ARFEN 125 SUPPOSITORIES

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

Paracetamol

Dostupné z:

KOMEDIC SDN BHD

INN (Medzinárodný Name):

Paracetamol

Počet v balení:

20 Suppositories; 100 Suppositories

Výrobca:

MEDOCHEMIE LTD (COGOLS FACILITY)

Príbalový leták

_Consumer Medication Information Leaflet (RiMUP) _
ARFEN SUPPOSITORY
Paracetamol (125mg, 250mg)
1
IN THIS LEAFLET
:
1.
What ARFEN SUPPOSITORY is
used for
2.
How
ARFEN
SUPPOSITORY
works
3.
Before
you
use
ARFEN
SUPPOSITORY
4.
How
to
use
ARFEN
SUPPOSITORY
5.
While you were using it
6.
Side effects
7.
Storage and disposal of ARFEN
SUPPOSITORY
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ARFEN SUPPOSITORY IS
USED FOR
A
suppository
is
a
small,
torpedo-
shaped medicine which is inserted into
the back passage (rectum).
These suppositories are used to treat
pain and fever in children. They are
used by children who find it difficult to
take paracetamol as tablets or syrup.
Suppositories are also useful in patients
who are unable to take oral forms of
paracetamol (post-operatively or with
nausea and vomiting).
HOW
ARFEN
SUPPOSITORY
WORKS
ARFEN
suppositories
contain
a
medicine
called
paracetamol.
This
belongs to a group of medicines with
analgesic (painkiller) and anti-pyretic
(reduce fever) activity.
BEFORE YOU USE ARFEN
SUPPOSITORY
_When you must not use it _
DO NOT USE ARFEN:
-
If
your
child
is
allergic
(hypersensitive) to paracetamol or
to
the
other
ingredients
in
the
suppository
_Before you start to use it _
Before taking any of this medicine, tell
the doctor:
-
if your child has renal or hepatic
problems
-
if
your
child
is
taking
other
medicines which can affect their
liver
_Taking other medicines _
Please tell the doctor or pharmacist if
your child is taking or have recently
taken any other medicines, including
medicines
obtained
without
a
prescription, including:
-
Medicines
that
contain
paracetamol – DO NOT give your
child ARFEN at the same time
-
Barbiturates (a type of sedative).
-
Medicines for epilepsy or fits (also
called anti-convulsants).
-
Medicines
such
as
warfarin
for
treating blood clots.
-
Rifampicin and St. John’s wort.
-
Probenecid
acid
(for
gout
treatment)
-
Chloramphenicol (a medicine used
to treat bacterial infection)
-
Cholestyramine
(bile
aci

Súhrn charakteristických

PACKAGE INSERT – ARFEN
1.
NAME OF THE MEDICINAL PRODUCT
Arfen 125 mg, suppositories
Arfen 250 mg, suppositories
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Arfen 125mg: Each suppository contains 125mg paracetamol.
Arfen 250mg: Each suppository contains 250mg paracetamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suppository
Arfen 125mg and 250mg suppositories are creamy, smooth homogenous and
torpedo shaped.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain and pyrexia in children:
Arfen 125 mg is indicated in children aged 1 to 5 years.
Arfen 250 mg is indicated in children aged 6 to 12 years.
Arfen 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
Posology
_Paediatric population _
CHILDREN 1 TO 5 YEARS (125 MG SUPPOSITORIES)
The dosage should be based on age and weight i.e.
1 year (10 Kg)
125mg (1 suppository)
5 years (20 Kg)
250mg (2 suppositories)
CHILDREN 6 TO 12 YEARS (250 MG SUPPOSITORIES)
The dosage should be based on age and weight i.e.
6 years (20 Kg)
250mg (1 suppository)
12 years (40 Kg)
500mg (2 suppositories)
Method of administration
Intrarectal use.
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. Only whole suppositories should be
administered – do not break suppository before
administration.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Arfen should not be combined with other analgesic medications that
contain paracetamol (e.g. combination
drugs).


Paracetamol should be given with care to patients with impaired kidney
or liver function. Doses higher than
those recomme