Apap for children forte

Package leaflet: Information for the patient

APAP dla dzieci FORTE, 40 mg/ml, oral suspension
Paracetamolum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.
This medicine for children should always be used exactly as described in this leaflet or
as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 2 days of treatment, or if the patient feels worse, consult a doctor.

Table of contents:

1. What APAP dla dzieci FORTE is and what it is used for
2. Important information before using APAP dla dzieci FORTE
3. How to use APAP dla dzieci FORTE
4. Possible side effects
5. How to store APAP dla dzieci FORTE
6. Contents of the pack and other information

1. What APAP dla dzieci FORTE is and what it is used for

APAP dla dzieci FORTE contains paracetamol. Paracetamol is an analgesic and antipyretic agent used to treat mild to moderate pain and/or fever.
APAP dla dzieci FORTE is indicated for short-term, symptomatic treatment of fever (high temperature) and/or mild to moderate pain (e.g. headache, sore throat, pain and/or fever associated with influenza or common cold, pain due to otitis media, toothache, painful teething, menstrual pain, muscle and bone pain, pain and/or fever following vaccination, fever during chickenpox or viral gastroenteritis, pain after tonsillectomy).
APAP dla dzieci FORTE is used to treat mild to moderate pain and/or fever in children weighing up to 40 kg (approximately from 0 months to 12 years of age), adolescents, and adults (including elderly individuals).
In children under 3 months of age, this medicine should be used only on medical advice.
If there is no improvement after 2 days of treatment, or if the patient feels worse,
consult a doctor.

2. Important information before using the medicine for children

When not to use the medicine for children

• if the patient is allergic (hypersensitive) to paracetamol or any of the other ingredients of the medicine for children (listed in section 6).

Warnings and precautions
Consult a doctor or pharmacist before taking the medicine for children:

• if the patient has liver diseases (including Gilbert's syndrome or hepatitis);
• if the patient has kidney function disorders;
• if the patient has haemolytic anaemia (abnormal breakdown of red blood cells);
• if the patient is dehydrated or chronically undernourished;
• if the patient has glucose-6-phosphate dehydrogenase deficiency;
• if the patient is taking other medicines affecting liver function;
• if the patient is taking other medicines containing paracetamol, as this may cause severe liver damage;
• if the patient with bronchial asthma has an allergy to acetylsalicylic acid.

During treatment with the medicine for children, immediately inform the doctor if:
If the patient has serious illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (an abnormality in blood and body fluids), when they took paracetamol regularly over a long period or took paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.
Taking painkillers frequently, often for a long time, may cause headaches or worsen existing headaches. In such cases, do not increase the dose of the painkiller, but consult a doctor for advice.
Warning: Taking higher than recommended doses does not result in stronger pain relief, but is associated with the risk of severe liver damage. Therefore, the maximum daily dose of paracetamol must not be exceeded. Consult a doctor or pharmacist before using other medicines simultaneously, especially those also containing paracetamol. Symptoms of liver damage usually appear after several days. Therefore, it is important to seek medical advice immediately after taking a higher than recommended dose. See also section 3 "Taking more medicine for children than recommended".
In case of high fever (>39°C), signs of infection, or prolonged symptoms lasting longer than 2 days, the patient should contact a doctor.
Children and adolescents
See section 1 and 3.
Medicine for children and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken. This is especially important in the case of:

• other medicines containing paracetamol, such as those used to treat flu;
• warfarin or acenocoumarol (oral anticoagulants used to "thin" the blood);
• glycopyrronium and propantheline (anticholinergic drugs that may reduce paracetamol absorption);
• oral contraceptives;
• phenytoin, phenobarbital, primidone and lamotrigine (medicines used to treat epilepsy);
• chloramphenicol (an antibiotic);
• isoniazid and rifampicin (medicines used to treat tuberculosis);
• metoclopramide and domperidone (medicines that speed up gastric emptying);
• probenecid (a medicine used to treat high levels of uric acid in the blood (gout));
• propranolol (a medicine used to treat high blood pressure);
• cholestyramine (a medicine used to reduce cholesterol levels);
• zidovudine (a medicine used to treat AIDS);
• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Paracetamol may affect the results of certain laboratory tests, such as blood uric acid and glucose levels.
Medicine for children with food, drink and alcohol
The medicine for children is ready to use and may be taken with food and drink (except alcoholic beverages). If the patient usually consumes large amounts of alcoholic drinks, they should take the medicine for children with particular caution, and during treatment with the medicine for children, must not drink alcoholic beverages. Eating food has not been shown to affect the effectiveness of the medicine, but taking the medicine after a meal may delay its onset of action.
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.
The medicine for children may be used during pregnancy if clinically justified.
The lowest recommended dose that reduces pain and (or) fever should be taken for the shortest possible time and as infrequently as possible. Consult a doctor if pain and (or) fever do not subside or if the patient needs to take the medicine more frequently.
During pregnancy, paracetamol should not be taken in combination with other medicines.
The medicine for children may be taken during breastfeeding at the recommended doses.
Driving and using machines
Usually, the medicine for children does not affect the ability to drive or operate machinery. However, if the patient experiences slight drowsiness or dizziness as side effects, they should not drive or operate machinery.
The medicine for children contains sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216) and ethanol.
This medicine contains sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before using the medicine. A dose exceeding 10 ml of oral suspension contains more than 5 g of sucrose per dose, which should be considered in patients with diabetes. Sucrose may be harmful to teeth.
This medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (including delayed-type reactions).
This medicine contains 1.9 mg of alcohol (ethanol) in each 1 ml, equivalent to 161.5 mg/85 ml or 256 mg/135 ml (0.19% w/v). The amount of alcohol in 85 ml of this medicine is equivalent to less than 4 ml of beer or 2 ml of wine. The amount of alcohol in 135 ml of this medicine is equivalent to less than 6 ml of beer or 3 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
The medicine contains less than 1 mmol (23 mg) of sodium per 25 ml (maximum single dose), meaning the medicine is considered "sodium-free".

