Paracetamol 250mg suppositories

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Paracetamol

Disponível em:

A A H Pharmaceuticals Ltd

Código ATC:

N02BE01

DCI (Denominação Comum Internacional):

Paracetamol

Dosagem:

250mg

Forma farmacêutica:

Suppository

Via de administração:

Rectal

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04070100; GTIN: 5025903084969

Folheto informativo - Bula

PARACETAMOL 250MG SUPPOSITORIES
FOR RECTAL ADMINISTRATION ONLY
This medicine is available in other strengths (500mg). Your medicine
is
known
by
the
above
name,
but
will
be
referred
to
as
Paracetamol
Suppositories throughout this:
PATIENT INFORMATION LEAFLET
IN THIS LEAFLET:
1) What Paracetamol Suppositories are and what they are used for
2) Before you give Paracetamol Suppositories to your child.
3) How to give Paracetamol Suppositories to your child.
4) Possible side effects.
5) How to store Paracetamol Suppositories.
6) Further information.
1) WHAT PARACETAMOL SUPPOSITORIES ARE AND WHAT THEY ARE
USED FOR
Paracetamol
Suppositories
contain
a
medicine
called
paracetamol.
Paracetamol is one of a group of medicines called pain-killers
(analgesics).
A suppository is a small, torpedo-shaped medicine which is inserted
into
the back passage (rectum). Paracetamol Suppositories are used to treat
pain and high temperature (fever) in children from the age of 6 years.
They
are used by children who find it difficult to take paracetamol as
tablets or
syrup.
2) BEFORE YOU GIVE PARACETAMOL SUPPOSITORIES TO YOUR CHILD
DO NOT GIVE YOUR CHILD THESE SUPPOSITORIES IF:
•
They are allergic to paracetamol or to the other main ingredient which
is
called 'hard fat'.
TAKE SPECIAL CARE WITH PARACETAMOL SUPPOSITORIES
Check with your doctor or pharmacist before using these suppositories
if
•
Your child has liver or kidney problems.
TAKING OTHER MEDICINES
Please tell your child's doctor or pharmacist if your child is taking,
or has
recently taken, any other medicines. This includes medicines that you
buy
without
a
prescription
and
herbal
medicines.
This
is
because
the
suppositories
can
affect
the
way
some
medicines
work
and
some
medicines can have an effect on Paracetamol Suppositories.
In particular, tell your child's doctor or pharmacist if your child is
taking any
of the following:
•
Other medicines that contain paracetamol - DO NOT GIVE YOUR CHILD
PARACETAMOL SUPPOSITORIES AT THE SAME TIME.
•
Barbiturates (a type of sedative).
•

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paraserts 250mg Suppositories
Paracetamol 250mg Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains Paracetamol 250mg
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Suppositories
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain such as toothache and/or
pyrexia.
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:
6 – 9 years (20 – 30kg):
1 suppository every 4 to 6 hours
10 – 12 years (30 – 40kg):
1-2 suppositories every 4 to 6 hours
Dosages should be based on the child’s age and weight. These doses
may be repeated
up to a maximum of 4 times in 24 hours. 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 with any other