Panadol for children

Package leaflet: information for the user

Panadol dla dzieci, 120 mg/5 ml, oral suspension
Paracetamolum
Please read all of this leaflet carefully because it contains important information for the patient.
This medicine should always be used exactly as described in this leaflet or as directed by the doctor, pharmacist, or nurse.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if the patient's condition worsens, consult a doctor.

Contents of the leaflet
What Panadol dla dzieci is and what it is used for
Important information before taking Panadol dla dzieci
How to take Panadol dla dzieci
Possible side effects
How to store Panadol dla dzieci
Contents of the pack and other information

1. What Panadol dla dzieci is and what it is used for

Panadol dla dzieci contains paracetamol as the active substance.
The medicine has antipyretic and analgesic effects.
Indications:
Fever and pain occurring, for example:

• during colds and influenza
• after vaccinations.

Pain of various origins, for example:

• teething pain
• toothache
• headache
• sore throat
• earache.

Without consulting a doctor, this medicine should not be used regularly for longer than 3 days. If symptoms persist, medical advice should be sought.

2. Important information before using Panadol dla dzieci

When not to use Panadol dla dzieci:

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• if other medicines containing paracetamol are being used at the same time,
• in case of severe liver or kidney failure in the child.

Warnings and precautions
The medicine contains paracetamol. This medicine should not be used simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat symptoms of flu and colds. Overdose of paracetamol may lead to severe liver damage.
Read the leaflet carefully before using the medicine and follow the instructions contained therein.
Exercise particular caution in patients:

• with liver or kidney impairment,
• with deficiency of the enzymes glucose-6-phosphate dehydrogenase or methemoglobin reductase,
• who are underweight or malnourished due to anorexia,
• who regularly consume alcohol. In the above situations, it may be necessary to completely discontinue taking this medicine or reduce the dose.

During treatment with Panadol dla dzieci, immediately inform the doctor if the patient develops 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 the patient is also taking flucloxacillin (an antibiotic). In such cases, patients have experienced a serious condition called metabolic acidosis (an abnormality in blood and body fluids) when paracetamol was used in regular doses over a prolonged period or when paracetamol was taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Immediately contact a doctor if the patient experiences the symptoms described above.
Consult a doctor if the patient suffers from chronic headaches.
If symptoms persist, consult a doctor.
Do not use a higher dose than recommended.
Paracetamol use may lead to false results in certain laboratory tests (e.g. blood glucose measurement).

Panadol dla dzieci and other medicines
Inform the doctor about all medicines recently taken, even those available without a prescription.
Consult a doctor if the patient is taking any of the following medicines:

• metoclopramide, domperidone (used for nausea and vomiting),
• cholestyramine (used to reduce high blood cholesterol levels),
• zidovudine (an antiviral medicine),
• anticoagulants,
• if long-term use of a painkiller is necessary,
• sedatives, antiepileptics, antituberculosis medicines, MAO inhibitors (medicines used for depression), non-steroidal anti-inflammatory drugs (including acetylsalicylic acid).

Inform the doctor or pharmacist if the patient is 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).

Paracetamol taken together with MAO inhibitors may cause a state of excitation and high fever.
Do not drink alcohol while taking this medicine due to increased risk of liver damage. The risk of liver damage is particularly high in malnourished patients and those who regularly drink alcohol.

Pregnancy, breastfeeding and fertility
This medicine is intended for children.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Driving and using machines
This medicine is intended for children.
Panadol dla dzieci has no effect or has a negligible effect on the ability to drive and operate machinery.

Panadol dla dzieci contains sorbitol, maltitol, methyl parahydroxybenzoate and propyl parahydroxybenzoate.
The medicine contains maltitol. If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking the medicine.
The medicine contains 150 mg of sorbitol in 1 ml of suspension, equivalent to 750 mg in 5 ml. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or has hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking the medicine or giving it to a child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible delayed-type reactions).
The medicine contains 0.63–4.68 mg of sodium per dose, i.e. less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Panadol dla dzieci

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
For oral use only.
Shake the bottle before use.
The speed and effectiveness of the medicine depend, among other factors, on accurate dosing.
The Panadol dla dzieci bottle contains 100 ml of suspension.
1 ml of suspension contains 24 mg of paracetamol.
A dosing syringe is included in the package.
The dosage is determined according to the child's body weight.

