Naklofen tablets gastro-resistant

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

diclofenac (diclofenac sodium)

Dostupné s:

KRKA d.d.

ATC kód:

M01AB05

INN (Mezinárodní Name):

diclofenac (diclofenac sodium)

Dávkování:

50mg

Léková forma:

tablets gastro-resistant

Jednotky v balení:

(20/2x10/) in blister

Druh předpisu:

Prescription

Stav Autorizace:

Registered

Datum autorizace:

2017-03-17

Informace pro uživatele

1.3.1
Diclofenac
sodium
SPC,
Labeling
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Charakteristika produktu

69/768
1.3.1
Diclofenac
sodium
SPC,
Labelin
NAME OF THE MEDICINAL PRODUCT
Naklofen
gastro-resistant
tablets
50 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant
tablet
contains
50 mg diclofenac
sodium.
For excipients,
see section 6.1.
PHARMACEUTICAL FORM
Gastro-resistant
tablets:
round,
slightly biconvex,
gastro-resistant,
film coated,
smooth,
brown-yellow
tablets.
CLINICAL PARTICULARS
Therapeutic
indications
Inflammatory
and degenerative
forms
of rheumatic
diseases
(rheumatoid
arthritis,
juvenile
rheumatoid
arthritis,
ankylosing
spondylitis,
osteoarthrosis,
spondyloarthritis),
painful
Vertebral
Syndrome,
extra-articular
rheumatism.
Acute gout
attacks.
Post-traumatic
and post-operating
pain syndrome
that
is associated
with inflammation
and
swelling,
for
example
after
dental,
surgical
or orthopaedic
procedures.
Gynecological
diseases
accompanied
by pain syndrome
and inflammation,
for example
primary
dysmenorrhea
or adnexitis.
As an adjuvant
in severe inflammatory
diseases
ofENT
organs,
accompanied
by a sensation of
pain,
for
example
faringotonzilitis
and otitis.
According
to the general
therapeutic
principles
underlying
disease should be treated by means
of
primary therapy.
Fever
itself
is not
indication
for the drug appl ication.
Posology and method of administration
Initial
dose:
1 tablet
(50 mg) 2-3 times daily.
Maintenance
treatment:
I tablet
(50 mg)
1-2 times
daily.
The maximal
daily dose of
150 mg must
not
be exceeded.
Treatment
is possible
with only one form of the drug or with a combination,
still
taking into account
the maximal
daily dose.
The tablets
should be taken during or immediately
after
meals
and swallowed
whole with some liquid.
_Patients_
_with congestive_
_heart_
_failure_
_(NYHA-J)_
_or significant_
_cardiovascular_
_risk factors_
In patients
with congestive
heart
failure (NYHA-I)
or significant
risk factors
for cardiovascular
events
diclofenac
may only be used after
careful
consideration.
If the duration of therapy
is I.onger than 4.
weeks
- only at doses
~
100
mg per day may