Apap dla dzieci Forte smak malinovi

Leaflet attached to the packaging: patient information

APAP for children FORTE raspberry flavor, 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 with a raspberry flavor should always be used in accordance with the description in the patient leaflet or as directed 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 after 2 days of taking the medicine there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What APAP for children raspberry flavor is and what it is used for
• 2. Important information before taking APAP for children raspberry flavor
• 3. How to take APAP for children raspberry flavor
• 4. Possible side effects
• 5. How to store APAP for children raspberry flavor
• 6. Package contents and other information

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

APAP for children raspberry flavor contains paracetamol. Paracetamol is a medicine with analgesic and antipyretic properties used to treat mild to moderate pain and/or fever.

• (i) pain of mild to moderate intensity (e.g., headache, sore throat, pain or fever in the course of flu or cold, ear pain, toothache, painful teething, menstrual cramps, muscle and bone pain, pain or fever associated with post-vaccination reaction, fever in the course of chickenpox or viral diarrhea, pain after tonsillectomy).

APAP for children raspberry flavor is a medicine intended for the treatment of mild to moderate pain and/or fever in children with a body weight 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, they should contact their doctor.

2. Important information before taking APAP for children raspberry flavor

When not to take APAP for children raspberry flavor

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

Warnings and precautions

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

• 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 malnourished for a long time;
• 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 raspberry flavor, a 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 if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have developed a severe disease called metabolic acidosis (a blood and body fluid disorder) when taking paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. 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 a doctor should be consulted for advice.

Warning: Taking higher doses than recommended does not lead to stronger analgesic effects but is associated with the risk of severe liver damage. Therefore, the maximum daily dose of paracetamol should not be exceeded. A doctor or pharmacist should be consulted before taking other medicines that also contain paracetamol. 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 raspberry flavor than recommended".

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

Children and adolescents

See sections 1 and 3.

APAP for children raspberry flavor 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. APAP for children FORTE raspberry flavor may interact with other medicines, and other medicines may affect its action. 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 medicines 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 uric acid levels in the blood);
• propranolol (a medicine used to treat high blood pressure);
• cholestyramine (a medicine used to reduce cholesterol levels);
• zidovudine (a medicine used to treat AIDS).

The doctor or pharmacist should be informed if the patient is taking:

• flucloxacillin (an antibiotic) due to the serious 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 raspberry flavor with food, drink, and alcohol

APAP for children raspberry flavor 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 the medicine with caution and not drink alcoholic beverages during treatment.Food intake has not been shown to affect the efficacy of the medicine, but taking the medicine after a meal may delay its action.

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.

The medicine can be used during pregnancy if it is clinically justified. The patient should take the smallest recommended dose that reduces pain and/or fever, for the shortest possible time and as infrequently as possible. The patient should consult their doctor if pain and/or fever do not decrease or if they need to take the medicine more frequently.

During pregnancy, paracetamol should not be taken in combination with other medicines.

APAP for children raspberry flavor can be taken in recommended doses during breastfeeding.

Driving and using machines

APAP for children raspberry flavor 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 raspberry flavor contains

This medicine contains sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. A dose greater 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 0.195 mg of ethanol in each 1 ml, which is equivalent to 4.875 mg/25 ml (the maximum single dose). The amount of ethanol in 25 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of ethanol 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".

The medicine contains 6.4 mg of propylene glycol in each 1 ml, which corresponds to 160 mg per 25 ml (the maximum single dose). Before administering the medicine to a child under 4 weeks of age, a doctor or pharmacist should be consulted, especially if the child is taking other medicines that contain propylene glycol or alcohol.

3. How to take APAP for children raspberry flavor

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

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

The 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.

Example dosing instruction for 15 mg/kg body weight every 6 hours:
Body weight (approximate age in months or years)
Single dose of paracetamol (every 6 hours)
Volume of single dose of APAP for children raspberry flavor (every 6 hours)
Daily dose of paracetamol
Volume of APAP for children raspberry flavor
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

5 ml of oral suspension (a full 5 ml oral syringe) = 200 mg of paracetamol
6 ml of oral suspension (a full 6 ml oral syringe) = 240 mg of paracetamol
The interval between consecutive doses must be at least 6 hours.

