PANADOL 2.4 % (W/V) Suspension

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Panadol for children, 120 mg/5 ml, oral suspension
   1. Read the leaflet carefully, as it contains important information for
   2. Table of contents of the leaflet
3. What is Panadol for children and what is it used for
   1. Indications for use:
4. Important information before taking Panadol for children
   1. When not to take Panadol for children:
   2. Warnings and precautions
   3. Panadol for children and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
5. How to take Panadol for children
   1. Do not take a higher dose than recommended.
   2. Use the lowest effective dose of the medicine for the shortest possible time.
   3. Instructions for using the medicine with the included dosing syringe:
   4. INSERT
   5. THE SYRINGE
   6. INTO THE BOTTLE:
   7. REMOVE
   8. THE SYRINGE
   9. FROM THE BOTTLE:
   10. DRAW
   11. THE CORRECT
   12. DOSE:
   13. Taking a higher dose of Panadol for children than recommended
6. Possible side effects
   1. Reporting side effects
7. How to store Panadol for children
8. Contents of the pack and other information
   1. What Panadol for children contains
   2. What Panadol for children looks like and what the pack contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Importer:
   6. Date of last revision of the leaflet:

Leaflet attached to the packaging: information for the user

Panadol for children, 120 mg/5 ml, oral suspension

Paracetamol

Read the leaflet carefully, as it contains important information for

the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.
Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

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

Panadol for children contains the active substance paracetamol.
The medicine works as an antipyretic and analgesic.

Indications for use:

Fever and pain occurring, for example:

• during a cold and flu
• after vaccinations.

Pains of various origins, for example:

• teething pain
• toothache
• headache
• throat pain
• ear pain.

Without consulting a doctor, the medicine should not be used regularly for more than 3 days. If symptoms persist, you should consult a doctor.

2. Important information before taking Panadol for children

When not to take Panadol for children:

Warnings and precautions

The medicine contains paracetamol.The medicine should not be taken at the same time as other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat flu and cold symptoms. Paracetamol overdose can lead to severe liver damage.
One should read the leaflet before taking the medicine and follow the recommendations contained therein.
One should be particularly careful with patients:

During the use of Panadol for children, one should immediately inform the doctor if the patient has severe diseases, including severe kidney dysfunction 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 been reported to develop a severe disease called metabolic acidosis (a blood and body fluid disorder), which must be treated urgently (see section 2). Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
One should immediately contact a doctor if the patient experiences the above symptoms.
One should consult a doctor if the patient suffers from chronic headaches.
If the symptoms persist, one should consult a doctor.
One should not take a higher dose than recommended.
Taking paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).

Panadol for children and other medicines

One should inform the doctor about all medicines taken recently, even those that are available without a prescription.
One should consult a doctor when taking the following medicines:

• metoclopramide, domperidone (used against nausea and vomiting),
• cholestyramine (used to reduce high cholesterol levels in the blood)
• zydovudine (an antiviral medicine),
• anticoagulant medicines

One should 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 must be treated urgently (see section 2).

Paracetamol taken with MAO inhibitors may cause excitement and high temperature.
One should not drink alcohol while taking the medicine due to the increased risk of liver damage. There is a particular risk of liver damage in malnourished patients and those who regularly drink alcohol.

Pregnancy, breastfeeding, and fertility

The medicine is intended for children.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine.

Driving and using machines

The medicine is intended for children.
Panadol for children has no influence or negligible influence on the ability to drive and use machines.
Panadol for children contains sorbitol, maltitol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate.
The medicine contains maltitol. If the patient has been diagnosed with intolerance to some sugars, they should contact a doctor before taking the medicine.
The medicine contains 150 mg of sorbitol in 1 ml of suspension, which corresponds to 750 mg in 5 ml. Sorbitol is a source of fructose. If the patient has been diagnosed with intolerance to some sugars or has a rare genetic disease, hereditary fructose intolerance, in which the patient's body does not break down fructose, the patient should contact a doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible late reactions).
The medicine contains 0.63-4.68 mg of sodium per dose, which is less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Panadol for children

