Paracetamol 500mg suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

N02BE01

INN (International Name):

Paracetamol

Dosage:

500mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 500MG SUPPOSITORIES
Your medicine is available using the name Paracetamol 500mg
Suppositories but will be referred
to as Paracetamol Suppositories throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD STARTS
TAKING THIS MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor, nurse or
pharmacist.
•
This medicine has been prescribed for your child. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist.
IN THIS LEAFLET:
1.
WHAT PARACETAMOL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
2.
BEFORE YOU USE PARACETAMOL SUPPOSITORIES
3.
HOW TO USE PARACETAMOL SUPPOSITORIES
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PARACETAMOL SUPPOSITORIES
6.
FURTHER INFORMATION
1.
WHAT PARACETAMOL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
The active ingredient Paracetamol is a medicine with pain relieving
properties.
Paracetamol Suppositories are used:
•
for the relief of mild to moderate pain
•
for the relief of a high temperature (fever)
•
if you are unable to take paracetamol orally e.g. after an operation
or if you are feeling or
being sick.
2.
BEFORE YOU USE PARACETAMOL SUPPOSITORIES
YOU OR YOUR CHILD SHOULD NOT TAKE PARACETAMOL SUPPOSITORIES IF:
•
you or your child are allergic (hypersensitive) to paracetamol or to
any of the ingredients
listed in section 6 of this leaflet
If this applies to you or your child, please tell your doctor before
taking this medicine.
TAKE SPECIAL CARE WITH PARACETAMOL SUPPOSITORIES IF:
•
you or your child suffer from severe liver or kidney problems
•
you or your child suffer from alcoholism
If your’s or your child’s symptoms persist you should consult your
doctor.
Do not use Paracetamol Suppositories with other medicines that contai

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol or Paralink Suppositories 500mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains Paracetamol Ph.Eur. 500mg
3
PHARMACEUTICAL FORM
White, tapered, cylindrical suppositories with a smooth surface and
rounded
head, containing 500mg Ph.Eur.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain and pyrexia. The
suppositories may
be particularly useful in patients unable to take oral forms of
Paracetamol e.g.
post-operatively or with nausea and vomiting.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, elderly and children 12 – 18 years:
1 – 2 suppositories; maximum of
4g in 24 hours
Dose may be repeated every 4 – 6 hours with a maximum of 4 doses in
24
hours.
The dose should be based on age and weight i.e.
12 years (39kg) – (500mg) 1 suppository
Adults and the elderly (1g) 2 suppositories
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the other constituents.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care is advised in the administration of paracetamol to patients with
severe
renal or severe hepatic impairment. The hazard of overdose is greater
in those
with non-cirrhotic alcoholic liver disease. Do not exceed the
recommended
dose. Patients should be advised not to take other paracetamol
containing
products concurrently. If symptoms persist, consult your doctor. Keep
out of
the sight and reach of children.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The anticoagulant effect of warfarin and other coumarins may be
enhanced by
prolonged regular daily use of paracetamol with increased risk of
bleeding;
occasional doses have no significant effect. The rate of absorption of
paracetamol may be increased by metoclopramide or domperidone and
absorption reduced by coleystyramine.
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
A large amount of data on pregnant women indicate neither
malformative, nor
feto/neonatal toxicity. Epid