POLOPIRYNA 500 mg/200 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Polopiryna C, 500 mg + 200 mg, Effervescent Tablets
   1. Read the Leaflet Carefully Before Taking the Medication, as it Contains
   2. Table of Contents of the Leaflet
3. What is Polopiryna C and what is it used for
   1. Indications:
4. Important information before taking Polopiryna C
   1. When not to take Polopiryna C
   2. Warnings and precautions
   3. Use in patients with liver and/or kidney function disorders
   4. Use in elderly patients
   5. Polopiryna C and other medications
   6. Polopiryna C with food, drink, and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Polopiryna C contains sodium
5. How to take Polopiryna C
   1. Taking a higher dose of Polopiryna C than recommended
   2. Missing a dose of Polopiryna C
6. Possible side effects
   1. Blood and lymphatic system disorders
   2. Immune system disorders
   3. Nervous system disorders
   4. Cardiac disorders
   5. Vascular disorders
   6. Gastrointestinal disorders
   7. Hepatobiliary disorders
   8. Renal and urinary disorders
   9. Reporting side effects
7. How to store Polopiryna C
8. Contents of the pack and other information
   1. What Polopiryna C contains
   2. What Polopiryna C looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Date of the last update of the leaflet:

Package Leaflet: Information for the Patient

Polopiryna C, 500 mg + 200 mg, Effervescent Tablets

Acetylsalicylic Acid + Ascorbic Acid

Read the Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet to be able to read it again if necessary.
• If advice or additional information is needed, 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 or the patient feels worse after 3 days, they should contact their doctor.

Table of Contents of the Leaflet

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

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

Polopiryna C is a combined medication containing acetylsalicylic acid and ascorbic acid (vitamin C). Acetylsalicylic acid has analgesic, antipyretic, and anti-inflammatory effects. Vitamin C plays an important role in the body's metabolic processes. During illness and recovery, the body's need for vitamin C increases. The effervescent tablet ensures rapid and complete absorption of the medication's components.

Indications:

• Pain of mild or moderate intensity, e.g., headaches, muscle and joint pain, and other types.
• Fever in the course of a cold, viral infections, and other diseases.

2. Important information before taking Polopiryna C

When not to take Polopiryna C

• if the patient is allergic to acetylsalicylic acid or ascorbic acid, or any of the other components of this medication (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, even anaphylaxis) may occur within 3 hours of taking acetylsalicylic acid;
• if the patient has been diagnosed with an allergy (hypersensitivity) to other non-steroidal anti-inflammatory drugs, with symptoms such as bronchospasm, hay fever, anaphylaxis;
• if the patient has asthma, chronic respiratory diseases, hay fever, or nasal mucosa edema, as these patients 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 gastric or duodenal ulcer disease and/or gastrointestinal bleeding (gastrointestinal bleeding or ulcer disease may occur);
• if the patient has severe liver, kidney, or heart failure;
• if the patient has blood coagulation disorders (e.g., hemophilia, thrombocytopenia) and is being treated with anticoagulant medications (e.g., coumarin derivatives, 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 the harmful effect on the bone marrow;
• in children under 12 years of age, especially during viral infections (chickenpox, flu), due to the risk of Reye's syndrome, a rare but severe disease causing liver and brain damage;
• if the patient is in the last three months of pregnancy, doses greater than 100 mg of acetylsalicylic acid per day should not be taken (see "Pregnancy and breastfeeding");
• during breastfeeding;
• in case of damage to the direct packaging, due to the action of external factors (air and moisture), the vitamin C contained in the tablet undergoes gradual oxidation, leading to a change in the tablet's color from white to brown. A tablet with a changed color should not be used.

Warnings and precautions

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

• in patients with kidney function disorders and chronic kidney failure;
• in patients with juvenile rheumatoid arthritis and/or systemic lupus erythematosus, and with liver failure, as the toxicity of salicylates increases; in these patients, liver function should be monitored;
• in case 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 toxic effect of methotrexate on the bone marrow. Concurrent use with methotrexate in doses greater than 15 mg per week is contraindicated.

Polopiryna C should not be taken if the patient is taking oral anti-diabetic medications from the sulfonylurea group, due to the risk of increased hypoglycemic effect (reducing blood glucose levels), and if the patient is taking anti-gout medications.
Acetylsalicylic acid should be discontinued 5 to 7 days before a planned surgical procedure, due to the risk of prolonged bleeding time, both during and after the procedure.
During treatment with acetylsalicylic acid, alcohol should not be consumed, due to the increased risk of damage to the gastrointestinal mucosa.
This medication belongs to the group of non-steroidal anti-inflammatory drugs, which may adversely affect fertility in women. This effect is temporary and disappears after the end of treatment.

Use in patients with liver and/or kidney function disorders

In patients with liver and/or kidney function disorders, there is a risk of increased side effects of the medication, so it may be necessary to adjust the dose depending on the severity of liver and/or kidney failure.
The medication is contraindicated in case of severe liver and/or kidney failure.