* According to the percentile grid developed by I. Palczewska, Z. Niedźwiecka, 1999.
The medicine should not be administered more frequently than every 4 hours, nor should more than 4 doses be used within 24 hours (60 mg paracetamol/kg body weight/24 hours).
Before administering the medicine to a child under 2 years of age, consultation with a doctor is recommended. The medicine is not recommended for children under 3 months of age. If fever does not subside within 24 hours (4 doses), medical advice should be sought, as fever may be a symptom of a serious infection requiring prompt diagnosis.
The medicine should not be used for longer than 3 days without consulting a doctor.
Do not use a dose higher than the recommended dose.
The lowest effective dose should be used for the shortest possible duration.
Instructions for using the medicine with the enclosed oral syringe:

INSERT DRAW UP REMOVE

SYRINGE CORRECT SYRINGE

INTO BOTTLE: DOSE: FROM BOTTLE:
Push the plunger of the syringe to the bottom of its barrel; then firmly press the tip of the syringe against the neck of the bottle. Turn the bottle upside down and draw up the appropriate amount of medicine by gently pulling back the plunger. Hold the syringe upright and check the dose. The amount of medicine in the syringe is indicated by the widest part of the plunger that aligns with the millilitre markings visible on the syringe barrel. Turn the bottle back upright and remove the syringe by gently twisting it.

After administering the medicine:

• To close the bottle, press the cap down and tighten it firmly, then turn it backwards until a click is heard. After use, wash the syringe with warm water and dry it thoroughly. Sterilization is not necessary.

Overdose of Panadol dla dzieci
Exceeding the recommended dose of paracetamol may lead to liver damage. Immediate medical advice must be sought, even if the patient feels well and no symptoms of poisoning are observed, due to the risk of delayed, severe liver damage, which may result in liver transplantation or death. If a dose greater than recommended has been taken and less than one hour has passed since ingestion, vomiting should be induced. Alternatively, 60–100 g of activated charcoal may be administered orally, preferably mixed with water.
There are no well-defined data regarding paracetamol overdose in children. Symptoms during the first two days of acute paracetamol poisoning do not reflect the extent of toxicity. Most signs of liver damage, such as jaundice, hypoglycaemia (abnormally low blood glucose levels), and metabolic acidosis (see section 2), may appear only after 2 days from overdose. Overdose may cause symptoms within several to several dozen hours, such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, even though liver damage may have already started developing, later manifesting as abdominal pain, recurrence of nausea, and jaundice.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everybody will experience them.
You should stop using the medicine immediately and consult a doctor if any of the following occur:

• Very rare (affects fewer than 1 in 10,000 patients):
  • Allergic reaction (hypersensitivity) such as skin rash or itching, sometimes associated with difficulty breathing or swelling of the lips, tongue, throat or face,
  • Skin rash or severe skin reaction, manifesting as sudden widespread blistering rash or blisters and erosions on the skin, inside the mouth, eyes and genital organs, fever and joint pain, or subcutaneous rupturing large blisters, extensive skin erosions, peeling of large skin sheets and fever,
  • Breathing problems, especially if similar problems occurred previously during treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
  • Bruising or unexplained bleeding,
  • Liver function disorders.
• Frequency unknown (cannot be estimated from available data):
  • Metabolic acidosis – a serious condition which may cause blood acidification in patients with severe illness receiving paracetamol (see section 2).

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

5. How to store Panadol dla dzieci

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
Store below 30°C. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine Panadol dla dzieci contains

• The active substance is paracetamol. 5 ml of oral suspension contains 120 mg of paracetamol.
• The other ingredients are: xanthan gum, sorbitol 70% (non-crystallising) (E420), methyl parahydroxybenzoate, propyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, glycerol, strawberry flavour 500564AH, disodium EDTA, sucralose, liquid maltitol, purified water.

What Panadol dla dzieci looks like and contents of the pack
Panadol dla dzieci is an opaque or semi-transparent suspension, white to slightly brownish in colour.
The pack contains an amber glass bottle with a 10 ml syringe composed of a polyethylene plunger (HDPE) and a cylinder made of polypropylene (PP).
The pack contains 100 ml of suspension.
Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849
Manufacturer
Farmaclair
440 Avenue du General de Gaulle
14200, Herouville Saint-Clair
France
Importer:
Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany
Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.