Movalis tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

meloxicam

Available from:

Boehringer Ingelheim Ellas A.E.

ATC code:

M01AC06

INN (International Name):

meloxicam

Dosage:

7,5mg

Pharmaceutical form:

tablets

Units in package:

(20/2x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-03-17

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Movalis 7.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.5 mg of Meloxicam.
Excipient(s) with known effect
Each tablet contains 22.3 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Light yellow round tablet with the logotype of the company on one side
and a score with 59D/59D on the
other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide 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 (one 7.5 mg tablet).
If necessary, in the absence of improvement, the dose may be increased
to 15 mg/day (two 7.5 mg
tablets).
-
Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (two 7.5 mg
tablets) (see also section ‘Special
populations’ below).
According to the therapeutic response, the dose may be reduced to 7.5
mg/day (one 7.5 mg tablet).
DO NOT EXCEED THE DOSE OF 15MG/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 incre