Use in elderly patients

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

Polopiryna C and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Caution should be exercised when taking Polopiryna C with:

• angiotensin-converting enzyme inhibitors (e.g., enalapril, captopril), as acetylsalicylic acid reduces the antihypertensive effect of these medications;
• acetazolamide, as acetylsalicylic acid may increase the toxicity of acetazolamide;
• anticoagulant medications (heparin and warfarin), as there is an increased risk of bleeding;
• valproic acid, as acetylsalicylic acid increases the toxic effect of valproic acid, and valproic acid increases the anti-aggregatory effect (preventing platelet aggregation) of acetylsalicylic acid;
• diuretics, as acetylsalicylic acid may reduce the effectiveness of these medications and increase the ototoxicity (hearing damage) of furosemide;
• methotrexate, as acetylsalicylic acid increases its toxic effect on the bone marrow. Taking acetylsalicylic acid concurrently with methotrexate in doses of 15 mg per week or higher is contraindicated;
• non-steroidal anti-inflammatory drugs (e.g., ibuprofen), as there is an increased risk of gastrointestinal side effects;
• systemic glucocorticosteroids (except for hydrocortisone used as replacement therapy in Addison's disease), as they increase the risk of gastric ulcer and gastrointestinal bleeding, and reduce the salicylate levels in the blood during treatment, and after its completion, increase the risk of salicylate overdose;
• anti-diabetic medications, as acetylsalicylic acid increases the hypoglycemic effect (reducing blood glucose levels) of these medications;
• medications that increase uric acid excretion (e.g., probenecid, sulfinpyrazone), as salicylates weaken the effect of these medications. Acetylsalicylic acid should not be taken concurrently with these medications;
• digoxin, as acetylsalicylic acid may increase the effect of this medication;
• thrombolytic medications (dissolving blood clots), such as streptokinase and alteplase, as acetylsalicylic acid may increase the effect of these medications.

Omeprazole does not affect the absorption of acetylsalicylic acid.
Ascorbic acid lowers the pH of urine, which may affect the excretion of other medications.
Ascorbic acid may also change the results of some laboratory tests.

Polopiryna C with food, drink, and alcohol

The medication should be taken during a meal.
During treatment with acetylsalicylic acid, alcohol should not be consumed, due to the increased risk of damage to the gastrointestinal mucosa.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Pregnancy
If the patient continues or starts treatment with Polopiryna C during pregnancy according to the doctor's recommendations, they should take Polopiryna C as recommended and not take a higher dose than recommended.
Pregnancy - third trimester
Acetylsalicylic acid should not be taken in doses greater than 100 mg per day in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Polopiryna C may cause kidney and heart disorders in the unborn child. This may affect the patient's and their child's tendency to bleed and cause delayed or prolonged labor.
If the patient takes acetylsalicylic acid in small doses (up to 100 mg per day), close obstetric monitoring is necessary according to the doctor's recommendations.
Pregnancy - first and second trimester
Due to the content of acetylsalicylic acid, this medication should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose of the medication should be used for the shortest possible time. Taking acetylsalicylic acid 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 blood vessel (ductus arteriosus) in the child's heart. If longer treatment is necessary, the doctor may recommend additional monitoring.
Breastfeeding
The medication is contraindicated during breastfeeding.

Driving and using machines

The medication does not affect psychophysical abilities.

Polopiryna C contains sodium

The medication contains 356 mg of sodium (the main component of table salt) per tablet. This corresponds to 17.8% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.

3. How to take Polopiryna C

This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The medication should be taken during a meal. Before use, the tablet should be dissolved in ¾ of a glass of water.
For analgesic and antipyretic purposes, the following doses are usually taken:
Adults: 1 to 2 tablets at a time. If necessary, the dose may be repeated 2 to 3 times a day. Do not take more than 6 tablets per day.
Adolescents over 12 years of age: 1 to 2 tablets per day.
The smallest effective doses should be used.
Symptomatic treatment without medical advice should not be taken for more than 3 days.

Taking a higher dose of Polopiryna C than recommended

In case of taking a higher dose of the medication 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, motor agitation, sleepiness, and coma, seizures, hyperthermia (body temperature above normal values), have also been observed. In severe poisonings, there are disturbances in acid-base and water-electrolyte balance (metabolic acidosis and dehydration).
The patient should be taken to the hospital. There is no specific antidote.

Missing a dose of Polopiryna C

In case of missing a dose, the patient should take the next dose at the scheduled time. A double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like all medications, Polopiryna C can cause side effects, although they may not occur in every patient.

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). If these occur, the patient should immediately inform their doctor.

Nervous system disorders

tinnitus (usually as a symptom of overdose), hearing disturbances, dizziness, fatigue, burning sensation behind the breastbone, insomnia or drowsiness.

Cardiac disorders

heart failure.

Vascular disorders

Hypertension, flushing.

Gastrointestinal disorders

dyspepsia, heartburn, feeling of fullness in the upper abdomen, nausea, vomiting, loss of appetite, abdominal pain, gastrointestinal bleeding, damage to the gastric mucosa, exacerbation of ulcer disease, perforations.
Gastric ulcer occurs in 15% of patients taking acetylsalicylic acid for a long time.

Hepatobiliary disorders

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

Renal and urinary disorders

proteinuria, presence of leukocytes and erythrocytes in urine, renal papillary necrosis, interstitial nephritis.
Ascorbic acid reduces the pH of urine, which facilitates the precipitation of urates, cystine, or oxalates.

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, 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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Polopiryna C

Store in the original packaging at a temperature below 25°C.
The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
Medications should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Polopiryna C contains

• The active substances of the medication are acetylsalicylic acid and ascorbic acid. Each effervescent tablet contains 500 mg of acetylsalicylic acid and 200 mg of ascorbic acid.
• The other components of the medication are: anhydrous citric acid, sodium bicarbonate.

What Polopiryna C looks like and what the pack contains

White, round, flat tablets, which when dropped into water dissolve with intense effervescence.
The packaging contains 6, 10, or 18 effervescent tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of the last update of the leaflet: