Apenal

Leaflet attached to the packaging: information for the user

Apenal, 100 mg/ml, oral solution

Paracetamol

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

important information for the patient.
The medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse.

• The 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 this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or the patient feels worse, 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 packaging and other information

1. What is Apenal and what is it used for

The active substance of Apenal is paracetamol.
Apenal belongs to a group of pain-relieving and antipyretic medicines. The medicine is used to treat symptomatic fever lasting no longer than 3 days and pain of mild to moderate severity.
Apenal is intended for children with a body weight of up to 32 kg (approximately from 0 months to 10 years). In children under 3 months of age, the medicine should only be used on the advice of a doctor.
If the pain persists for more than 3 days or the fever lasts for more than 3 days, worsens, or other symptoms appear, treatment should be discontinued and a doctor consulted.

2. Important information before taking Apenal

When not to take Apenal

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
• severe renal or hepatic impairment.

Warnings and precautions

Before starting treatment with Apenal, the patient should discuss it with their doctor or pharmacist.
Care should be taken:

• to consult a doctor before giving this medicine to children under 3 years of age;
• not to exceed the recommended dose stated in section 3;
• if the patient has renal, cardiac, or pulmonary disorders, or anemia (reduced hemoglobin levels in the blood, associated or not with a reduced number of red blood cells), or the activity of the enzyme glucose-6-phosphate dehydrogenase in the blood is low, they should consult their doctor before taking the medicine;
• in case of liver disease (including Gilbert's syndrome), they should consult their doctor to reduce the dose and (or) increase the intervals between doses;
• in patients with a body weight below 50 kg due to anorexia, malnutrition, or dehydration, because of the possibility of increased hepatotoxicity;
• consuming alcoholic beverages while taking paracetamol may cause liver damage;
• if there is a high fever (>39°C), they should consult their doctor before taking Apenal;
• if the pain persists for more than 3 days or the fever lasts for more than 3 days, symptoms worsen, or other symptoms appear, treatment should be discontinued and a doctor consulted;
• care should be taken in patients with asthma who are sensitive to acetylsalicylic acid, as the medicine may cause asthma symptoms;
• the medicine contains propylene glycol (E 1520). Concurrent administration with other substrates of alcohol dehydrogenase, such as ethanol, may cause severe side effects in newborns.

Prolonged or frequent use of Apenal is not recommended. The patient's caregiver and/or the patient should be informed not to take other medicines containing paracetamol at the same time. Taking a multiple of the daily dose at once may cause severe liver damage. In such cases, there is no loss of consciousness, but immediate medical attention is necessary. Prolonged use without medical supervision may be harmful.

Apenal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
This is especially important when taking medicines containing any of the following active substances, as a dose change or discontinuation of one of the following medicines may be necessary:

• antibiotics (chloramphenicol);
• oral anticoagulants (acenocoumarol, warfarin);
• oral contraceptives and estrogens;
• antiepileptic drugs (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine);
• antituberculosis drugs (isoniazid, rifampicin);
• barbiturates (used as sedatives, tranquilizers, and anticonvulsants);
• activated charcoal, used to treat diarrhea and bloating;
• cholestyramine (used to reduce blood cholesterol levels);
• drugs used to treat gout (probenecid and sulfinpyrazone);
• drugs used to relieve spasms and cramps of the stomach, intestines, and bladder (anticholinergic drugs);
• metoclopramide and domperidone (used to prevent nausea and vomiting);
• propranolol used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmia);
• zidovudine (used to treat people infected with the human immunodeficiency virus that causes AIDS);
• flucloxacillin (an antibiotic), due to the risk of a serious blood and fluid disorder (metabolic acidosis with a large anion gap), which requires emergency treatment and may occur especially in patients with severe renal impairment, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and those taking maximum daily doses of paracetamol;

Other medicines containing paracetamol.

Effect on laboratory test results:
In the event of planned laboratory tests (such as blood tests, urine tests, skin allergy tests, etc.), the doctor should be informed about the use of this medicine, as it may affect the results of these tests.

