Apap dla dzieci Forte

Leaflet attached to the packaging: patient information

APAP for children FORTE, 40 mg/ml, oral suspension

Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

The medicine for children should always be used in accordance with the description in the patient leaflet or according to the doctor's or pharmacist's recommendations.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 2 days of taking the medicine there is no improvement or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet:

• 1. What APAP for children is and what it is used for
• 2. Important information before taking APAP for children
• 3. How to take APAP for children
• 4. Possible side effects
• 5. How to store APAP for children
• 6. Contents of the packaging and other information

1. What APAP for children is and what it is used for

APAP for children contains paracetamol. Paracetamol is a medicine with analgesic and antipyretic properties used to treat mild to moderate pain and/or fever.
APAP for children is a medicine used for short-term, symptomatic treatment of fever (high temperature) or mild to moderate pain (e.g. headache, sore throat, pain and/or fever in the course of flu or cold, ear pain, toothache, painful teething, menstrual cramps, muscle and bone pain, pain and/or fever associated with post-vaccination reaction, fever in the course of chickenpox or viral diarrhea, pain after tonsillectomy).
APAP for children FORTE is a medicine used to treat mild to moderate pain and/or fever in children with a body weight of up to 40 kg (approximately from 0 months to 12 years), adolescents, and adults (including the elderly).

In children under 3 months of age, the medicine should only be used after consulting a doctor.

If after 2 days of taking the medicine there is no improvement or the patient feels worse, the doctor should be contacted.

2. Important information before taking APAP for children

When not to take APAP for children

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

Warnings and precautions

A doctor or pharmacist should be consulted before taking APAP for children:

• if the patient has liver disease (including Gilbert's syndrome or hepatitis);
• if the patient has kidney function disorders;
• if the patient has hemolytic anemia (abnormal breakdown of red blood cells);
• if the patient is dehydrated or chronically malnourished;
• if the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase;
• if the patient is taking other medicines that affect liver function;
• if the patient is taking other medicines that contain paracetamol, as this may cause severe liver damage;
• if the patient has asthma and is allergic to acetylsalicylic acid.

While taking APAP for children, the doctor should be informed immediately if:

the patient has severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have reported developing a severe condition called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
Taking painkillers, often for a long time, can cause headaches or worsen them. In this case, the dose of the painkiller should not be increased, but the doctor should be consulted for advice.
Warning:Taking higher doses than recommended does not lead to stronger analgesic action, but is associated with the risk of severe liver damage.
Therefore, the maximum daily dose of paracetamol should not be exceeded. The doctor or pharmacist should be consulted before taking other medicines that also contain paracetamol. The symptoms of liver damage usually occur after several days. Therefore, it is essential to consult a doctor promptly after taking a higher dose than recommended. See also section 3 "Taking a higher dose of APAP for children than recommended".
In case of high fever (>39°C), signs of secondary infection, or prolonged symptoms lasting more than 2 days, the patient should contact a doctor.

Children and adolescents

See sections 1 and 3.

APAP for children and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken. This is especially important in the case of:

• other medicines that contain paracetamol, such as those used to treat flu;
• warfarin or acenocoumarol (oral anticoagulants used to "thin" the blood);
• glycopyrronium and propantheline (anticholinergic medicines that may reduce the absorption of paracetamol);
• 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 uric acid levels in the blood);
• propranolol (a medicine used to treat high blood pressure);
• cholestyramine (a medicine used to lower cholesterol levels);
• zidovudine (a medicine used to treat AIDS);
• flucloxacillin (an antibiotic), due to the high risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Paracetamol may affect the results of some laboratory tests, such as uric acid and glucose levels in the blood.
APAP for children with food, drink, and alcohol
APAP for children is a ready-to-use medicine and can be taken with food and drink (except for alcoholic beverages). If the patient usually consumes a large amount of
alcoholic beverages, they should take APAP for children with special caution, and during treatment with APAP for children, they should not drink alcoholic beverages.Taking the medicine with food has not been shown to affect its efficacy, but taking the medicine after food may delay its action.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist.
APAP for children can be used during pregnancy if it is clinically justified.
The lowest possible recommended dose should be taken to reduce pain and/or fever, for the shortest possible time and as infrequently as possible. The doctor should be consulted if the pain and/or fever do not decrease or if the patient needs to take the medicine more frequently.
During pregnancy, paracetamol should not be taken in combination with other medicines.
APAP for children can be taken in recommended doses during breastfeeding.

Driving and using machines

APAP for children usually does not affect the ability to drive or use machines. However, if the patient experiences mild drowsiness and dizziness as side effects, they should not drive or operate machines.

APAP 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 some sugars, they should consult a doctor before taking the medicine. A dose of more than 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 (possible late reactions).
This medicine contains 1.9 mg of alcohol (ethanol) per 1 ml, which is equivalent to 161.5 mg/85 ml or 256 mg/135 ml (0.19% v/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 have noticeable effects.
The medicine contains less than 1 mmol (23 mg) of sodium per 25 ml (the maximum single dose), which means the medicine is considered "sodium-free".

3. How to take APAP for children

This medicine should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's recommendations. In case of doubt, the doctor or pharmacist should be consulted.
Dosage should be determined primarily 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 per day, i.e. 15 mg/kg body weight every 6 hours or

10 mg/kg body weight every 4 hours.

