Maxipirin C

Leaflet accompanying the packaging: patient information

Maxipirin C, 400 mg + 240 mg, effervescent tablets

Acetylsalicylic acid + Ascorbic acid

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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days in the case of children and adolescents or 5 days in the case of adults, there is no improvement or the patient feels worse, they should consult a doctor.

Table of contents of the leaflet:

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

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

Maxipirin C contains two active substances: acetylsalicylic acid and ascorbic acid (vitamin C).
Acetylsalicylic acid belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). Acetylsalicylic acid reduces pain, fever, and inhibits inflammation by reducing the production of prostaglandins (compounds involved in the inflammatory process).
Ascorbic acid (vitamin C) supports the body's immune system in the course of inflammatory processes.
Maxipirin C can be taken in case of mild to moderate pain (e.g., headache, toothache, sore throat, muscle pain, joint pain, back pain, and menstrual pain) and in inflammatory diseases of the upper respiratory tract (such as colds and flu) to relieve pain and fever symptomatically.
On the doctor's recommendation, Maxipirin C can be used in case of mild pain accompanying joint inflammation.
Maxipirin C is indicated for use in adults, adolescents, and children with a body weight over 30 kg (over 9 years of age). Children and adolescents may only take the medicine on the recommendation of a doctor.
If after 3 days in the case of children and adolescents or 5 days in the case of adults, there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Maxipirin C

When not to take Maxipirin C:

• if the patient is hypersensitive to acetylsalicylic acid, other salicylates, ascorbic acid, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has had an asthma attack, hives, rhinitis, or a similar reaction to salicylates or other nonsteroidal anti-inflammatory drugs,
• if the patient has stomach or duodenal ulcers,
• if the patient has a bleeding disorder (hemorrhagic diathesis),
• if the patient has severe renal or hepatic impairment,
• if the patient has severe heart failure,
• if the patient is taking methotrexate at doses of 15 mg/week or higher,
• if the patient is in the last three months of pregnancy, doses of acetylsalicylic acid above 100 mg/day should not be used (see section "Pregnancy, breastfeeding, and fertility"),
• if the patient has kidney stones (nephrolithiasis),
• if the patient has increased oxalate levels in the urine (hyperoxaluria),
• if the patient has excessive iron accumulation in the body due to dietary intake (hemochromatosis).

Warnings and precautions

Before starting treatment with Maxipirin C, the patient should discuss it with their doctor or pharmacist.
Caution should be exercised when takingMaxipirin C

• if the patient has hypersensitivity (allergy) to other painkillers, anti-rheumatic drugs (drugs used to treat inflammatory diseases of the joints, muscles, and tendons), anti-inflammatory drugs, or other allergenic substances,
• if the patient has had stomach or duodenal ulcers or gastrointestinal bleeding in the past,
• if the patient is taking anticoagulant medications (e.g., coumarin, heparin),
• if the patient has kidney or cardiovascular disease (e.g., kidney disease, congestive heart failure, decreased blood volume, extensive surgery, sepsis, or severe bleeding), as acetylsalicylic acid may further increase the risk of kidney dysfunction and acute kidney failure,
• if the patient has impaired liver function,
• 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 increasing the potential risk of hemolysis include high doses of the medicine, fever, or acute infections.
• if the patient has reduced uric acid excretion, as the medicine may cause a gout attack at low doses.

In these cases, before taking Maxipirin C, the patient should consult their doctor.
Patients with asthma, hay fever, nasal polyps, or chronic respiratory infections (especially if accompanied by symptoms similar to hay fever) or with hypersensitivity to any type of painkillers and anti-rheumatic drugs are at risk of asthma attacks (aspirin-induced asthma) if they take Maxipirin C.
If the patient has such diseases, they should consult their doctor before taking Maxipirin C. The same applies to patients who are allergic to other substances, manifesting as skin reactions, itching, or hives.
The patient should inform their doctor or dentist about taking Maxipirin C before a planned surgical procedure.
Medicines containing acetylsalicylic acid should not be taken for a long time or in high doses without consulting a doctor.
Before taking acetylsalicylic acid, the patient should tell their doctor about all the medicines they are taking. In the case of regular use of acetylsalicylic acid, the patient should discuss with their doctor before taking any other medicine (including over-the-counter medicines).
Caution should be exercised when taking ascorbic acid in patients who have a tendency to develop kidney stones (oxalate stones) or recurrent kidney stones.

