Apap Iunior

LEAFLET ATTACHED TO THE PACKAGING: INFORMATION FOR THE PATIENT

Apap Junior, 250 mg, granules in a sachet

Paracetamol

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 Apap Junior is and what it is used for
• 2. Important information before taking Apap Junior
• 3. How to take Apap Junior
• 4. Possible side effects
• 5. How to store Apap Junior
• 6. Contents of the pack and other information

1. WHAT IS Apap Junior AND WHAT IS IT USED FOR

Paracetamol belongs to the pharmacotherapeutic group of analgesics (pain relievers) that also act as antipyretics (fever reducers) and weak anti-inflammatory drugs. Apap Junior is used to reduce fever and relieve mild or moderate pain.

2. IMPORTANT INFORMATION BEFORE TAKING Apap Junior

When not to take Apap Junior

if the patient is allergic (hypersensitive) to paracetamol or any of the other ingredients of Apap Junior, or if the patient has severe liver failure.

Warnings and precautions

Before starting Apap Junior, consult a doctor or pharmacist: if the patient has severe kidney or liver dysfunction, or if the patient has a history of alcoholism, or if the patient is taking other medicines that may interact with paracetamol.

• the risk of overdose is higher in patients with alcoholic liver disease without cirrhosis. Do not exceed the recommended dose: if the patient has chronic alcoholism,
• glucose-6-phosphate dehydrogenase deficiency,
• hemolytic anemia,
• Gilbert's syndrome (inherited non-hemolytic jaundice).

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During treatment with Apap Junior, the doctor should be informed immediately if: the patient has severe diseases, including severe kidney or liver dysfunction, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, or if the patient has chronic alcoholism or is taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop 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. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting. Long-term or frequent use is not recommended. The patient should be informed not to take other painkillers containing paracetamol without consulting a doctor or pharmacist. Taking a multiple of the daily dose may cause severe liver damage. In such a case, there is no loss of consciousness, but immediate medical attention is necessary. Prolonged use of the medicine without medical supervision can be harmful. In children treated with paracetamol at a daily dose of 60 mg/kg, it is not justified to administer another antipyretic drug at the same time, unless the use of paracetamol alone is ineffective. Caution is recommended when administering paracetamol to patients with severe kidney impairment (creatinine clearance ≤ 30 ml/min) or liver impairment (mild to moderate) (see section 3).

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The risk of overdose is higher in individuals with post-alcoholic liver damage without cirrhosis. Caution should be exercised in cases of chronic alcoholism. In such cases, the daily dose should not exceed 2 g. In the event of high fever or symptoms of secondary infection, or if symptoms persist for more than 3 days, the treatment should be reassessed. Caution should be exercised when administering paracetamol to dehydrated or chronically malnourished individuals. The total dose of paracetamol should not exceed 3 g per day in adults and children weighing at least 50 kg. If symptoms worsen or do not improve after 3 days, or if high fever occurs, the patient should consult a doctor. Paracetamol should not be taken unless prescribed by a doctor if the patient is addicted to alcohol or has liver damage. Paracetamol should not be taken with alcohol. Paracetamol does not enhance the effects of alcohol. If the patient is taking other painkillers containing paracetamol, they should not take Apap Junior without consulting a doctor or pharmacist. Never take more than the recommended dose. Higher doses do not have a stronger analgesic effect, but may cause severe liver damage. The first symptoms of liver damage appear after several days. Therefore, it is very important to contact a doctor immediately if Apap Junior is taken in a dose higher than recommended in this leaflet. After prolonged, high-dose, improper use of painkillers, headaches may occur, which may not improve with higher doses of the medicine. Generally, habitual use of painkillers, especially combinations of several painkillers, can lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy). Sudden withdrawal of the medicine after prolonged, high-dose, improper use of painkillers may cause headaches, weakness, muscle pain, restlessness, and vegetative symptoms. These withdrawal symptoms subside after a few days. Until then, further use of painkillers should be avoided, and they should not be taken again without consulting a doctor. Apap Junior should not be taken for long periods or in high doses without consulting a doctor or dentist.

Children

The medicine is not indicated for children under 4 years of age.

Apap Junior and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.

Medicines that may interfere with the action of Apap Junior:

• probenecid (a medicine used to treat gout);
• medicines that may damage the liver, such as phenobarbital (sleeping pills), phenytoin, carbamazepine, primidone (antiepileptic drugs), and rifampicin (used to treat tuberculosis). Taking these medicines and paracetamol at the same time may cause liver damage;
• metoclopramide and domperidone (used to treat nausea) may accelerate the absorption and onset of action of paracetamol;
• medicines that slow down gastric emptying may delay the absorption and onset of action of paracetamol;
• cholestyramine (used to reduce elevated blood lipid levels) may reduce the absorption and onset of action of paracetamol. Therefore, cholestyramine should not be taken within the first hour after paracetamol administration;
• medicines that reduce blood clotting (oral anticoagulants, especially warfarin). Repeated use of paracetamol for more than a week increases the tendency to bleed. Therefore, long-term use of paracetamol should only be done under medical supervision. Occasional use of paracetamol does not have a significant effect on the tendency to bleed.

Concomitant administration of paracetamol and AZT (zidovudine, a medicine used to treat HIV infections) increases the risk of decreasing the number of white blood cells (neutropenia), which impairs the immune system and increases the risk of infections. Therefore, Apap Junior can be taken with zidovudine only on the advice of a doctor. Tell your doctor or pharmacist if you are 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).

