Package leaflet: Information for the patient

Apenal, 250 mg, suppositories
Apenal, 500 mg, suppositories
Paracetamolum

Please read the entire 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 as directed by a
physician 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 after 3 days, or if you feel worse, consult your doctor.

Table of contents

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 pack and other information

1. What Apenal is and what it is used for

Apenal suppositories have analgesic and antipyretic effects.
The medicine is used to relieve pain of various origins (headache, toothache, muscular, joint and bone pain, painful menstruation, postoperative or post-procedural pain), for symptomatic treatment of cold and flu, to reduce fever associated with various infections, and after vaccinations.

2. Important information before using Apenal

When not to use Apenal
Do not use Apenal if the patient has:

hypersensitivity (allergy) to paracetamol;
hypersensitivity (allergy) to any of the other ingredients of this medicine (listed in section 6);
severe renal and (or) hepatic impairment;
alcoholic liver disease.

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 medicinal products affecting liver function;
who are chronically undernourished, dehydrated and (or) regularly consume alcohol;
with glucose-6-phosphate dehydrogenase deficiency;
with haemolytic anaemia.

Less than 5% of patients allergic to acetylsalicylic acid derivatives may be allergic to paracetamol.
Apenal and other medicines
Tell your 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 available 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;
medicines containing ethanol (e.g. some traditional herbal remedies);
probenecid (a medicine used in gout);
warfarin (an anticoagulant).

Note: Do not take other medicines containing paracetamol simultaneously.
Apenal and alcohol
Do not consume alcohol during treatment with this medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Apenal may be administered to pregnant women if necessary. The lowest effective dose providing adequate pain relief or fever reduction should be used, and the medicine should be taken for the shortest possible duration. If pain is not relieved or fever does not subside, or if it becomes necessary to increase the frequency of dosing, medical advice should be sought.
During pregnancy and lactation, the medicine may be used only if clearly necessary.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

3. How to use Apenal

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Apenal suppositories in strengths of 250 mg and 500 mg are intended for rectal administration.

Recommended dose
Apenal 250 mg suppositories:
The dosage should be calculated according to the child's body weight; the approximate age of the child is provided only 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 medicines containing paracetamol.
Children weighing from 16.7 kg to 25 kg (approximately 3 to 7 years of age): 1 suppository 3 to 4 times daily.
Do not administer more frequently than every 4 hours.

Apenal 500 mg suppositories:
Adults and children weighing over 50 kg:
1 to 2 suppositories every 4 to 6 hours.
Do not exceed the maximum daily dose of 4 g per day, taking into account all medicines containing paracetamol.

Use in children and adolescents:
The dosage should be calculated according to the child's body weight; the approximate age of the child is provided only 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 medicines containing paracetamol.
Children weighing from 33.3 kg to 50 kg (approximately 10 to 13 years 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.
This medicine is also available in other strengths: 50 mg and 80 mg.
If in doubt about how to use the medicine, seek advice from a doctor or pharmacist.

Use of more than the recommended dose of Apenal
If more than the recommended dose is used, seek medical advice immediately.
Overdose may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may subside the following day, even though liver damage may have started to develop, which may present as abdominal fullness, return of nausea, and jaundice.

Missed dose of Apenal
Do not take 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 experiences them.
You should stop using Apenal and immediately contact your doctor if any of the following adverse reactions occur:

allergic reactions manifesting as itching, urticaria, rash, redness, swelling of the face and throat causing breathing difficulties (rare – occurring in 1 to 10 people per 10,000)
severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis) manifesting as blistering rash over the entire body, erosions in the mouth, eyes, genital organs and on the skin, red spots on the trunk, often with central blisters, ruptured large blisters, peeling of large sheets of epidermis, weakness, fever and joint pain (very rare cases)
low platelet count manifesting as tendency to develop bruises, petechiae, and bleeding gums, etc. (very rare – less than 1 person per 10,000).

Other adverse reactions occurring very rarely (in less than 1 person per 10,000):
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 Drug Reactions, 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 can 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 the 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 and 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
2019-07-01