Taking Apenal with food, drink, and alcohol

Apenal may be diluted with water, milk, or fruit juices. Taking paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day) may cause liver damage.

Pregnancy, breastfeeding, and fertility

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 to relieve pain or reduce fever, and the medicine should be taken for as short a time as possible. If the pain is not relieved or the fever does not subside, or if it becomes necessary to increase the frequency of taking the medicine, they should consult their doctor or midwife.
During pregnancy, paracetamol should not be taken at the same time as other medicines.
Paracetamol can be used in therapeutic doses during breastfeeding.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

Apenal contains sodium and propylene glycol (E 1520)

Apenal contains less than 1 mmol (23 mg) of sodium per 1 ml, which means the product is considered "sodium-free".
Apenal contains 7.64 mg of propylene glycol (E 1520) per 1 ml. Before administering the medicine to a child under 4 weeks of age, they should consult their doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take Apenal

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor, pharmacist, or nurse. In case of doubt, they should consult their doctor, pharmacist, or nurse.
Apenal is intended for use in children with a body weight of up to 32 kg (approximately from 0 months to 10 years). It is necessary to follow the dosing based on the child's body weight and determine the appropriate dose of the oral solution in milliliters.
The approximate age ranges given in relation to body weight are provided only as additional information for the patient.
In children under 3 years of age, paracetamol should only be used on the advice of a doctor.
The recommended daily dose of paracetamol is approximately 60 mg/kg body weight per day and is given in 4 to 6 doses per day, e.g., 15 mg/kg body weight every 6 hours or 10 mg/kg body weight every 4 hours.
In children under 3 yearsof age, it is recommended to administer Apenal using the pipette provided with the 30 ml packaging.
In children from 3 yearsof age, it is recommended to administer Apenal using the oral syringe provided with the 60 ml packaging.
Below is the instruction for administering the medicine in a dose of 15 mg/kg every 6 hours:

To directly determine the dose, multiply the child's body weight in kilograms by

0.15. The result is the number of milliliters of Apenal to be administered.
In children, this dose should be administered every 6 hours, also at night.
If the desired effect is not achieved within 3-4 hours, the medicine may be administered every 4 hours. In this case, a dose of 10 mg/kg body weight should be administered.
Below is the instruction for administering the medicine in a dose of 10 mg/kg every 4 hours:

To directly determine the dose, multiply the child's body weight in kilograms by

0.1. The result is the number of milliliters of Apenal to be administered.
In infants with a body weight below 7 kg (6 months of age), it is recommended to use suppositories (if available), except in cases where administration of this pharmaceutical form is impossible for clinical reasons (e.g., diarrhea).

Never exceed the maximum daily dose of 60 mg/kg. Remember that higher doses than recommended may cause a risk of very severe liver damage.

Patients with liver or kidney disease, see section 2, Warnings and precautions.
Administration of the medicine depends on the presence of pain and fever symptoms. If the symptoms subside, the medicine should be discontinued.
In case of recurring fever, high fever (>39°C), symptoms of secondary infection, or persistence of symptoms for more than 3 days, the doctor should re-evaluate the treatment.

Instructions for proper administration of the product

Apenal is administered orally.
The 30 ml bottle with a child-resistant pipette (2 ml):

• Hold the bottle firmly in one hand. With the other hand, grasp the cap with your thumb and index finger in the place marked with triangles on the cap, where "PRESS" is written.
• To open the bottle, press the triangle and unscrew the cap by turning it to the left (counterclockwise). Draw up the required amount of solution using the pipette. It can be administered directly or diluted with water.
• To close the bottle, turn the cap to the right (clockwise) until you hear a click. The bottle should be closed tightly after each use. If it is visibly contaminated, the pipette should be rinsed with water and dried before being put back on the bottle.

