Apenal

Package Leaflet: Information for the Patient

Apenal, 250 mg, Suppositories

Apenal, 500 mg, Suppositories

Paracetamol

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

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as advised by 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 taking Apenal
• 3. How to take 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 for pain of various origins (headache, toothache, muscle, joint, and bone pain, painful menstruation, post-surgical or post-dental pain), for symptomatic treatment of colds and flu, to reduce fever in various infections, and after vaccinations.

2. Important information before taking Apenal

When not to take Apenal

Apenal should not be taken if the patient has:

• hypersensitivity (allergy) to paracetamol;
• hypersensitivity (allergy) to any other component of this medicine (listed in section 6);
• severe kidney or liver failure;
• alcoholic liver disease.

Warnings and precautions

The medicine should be used with caution in patients

• with moderate kidney impairment
• with mild to moderate liver failure (including Gilbert's syndrome), in patients also treated with other medicinal products that affect liver function
• who are chronically malnourished, dehydrated, and/or regularly consume alcohol
• with glucose-6-phosphate dehydrogenase deficiency
• with hemolytic anemia

Less than 5% of patients allergic to acetylsalicylic acid derivatives may be allergic to paracetamol.

Apenal and other medicines

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

• carbamazepine, phenobarbital, phenytoin (used in epilepsy);
• omeprazole (used in stomach ulcer disease);
• rifampicin (antibiotic);
• zidovudine (antiviral medicine);
• medicines containing St. John's Wort;
• medicines containing ethyl alcohol (e.g., some traditional herbal medicines);
• probenecid (used in gout);
• warfarin (anticoagulant).

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

Apenal and alcohol

Do not consume alcohol during treatment with this medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Apenal can be given to pregnant women if necessary. The lowest effective dose should be used for the shortest possible time. If pain is not relieved or fever does not subside, or if it becomes necessary to increase the frequency of administration, the patient should consult their doctor.
The medicine can be used during pregnancy and lactation if necessary.

Driving and using machines

The medicine does not affect driving or operating machinery.

3. How to take Apenal

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Apenal suppositories of 250 mg and 500 mg are intended for rectal administration.
Recommended dose:
Apenal, 250 mg, suppositories:
The medicine should be taken based on the child's body weight, with the approximate age of the child 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, considering all medicines containing paracetamol.
Children from 16.7 kg to 25 kg (approximately 3 to 7 years old) – 1 suppository 3 to 4 times a day.
Do not take more often than every 4 hours.
Apenal, 500 mg, suppositories:
Adults and children over 50 kg:
1 to 2 suppositories every 4 to 6 hours.
Do not exceed the maximum daily dose of 4 grams per day, considering all medicines containing paracetamol.
Use in children and adolescents:
The medicine should be taken based on the child's body weight, with the approximate age of the child 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, considering all medicines containing paracetamol.
From 33.3 kg to 50 kg (approximately 10 to 13 years old) – 1 suppository 3 to 4 times a day.
Do not take more often than every 4 hours.
If symptoms worsen or do not improve after 3 days, the patient should consult their doctor.
The medicine is also available in other strengths: 50 mg and 80 mg.
In case of doubt about taking the medicine, the patient should consult their doctor or pharmacist.

Taking a higher dose of Apenal than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their 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. These symptoms may subside 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

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

4. Possible side effects

Like all medicines, Apenal can cause side effects, although not everybody gets them.
The patient should stop taking Apenal and immediately consult their doctor if they experience the following side effects:

• allergic reactions manifested by 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 by a rash with blisters 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 platelets in the blood, 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they 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: ndl@urpl.gov.pl
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 in a temperature below 25°C.
Store in a place inaccessible and invisible to children.
Do not use after the expiration 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 contents of the pack

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 last revision of the leaflet:

2019-07-01