Paracetamol 125mg suppositories

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Paracetamol

Commercializzato da:

A A H Pharmaceuticals Ltd

Codice ATC:

N02BE01

INN (Nome Internazionale):

Paracetamol

Dosaggio:

125mg

Forma farmaceutica:

Suppository

Via di somministrazione:

Rectal

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04070100; GTIN: 5025903084884

Foglio illustrativo

Information for the user
FOR RECTAL ADMINISTRATION ONLY PARACETAMOL 125MG SUPPOSITORIES
Your medicine is known by the above name, but will be referred to as
Paracetamol Suppositories throughout the
following leaflet.
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 babies and children from the age of 1 year. 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 ha

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paraserts 125mg Suppositories
Paracetamol 125mg Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains Paracetamol 125mg
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:
1year – 5 years:
1-2 suppositories every 4 to 6 hours
Dosages should be based on the child’s age and weight i.e.
1 year (10kg) – 125mg (1 suppository)
5 years (20kg) – 250mg (2 suppositories)
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 (analgesic 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 Paracetam