3. How to use the medicine for children

This medicine should always be taken exactly as described in the patient information leaflet or
as directed by the doctor or pharmacist. If in doubt, consult your doctor or
pharmacist.
The dosage should primarily be based on the patient's body weight.
The recommended daily dose of paracetamol is approximately 60 mg/kg body weight/day,
divided into 4 to 6 doses throughout the day, i.e. 15 mg/kg body weight every 6 hours or
10 mg/kg body weight every 4 hours.
Dosing instructions for an example regimen of 15 mg/kg body weight every 6 hours:
Volume of
Body weight Single dose Daily dose
single dose of
(approximate age in months or paracetamol mg
APAP for children APAP for
years) (every 6 hours) paracetamol
(every 6 hours) children FORTE
3 kg (0 months) 45 mg 1.125 ml 180 mg 4.5 ml
4 kg (1 month) 60 mg 1.5 ml 240 mg 6 ml
5 kg (2 months) 75 mg 1.875 ml 300 mg 7.5 ml
6 kg (3 months) 90 mg 2.25 ml 360 mg 9 ml
7 kg (4-5 months) 105 mg 2.625 ml 420 mg 10.5 ml
8-10 kg (6-12
120-150 mg 3-3.75 ml 480-600 mg 12-15 ml
months)
11-15 kg (2-3 years) 165-225 mg 4.125-5.625 ml 660-900 mg 16.5-22.5 ml
16-22 kg (4-6 years) 240-330 mg 6-8.25 ml 960-1320 mg 24-33 ml
23-30 kg (6-9 years) 345-450 mg 8.625-11.25 ml 1380-1800 mg 34.5-45 ml
31-40 kg (9-12 years) 465-600 mg 11.625-15 ml 1860-2400 mg 46.5-60 ml
2460-3000 mg
(over 41 kg up to 50 kg)
over 41 kg 61.5-75 ml
4000 mg
(over 51 kg)
100 ml
6 ml (full oral syringe) of oral suspension = 240 mg paracetamol
With the above dosing regimen, the interval between doses must be at least 6 hours.
Dosing instructions for an example regimen of 10 mg/kg body weight every 4 hours:
Volume of
Body weight Single dose Daily dose
single dose of
(approximate age in months or paracetamol mg
APAP for children APAP for
years) (every 4 hours) paracetamol
(every 4 hours) children FORTE
3 kg (0 months) 30 mg 0.75 ml 180 mg 4.5 ml
4 kg (1 month) 40 mg 1.0 ml 240 mg 6 ml
5 kg (2 months) 50 mg 1.25 ml 300 mg 7.5 ml
6 kg (3 months) 60 mg 1.5 ml 360 mg 9 ml
7 kg (4-5 months) 70 mg 1.75 ml 420 mg 10.5 ml
8-10 kg (6-12
80-100 mg 2-2.5 ml 480-600 mg 12-15 ml
months)
11-15 kg (2-3 years) 110-150 mg 2.75-3.75 ml 660-900 mg 16.5-22.5 ml
16-22 kg (4-6 years) 160-220 mg 4-5.5 ml 960-1320 mg 24-33 ml
23-30 kg (6-9 years) 230-300 mg 5.75-7.5 ml 1380-1800 mg 34.5-45 ml
31-40 kg (9-12 years) 310-400 mg 7.75-10 ml 1860-2400 mg 46.5-60 ml
2460-3000 mg
(over 41 kg up to 50 kg)
over 41 kg 61.5-75 ml
4000 mg
(over 51 kg)
100 ml
6 ml (full oral syringe) of oral suspension = 240 mg paracetamol
With the above dosing regimen, the interval between doses must be at least 4 hours.
In children under 3 months of age, this medicine should only be used on medical advice.
The exact amount of medicine for children should be administered using the 6 ml oral
syringe (with 0.25 ml graduations) supplied in the package. After use, the oral syringe should
be rinsed several times up to its tip (by filling it with water).
In case of high fever (>39°C), signs of secondary infection, or symptoms lasting longer than
2 days, consult your doctor.
Patients with impaired liver or kidney function
In patients with mild to moderate liver impairment or Gilbert's syndrome (hereditary
non-hemolytic jaundice), the effective daily dose should not exceed 60 mg/kg body
weight/day (up to a maximum dose of 2 g/day).
In patients with impaired kidney function, the dose should be reduced or the intervals between
doses extended. In patients with severe kidney impairment, the intervals between doses of
medicine for children must be at least 8 hours.
Consult your doctor or pharmacist for advice.
In infants weighing less than 7 kg (6 months of age), suppositories should be considered if
available and if administration of this pharmaceutical form is not clinically contraindicated
(e.g. due to diarrhea).
In children weighing more than 41 kg, adolescents and adults, other pharmaceutical forms of
paracetamol may be considered more appropriate.
Route and method of administration:

