Acetaminophen junior

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Apap Junior, 250 mg, granules in sachet
Paracetamolum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if you feel worse, contact your doctor.

Table of contents:

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-relieving medicines),
which also act as antipyretics (fever-reducing medicines) and have weak anti-inflammatory
properties.
Apap Junior is used to reduce fever and relieve mild to moderate pain.

2. IMPORTANT INFORMATION BEFORE TAKING Apap Junior

When not to take Apap Junior

• if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of Apap Junior,
• if you have severe liver impairment.

Warnings and precautions

Before taking Apap Junior, consult your doctor or pharmacist:

• if you have severe kidney or liver dysfunction,

• the risk of overdose is higher in patients with alcoholic liver disease without signs of cirrhosis. Do not exceed the recommended dose:

• if you suffer from chronic alcoholism,

• glucose-6-phosphate dehydrogenase deficiency,

• haemolytic anaemia,

• Gilbert's syndrome (hereditary non-haemolytic jaundice).

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While taking Apap Junior, inform your doctor immediately if:

you have serious illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic).

In these situations, severe metabolic acidosis (a disturbance in blood and body fluid balance) has been reported in patients taking paracetamol regularly over a long period or taking paracetamol together with flucloxacillin.

Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.

Prolonged or frequent use is not recommended. Patients should be advised not to take other medicines containing paracetamol simultaneously. Taking multiple daily doses may cause severe liver damage. In such cases, loss of consciousness does not occur, but immediate medical attention is required.

Prolonged use of the medicine without medical supervision may be harmful. In children treated with paracetamol at a daily dose of 60 mg/kg, there is no justification for simultaneously administering another antipyretic, unless paracetamol alone is ineffective.

Caution is advised when administering paracetamol to patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) or mild to moderate hepatic impairment (see section 3).

The risk of overdose is higher in individuals with alcohol-related liver damage without cirrhosis. Caution is required in cases of chronic alcoholism.

In such cases, the daily dose should not exceed 2 g.

If high fever or signs of secondary infection occur, or if symptoms persist beyond 3 days, the treatment should be reassessed.

Caution is advised when administering paracetamol to dehydrated or chronically malnourished individuals. The total daily dose of paracetamol should not exceed 3 g in adults and children weighing at least 50 kg.

If symptoms worsen or do not resolve after 3 days, or if high fever develops, consult your doctor.

Do not use paracetamol unless prescribed by a doctor if you are alcohol-dependent or have liver damage. Do not take paracetamol together with alcohol. Paracetamol does not enhance the effects of alcohol.

If you are taking other painkillers containing paracetamol, do not take Apap Junior without consulting your doctor or pharmacist.

Never take more than the recommended dose. Higher doses do not provide stronger pain relief but may cause severe liver damage.

The first signs of liver damage may appear several days after overdose. Therefore, it is very important to contact a doctor immediately if Apap Junior has been taken in a dose higher than recommended in this leaflet.

Headaches may occur after prolonged, high-dose, inappropriate use of painkillers, which may not resolve with higher doses of the medicine.

Generally, habitual use of painkillers, especially combinations of several analgesic substances, may lead to permanent kidney damage with risk of kidney failure (analgesic nephropathy).

Sudden discontinuation of the medicine after prolonged, high-dose, inappropriate use of painkillers may cause headaches, weakness, muscle pain, restlessness, and autonomic symptoms.

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These withdrawal symptoms resolve within a few days. During this time, further use of painkillers should be avoided and should not be restarted without consulting a doctor.

Do not take Apap Junior for long periods or in high doses without consulting a doctor or dentist.

Children

This 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 Apap Junior:

• probenecid (used in the treatment of gout);
• medicines that may damage the liver, e.g. phenobarbital (sleeping tablets), phenytoin, carbamazepine, primidone (antiepileptic medicines), and rifampicin (used in the treatment of tuberculosis). Concurrent use of these medicines with paracetamol may cause liver damage;
• metoclopramide and domperidone (used to treat nausea) may accelerate the absorption and onset of action of paracetamol;
• medicines that slow gastric emptying may delay the absorption and onset of action of paracetamol;
• cholestyramine (used to reduce elevated serum 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;
• anticoagulant medicines (oral anticoagulants, especially warfarin). Repeated use of paracetamol for more than one week increases the tendency to bleeding. Therefore, prolonged use of paracetamol should only be under medical supervision. Occasional use of paracetamol has no significant effect on bleeding tendency.

Concurrent administration of paracetamol and AZT (zidovudine, a medicine used in HIV infections) increases the tendency to reduced white blood cell count (neutropenia), which impairs the immune system and increases the risk of infections. Therefore, Apap Junior may be taken together with zidovudine only on a doctor's advice.

Inform 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 require urgent treatment (see section 2).

