, sodium saccharin, lemon flavor 96833-51 (contains, among others: sucrose, sulfites, butylhydroxyanisole (E320)), sodium cyclamate.

What Polopiryna Max Hot looks like and what the packaging contains

The medicine is a lemon-flavored powder for oral solution in sachets.
The outer packaging - a cardboard box, contains 8 or 14 sachets.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

ALCALÁ FARMA S.L.
Avenida de Madrid 82
28802 Alcalá de Henares
(Madrid) Spain
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
POLPHARMA Sales Office Ltd.
ul. Bobrowiecka 6, 00-728 Warsaw
phone: 22 364 61 01

Date of last revision of the leaflet: