Apenal

Package Leaflet: Information for the Patient

Apenal, 50 mg, Suppositories

Apenal, 80 mg, Suppositories

Paracetamol

Read the package 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 package leaflet for the patient or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your 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. Contents of the pack 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 of the other ingredients 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

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use, including those available without a prescription.
In particular, you 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 package leaflet for the patient or as advised by your doctor or pharmacist. If you are not sure, you should ask your doctor or pharmacist.
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, you should contact your doctor.
In case of doubts about the use of the medicine, you should consult your doctor or pharmacist.
The medicine is also available in other strengths: 250 mg and 500 mg.

Using a higher dose of Apenal than recommended

If you use a higher dose of the medicine than recommended, you should immediately consult your doctor.
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 disappear the next day, despite the fact that liver damage is beginning to develop, which is manifested by abdominal distension, return of nausea, and jaundice.

Missing a dose of Apenal

You should not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Apenal can cause side effects, although not everybody gets them.
You should stop using Apenal and immediately consult your doctor if you experience any of the following side effects:

• allergic reactions manifested by itching, hives, rash, flushing, facial and throat edema causing difficulty breathing (rare - in 1 to 10 people out of 10,000)
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis) manifested by a rash with pustules all over the body, erosions 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 by 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 you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Apenal

Store in 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. Contents of the pack 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 pack contains

The medicine is in the form of white or almost white, cylindrical suppositories packaged in blisters and a cardboard box.
The pack 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: