MOBIC TABLET 7.5 mg

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

MELOXICAM

Commercializzato da:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Codice ATC:

M01AC06

Dosaggio:

7.5 mg

Forma farmaceutica:

TABLET

Composizione:

MELOXICAM 7.5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

BOEHRINGER INGELHEIM PHARMA GMBH & CO KG

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

1997-11-28

Foglio illustrativo

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Scheda tecnica

MOBIC®
abcd
1.
NAME OF THE MEDICINAL PRODUCT
MOBIC® Tablet 7.5mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1
tablet
contains
7.5
mg
4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-
carboxamide-1,1-dioxide (= meloxicam)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
3.1
PRODUCT DESCRIPTION
Round, pastel yellow, snap-tab tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MOBIC® is a non-steroidal anti-inflammatory drug indicated for
- symptomatic treatment of painful osteoarthritis (arthrosis,
degenerative joint disease).
- symptomatic treatment of rheumatoid arthritis.
- symptomatic treatment of ankylosing spondylitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
As the potential for adverse reactions increases with dose and
duration of exposure, the shortest
duration possible and the lowest effective daily dose should be used.
The total daily dose of MOBIC® should be administered as a single
dose. For adults the maximum
recommended daily dose regardless of formulation is 15 mg.
Painful osteoarthritis: 7.5 mg/day. If necessary, the dose may be
increased to 15 mg/day.
Rheumatoid arthritis: 15 mg/day. According to the therapeutic
response, the dose may be reduced to
7.5 mg/day.
Ankylosing spondylitis: 15 mg/day.
SPECIAL POPULATIONS
In patients with increased risks of adverse reactions, e.g. a history
of gastro-intestinal disease or risk
factors for cardiovascular disease, the treatment should be started at
a dose of 7.5 mg/day (see Special
warnings and precautions for use).
No dose reduction is required in patients with mild or moderate renal
impairment (i.e. in patients with a
creatinine clearance of greater than 25 ml/min). In non-dialysed
patients with severe renal impairment
MOBIC®
is
contraindicated
(see
Contraindications).
In
patients
with
end-stage
renal
failure
on
haemodialysis the maximum daily dose should not exceed 7.5 mg/day.
As a dosage for use in adolescents has not yet been established, usage
should be restricted to adults.
MET