Children and adolescents

Maxipirin C should not be taken by children and adolescents with feverish diseases unless recommended by a doctor and other treatment methods have failed. Persistent vomiting in these diseases may be a symptom of Reye's syndrome, a very rare but life-threatening disease that requires immediate medical attention.

Maxipirin C and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Maxipirin C should not be taken at the same time as:

• methotrexate (used to treat cancer or rheumatoid arthritis) at doses of 15 mg/week or higher, as acetylsalicylic acid may increase the toxicity of methotrexate.

Caution should be exercised when taking this medicine with:

• methotrexate (used to treat cancer or rheumatoid arthritis) at doses less than 15 mg/week, as acetylsalicylic acid may increase the toxicity of methotrexate
• anticoagulant medications (e.g., coumarin, heparin) and medications that inhibit platelet aggregation (substances that prevent platelet aggregation and blood clot formation), e.g., ticlopidine, as acetylsalicylic acid may increase the risk of bleeding
• anti-inflammatory drugs containing salicylates, as acetylsalicylic acid may increase the risk of gastrointestinal bleeding and ulcers
• serotonin reuptake inhibitors (medicines used to treat depression), as acetylsalicylic acid may increase the risk of gastrointestinal bleeding
• digoxin (a substance that improves heart contraction), as acetylsalicylic acid may increase its blood levels
• medicines that lower blood sugar levels (antidiabetic medicines), as acetylsalicylic acid may enhance their hypoglycemic effect
• diuretics (medicines that increase urine production), as acetylsalicylic acid may reduce glomerular filtration
• systemic glucocorticosteroids, as when taken with acetylsalicylic acid, reduced salicylate levels may be observed
• ACE inhibitors (medicines that lower blood pressure), as acetylsalicylic acid may reduce glomerular filtration
• valproic acid, as acetylsalicylic acid may increase its toxicity
• medicines used to treat gout (uricosuric agents), which improve uric acid excretion in the urine (e.g., probenecid, benzbromarone), as acetylsalicylic acid may reduce their effect
• deferiprone, as concurrent use with ascorbic acid may increase iron toxicity in tissues, especially in the heart.

Laboratory tests

Vitamin C (ascorbic acid) may interfere with certain laboratory tests, e.g., glucose, creatinine, carbamazepine, uric acid in urine and serum, and tests for occult blood in stool.
Vitamin C may interfere with glucose level measurements in urine and blood, leading to false results, although it does not affect blood glucose levels.

Maxipirin C and alcohol

Alcoholic beverages should not be consumed while taking this medicine.

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.
If the patient continues or starts treatment with Maxipirin C during pregnancy according to the doctor's recommendations, they should take the medicine strictly as directed by the doctor and not exceed the recommended dose.

Pregnancy - third trimester

A dose of acetylsalicylic acid above 100 mg/day should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart dysfunction in the unborn child. The medicine may increase the risk of bleeding in the patient and their child and cause prolonged or delayed delivery.
If the patient takes acetylsalicylic acid in low doses (up to 100 mg/day), they should be closely monitored by their doctor.

Pregnancy - first and second trimester

During the first six months of pregnancy, Maxipirin C should not be taken unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.
Taking Maxipirin C from the 20th week of pregnancy for a period longer than a few days may lead to kidney dysfunction in the unborn child, resulting in reduced amniotic fluid or narrowing of the arterial duct in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Small amounts of acetylsalicylic acid and its metabolites, as well as ascorbic acid, pass into breast milk. With short-term use, no adverse effects have been observed in infants, so it is not necessary to stop breastfeeding. However, with regular use of high doses, breastfeeding should be discontinued.

Fertility

Based on limited available data, human studies have not shown any lasting effect of acetylsalicylic acid on fertility, and there is no conclusive evidence from animal studies.

Driving and using machines

Maxipirin C does not affect the ability to drive or operate machines.

Maxipirin C contains sodium

This medicine contains 447.48 mg of sodium (the main component of table salt) in each effervescent tablet.
This corresponds to 22.37% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Maxipirin C

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
If after 3 days in the case of children and adolescents or 5 days in the case of adults, the fever or pain does not subside, the patient should consult a doctor.
Before taking the effervescent tablet, it should be dissolved in a glass of water (200 mL). The medicine should not be taken on an empty stomach.
In adults, usually 1 to 2 effervescent tablets (i.e., 400 to 800 mg of acetylsalicylic acid) are taken. If necessary, a single dose can be repeated at intervals of at least 4 hours.
The maximum daily dose should not be exceeded.