Example dosing instruction for 10 mg/kg body weight every 4 hours:

Body weight (approximate age in months or years)
Single dose of paracetamol (every 4 hours)
Volume of single dose of APAP for children FORTE raspberry flavor (every 4 hours)
Daily dose of paracetamol
Volume of APAP for children FORTE raspberry flavor
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
more than 41 kg
410-1000 mg
10.25-25 ml
2460-3000 mg (more than 41 to 50 kg body weight)
61.5-75 ml
4000 mg (more than 51 kg body weight)
100 ml
5 ml of oral suspension (a full 5 ml oral syringe) = 200 mg of paracetamol
6 ml of oral suspension (a full 6 ml oral syringe) = 240 mg of paracetamol
The interval between consecutive doses must be at least 4 hours.

In infants with a body weight 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 greater than 41 kg (over 12 years of age), adolescents, and adults, the administration of other paracetamol pharmaceutical forms may be considered more appropriate.

Route and method of administration:

• The medicine is intended for oral use;
• Shake 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. Remember that higher doses than recommended may cause a risk of severe liver damage.

The exact amount of medicine should be administered using a 5 ml oral syringe (with 0.25 ml gradations) or a 6 ml oral syringe (with 0.25 ml gradations) provided with the packaging.

The oral syringe should be rinsed several times with water after use.

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

Patients with liver or kidney function disorders

In patients with mild to moderate liver failure or those 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 raspberry flavor must be at least 8 hours.

A doctor or pharmacist should be consulted for advice.

Taking a higher dose of APAP for children raspberry flavor 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, irreversible 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. Symptoms of liver damage usually do not appear until after several days. The symptoms of overdose may include nausea, vomiting, loss of appetite (anorexia), pallor, and abdominal pain, and these symptoms usually occur within 24 hours of taking the medicine.

Missing a dose of APAP for children raspberry flavor

A double dose should not be taken to make up for a missed dose, but the dose should be taken at the usual time.

In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

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

The medicine should be stopped immediately, and a doctor consulted if the following 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 1,000 patients):

• skin redness.

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

• blood disorders (reduced platelet count, reduced white blood cell count, and rare cases of aplastic anemia);
• in predisposed patients, bronchospasm.

Very rare cases of 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 (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 this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych.

Al. Jerozolimskie 181C, 02-222 Warszawa

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.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store APAP for children raspberry flavor

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 deterioration are observed.

Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What APAP for children raspberry flavor contains

The active substance of the medicine is paracetamol. Each 1 ml contains 40 mg of paracetamol.

The other ingredients are: citric acid monohydrate, sodium citrate, sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum, purified water, raspberry flavor (23688A): flavoring substances, flavoring preparations, natural flavoring substances, propylene glycol (E-1520), ethanol; cream flavor (63.3626): flavoring substances, flavoring preparations, propylene glycol (E-1520), glycerol (E-422), ethanol.

What APAP for children raspberry flavor looks like and what the package contains

APAP for children raspberry flavor is a white to almost white liquid with a uniform appearance and a raspberry flavor. The pH is between 4-6.

The bottle is made of orange glass type III with a PPH/HDPE cap and a LDPE plug and a LDPE ring, which is child-resistant, and a 5 ml oral syringe made of LDPE/PS with 0.25 ml gradations, in a cardboard box.

The bottle is made of orange glass type III with a PP cap and a PP ring, which is child-resistant, with a LDPE connector for the oral syringe and a 6 ml oral syringe made of LDPE/PS with 0.25 ml gradations, in a cardboard box.

The bottle contains 85 ml of oral suspension.

Marketing authorization holder and manufacturer

Marketing authorization holder

US Pharmacia Sp. z o.o.

ul. Ziębicka 40

50-507 Wrocław

Manufacturer

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, lotes 8, 15 e 16

3450-232 Mortágua

Portugal