Paralink Paracetamol Oral Solution 120mg/5ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

Ricesteele Manufacturing Ltd

ATC code:

N02BE; N02BE01

INN (International Name):

Paracetamol

Dosage:

120.0 mg/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

1984-03-01

Patient Information leaflet

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS
MEDICINE OR GIVE IT TO A CHILD.
•
Keep this leaflet. You may need to read it again
•
If you need more information or advice, please ask your doctor or
pharmacist
•
You must contact your doctor if your child’s symptoms get worse or
do not improve
•
If any of the side effects get serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
. 2. BEFORE YOU GIVE PARALINK PARACETAMOL ORAL SOLUTION TO YOUR CHILD
PARACETAMOL
ORAL SOLUTION 120MG/5ML
IN THIS LEAFLET:
1.
What Paralink Paracetamol Oral Solution is and what is it used for
2.
Before you give Paralink Paracetamol Oral Solution to your child
3.
How to give Paralink Paracetamol Oral Solution
4.
Possible side effects
5.
How to store Paralink Paracetamol Oral Solution
6.
Further information. 1. WHAT PARALINK PARACETAMOL ORAL SOLUTION IS AND WHAT IT IS USED FOR
Paralink Paracetamol Oral Solution 120mg/5ml is a strawberry
flavoured, colourless, sugar-free solution
which contains paracetamol as the active ingredient.
Paralink Paracetamol Oral Solution 120mg/5ml is used for the treatment
of mild to moderate pain and to
relieve symptoms of colds and flu. It is also used to lower a high
temperature (fever), including fever
following a child’s immunisation.
It is suitable for children aged from 2 months.
DO NOT GIVE PARALINK PARACETAMOL ORAL SOLUTION TO YOUR CHILD IF:
•
Your child is allergic to paracetamol or to any of the other
ingredients listed (see ingredients list
in section 6)
•
Your child has a ‘hereditary fructose intolerance’, a condition
where some sugars can’t be
broken down
•
Your child is taking any other paracetamol containing medicines.
TAKE SPECIAL CARE, SPEAK TO YOUR DOCTOR OR PHARMACIST BEFORE USING
PARALINK PARACETAMOL
ORAL SOLUTION IF:
•
Your child has kidney or liver problems.
TAKING OTHER MEDICINES:
Paralink Paracetamol Oral Solution can affect some other medicines
your child may be taking. Always
tell your docto

Summary of Product characteristics

Health Products Regulatory Authority
17 February 2020
CRN0095YK
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paralink Paracetamol Oral Solution 120mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains Paracetamol 120mg.
Each 5ml also contains:
Sorbitol 70% (E420) 1.5 g
Propylene Glycol 0.5 g
Liquid Maltitol 0.3 g
Nipasept 5.0 mg
Nipasept contains a mixture of methyl, ethyl and propyl
parahydroxybenzoate (E218, E216, E214).
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Oral Solution.
Colourless liquid with strawberry odour and taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paralink Paracetamol Solution is indicated as an analgesic and
antipyretic. It is used in the treatment of mild to moderate pain,
for the relief of symptoms of colds and influenza and to reduce fever,
including post-vaccination fever in childhood.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
AGE
DOSE
For post-vaccination fever for babies aged between 2 – 3 months
2.5mL
If necessary, after 4 – 6 hours, give a second 2.5mL dose.
o Do not give to babies less than 2 months of age
o Do not give more than 2 doses
o Leave at least 4 hours between doses
o If further doses are needed, talk to your doctor or pharmacist
Health Products Regulatory Authority
17 February 2020
CRN0095YK
Page 2 of 5
CHILD’S AGE
HOW MUCH
HOW OFTEN (IN 24 HOURS)
3 – 6 months
2.5mL
4 times
6 – 24 months
5mL
4 times
2 – 4 years
7.5mL
4 times
4 – 6 years
10mL
4 times
o Do not give more than 4 doses in any 24 hour period
o Leave at least 4 hours between doses
o Do not give this medicine to your child for more than
3 days without speaking to your doctor or pharmacist
4.3 CONTRAINDICATIONS
Patients with rare hereditary problems of fructose intolerance should
not take this medicine.
Hypersensitivity to paracetamol or to any of the other constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Never give more medicine than shown in the table.
Always use the syringe supplied with the pack.
Do