Paralink 180mg Suppositories

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:

180 milligram(s)

Pharmaceutical form:

Suppository

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Marketed

Authorization date:

1988-12-30

Patient Information leaflet

PATIENT INFORMATION LEAFLET
PARALINK 180MG SUPPOSITORIES
Paracetamol
In
THIS LEAFLET:
1.
What Paralink Suppositories are and what they
are used for
2.
Before you give Paralink Suppositories
3.
How to give Paralink Suppositories
4.
Possible side effects
5.
How to store Paralink Suppositories
6.
Further information.
Paralink Suppositories contain the active
ingredient paracetamol. Paracetamol is a pain
killer and can reduce high temperatures (fever).
It provides effective relief of fever and pain
associated with colds and flu, headaches,
rheumatism and teething. Paralink Suppositories
may also be used after an operation.
Paralink 180mg Suppositories can be used in
children from 3 months to 6 years of age.
It
is a
smooth, white, tapered cylindrical medicine which
is inserted into the back passage (rectum) and is
recommended for use in children who may find it
difficult to take paracetamol by mouth.
DO NOT GIVE PARALINK 180MG SUPPOSITORIES TO
YOUR CHILD
IF:
•
Your child is allergic to paracetamol or to any
of the other ingredients listed
(see ingredients section)
•
Your child is under 3 months of age
•
Your child is taking any other paracetamol
containing products.
YOU MUST BE ESPECIALLY CAREFUL. SPEAK TO YOUR
DOCTOR OR PHARMACIST BEFORE GIVING PARALINK
SUPPOSITORIES
IF:
•
Your child has kidney or liver problems.
OTHER SPECIAL WARNINGS:
•
Contains paracetamol. Do not give with any
other paracetamol containing products
•
Immediate medical advice should be sought
in the event of overdosage, because of the
risk of irreversible liver damage
•
Do not exceed the stated dose
•
If
symptoms persist, consult your doctor
•
Using Paralink 180mg Suppositories for a long
period of time without medical supervision can
be harmful to your child.
DO NOT GIVE THIS
MEDICINE TO YOUR CHILD FOR LONGER THAN 3
DAYS WITHOUT SPEAKING
to
YOUR DOCTOR OR
PHARMACIST FIRST.
If
ANY OF THE ABOVE APPLIES, PLEASE TALK TO A DOCTOR
OR PHARMACIST BEFORE GIVING THIS MEDICINE.
If
ADULTS USE THIS MEDICINE:
THE FOLLOWING WARNINGS ALSO APPLY

Summary of Product characteristics

Health Products Regulatory Authority
17 February 2020
CRN0095YK
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paralink 180mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains Paracetamol 180 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suppository
White, tapered cylindrical suppositories.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated in the management of pain and fever associated with such
conditions as influenza, the common cold, headache,
rheumatism, teething, post-operative pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For rectal use only
3 months - 1 year (5 - 10kg): ½ Suppository
1 - 3 years (10 - 15kg): 1 Suppository
3 - 6 years (15 - 20kg): 1½ Suppositories
Dose may be repeated 6 hourly as necessary or as directed by the
physician.
4.3 CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the other constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Paralink suppositories should be administered with caution to patients
with known liver or renal impairment.
The hazard of overdose is greater in those with non-cirrhotic
alcoholic liver disease.
Do not exceed the recommended dose.
Do not take other paracetamol-containing products.
If symptoms persist, consult your doctor.
Keep out of the reach and sight of children.
Prolonged use except on doctor's advice can be harmful.
Maximum duration of continued use without medical advice: 3 days.
Immediate medical advice should be sought in the event of overdosage,
because of the risk of irreversible liver damage.
This product should be used only when clearly necessary.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
The anticoagulant effect of warfarin and other coumarins may be
enhanced by prolonged regular use of paracetamol with
increased bleeding; occasional doses have no significant effect.
Health Products Regulatory Authority
17 February 2020
CRN0095YK
Page 2 of 4
The rate of absorption of paracetamol may be inc