Infacetamol

Package Leaflet: Information for the Patient

Infacetamol, 50 mg, suppositories
Paracetamolum

Read the leaflet carefully before using the medicine, because

it contains important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or
according to the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 3 days, the doctor should be contacted.

Table of Contents of the Leaflet

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

1. What is Infacetamol and what is it used for

Infacetamol in the form of suppositories has analgesic and antipyretic effects.
The medicine is used in infants for pain and fever of various origins, e.g., during teething,
after vaccinations, as well as in the symptomatic treatment of flu-like conditions
and colds.

2. Important information before using Infacetamol

When not to use Infacetamol

Infacetamol should 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

The medicine should be used with caution in patients with liver and/or kidney function disorders
and in patients with glucose-6-phosphate dehydrogenase deficiency.
Prolonged or frequent use should be avoided. The patient and/or caregiver should be informed that the medicinal product must not be taken at the same time as other products containing paracetamol.

Infacetamol and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including those available without a prescription. In particular, the following medicines should be reported:

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

Note: Do not use other medicines containing paracetamol at the same time.

Driving and using machines

Not applicable. The medicine is intended for children.

3. How to use Infacetamol

Infacetamol is intended for rectal administration. The medicine should be used based on the child's body weight, with the approximate age of the child provided as a general guideline. A single dose of 10 to 15 mg of paracetamol per kilogram of body weight is recommended. The maximum dose is 60 mg of paracetamol per kilogram of body weight per day.
Dosage
Patients with a body weight of 3.3 kg to 5 kg (under 3 months old) – 1 suppository 3 to 4 times a day.
In infants under 3 months old, use only in consultation with a doctor.
Patients with a body weight of 6 kg to 10 kg (from 3 months to 1 year old) – 2 suppositories 3 to 4 times a day.
Do not use 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 after 3 days, the doctor should be contacted.
Administration of this pharmaceutical form is not recommended in case of diarrhea.
In case of doubts about the use of the medicine, the doctor or pharmacist should be consulted.

Using a higher dose of Infacetamol than recommended

In case of using a higher dose of the medicine than recommended, the doctor should be contacted immediately. Overdose of the medicine may cause symptoms such as nausea, vomiting, excessive sweating, and drowsiness, as well as general weakness, within a few or several hours. They may resolve the next day, despite the fact that liver damage is beginning to develop, which manifests as abdominal distension, return of nausea, and jaundice.

Missing a dose of Infacetamol

A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medicines, Infacetamol can cause side effects, although not everyone gets them.
Uncommon side effects (in 1 to 10 people out of 10,000):

• skin and subcutaneous tissue disorders such as: itching, hives, rash, erythema, angioedema. Rare side effects (in less than 1 person out of 10,000):
• blood and lymphatic system disorders such as: changes in blood morphology (thrombocytopenia with signs of thrombocytopenic purpura);
• liver and bile duct disorders such as: impaired liver function;
• kidney and urinary tract disorders such as: impaired kidney function.

Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist, or nurse should be informed. 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, 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Infacetamol

Store at a temperature below 25°C.
Store in a place inaccessible and invisible to children.
Do not use after the expiry date stated on the packaging.

6. Package contents and other information

What Infacetamol contains

The active substance of the medicine is paracetamol.
The excipient is solid fat.

What Infacetamol looks like and what the package contains

The medicine is in the form of suppositories packaged in aluminum/LDPE or PVC/PE blisters, in a cardboard box.
The package contains 10 suppositories.

Marketing authorization holder and manufacturer

Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
tel.: +48 12 290 90 00
[Logo of the marketing authorization holder]
Date of the last update of the leaflet: