Paracetamol 500mg suppositories

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Paracetamol

Verfügbar ab:

Accord-UK Ltd

ATC-Code:

N02BE01

INN (Internationale Bezeichnung):

Paracetamol

Dosierung:

500mg

Darreichungsform:

Suppository

Verabreichungsweg:

Rectal

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 04070100; GTIN: 5012617023353

Gebrauchsinformation

Information for the user
FOR RECTAL ADMINISTRATION ONLY
PARACETAMOL 500MG SUPPOSITORIES
Your medicine is known by the above name, but will be referred to as
Paracetamol Suppositories throughout
the following leaflet. This medicine is available in other strength
(250mg).
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU AND YOUR CHILD.
This medicine is available without prescription. However, you still
need to use it carefully to get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
YOU MUST CONTACT YOUR CHILD'S DOCTOR IF YOUR CHILD'S SYMPTOMS GET
WORSE OR DO NOT IMPROVE.
•
If your child gets any side effects after being given this medicine,
please tell a doctor or pharmacist.
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 administer 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

Fachinformation

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