Monkasta 4 mg chewable tablets

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

MONTELUKAST SODIUM

Tilgjengelig fra:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

MONTELUKAST SODIUM

Enheter i pakken:

28 mcg/mL

Produsert av:

KRKA, d.d., Novo mesto

Preparatomtale

1.3.1
Montelukast sodium
SPC, Labeling and Package Leaflet
MY
SmPCPIL136738_4
31.07.2019 – Updated: 22.04.2021
Page 1 of 6
NAME OF THE MEDICINAL PRODUCT
Monkasta chewable tablets 4 mg
Monkasta chewable tablets 5 mg
QUALITY AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 5 mg montelukast (equivalent to 5.20 mg
montelukast sodium).
Each chewable tablet contains 4 mg montelukast (equivalent to 4.16 mg
montelukast sodium).
Excipient:
4 mg tablets
5 mg tablets
aspartame
1.2 mg
1.5 mg
PHARMACEUTICAL FORM
Chewable tablet.
Monkasta chewable tablets 4 mg are presented as pink, marbled, round,
slightly biconvex tablets with
bevelled edges and inscription 4 on one side.
Monkasta chewable tablets 5 mg are presented as pink, marbled, round,
slightly biconvex tablets with
bevelled edges and inscription 5 on one side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
For the prophylaxis and chronic treatment of asthma in adults and
paediatric patients 2 years of age
and older.
Monkasta is indicated if adults 15 years of age and older for the
relief of daytime and night-time
symptoms of seasonal allergic rhinitis.
POSOLOGY AND METHOD OF ADMINISTRATION
Monkasta should be taken once daily. For the treatment of asthma, the
dose should be taken in the
evening. For seasonal allergic rhinitis, the time of administration
may be individualised to suit patient
needs.
Patients with asthma and seasonal allergic rhinitis should take only
one tablet daily, in the evening.
_Pediatric Patients 6 to 14 Years of Age with Asthma _
The dosage for children 6 to 14 years of age is one 5 mg chewable
tablet daily.
_Pediatric Patients 2 to 5 Years of Age with Asthma _
The dosage for children 2 to 5 years of age is one 4 mg chewable
tablet daily
.
_General recommendations_
The therapeutic effect of Monkasta on parameters of asthma control
occurs within one day. Patients
should be advised to continue taking Monkasta even if their asthma is
under control, as well as during
periods of worsening asthma.
1.3.1
Montelukast sodium
SPC, Labeling and Pac