Effect of paracetamol on laboratory test results

Paracetamol may affect the determination of uric acid and blood sugar levels.

Apap Junior with food, drink, or alcohol

Do not take alcohol during treatment with paracetamol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. After oral administration, paracetamol passes into breast milk in small amounts. Page3of7

Driving and using machines

Taking Apap Junior does not affect the ability to drive or operate machines.

Apap Junior contains 600 mg/sachet of sorbitol.

Sorbitol is a source of fructose. If the patient (or their child) has been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to their child. Apap Junior contains sucrose, glucose (a component of maltodextrin), and sodium.
If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

3. HOW TO TAKE Apap Junior

Apap Junior should always be taken exactly as directed in this leaflet. In case of doubt, consult a doctor or pharmacist. The dose is determined based on the information provided in the table below. The dose of Apap Junior depends on the age and weight of the patient, usually a single dose is 10-15 mg of paracetamol per kilogram of body weight, up to a total daily dose of 60-75 mg/kg of body weight. The appropriate interval between doses depends on the symptoms and the maximum total daily dose. An interval of at least 6 hours should be maintained between two doses, which means the medicine should be taken no more than 4 times a day. If symptoms persist for more than 3 days, consult a doctor.

Body weight (age) Single dose Maximum daily dose

17 kg-25 kg
250 mg of paracetamol
1000 mg of paracetamol
(4 sachets)
26 kg-40 kg
(4-8 years)
(1 sachet)
500 mg of paracetamol
1500 mg of paracetamol
(6 sachets)

Method/route of administration

Apap Junior is administered orally only. Do not take Apap Junior after a meal. The granules should be taken directly into the mouth onto the tongue and then swallowed without water. Adults and adolescents should determine the dosage with a doctor or pharmacist before taking the medicine.

Special patient groups

Liver or kidney dysfunction: in patients with liver or kidney dysfunction, the dose should be reduced or the interval between doses prolonged. Consult a doctor or pharmacist. Chronic alcoholism: chronic alcohol consumption may lower the toxicity threshold of paracetamol. In such patients, the minimum interval between two doses should be at least 8 hours. Do not take more than 2 g of paracetamol per day. Elderly patients: no dose adjustment is required. Page4of7

Overdose of Apap Junior

In case of overdose of Apap Junior, consult a doctor or emergency department. Overdose has very serious consequences and can even lead to death. Immediate treatment is necessary, even if the patient feels well, due to the risk of delayed severe liver damage. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage.

Missed dose of Apap Junior

Do not take a double dose to make up for a missed dose. If you have any further doubts about taking the medicine, consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Apap Junior can cause side effects, although not everybody gets them. The following side effects may occur:

Uncommon side effects (affecting 1 to 10 in 10,000 patients):

• anemia (both reduced red blood cell count and low hemoglobin level in red blood cells), non-hemolytic anemia, and bone marrow disorders with impaired blood cell production (called bone marrow depression), thrombocytopenia (reduced platelet count),
• edema,
• exocrine pancreatic disorders, acute and chronic pancreatitis, bleeding, abdominal pain, diarrhea, nausea, vomiting, liver failure (liver damage, liver necrosis), jaundice,
• itching (pruritus), rash, sweating, purpura, angioedema (subcutaneous edema involving the face, limbs, which can close the airways), urticaria (pruritic rash),
• kidney diseases.

Rare side effects (affecting less than 1 in 10,000 patients):

• severe skin reactions.

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).

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Paracetamol is a widely used medicine, and reports of side effects are rare and usually related to overdose. Nephrotoxic effects are rare and have not been reported to be related to therapeutic doses, except in cases of prolonged use of the medicine. 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 Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. HOW TO STORE Apap Junior

Keep out of sight and reach of children. Do not use the medicine after the expiry date stated on the carton and sachet (marked as EXP). The expiry date refers to the last day of the given month. Do not store above 30°C. Store in the original packaging to protect from light and moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Apap Junior contains

1 sachet contains: active substance: paracetamol 250 mg; excipients: sorbitol (E 420), talc, butyl methacrylate copolymer, light magnesium oxide, sodium carmellose, sucralose (E 955), magnesium stearate, hypromellose, stearic acid, sodium lauryl sulfate, titanium dioxide (E 171), simethicone, strawberry flavor (contains maltodextrin, gum arabic, natural and identical to natural flavors, propylene glycol, triacetin, 3-hydroxy-2-methyl-4H-pyran-4-one), vanilla flavor (contains maltodextrin, natural and identical to natural flavors, propylene glycol, sucrose).

What Apap Junior looks like and contents of the pack

Sachets made of PETP/Aluminum/LDPE film with white or almost white granules. Apap Junior is available in the following packs containing: 10, 24 sachets in a cardboard box. Page6of7

Marketing authorization holder and manufacturer

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

Manufacturer

Losan Pharma GmbH, Otto-Hahn-Str. 13, 79395 Neuenburg, Germany. For more detailed information, please contact: USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, tel. +48 (22) 543 60 00.

This medicinal product has been authorized in the EEA member states under the following names:

Poland: Apap Junior
Lithuania: Apap 250 mg granules, for children

Date of last revision of the leaflet: May 2025

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