Maxipirin

Leaflet attached to the packaging: patient information

Maxipirin, 500 mg, tablets

Acetylsalicylic acid

Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.

• Keep this leaflet to be able to read it again if necessary.
• Consult a pharmacist if advice or additional information is needed.
• If any side effects occur, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• Consult a doctor if there is no improvement or the patient feels worse after 3 days in the case of fever or 5 days in the case of pain.

Table of contents of the leaflet:

• 1. What is Maxipirin and what is it used for
• 2. Important information before taking Maxipirin
• 3. How to take Maxipirin
• 4. Possible side effects
• 5. How to store Maxipirin
• 6. Package contents and other information

1. What is Maxipirin and what is it used for

Maxipirin belongs to a group of medicines with analgesic, anti-inflammatory (reducing inflammation) and antipyretic (lowering fever) properties.
Maxipirin is intended for the treatment of mild or moderate pain, such as headache, toothache, muscle and joint pain or menstrual pain, as well as fever and inflammatory conditions.
Maxipirin is intended for use in adults and adolescents over 16 years of age.
Consult a doctor if there is no improvement or the patient feels worse after 3 days in the case of fever or 5 days in the case of pain.

2. Important information before taking Maxipirin

When not to take Maxipirin:

• if the patient is hypersensitive to acetylsalicylic acid, other salicylates or any of the excipients listed in section 6.1.
• if the patient has a history of allergic reactions with asthma or has similar reactions to salicylates or other non-steroidal anti-inflammatory drugs.
• stomach or duodenal ulcer disease.
• if the patient has a tendency to bleed excessively (hemorrhagic diathesis).
• if the patient has severe kidney or liver disorders.
• if the patient has severe heart failure.
• in combination with methotrexate at doses greater than 15 mg per week.
• if the patient is in the last three months of pregnancy, doses greater than 100 mg per day should not be taken (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting Maxipirin, discuss with your doctor or pharmacist:

• if the patient is allergic to other painkillers, anti-rheumatic (medicines used to treat inflammatory diseases of the joints, muscles and tendons) or other anti-inflammatory medicines or other allergenic substances
• if the patient has a history of stomach ulcers or gastrointestinal bleeding
• if the patient is taking medicines to prevent blood clotting (anticoagulants)
• if the patient has impaired kidney function or circulatory disorders (e.g. kidney vessel disease, congestive heart failure, reduced blood volume, extensive surgery, sepsis, severe bleeding), as acetylsalicylic acid may further increase the risk of kidney function disorders and severe kidney failure
• if the patient has liver failure
• if the patient has a severe deficiency of glucose-6-phosphate dehydrogenase - acetylsalicylic acid may cause hemolysis (red blood cell breakdown) or hemolytic anemia (anemia due to red blood cell breakdown). Factors that increase the potential risk of hemolysis include high doses of the medicine, fever or acute infection
• if the patient has reduced uric acid excretion, which may cause a gout attack
• if the patient is pregnant (first 6 months)
• if the patient is breastfeeding.

The risk of an asthma attack (intolerance to painkillers or asthma caused by painkillers) occurs in patients with asthma, hay fever, nasal polyps or chronic respiratory infections (especially with symptoms similar to those of hay fever) or in patients sensitive to certain types of painkillers and anti-rheumatic drugs who take Maxipirin. If the patient has any of the above, consult a doctor before taking Maxipirin. The same applies to patients who react to other substances with allergic skin reactions, itching or hives.
Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, have been reported very rarely in patients taking non-steroidal anti-inflammatory drugs. Often, the rash may include ulcers of the mouth, throat, nose, eyes and genitals (red and swollen eyes). These serious skin reactions are often preceded by flu-like symptoms, such as fever, headache, body aches. The rash may develop into widespread blisters and skin peeling. If a rash or such skin symptoms occur, stop taking Maxipirin and contact a doctor immediately. See also section 4.
Before surgery, consult a doctor or dentist or inform them about any consumption of Maxipirin.
Medicines containing acetylsalicylic acid should not be taken for a long time or in large doses without consulting a doctor.

Children and adolescents

Maxipirin should not be used in children and adolescents with feverish illnesses, unless a doctor recommends it and other therapeutic measures have failed. Persistent vomiting in combination with these illnesses may be a sign of Reye's syndrome, a very rare but life-threatening disease that requires immediate medical attention. The risk of Reye's syndrome is higher in certain viral diseases, especially flu and chickenpox.

Maxipirin and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Acetylsalicylic acid enhances the effect of the following medicines:

• methotrexate (a medicine used to treat cancer or rheumatoid arthritis)
• anticoagulants (such as coumarins, heparin) and platelet aggregation inhibitors (substances used to prevent blood clots, such as ticlopidine)
• anti-inflammatory and analgesic medicines (such as ibuprofen)
• selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat depression)
• digoxin (used to treat heart failure)
• anti-diabetic medicines (substances used to lower blood sugar levels)
• corticosteroid treatment or alcohol consumption - increased risk of stomach and intestinal bleeding and ulceration
• valproic acid (medicines used to treat epilepsy)

Acetylsalicylic acid reduces the effect of the following medicines:

• diuretics (medicines that increase urine production)
• blood pressure lowering medicines (ACE inhibitors)
• medicines used to treat gout (uricosuric action) that increase uric acid excretion (such as probenecid, benzbromarone)

Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and clot formation) if these medicines are taken at the same time. Therefore, caution should be exercised when taking metamizole in patients receiving acetylsalicylic acid.

