Panadol Baby 120 mg/5 ml, Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

Haleon Ireland Limited

ATC code:

N02BE; N02BE01

INN (International Name):

Paracetamol

Dosage:

120 mg/5ml

Pharmaceutical form:

Oral suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

1992-12-22

Patient Information leaflet

_PATIENT INFORMATION LEAFLET _
_ _
PANADOL BABY 120MG/5ML ORAL SUSPENSION PARACETAMOL
PACKAGE LEAFLET: INFORMATION FOR THE USER.
Please read right through this leaflet before you start using this
medicine. This medicine is available
without prescription, but you still need to use Panadol Baby
suspension carefully to get the best
results from it.
•
Keep this leaflet, you may need to read it again.
•
If you have any further questions, ask your pharmacist.
•
You must contact a doctor if symptoms worsen or do not improve after 1
day.
•
If any of the side effects get serious, or if you notice any side
effect not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Panadol Baby is and what it is used for
2.
Before you give Panadol Baby to the child
3.
How should you give Panadol Baby to the child
4.
Possible side effects
5.
How to store Panadol Baby
6.
Further information
1.
WHAT PANADOL BABY IS AND WHAT IT IS USED FOR
Panadol Baby suspension contains PARACETAMOL which is an analgesic (a
painkiller that reduces
aches and shivers) and antipyretic (it reduces temperature when a
child has a fever).
Panadol Baby suspension relieves the pain of teething, toothache and
sore throats and reduces the
fever often associated with colds and ‘flu and childhood infections
such as chickenpox, whooping
cough, measles and mumps.
2.
BEFORE YOU GIVE PANADOL BABY TO THE CHILD
DO NOT GIVE PANADOL BABY TO THE CHILD:
•
If the child is allergic to PARACETAMOL or any of the ingredients
listed in Section 6.
•
If the child is taking any OTHER MEDICINES CONTAINING PARACETAMOL.
•
If the child has a known intolerance to the sugar called fructose.
TAKE SPECIAL CARE. PLEASE SPEAK TO YOUR
DOCTOR BEFORE YOU GIVE PANADOL
BABY TO THE CHILD IF:
•
The child suffers from liver or kidney problems.
•
The child is underweight or malnourished.
•
The baby was born prematurely and is under 3 months.
•
The child has a SEVERE INFECTION as this may increase the risk

Summary of Product characteristics

Health Products Regulatory Authority
05 July 2023
CRN00DPJ2
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol Baby 120 mg/5 ml, Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml measure of suspension contains paracetamol 120mg.
Excipients: Each 5ml contains: Sorbitol 0.75g, Maltitol 2.7g, and
Parahydroxybenzoates 12.2mg (E216, E218).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
Opaque to translucent, white to slightly brownish suspension..
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Panadol Baby suspension is recommended for the relief of pains of
teething, toothache and sore throats and for reducing the
fever often associated with colds and ‘flu’ and childhood
infections such as chicken pox, whooping cough, measles and mumps.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This product is intended for oral use in children ages:
AGE : 2 – 3 MONTHS
DOSE
1. POST-VACCINATION FEVER
2.5 ML
IF NECESSARY, AFTER 4-6 HOURS, GIVE A SECOND 2.5 ML DOSE
1.
OTHER CAUSES OF PAIN AND FEVER ONLYIF
o
Weighs over 4 kg
o
Born after 37 weeks
​

DO NOT GIVE TO BABIES LESS THAN 2 MONTHS OFAGE

DO NOT GIVE MORE THAN 2 DOSES

LEAVE AT LEAST 4 HOURS BETWEENDOSES

IF FURTHER DOSES ARE NEEDED, TALK TO YOUR DOCTOR
ORPHARMACIST
​
CHILD'S AGE
HOW MUCH
HOW OFTEN (IN 24 HOURS)
3 – 6 MONTHS
2.5 ML
4 TIMES
6 – 24 MONTHS
5 ML
4 TIMES
2 – 4 YEARS
7.5 ML
4 TIMES
4 – 8 YEARS
10 ML
4 TIMES
8 – 10 YEARS
10 ML + 5 ML
4 TIMES
10 – 12 YEARS
10 ML + 10 ML
4 TIMES

DO NOT GIVE MORE THAN 4 DOSES IN ANY 24 HOURPERIOD

LEAVE AT LEAST 4 HOURS BETWEENDOSES

THE LOWEST DOSE NECESSARY TO ACHIEVE EFFICACY SHOULD BEUSED.
​
​
Health Products Regulatory Authority
05 July 2023
CRN00DPJ2
Page 2 of 6

DO NOT GIVE THIS MEDICINE TO YOUR CHILD FOR MORE THAN 3 DAYS
WITHOUT SPEAKING TO YOUR DOCTOR ORPHARMACIST
It is important to SHAKE THE BOTTLE for at least 10 seconds before use
If your baby was born prematurely and is less than 3