• For children, intended for oral use;
• Shake well before use;
• The bottle cap is child-resistant. To open, press down on the cap while turning it counter-clockwise;
• The oral suspension should not be diluted or mixed with other drinks;
• Do not exceed the recommended dose. Remember that doses higher than recommended may cause a risk of severe liver damage.

Taking more than the recommended dose of medicine for children
Seek immediate medical advice in case of overdose, even if the patient feels well, as there is a
risk of delayed, severe liver damage. Bring the bottle or empty packaging to assist in
identifying the medicine. To avoid potential liver damage, it is important that an antidote is
administered by a doctor as quickly as possible. Symptoms of liver damage usually do not
appear until several days later. Symptoms of overdose may include nausea, vomiting, loss of
appetite (anorexia), pallor, and abdominal pain, and these symptoms typically occur within
24 hours after taking the medicine.
Missing a dose of medicine for children
Do not take a double dose to make up for a missed dose, but take the next dose at the usual
scheduled time.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, APAP dla dzieci FORTE may cause adverse reactions, although
they do not occur in everyone.
The medicine must be discontinued immediately and medical advice sought if
hypersensitivity reactions to paracetamol occur, such as: Quincke's edema (swelling
of the face, neck, and genital organs), dyspnea (shortness of breath), profuse sweating,
nausea, or drop in blood pressure.

Common (may occur in up to 1 in 10 patients):

• moderate drowsiness;
• nausea;
• vomiting.

Uncommon (may occur in up to 1 in 100 patients):

• dizziness;
• drowsiness;
• irritability;
• burning sensation in the throat;
• diarrhea;
• abdominal pain (including cramps and heartburn);
• constipation;
• headache;
• increased sweating;
• decreased body temperature (chills).

Rare (may occur in up to 1 in 1,000 patients):

• skin redness.

Very rare (may occur in up to 1 in 10,000 patients):

• blood disorders (reduced platelet count, reduced or sporadic cases of absent white blood cells, disturbances in blood cell formation in the bone marrow);
• bronchospasm in predisposed patients.

Serious skin reactions have been very rarely reported.

Frequency not known (cannot be estimated from available data):

• severe condition that may lead to blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorization Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine for children

Store below 30°C.
Store in the original packaging to protect from light.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle label after "EXP". The expiry date refers to the last day of the specified month.
Expiry after first opening - 6 months.
Do not use this medicine if signs of deterioration are observed.
Medicines must not be disposed of via the sewage system or household waste.
Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What the medicinal product contains for children

• The active substance is paracetamol. Each 1 ml contains 40 mg of paracetamol.
• The other ingredients are:
• citric acid monohydrate, sodium citrate dihydrate, sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), orange flavour [natural flavours, artificial flavours, ethanol, butylhydroxyanisole (E 320)], xanthan gum, purified water.

What the medicinal product for children looks like and contents of the pack
For children is a white to almost white, homogeneous liquid with an orange flavour.
The bottle is made of amber glass (type III) with a white plastic screw cap (PP) with child-resistant safety closure, accompanied by an opening instruction with a ring (PP) and connector (LDPE) for the oral syringe, packed in a cardboard box.
The bottle contains 85 ml or 135 ml of oral suspension.
An oral syringe made of LDPE/PS with a capacity of 6 ml is supplied with the pack.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław
Poland

For further information on this medicinal product, please contact:
USP Zdrowie Sp. z o.o.
Poleczki Street 35, 02-822 Warsaw
Phone +48 (22) 543 60 00

Manufacturer
Laboratórios Basi – Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, lots 8, 15 and 16
3450-232 Mortágua
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: for children