Apenal

Leaflet attached to the packaging: patient information

Apenal, 50 mg, suppositories

Apenal, 80 mg, suppositories

Paracetamol

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to the
recommendations of a doctor or pharmacist.

• This 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 any possible side effects not listed in the 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 Apenal and what is it used for
• 2. Important information before using Apenal
• 3. How to use Apenal
• 4. Possible side effects
• 5. How to store Apenal
• 6. Package contents and other information

1. What is Apenal and what is it used for

Apenal suppositories have analgesic and antipyretic effects.
The medicine is used in infants and children 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 Apenal

When not to use Apenal:

• if the patient is hypersensitive (allergic) to paracetamol or hypersensitive (allergic) to any other component of this medicine (listed in section 6);
• if the patient has severe renal and/or hepatic impairment.

Warnings and precautions

The medicine should be used with caution in patients

• with moderate renal impairment
• with mild to moderate hepatic impairment (including Gilbert's syndrome), in patients being treated with other medicinal products that affect liver function
• who are chronically malnourished, dehydrated
• with glucose-6-phosphate dehydrogenase deficiency
• with hemolytic anemia.

Apenal and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use, including those available without a prescription.
Particularly, they should inform about the use of the following medicines:

• 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).

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

Pregnancy and breastfeeding

Not applicable. The medicine is intended for children.

Driving and using machines

Not applicable. The medicine is intended for children.

3. How to use Apenal

This medicine should always be used exactly as described in the patient leaflet or according to the
recommendations of a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
Apenal suppositories of 50 mg and 80 mg are intended for rectal administration.
Recommended dose
The medicine should be used based on the child's body weight, and the approximate age of the child is given 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, taking into account all medicines containing paracetamol.
Apenal, 50 mg, suppositories:
Infants from 3.3 kg to 5 kg (under 3 months) – 1 suppository 3 to 4 times a day.
From 6.7 kg to 10 kg (from 3 months to 1 year) – 2 suppositories 3 to 4 times a day.
Do not use more frequently than every 4 hours.
In infants under 3 months, use only in consultation with a doctor.
Apenal, 80 mg, suppositories:
Infants and children from 5.3 kg to 8 kg (from about 3 to 9 months) – 1 suppository 3 to 4 times a day.
Do not use more frequently than every 4 hours.
If symptoms worsen or do not improve after 3 days, a doctor should be consulted.
In case of doubt about the use of the medicine, a doctor or pharmacist should be consulted.
The medicine is also available in other strengths: 250 mg and 500 mg.

Using a higher dose of Apenal than recommended

In case of using a higher dose of the medicine than recommended, a doctor should be consulted 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. These symptoms may resolve the next day, despite the fact that liver damage is developing, which manifests as abdominal distension, return of nausea, and jaundice.

Missing a dose of Apenal

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

4. Possible side effects

Like all medicines, Apenal can cause side effects, although not everybody gets them.
Use of Apenal should be stopped and a doctor should be consulted immediately in case of the following side effects:

• allergic reactions manifested as itching, hives, rash, redness, swelling of the face and throat, making breathing difficult (rare - in 1 to 10 people out of 10,000)
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis) manifested as a rash with pustules all over the body, ulcers in the mouth, eyes, genitals, and skin, red spots on the torso, often with large blisters, peeling of large skin flakes, weakness, fever, and joint pain. (very rare cases)
• too few blood platelets manifested as a tendency to bruise, petechiae, and bleeding from the gums, etc. (very rare - in less than 1 person out of 10,000).

Other side effects occur very rarely (in less than 1 person out of 10,000):

• liver function impairment;
• kidney function impairment.

Reporting side effects

If any side effects occur, including any side effects not listed in the 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
e-mail: [email protected]
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 Apenal

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 after EXP.

6. Package contents and other information

What Apenal contains

The active substance of the medicine is paracetamol.
The excipient is solid fat (Witepsol S58).

What Apenal looks like and what the package contains

The medicine is in the form of white or almost white, cylindrical suppositories packaged in blisters
and a cardboard box.
The package contains 5, 10, 15, or 20 suppositories.

Marketing authorization holder and manufacturer

Przedsiebiorstwo Farmaceutyczne Lek-Am Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym

Date of the last update of the leaflet: