Paralink Six Plus Paracetamol 250 mg/5 ml oral solution

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:

250 mg/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

2009-07-31

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 you or 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.
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SIX PLUS PARACETAMOL
250MG/5ML ORAL SOLUTION
IN THIS LEAFLET:
1.
What Paralink Six Plus is and what is it used for
2.
Before you take or give Paralink Six Plus
3.
How to take or give Paralink Six Plus
4.
Possible side effects
5.
How to store Paralink Six Plus
6.
Further information. 1. WHAT PARALINK SIX PLUS IS AND WHAT IT IS USED FOR
Paralink Six Plus Paracetamol 250mg/5ml Oral Solution is a strawberry
flavoured, colourless/straw
coloured, sugar-free, solution which contains paracetamol as the
active ingredient.
Paralink Six Plus Paracetamol 250mg/5ml Oral Solution is used for the
treatment of mild to moderate
pain, including headache, migraine, nerve pain (neuralgia), toothache
and pain associated with teething.
It is also used to relieve the symptoms of colds and flu and to lower
a high temperature (fever).
It is suitable for children aged 6 years and over. 2. BEFORE YOU TAKE OR GIVE PARALINK SIX PLUS
DO NOT USE PARALINK SIX PLUS IF:
You or your child are allergic to paracetamol or to any of the other
ingredients listed (see ingredients
list in section 6)
You or your child have ‘hereditary fructose intolerance’, a
condition where some sugars can’t be
broken down
You or your child are taking any other paracetamol containing
medicines.
TAKE SPECIAL CARE, SPEAK TO YOUR DOCTOR OR PHARMACIST BEFORE USING
PARALINK SIX PLUS IF:
You or your child has kidney or liver problems.
TAKING OTHER MEDICINES:
Paralink Six Plus can affect some other medicines you or your child
may be taking. Always tell your
doctor or pharmacist about all the medi

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 Six Plus Paracetamol 250 mg/5 ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains paracetamol 250 mg.
Excipients
Each 5 ml also contains:
Liquid sorbitol (non-crystallising) (E420) 1300 mg
Propylene glycol 200 mg
Liquid maltitol (E965) 550 mg
Nipasept 5 mg
Nipasept is a mixture of methyl, ethyl and propyl parahydroxybenzoate
(E218, E214, E216).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
Colourless / straw coloured sugar free oral solution with a strawberry
odour and taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paralink Six Plus Paracetamol Oral Solution is indicated as an
analgesic and antipyretic. It is used in the treatment of mild to
moderate pain, including headache, migraine, neuralgia, toothache and
pain associated with teething. It is also indicated for
the relief of symptoms of colds and influenza and to reduce fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CHILD’S AGE
HOW MUCH
HOW OFTEN (IN 24 HOURS)
6 – 8 years
5mL
4 times
8 – 10 years
7.5mL
4 times
10 – 12 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
o Do not give to children under the age of 6 years.
Children aged 12 – 16 years: 10 – 15mL up to 4 times a day.
Adults and children over 16 years: 10 – 20mL up to 4 times a day.
Health Products Regulatory Authority
17 February 2020
CRN0095YK
Page 2 of 5
4.3 CONTRAINDICATIONS
Hereditary fructose intolerance.
Hypersensitivity to paracetamol or to any of the other constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Never take or give more medicine than shown in the table.
Always use the syringe supplied with the pack.
Do not take or give more than 4 doses in any 24 hour period.
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