Maxipirin with food, drink and alcohol

Always take this medicine after meals, drinking plenty of water. Do not consume alcohol while taking Maxipirin.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
If the patient continues or starts treatment with Maxipirin during pregnancy in accordance with the doctor's recommendations, she should take the medicine as recommended by the doctor and not exceed the recommended dose.

Pregnancy - third trimester

Do not take more than 100 mg of Maxipirin per day if the patient is in the last 3 months of pregnancy, as this may harm the unborn child or cause complications during delivery. Maxipirin may cause kidney and heart disorders in the unborn child. It may increase the risk of bleeding in the patient and her child and cause prolonged or delayed delivery.
If the patient takes Maxipirin in small doses (up to 100 mg per day), the patient's condition should be closely monitored according to the doctor's recommendations.

Pregnancy - first and second trimester

During the first 6 months of pregnancy, Maxipirin should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Maxipirin may cause kidney disorders in the unborn child if taken for more than a few days. This may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is required for more than a few days, the doctor may recommend additional monitoring.
Only small amounts of acetylsalicylic acid and its metabolites pass into breast milk. No adverse effects have been observed in the child during short-term treatment. Therefore, it is not necessary to stop breastfeeding. If the patient cannot avoid regular intake of large doses of the medicine, breastfeeding should be stopped.

Driving and using machines

No effect on the ability to drive and use machines has been observed.

3. How to take Maxipirin

This medicine should always be taken in accordance with this leaflet or as directed by a doctor or pharmacist.
In case of doubt, consult a doctor or pharmacist.
Consult a doctor if there is no improvement or the patient feels worse after 3 days in the case of fever or 5 days in the case of pain. Do not use for more than 3-5 days without consulting a doctor.
Swallow the tablet with a large amount of water. Do not take on an empty stomach.
The recommended dose for adults and adolescents over 16 years of ageis 1-2 tablets in a single dose. If necessary, the dose can be repeated 3-4 times a day, with an interval of 4-8 hours between doses. Do not take more than the maximum daily dose - 8 tablets (4 g of active substance).

Taking a higher dose of Maxipirin than recommended

In case of accidental ingestion of too many tablets or if it is suspected that a child may have swallowed a tablet, contact a doctor or the nearest hospital emergency department immediately.

Missing a dose of Maxipirin

Do not take a double dose to make up for a missed dose.
Do not take more than one dose every 4 hours.
If in doubt about taking the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Maxipirin can cause side effects, although not everybody gets them .
Tell your doctorif you experience any of the following side effects or any other side effects not listed in this leaflet:
Common(may occur in less than 1 in 10 people):

• indigestion
• gastrointestinal pain and abdominal pain

Uncommon(may occur in less than 1 in 1,000 people):

• inflammatory conditions of the gastrointestinal tract, stomach ulcers
• allergic reactions, including symptoms such as rash, hives, swelling, itching, rhinitis, nasal congestion, breathing and heart problems

Rare(may occur in less than 1 in 10,000 people):

• ulceration with bleeding and perforation
• stomach bleeding
• intracranial bleeding
• anaphylactic reactions, including shock
• transient liver function disorders with increased liver enzyme activity
• severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis

Frequency not known(frequency cannot be estimated from the available data):

• peroperative bleeding
• hematoma
• nasal bleeding
• genitourinary tract bleeding
• bleeding gums
• acute and chronic anemia or iron deficiency anemia (due to hidden microbleeding) - reduction of red blood cells may cause pale skin and may cause weakness or shortness of breath
• hemolytic anemia and hemolysis - reduction of red blood cells or their destruction, which causes yellowish skin discoloration and may cause weakness or shortness of breath, if the patient has a severe deficiency of glucose-6-phosphate dehydrogenase
• dizziness and tinnitus (ringing and buzzing in the ears), which may be caused by overdose
• reduced kidney function

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Maxipirin

Keep the medicine out of sight and reach of children.
Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Maxipirin contains

• The active substance of Maxipirin is acetylsalicylic acid. Each tablet contains 500 mg of acetylsalicylic acid.
• The excipients are: cornstarch and cellulose powder.

What Maxipirin looks like and what the package contains
Maxipirin is a white or almost white, round, biconvex tablet with a dividing line on one side, 13 mm in diameter, packaged in PVC/PVDC/Aluminum blisters in a cardboard box.
The tablet can be divided into equal doses.
Package sizes: 8, 10, 20 tablets.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
110 00 Prague
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

Saneca Pharmaceuticals
Nitrianska 100
920 27 Hlohovec
Slovakia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Slovakia:
Algirin 500 mg
Czech Republic:
Algirin
Poland:
Maxipirin
Romania:
Maxipirin 500 mg tablets

Date of last revision of the leaflet: 02/2025