The 60 ml bottle with a child-resistant closure and a 5 ml oral syringe:

• Open the bottle according to the instructions on the cap (when opening for the first time, break the one-time seal).
• Insert the oral syringe by pressing the perforated hole.
• Turn the bottle upside down and draw up the required amount of solution.
• Administer directly or diluted with water, milk, or juice.
• The oral syringe should be washed with water after use. The bottle should be closed tightly after each use.

Taking a higher dose of Apenal than recommended

In case of taking (administering to a child) a higher dose of paracetamol than recommended, they should immediately consult their doctor or pharmacist and provide the name of the medicine and the amount taken.
It is helpful to take the packaging and leaflet with them and give them to the specialist.
In case of overdose, they should go to a health center as soon as possible, even if no symptoms have appeared, because even in severe poisoning, symptoms may not appear until up to 3 days after taking the medicine. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
Paracetamol overdose is considered when an adult has taken a total of more than 6 g, and a child more than 100 mg per kilogram of body weight. Treatment of overdose is more effective if started within 4 hours of taking the medicine.
Patients taking barbiturates and those with chronic alcoholism may be more sensitive to paracetamol overdose.
Generally, in case of paracetamol overdose, treatment is symptomatic.

Missing a dose of Apenal

A double dose should not be taken to make up for a missed dose.
If a dose is missed, the next dose should be taken as soon as possible, and then the medicine should be continued according to the normal schedule. However, if the time to take the next dose is very short, the missed dose should be skipped and the next dose taken as scheduled.

Stopping treatment with Apenal

In case of any further doubts about the use of the medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Apenal can cause side effects, although not everybody gets them.
Adverse reactions to paracetamol are rare (occurring in 1 to 10 per 10,000 patients) or very rare (occurring in less than 1 per 10,000 patients).
Rare side effects include general malaise, hypotension, and increased liver enzyme activity.
Very rarely, during the use of high doses of the medicine or during prolonged treatment, liver damage may occur. Very rarely, hypoglycemia, cloudy urine, adverse effects on the kidneys (kidney function disorders), skin rash, urticaria, anaphylactic shock, and changes in blood cell count, such as thrombocytopenia, agranulocytosis, neutropenia, leukopenia, and hemolytic anemia, may occur.
In very rare cases, serious skin reactions have been reported.

Stop taking the medicine and consult a doctor immediately if allergic reactions (hypersensitivity) to paracetamol occur.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181 C,
02-222 Warsaw,
phone (22) 49 21 301,
fax (22) 49 21 309;
Website: https://smz.ezdrowie.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

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP:. The expiry date refers to the last day of the month.
After opening the packaging, the contents should be used within 6 months.
Store in the original packaging to protect from light.
Do not store in the refrigerator.
After opening, store the medicine at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. They should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Apenal contains

• The active substance of Apenal is paracetamol. Each ml of the solution contains 100 mg of paracetamol.
• The other ingredients (excipients) are: glycerol, macrogol 600, sodium saccharin (E 954), strawberry flavor (propylene glycol (E 1520), flavoring substances), purified water.

What Apenal looks like and what the packaging contains

Apenal is a thick, viscous, clear oral solution, with a very light pink color and a strawberry flavor, packaged in plastic bottles of 30 or 60 ml capacity.

• 30 ml bottle:an orange-colored PET (polyethylene terephthalate) bottle with a PP (polypropylene) cap that is child-resistant, connected to a 2 ml LDPE (low-density polyethylene) pipette with a scale, in a cardboard box.
• 60 ml bottle:an orange-colored PET (polyethylene terephthalate) bottle with a PP/HDPE (polypropylene and high-density polyethylene) cap that is child-resistant, with an LDPE (low-density polyethylene) connector for an oral syringe and a seal (tresylene) or an HDPE cap that is child-resistant, with a guarantee ring and an LDPE connector for an oral syringe, with a 5 ml LDPE/PS (low-density polyethylene and polystyrene) oral syringe with a scale, in a cardboard box.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A, 05-170 Zakroczym
Phone: +48 22 635-80-41

Date of the last update of the leaflet: