Naklofen suppositories rectal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

diclofenac (diclofenac sodium)

Available from:

KRKA d.d.

ATC code:

M01AB05

INN (International Name):

diclofenac (diclofenac sodium)

Dosage:

50mg

Pharmaceutical form:

suppositories rectal

Units in package:

(10/2x5/) In strip

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-04-25

Patient Information leaflet

83 /683
1.3.1
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Read the complete document

Summary of Product characteristics

69/683
1.3.1
Diclofenac
sodium
SPC,
Labelin
AM
1.
NAME OF THE MEDICINAL
PRODUCT
Naklofen
50 mg suppositories
2.
QUALITATIVE
AND QUANTITATIVE
COMPOSITION
Each suppository
contains
50 mg diclofenac
sodium.
For a full
list of excipients,
see section
6.1.
3.
PHARMACEUTICAL
FORM
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Suppository.
The suppositories
are cone-shaped,
white to yellowish
white colour.
The presence
of seams/ribbed
lines on the sides
and at the bottom of the suppository
is allowed.
4.
CLINICAL
PARTICUl.ARS
4.1
Ther.apeutic indillations
Diseases
in which anti-inflammatory
andlor
analgesic
activity is required:
inflammatory
rheumatic
diseases:
rheumatoid
arthritis,
spondyloarthritides,
chronic
idiopathic
juvenile
arthritis,
other
arthritides,
degenerative
rheumatism of the joints
and spine:
arthrosis,
spondylosis,
crystal-induced
arthritides:
gout
and pseudogout,
extra-articular
rheumatism:
periarthritis,
bursitis,
myositis,
tendinitis,
synovitis,
other
inflammatory
and painful
states
of the musculoskeletal
system.
As an analgesic,
Naklafen
is used in soft
tissue injuries,
after
delivery if the mother
does not
breastfeed,
in primary
and secondary
dysmenorrhoea,
in various
dental
procedures
and after
surgery
4.2
Posology and method of administration
Treatment
may consist
of taking only one form of the drug or a combination,
but
the total
daily dose of
150 mg has to be taken into account.
Patients
who do not
tolerate
oral
administration
well
are given
suppositories
at
corresponding
doses.
At
the beginning of treatment,
diclofenac
sodium is given at
a daily dose of
100 to 150 mg,
i.e.
I
suppository
2 to 3 times
daily,
depending
on the severity
of the disease.
The usual
maintenance
dose is up to
100
mg diclofenac
sodium a day,
i.e.
1
suppository
twice
daily.
Undesirable
effects
may be minimised
by using the lowest
effective
dose for
the shortest
duration
necessary
to control
(relieve)
symptoms
(see section 4.4).
The suppository
should