Instructions for sample dosing of 15 mg/kg body weight every 6 hours:

Volume of
single dose of
APAP for children
FORTE (every 6
hours)
Daily dose
Body weight
(approximate age in
months or years)
Single dose of
paracetamol (every
6 hours)
Volume of APAP
for children FORTE
mg of
paracetamol
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
months)
120-150 mg
3-3.75 ml
480-600 mg
12-15 ml
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
(more than 41 to 50 kg body weight)
61.5-75 ml
more than 41 kg
615-1000 mg
15.375-25 ml
4000 mg
(more than 51 kg body weight)
100 ml
6 ml (full oral syringe) of oral suspension = 240 mg of paracetamol

With the above dosing schedule, the interval between consecutive doses must be at least 6 hours.

Instructions for sample dosing of 10 mg/kg body weight every 4 hours:

Volume of
single dose of
APAP for children
FORTE (every 4
hours)
Daily dose
Body weight
(approximate age in
months or years)
Single dose of
paracetamol (every
4 hours)
Volume of APAP
for children FORTE
mg of
paracetamol
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
months)
80-100 mg
2-2.5 ml
480-600 mg
12-15 ml
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
(more than 41 to 50 kg body weight)
61.5-75 ml
more than 41 kg
410-1000 mg
10.25-25 ml
4000 mg
(more than 51 kg body weight)
100 ml
6 ml (full oral syringe) of oral suspension = 240 mg of paracetamol

With the above dosing schedule, the interval between consecutive doses must be at least 4 hours.

In children under 3 months of age, the medicine should only be used after consulting a doctor.

The exact amount of APAP for children should be administered using a 6 ml oral syringe (with 0.25 ml gradations) provided with the packaging. The oral syringe should be rinsed several times after use until it is empty (by filling it with water).

In case of high fever (>39°C), signs of secondary infection, or prolonged symptoms lasting more than 2 days, the doctor should be contacted.

Patients with liver or kidney function disorders
In patients with mild to moderate liver failure or patients with Gilbert's syndrome (familial 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 kidney function disorders, the dose must be reduced or the intervals between consecutive doses prolonged. In patients with severe kidney function disorders, the intervals between consecutive doses of APAP for children must be at least 8 hours.
The doctor or pharmacist should be consulted for advice.
In infants with a body weight of less than 7 kg (6 months of age), the administration of suppositories should be considered if they are available and the administration of this pharmaceutical form is not impossible for clinical reasons (e.g. diarrhea).
In children with a body weight of more than 41 kg, adolescents, and adults, other pharmaceutical forms of paracetamol may be considered more suitable.
Route and method of administration:

• APAP for children is intended for oral use;
• The bottle should be shaken well before use;
• The bottle cap is child-resistant. To open, press the cap and turn it in the opposite direction of the arrow;
• The oral suspension should not be diluted or mixed with other beverages;
• Do not exceedthe recommended dose. It should be remembered that higher doses than recommended may cause a risk of very severe liver damage.

Taking a higher dose of APAP for children than recommended

A doctor should be consulted immediately in case of overdose, even if the patient feels well, as there is a risk of delayed, severe liver damage. The bottle or empty packaging should be taken along to facilitate identification of the medicine. To avoid possible liver damage, it is essential that the doctor administers an antidote as soon as possible. The symptoms of liver damage usually do not appear until after several days. The symptoms of overdose may include nausea, vomiting, loss of appetite, pallor, and abdominal pain, and these symptoms usually occur within 24 hours of taking the medicine.

Missing a dose of APAP for children

A double dose should not be taken to make up for a missed dose, but the dose of APAP for children should be taken at the usual time.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, APAP for children can cause side effects, although not everybody gets them.

The doctor should be consulted immediately if the following side effects occur:

allergic reactions (hypersensitivity) to paracetamol, such as:Quincke's edema (swelling of the face, neck, and genital organs), dyspnea (shortness of breath), diaphoresis (excessive sweating), nausea, or hypotension.
Frequent (may occur in up to 1 in 10 patients):

• mild 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;
• excessive sweating;
• decreased body temperature (chills). Rare (may occur in up to 1 in 1000 patients):
• skin redness. Very rare (may occur in up to 1 in 10,000 patients):
• blood disorders (decreased platelet count, decreased white blood cell count, and sporadic cases of aplastic anemia);
• in predisposed patients, bronchospasm. Very rare, severe skin reactions have been reported. Frequency not known (cannot be estimated from the available data):
• a serious condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store APAP for children

Store in a temperature below 30°C.
Store in the original packaging to protect from light.
Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the bottle after "EXP". The expiry date refers to the last day of the month.
Shelf life after first opening - 6 months.
Do not use this medicine if signs of spoilage are observed.
Medicines should not be disposed of via wastewater or household waste.
The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What APAP for children contains

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

What APAP for children looks like and what the packaging contains

APAP for children is a white to almost white liquid with a uniform appearance and orange flavor.
A brown glass bottle (type III) with a white plastic cap (PP) that is child-resistant and has an instruction for opening with a ring (PP) and a connector (LDPE) for the oral syringe in a cardboard box.
The bottle contains 85 ml or 135 ml of oral suspension.
An oral syringe with a capacity of 6 ml made of LDPE/PS is attached to the packaging.

Marketing authorization holder and manufacturer

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

To obtain more detailed information about this medicine, please contact:

USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warszawa
tel. +48 (22) 543 60 00

Manufacturer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: APAP for children

Date of last revision of the leaflet: