Infacetamol

Package leaflet: Information for the patient

Infacetamol, 50 mg, suppositories
Paracetamolum
Please read the entire leaflet carefully before use, as it contains important information for the patient.
This medicine should always be used exactly as described in the patient information leaflet or
as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.
• If there is no improvement or if the patient's condition worsens after 3 days, consult a doctor.

Table of contents

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

1. What Infacetamol is and what it is used for

Infacetamol suppositories have analgesic and antipyretic effects.
The medicine is used in infants for pain and fever of various origins, e.g. teething pain,
fever following vaccinations, as well as symptomatic treatment of influenza-like conditions
and common colds.

2. Important information before using Infacetamol

When not to use Infacetamol
Infacetamol must not be used if the patient has:

• hypersensitivity (allergy) to paracetamol;
• hypersensitivity (allergy) to any other component of this medicine (listed in section 6);
• severe renal and (or) hepatic impairment.

Warnings and precautions
Infacetamol should be used with caution in patients with hepatic and (or) renal function disorders, as well as in patients with glucose-6-phosphate dehydrogenase deficiency.
Prolonged or frequent use should be avoided. The patient and (or) caregiver should be informed that this medicinal product must not be taken concurrently with other products containing paracetamol.

Interaction of Infacetamol with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription, as well as any medicines the patient intends to use. In particular, inform about the use of the following medicines:

• carbamazepine, phenobarbital, phenytoin (medicines used in epilepsy);
• omeprazole (medicine used in peptic ulcer disease);
• rifampicin (antibiotic);
• zidovudine (antiviral medicine);
• herbal medicines containing St. John's wort;
• medicines containing ethanol (e.g. some traditional herbal remedies);
• probenecid (medicine used in gout);
• warfarin (anticoagulant);
• flucloxacillin (antibiotic), due to the serious risk of a disorder affecting blood and body fluids (metabolic acidosis with a high anion gap), which requires urgent treatment and may occur particularly in patients with severe renal function disorders, sepsis (a condition in which bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking maximum daily doses of paracetamol.

Warning: Do not take other medicines containing paracetamol at the same time.

Driving and operating machinery
Not applicable. This medicine is intended for children.

3. How to use Infacetamol

Infacetamol is intended for rectal administration. The dosage should be calculated according to the child's body weight; approximate age is provided as a general guideline. The recommended single dose is 10 to 15 mg of paracetamol per kg of body weight. The maximum daily dose is 60 mg of paracetamol per kg of body weight.

Dosage
Patients weighing from 3.3 kg to 5 kg (under 3 months of age) – 1 suppository 3 to 4 times daily.
In infants under 3 months of age, use only upon medical advice.
Patients weighing from 6 kg to 10 kg (aged 3 months to 1 year) – 2 suppositories 3 to 4 times daily.
Administer no more frequently than every 4 hours.
Do not exceed the maximum daily dose due to the risk of severe liver damage.
If symptoms worsen or do not improve within 3 days, consult a doctor.
This pharmaceutical form is not recommended in cases of diarrhoea.
In case of doubt regarding the use of the medicine, seek advice from a doctor or pharmacist.

Use of a higher than recommended dose of Infacetamol
In case of an overdose, seek immediate medical attention. Overdose may cause symptoms within a few to several hours, such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, even though liver damage may have started to develop, presenting as upper abdominal discomfort, recurrence of nausea, and jaundice.

Missed dose of Infacetamol
Do not administer a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, Infacetamol may cause adverse reactions, although not
all patients will experience them.
Adverse reactions occurring rarely (in 1 to 10 out of 10,000 people):

• Skin and subcutaneous tissue disorders such as: pruritus, urticaria, rash, erythema, angioedema.
  Adverse reactions occurring very rarely (in less than 1 out of 10,000 people):
• Blood and lymphatic system disorders such as: changes in blood morphology (thrombocytopenia with symptoms of thrombocytopenic purpura);
• Hepatobiliary disorders such as: impaired liver function;
• Renal and urinary disorders such as: impaired kidney function.

Reporting adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your
doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department
for Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Infacetamol

Store below 25°C.
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the packaging.

6. Contents of the package and other information

What Infacetamol contains
The active substance is paracetamol.
The excipient is hard fat.

What Infacetamol looks like and contents of the pack
Infacetamol is in the form of suppositories packed in blisters made of Aluminium/LDPE or PVC/PE foil, placed in a cardboard box.
The package contains 10 suppositories.

Marketing Authorisation Holder and Manufacturer
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
Poland
tel.: +48 12 290 90 00
[Logo of the Marketing Authorisation Holder]