Movalis tablets

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

meloxicam

Verfügbar ab:

Boehringer Ingelheim Ellas A.E.

ATC-Code:

M01AC06

INN (Internationale Bezeichnung):

meloxicam

Dosierung:

15mg

Darreichungsform:

tablets

Einheiten im Paket:

(20/2x10/) in blister

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2017-03-17

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Movalis 15 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg of Meloxicam.
Excipient(s) with known effect
Each tablet contains 19.0 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Light yellow round scored tablet with the logotype of the company on
one side and a score with 77C/77C on
the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Short-term symptomatic treatment of exacerbations of osteoarthrosis
-
Long-term symptomatic treatment of rheumatoid arthritis or ankylosing
spondylitis
-
Movalis tablets are indicated in adults and children aged 16 years and
older
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The total daily amount should be taken as a single dose.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary
to control symptoms (see section 4.4). The patient's need for
symptomatic relief and response to therapy
should be re-evaluated periodically, especially in patients with
osteoarthritis.
-
Exacerbations of osteoarthrosis: 7.5 mg/day (half a 15 mg tablet).
If necessary, in the absence of improvement, the dose may be increased
to 15 mg/day (one 15 mg tablet).
-
Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (one 15 mg
tablet) (see also section ‘Special
populations below).
According to the therapeutic response, the dose may be reduced to 7.5
mg/day (half a 15 mg tablet).
DO NOT EXCEED THE DOSE OF 15 MG/DAY.
Special populations
_Elderly patients (see section 5.2) _
The recommended dose for long term treatment of rheumatoid arthritis
and ankylosing spondylitis in elderly
patients is 7.5 mg per day (see also sections 4.2 ‘Patients with
increased risks for adverse reaction’ and 4.4).
_Patients with increased risks for adverse reaction (see section 4.4)
_
In patients with increased risks for adverse reactions, e.g. a history
of gastro