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubt, one should consult a doctor, pharmacist, or nurse.
For oral use only.
Shake the bottle before use.
The speed and effectiveness of the medicine depend on accurate dosing.
The Panadol for children bottle contains 100 ml of suspension.
1 ml of suspension contains 24 mg of paracetamol.
A dosing syringe is included in the packaging

* According to the centile grid developed by I. Palczewska, Z. Niedźwiecka, 1999.
Do not give the medicine more often than every 4 hours or take more than 4 doses in 24 hours (60 mg of paracetamol/kg of body weight/24 hours).
Before giving the medicine to a child under 2 years of age, it is recommended to consult a doctor. It is not recommended to use the medicine in children under 3 months of age. If the fever does not subside within 24 hours (4 doses), one should consult a doctor. Because fever can be a symptom of a severe infection that requires rapid diagnosis.
Without consulting a doctor, the medicine should not be used for more than 3 days.

Do not take a higher dose than recommended.

Use the lowest effective dose of the medicine for the shortest possible time.

Instructions for using the medicine with the included dosing syringe:

INSERT

THE SYRINGE

INTO THE BOTTLE:

Press the syringe plunger to the end; then firmly attach it to the bottle neck.

REMOVE

THE SYRINGE

FROM THE BOTTLE:

Turn the bottle upside down and gently twist and pull out the syringe.

DRAW

THE CORRECT

DOSE:

Turn the bottle upside down and gently pull the syringe plunger, drawing the appropriate amount of medicine.
The amount of medicine in the syringe is indicated by the widest part of the plunger, which touches the milliliter mark on the syringe walls.
After administering the medicine:

• Close the bottle by pressing the cap down and tightening it, then turn it back until you hear a click. After use, wash the syringe with warm water and dry it. There is no need for sterilization.

Taking a higher dose of Panadol for children than recommended

Paracetamol overdose can lead to liver damage. One should immediately seek medical advice, even if the patient feels well and no symptoms of poisoning have been observed, due to the risk of delayed, severe liver damage, which can result in liver transplantation or death. If a higher dose of paracetamol than recommended has been taken, and it has been less than an hour since ingestion, one should induce vomiting. One can also give 60-100 g of activated charcoal orally, preferably mixed with water.
There is a lack of well-defined data on paracetamol overdose in children.
Symptoms within the first two days of acute paracetamol poisoning do not reflect the scale of poisoning. Most symptoms of liver damage, such as jaundice, hypoglycemia (low blood glucose levels), and metabolic acidosis (see section 2), may occur only after 2 days of overdose. Overdose of the medicine can cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may subside the next day, despite the fact that liver damage is developing, which will later manifest as abdominal distension, return of nausea, and jaundice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
One should stop taking the medicine and consult a doctor if:

• very rare, i.e., less than 1 in 10,000 patients.
• an allergic reaction (hypersensitivity) such as: skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face,
• skin rash or severe skin reaction, manifested by acute generalized pustular rash or blisters and ulcers on the skin, mouth, eyes, and genitals, fever, and joint pain or large blisters under the skin, widespread ulcers on the skin, and fever,
• breathing problems, if similar problems have occurred in the past when taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• bruises or bleeding of unknown cause,
• frequency not known (cannot be estimated from the available data).
• metabolic acidosis - a serious condition that can cause blood acidification, in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Panadol for children

Medicines should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
Store in a temperature below 30°C. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. One should ask a 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 Panadol for children contains

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

What Panadol for children looks like and what the pack contains

Panadol for children is a non-transparent or semi-transparent suspension, white to light brown in color.
The pack contains a brown glass bottle with a dosing syringe with a capacity of 10 ml, consisting of a polyethylene (HDPE) plunger and a polypropylene (PP) cylinder.
The pack contains 100 ml of suspension.

Marketing authorization 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

Date of last revision of the leaflet:

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.