Junior Parapaed Paracetamol Oral Suspension 120 mg/5 ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

Pinewood Laboratories Ltd

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:

1982-12-01

Patient Information leaflet

PATIENT INFORMATION LEAFLET
JUNIOR PARAPAED PARACETAMOL ORAL SUSPENSION 120 MG/5 ML
PARACETAMOL 120 MG/5 ML
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU AND
YOUR CHILD.
This medicine is available without prescription; however, you still
need to give Junior
Parapaed Paracetamol Oral Suspension 120 mg/5 ml carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must see a doctor if your child’s symptoms worsen or do not
improve
after 3 days.
•
If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Paracetamol Suspension is and what it is used for
2. Before you give Paracetamol Suspension to your child
3. How to give Paracetamol Suspension to your child
4. Possible side effects
5. How to store Paracetamol Suspension
6. Further information
1. WHAT PARACETAMOL SUSPENSION IS AND WHAT IT IS USED FOR
Junior Parapaed Paracetamol Oral Suspension 120 mg/5 ml
(“Paracetamol Suspension”)
contains paracetamol to relieve pain and reduce high temperatures.
Paracetamol Suspension
can be used in babies and children for the treatment of mild or
moderate pain and
feverishness associated with teething, toothache, headache, colds and
flu. It can also be used
in babies who develop fever after vaccination.
2. BEFORE YOU GIVE PARACETAMOL SUSPENSION TO YOUR CHILD
DO NOT GIVE PARACETAMOL SUSPENSION IF YOUR CHILD IS TAKING ANY OTHER
PARACETAMOL
CONTAINING PRODUCTS, OTHER FLU, COLD, COUGH OR DECONGESTANT PRODUCTS,
OR ALCOHOL.
DO NOT GIVE PARACETAMOL SUSPENSION TO YOUR CHILD IF HE/SHE:
•
is allergic (hypersensitive) to paracetamol, or any of the other
ingredients of
Paracetamol Suspension _(see Section 6 and end of Section 2). _
If you are not sure about any of the above, please consult your
doctor.
TAKE SPECIAL CARE WITH PARACETAMOL SUSPENSION
•
if you have kidney or liv

Summary of Product characteristics

Health Products Regulatory Authority
12 May 2022
CRN00CX7Y
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Junior Parapaed Paracetamol Oral Suspension 120 mg/5 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 120mg of Paracetamol
Excipients:
Liquid Maltitol (E965) 4.25 g/5ml {equivalent to 3.19g dry substance}
Ethanol 75 mg/5ml
Amaranth (E123) 0.1 mg/5ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Suspension
Pink suspension with cherry odour and taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an analgesic or anti-pyretic in the treatment of teething pain,
toothache, headache, migraine, neuralgia, sore throat,
feverishness, colds, flu and post-immunisation fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration.
PAEDIATRIC POPULATION
AGE
DOSE
For post-vaccination fever for babies aged between 2 – 3 months
One 2.5 ml spoonful (small end)
If necessary, after 4-6 hours, give a second 2.5 ml dose

Do not give to babies less than 2 months of age

Do not give more than 2 doses unless your doctor or pharmacist has
advised otherwise

Leave at least 4 hours between doses
If further doses are needed, talk to your doctor or pharmacist
_CHILDREN AGED 3 MONTHS – 6 YEARS:_
CHILD’S AGE
HOW MUCH
HOW OFTEN
(IN 24 HOURS)
3 – 6 months
One 2.5 ml spoonful (small end)
4 times
6 – 24 months
One 5 ml spoonful (large end)
4 times
2 – 4 years
One 5.0 ml spoonful (large end) and
one 2.5 ml spoonful (small end)
4 times
4 – 6years
Two 5 ml spoonfuls (large end)
4 times

Do not give more than 4 doses in any 24 hour period

Leave at least 4 hours between doses

Do not give this medicine to your child for more than 3
days without speaking to your doctor or pharmacist
Health Products Regulatory Authority
12 May 2022
CRN00CX7Y
Page 2 of 7
It is important to SHAKE THE BOTTLE for at least 10 seconds before
use.
4.3 CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of its constituents.
4.4 SPECIAL WARNINGS AND