Package leaflet: Information for the user

Apenal, 50 mg, suppositories
Apenal, 80 mg, suppositories
Paracetamolum

Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if symptoms worsen after 3 days, consult a doctor.

Table of contents of the leaflet

What Apenal is and what it is used for
Important information before using Apenal
How to use Apenal
Possible side effects
How to store Apenal
Contents of the package and other information

1. What Apenal is and what it is 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. teething pain, post-vaccination symptoms, as well as symptomatic treatment of influenza-like conditions and colds.

2. Important information before using Apenal

When not to use Apenal:

if the patient has hypersensitivity (allergy) to paracetamol or hypersensitivity (allergy) to any of the excipients of this medicinal product (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), and in patients concurrently treated with other medicinal products affecting liver function;
who are chronically undernourished or dehydrated;
with glucose-6-phosphate dehydrogenase deficiency;
with haemolytic anaemia.

Apenal and other medicines
You should tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including those obtained without a prescription.
In particular, inform about the use of the following medicines:

carbamazepine, phenobarbital, phenytoin (medicines used in epilepsy);
omeprazole (a medicine used in peptic ulcer disease);
rifampicin (an antibiotic);
zidovudine (an antiviral medicine);
medicines containing St. John's wort (Hypericum perforatum);
medicines containing ethanol (e.g. some traditional herbal remedies);
probenecid (a medicine used in gout);
warfarin (an anticoagulant medicine).

Note: Do not use other medicines containing paracetamol simultaneously.
Pregnancy and breastfeeding
Not applicable. The medicine is intended for children.
Driving and operating machinery
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 as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Apenal suppositories in strengths of 50 mg and 80 mg are intended for rectal administration.

Recommended dose
The dose should be based on the child's body weight. The approximate age of the child is provided as a general guide.
The recommended single dose is 10 to 15 mg of paracetamol per kg of the child's body weight. The maximum daily dose is 60 mg of paracetamol per kg of body weight, taking into account all medicinal products containing paracetamol being used.

Apenal 50 mg suppositories:
Infants weighing 3.3 kg to 5 kg (under 3 months of age) – 1 suppository 3 to 4 times daily.
Infants weighing 6.7 kg to 10 kg (from 3 months to 1 year of age) – 2 suppositories 3 to 4 times daily.
Do not administer more frequently than every 4 hours.
In infants under 3 months of age, use only on medical advice.

Apenal 80 mg suppositories:
Infants and children weighing 5.3 kg to 8 kg (approximately 3 to 9 months of age) – 1 suppository 3 to 4 times daily.
Do not administer more frequently than every 4 hours.

If symptoms worsen or do not improve after 3 days, consult a doctor.
If in doubt about the use of this medicine, seek advice from a doctor or pharmacist.
This medicine is also available in other strengths: 250 mg and 500 mg.

Use of more than the recommended dose of Apenal
If more than the recommended dose is used, consult a doctor immediately.
Overdose may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may resolve the next day, even though liver damage may already be developing, which may manifest as abdominal discomfort, recurrence of nausea, and jaundice.

Missed dose of Apenal
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, Apenal may cause adverse reactions, although not everyone will experience them.
You should stop using Apenal and contact your doctor immediately if any of the following adverse reactions occur:

allergic reactions manifesting as itching, hives, rash, redness, swelling of the face and throat causing difficulty in breathing (rare - occurring in 1 to 10 out of 10,000 people)
severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis) manifesting as blistering rash all over the body, erosions in the mouth, eyes, genital organs and on the skin, red spots on the trunk, often with blisters in the center, rupturing large blisters, peeling off large sheets of epidermis, weakness, fever and joint pain (very rare cases)
too few blood platelets, manifesting as increased tendency to bruising, petechiae, bleeding gums, etc. (very rare - less than 1 in 10,000 people).

Other adverse reactions occurring very rarely (in less than 1 out of 10,000 people):

impaired liver function;
impaired kidney function.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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]
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Apenal

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

6. Contents of the package and other information

What Apenal contains
The active substance is paracetamol.
The excipient is hard fat (Witepsol S58).

What Apenal looks like and contents of the pack
The medicine is in the form of white or almost white, cylindrical suppositories, packed in blisters within a cardboard box.
The pack contains 5, 10, 15 or 20 suppositories.

Marketing authorisation holder and manufacturer
Lek-Am Sp. z o.o. Pharmaceutical Company
Ostrzykowizna 14A
05-170 Zakroczym