Effect of paracetamol on laboratory test results

Paracetamol may affect the measurement of serum uric acid and blood glucose levels.

Apap Junior with food, drink or alcohol

Do not consume 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, you should consult your doctor before using this medicine.

After oral administration, paracetamol passes into breast milk in small amounts.

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Driving and operating machinery

The use of Apap Junior does not affect the ability to drive or operate machinery.

Apap Junior contains 600 mg/sachet of sorbitol.

Sorbitol is a source of fructose. If you (or your child) have previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, you should consult your doctor before taking the medicine or giving it to your child.

Apap Junior contains sucrose, glucose (component of maltodextrin) and sodium.

If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking the medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. HOW TO USE THE MEDICINE Apap Junior

Apap Junior should always be taken exactly as directed in this leaflet.
If in doubt, consult a doctor or pharmacist.
The dose is determined according to the information provided in the table below. The dose of Apap Junior
depends on age and body weight; usually, a single dose is 10–15 mg of paracetamol per kilogram
of body weight, up to a maximum daily dose of 60–75 mg/kg body weight.
The appropriate interval between doses depends on symptoms and the maximum total daily dose.
At least a 6-hour interval should be maintained between two doses, meaning the medicine should be
administered no more than 4 times per 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 paracetamol 1000 mg paracetamol
(4–8 years) (1 sachet) (4 sachets)
26 kg–40 kg 500 mg paracetamol 1500 mg paracetamol
(8–12 years) (2 sachets) (6 sachets)

Method/route of administration
Apap Junior is administered orally only.
Do not take Apap Junior after a meal.
The granulate should be placed directly into the mouth onto the tongue and then swallowed without
water.
Adults and adolescents should consult a doctor or pharmacist to determine the dosing regimen before using the medicine.

Special patient groups

Hepatic or renal impairment
In patients with impaired liver or kidney function, the dose should be reduced or the dosing interval extended. Consult a doctor or pharmacist.

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Chronic alcoholism
Chronic alcohol consumption may lower the toxic threshold of paracetamol. In such patients, the minimum interval between two doses should be at least 8 hours.
Do not exceed 2 g of paracetamol per day.

Elderly patients
No dose adjustment is required.

Use of a higher than recommended dose of Apap Junior
In case of overdose of Apap Junior, contact a doctor or emergency department immediately. Overdose has very serious consequences and may 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 regarding the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Apap Junior may cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:

Adverse reactions occurring rarely (in 1 to 10 out of 10,000 patients taking the medicine):

• anaemia (both reduced number of red blood cells and low haemoglobin levels), non-haemolytic anaemia and bone marrow disorders with impaired blood cell production (called bone marrow depression), thrombocytopenia (reduced number of platelets),
• oedema,
• endocrine disorders of the pancreas, acute and chronic pancreatitis, bleeding, abdominal pain, diarrhoea, nausea, vomiting, liver failure (liver damage, liver necrosis), jaundice,
• pruritus (itching), rash, sweating, purpura, angioedema (subcutaneous swelling affecting the face and limbs, potentially obstructing airways), urticaria (itchy rash),
• kidney disorders.

Adverse reactions occurring very rarely (less frequently than in 1 out of 10,000 patients taking the medicine):

• severe skin reactions.

Frequency of occurrence: "frequency not known" (cannot be estimated from available data):

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

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Paracetamol is a widely used medicine, and reports of adverse reactions are rare and usually associated with overdose.
Nephrotoxic effects are rare; no association with therapeutic doses has been reported, except in cases of long-term treatment.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. HOW TO STORE Apap Junior

Keep the medicine out of sight and reach of children.
Do not use the medicine after the expiry date stated on the cardboard package
and sachet {marked as EXP}. The expiry date refers to the last day of the specified month.
Do not store above 30°C. Keep in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Apap Junior contains
Each sachet contains:
Active substance: paracetamol 250 mg;
Other ingredients: sorbitol (E 420), talc, basic 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 flavour (containing
maltodextrin, gum arabic, natural and nature-identical flavours, propylene glycol, triacetin,
3-hydroxy-2-methyl-4H-pyran-4-one), vanilla flavour (containing maltodextrin, natural and
nature-identical flavours, propylene glycol, sucrose).

What Apap Junior looks like and contents of the pack
Sachets made of PETP/Aluminium/LDPE foil containing white or almost white granules.
Apap Junior is available in the following pack sizes containing:
10, 24 sachets in a cardboard box.
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Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław, Poland

Manufacturer
Losan Pharma GmbH,
Otto-Hahn-Str. 13,
79395 Neuenburg,
Germany

For further information, please contact:
USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warszawa, Poland, tel. +48 (22) 543 60 00.

This medicinal product is authorised in the EEA countries under the following names:
Poland: Apap Junior
Lithuania: Apap 250 mg granulės, vaikams
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