Paracetamol 500mg suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol

Available from:

Sigma Pharmaceuticals Plc

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

L I M I T E D
L I M I T E D
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_Title:_
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_Date:_
_Size (mm):_
_Modified:_
Paracetamol 500mg Suppositories
PIL - Patient Information Leaflet
05/01/16
265(W) x 360(H)
12/02/17
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_(Non printed)_
PROCESS
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REFERENCE
TRIM
REFERENCE
PERF
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARASERTS 500MG SUPPOSITORIES
PARACETAMOL
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
-
Your product is called Paraserts 500mg Suppositories but will be
referred to as Paraserts throughout this leaflet.
1.
What Paraserts are and what they are used for
2.
What you need to know before you use Paraserts
3.
How to use Paraserts
4.
Possible side effects
5.
How to store Paraserts
6.
Contents of the pack and other information
1.
WHAT PARASERTS ARE AND WHAT THEY ARE USED FOR
Paraserts contain a medicine called paracetamol. This belongs to a
group of medicines called pain-killers (analgesics). A
suppository is a small, torpedo-shaped, medicine which is inserted
into the back passage (rectum). Paraserts are used to treat
pain and high temperature (fever) in adults and children over 10 years
of age. They are used when it is difficult to take
paracetamol as tablets or syrup.
You must talk to a doctor or pharmacist if you do not feel better or
if you feel worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PARASERTS
DO NOT USE PARASERTS:
•
if you are allergic to paracetamol, soya, peanuts or any of the other
ingredients of this medicine (listed in Section 6).

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paraserts 500mg Suppositories
Paracetamol 500mg Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains Paracetamol 500mg
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Suppositories
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For
the
treatment
of
mild
to
moderate
pain
and
fever.
Paraserts/Paracetamol
Suppositories may be especially 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
Method of administration: Rectal
Children 10 years – 12 years (30-40kg):
1 suppository every 4 to 6 hours up to a maximum of 4 suppositories in
24 hours.
Adults + Children 12 years and over:
1 -2 suppositories every 4 to 6 hours up to a maximum of 8
suppositories in 24 hours.
Dosages should be based on the child’s age and weight. The dose
should not be
repeated more frequently than every 4 hours. The recommended dose
should not be
exceeded. Higher doses do not produce any increase in analgesic
effect. The product
should not be used for more than 3 days, except on the advice of a
doctor. Only whole
suppositories
should
be
administered
–
do
not
break
the
suppository
before
administration
4.3
CONTRAINDICATIONS
Hypersensitivity to either paracetamol, soy, peanuts or any of the
other ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Paraserts/Paracetamol Suppositories should not be combined with other
analgesic
medications that contain paracetamol. Paracetamol should be given with
care to
patients with impaired kidney or liver function.
In general, the habitual use of painkillers, especially with
combinations of more than
one pain killing active ingredient, can lead to permanent kidney
damage with the risk
of liver failure (analgetic nephropathy).
Label and Leaflet will state the following warnings:
Label
:
“Immediate medical advice should be sought in the event of an
overdose, even if the
child seems well”.
“Do not give