Apenal

Package Leaflet: Information for the Patient

Apenal, 250 mg, Suppositories

Apenal, 500 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 as advised by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a 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 for pains of various origins (headache, toothache, muscle, joint and bone pain, painful menstruation, post-operative or post-dental surgery pain), for symptomatic treatment of colds and flu, to reduce fever in various infections and after vaccinations.

2. Important information before using Apenal

When not to use Apenal

Apenal should not be used if you have:

• 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

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to use, including those available without a prescription. In particular, inform about taking the following medicines:

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

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

Apenal and alcohol

Do not consume alcohol during treatment with this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Apenal can be given to pregnant women if necessary. Use the lowest effective dose 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, consult a 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 use Apenal

This medicine should always be used exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If you are unsure, consult your 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 used 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 kg of body weight is recommended. The maximum dose is 60 mg of paracetamol per kg of body weight per day, taking into account all medicines containing paracetamol.
Children from 16.7 kg to 25 kg (from about 3 to 7 years old) – 1 suppository 3 to 4 times a day.
Do not use more frequently 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 g per day, taking into account all medicines containing paracetamol.
Use in children and adolescents:
The medicine should be used 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 kg of body weight is recommended. The maximum dose is 60 mg of paracetamol per kg of body weight per day, taking into account all medicines containing paracetamol.
From 33.3 kg to 50 kg (from about 10 to 13 years old) – 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, consult a doctor.
The medicine is also available in other strengths: 50 mg and 80 mg.
In case of doubt about the use of the medicine, consult a doctor or pharmacist.

Using a higher dose of Apenal than recommended

If you use a higher dose of the medicine than recommended, consult a doctor immediately.
Overdose may cause symptoms such as nausea, vomiting, excessive sweating, and drowsiness, as well as general weakness within a few or several hours. They 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

Do 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.
Stop using Apenal and consult a doctor immediately if you experience any of the following side effects:

• allergic reactions with symptoms such 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) with symptoms such as rash with blisters all over the body, erosions in the mouth, eyes, genitals, and skin, red spots on the torso, often with blisters in the center, peeling of large skin flakes, weakness, fever, and joint pain. (very rare cases)
• too few platelets, which may cause 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 any side effects not listed in this leaflet, 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 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 this medicine.

5. How to store Apenal

Store 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 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 last update of the leaflet:

2019-07-01