Use in children and adolescents

Children with a body weight over 30 kg (over 9 years of age) and adolescents may only take this medicine in exceptional cases on the recommendation of a doctor and under constant medical supervision. The dose will be determined by the doctor based on body weight. The recommended single dose of acetylsalicylic acid is approximately 15 mg/kg body weight every 6 hours or 10 mg/kg body weight every 4 hours, with a total daily dose of approximately 60 mg/kg body weight. The patient should follow the doctor's recommendations regarding the dose and intervals between doses.
This medicine is not suitable for younger children due to its acetylsalicylic acid content. Other medicines with lower acetylsalicylic acid content are available for this population.

Elderly patients

Acetylsalicylic acid should be taken with caution in elderly patients due to the possibility of concomitant diseases. Acetylsalicylic acid may increase the risk of gastrointestinal bleeding and perforation. The lowest effective dose should be used.

Liver dysfunction

Acetylsalicylic acid should be taken with caution and only after consulting a doctor in patients with liver dysfunction. Acetylsalicylic acid should not be taken by patients with severe liver failure.

Kidney dysfunction

Acetylsalicylic acid should be taken with caution and only after consulting a doctor in patients with kidney dysfunction. Acetylsalicylic acid should not be taken by patients with severe kidney failure.

Overdose of Maxipirin C

In case of overdose or accidental ingestion of the medicine by a child, the patient should immediately consult a doctor.
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.
Side effects may occur with the following frequency:
Rare(may affect up to 1 in 1,000 people)

• gastrointestinal inflammation, stomach or duodenal ulcers (which may be accompanied by bleeding and perforation of the gastrointestinal ulcer)

Very rare(may affect up to 1 in 10,000 people)

• severe allergic reaction (anaphylactic shock)
• transient liver dysfunction with increased liver enzyme activity

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

• increased risk of bleeding during and after surgery, bruising, nosebleeds, bleeding from the urinary and genital tracts, gum bleeding, gastrointestinal bleeding, and intracranial bleeding (severe bleeding, especially in patients with uncontrolled hypertension and/or concomitantly taking anticoagulant medications, which can be life-threatening), iron deficiency anemia (e.g., due to occult bleeding), weakness, pallor due to insufficient blood supply to tissues, red blood cell breakdown, or hemolytic anemia (anemia due to red blood cell breakdown)
• hypersensitivity reactions (aspirin-induced respiratory disease), mild to moderate skin, respiratory, gastrointestinal, and cardiovascular reactions (rash, hives, swelling, itching, rhinitis, nasal congestion, respiratory disorders, and cardiac arrhythmias)
• dizziness (may be a sign of overdose)
• tinnitus (may be a sign of overdose)
• gastrointestinal disorders (indigestion, abdominal pain)
• intestinal stenosis - obstruction (especially during long-term treatment)
• diarrhea
• nausea
• vomiting
• reduced kidney function and acute kidney failure

Reporting side effects

If 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 Drug Safety Monitoring of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Maxipirin C

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store the tube tightly closed to protect from moisture.
After first opening: Do not use after 90 days.
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 stated.
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 Maxipirin C contains

• The active substances of the medicine are acetylsalicylic acid and ascorbic acid. Each effervescent tablet contains 400 mg of acetylsalicylic acid and 240 mg of ascorbic acid - vitamin C.
• The other ingredients are sodium bicarbonate, citric acid, and sodium carbonate.

What Maxipirin C looks like and contents of the pack
White, round, and flat tablet with a nominal mass of 3.2 grams and a diameter of 25 mm.
Tube made of PP, closed with a PE cap with silica gel as a desiccant, in a cardboard box.
Package sizes: 10 and 20 effervescent 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
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

E-Pharma Trento S.p.A.
Frazione Ravina
Via Provina 2
38123 Trento, TN
Italy

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

Slovakia:
Algirin Plus
Czech Republic:
Algirin Plus
Poland:
Maxipirin C
Romania:
Maxipirin C 400 mg/240 mg effervescent tablets

Date of last revision of the leaflet: