Six Plus Parapaed Paracetamol Oral Suspension 250 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:

250 mg/5ml

Pharmaceutical form:

Oral suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

1994-05-20

Patient Information leaflet

PATIENT INFORMATION LEAFLET
SIX PLUS PARAPAED PARACETAMOL ORAL SUSPENSION 250 MG/5 ML
PARACETAMOL 250 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 Six Plus
Parapaed Paracetamol Oral Suspension 250 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
Six Plus Parapaed Paracetamol Oral Suspension 250 mg/5 ml
(“Paracetamol Suspension”)
contains paracetamol to relieve pain and reduce high temperatures.
Paracetamol Suspension
can be used in children over 6 years and adults for the treatment of
mild or moderate pain and
feverishness associated with teething, toothache, headache, colds and
flu. It is suitable for
diabetics and adults who have difficulty swallowing tablets or who are
sensitive to Ibuprofen
or Aspirin.
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
doct

Summary of Product characteristics

Health Products Regulatory Authority
12 May 2022
CRN00CX7Y
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Six Plus Parapaed Paracetamol Oral Suspension 250 mg/5 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 250mg of Paracetamol.
Excipients:
Liquid Maltitol (E965) 3.93g/5ml (equivalent to 2.95g dry substance)
Ethanol 96% 150.00mg/5ml
Sunset Yellow (E110) 0.30mg/5ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension,
Orange to orange/brown coloured suspension with an orange flavour and
odour.
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
CHILD’S AGE
HOW MUCH
HOW OFTEN
(IN 24 HOURS)
6 – 8 years
One 5 ml spoonful (large end)
4 times
8 – 10 years
One 5.0 ml spoonful (large end) and
one 2.5 ml spoonful (small end)
4 times
10 – 12 years
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

Do not give to children under the age of 6 years.
Children aged 12 - 16 years: Two – three 5 ml spoonfuls (large end)
up to 4 times a day.
Adults and children over 16 years: Two – four 5 ml spoonfuls (large
end) up to 4 times a day.
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 PRECAUTIONS FOR USE
Health Products Regulatory Authority
12 May 2022
CRN00CX7Y
Page 2 of 5

Do not give with any other paracetamol-containing products.

Never give more medicine than shown in the table.

Do not overfill the spoon.

Always use the spoon supplied with the pack.

Do not give m