Montelukast Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Montelukast sodium 5.19mg equivalent to montelukast 5 mg

Available from:

Viatris Limited

INN (International Name):

Montelukast sodium 5.19 mg (equivalent to montelukast 5 mg)

Dosage:

5 mg

Pharmaceutical form:

Chewable tablet

Composition:

Active: Montelukast sodium 5.19mg equivalent to montelukast 5 mg Excipient: Aspartame Cherry flavour 501027 AP0551 Colloidal silicon dioxide Croscarmellose sodium Stear-o-wet M Mannitol Microcrystalline cellulose

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

Indicated in paediatric patients 6 to 14 years of age for the relief of daytime and night-time symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

Product summary:

Package - Contents - Shelf Life: Blister pack, comprises of a laminate with desiccant layer on one side and hard tempered Al foil on the other side - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, White HDPE with white PP cap and desiccant canister - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture

Authorization date:

2013-12-13

Patient Information leaflet

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
MONTELUKAST VIATRIS
_MONTELUKAST SODIUM 4 MG AND 5 MG CHEWABLE TABLET_
_MONTELUKAST SODIUM 10 MG FILM COATED TABLET_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
MONTELUKAST VIATRIS.
This leaflet answers some common
questions about MONTELUKAST
VIATRIS.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
MONTELUKAST VIATRIS against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT
MONTELUKAST
VIATRIS IS USED FOR
MONTELUKAST VIATRIS is used
to treat:
•
asthma, including preventing
asthma symptoms during the
day and night. It also prevents
the narrowing of airways
triggered by exercise.
•
seasonal and year-round
allergies, including daytime and
night time symptoms, including
nasal congestion, runny nose,
nasal itching, and sneezing;
nasal congestion upon
awakening, difficulty going to
sleep, and night time
awakenings; tearing, itchy, red,
and puffy eyes.
MONTELUKAST VIATRIS can be
used in children 2 years of age and
older, teenagers and adults.
MONTELUKAST VIATRIS tablets
are not used to treat an acute attack
of asthma. If an acute attack occurs,
follow your doctor’s instructions for
that situation.
Asthma is a lung disease and has
the following characteristics:
•
narrowed airways causing
breathing to become difficult.
•
inflamed airways, which means
the lining of airways become
swollen.
•
sensitive airways that react to
many things, such as cigarette
smoke, pollen, or cold air.
Symptoms of asthma include
coughing, wheezing and chest
tightness. Not all people with
asthma wheeze. For some,
coughing may be the only symptom
of asthma. Symptoms often occur
during the night or after exercise.
Seasonal allergies (also

Summary of Product characteristics

Page 1 of 15
NEW ZEALAND DATA SHEET
MONTELUKAST VIATRIS
1. PRODUCT NAME
Montelukast Viatris, 4 mg and 5 mg, chewable tablets and 10 mg film
coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4 mg chewable tablet contains 4.150 mg montelukast sodium, which
is equivalent to 4.0 mg
of montelukast.
Each 5 mg chewable tablet contains 5.190 mg montelukast sodium, which
is equivalent to 5.0 mg
of montelukast.
Excipients with known effect (Chewable Tablet): Aspartame and Cherry
Flavour
Allergen Declaration (Chewable Tablet): Aspartame and sulfites.
Each 10 mg film-coated tablet contains 10.4 mg montelukast sodium,
which is equivalent to 10.0
mg of the free acid montelukast.
Excipients with known effect (Film Coated Tablet): Mannitol
Allergen Declaration (Film Coated Tablet): Gluten from wheat
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
4 MG CHEWABLE TABLET: A white to off-white coloured, oval, biconvex
tablet debossed with “M” on
one side and “MS1” on the other side.
5 MG CHEWABLE TABLET: A white to off-white coloured, round, biconvex
tablet debossed with “M” on
one side and “MS2” on the other side.
10 MG FILM COATED TABLET: A blue film-coated, round bi-convex beveled
edge shaped tablet
debossed with “MO” over “10” on one side and “M” on the
reverse.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Montelukast Viatris tablets are indicated in paediatric patients 2
years of age and older for the
prophylaxis and chronic treatment of asthma, including the prevention
of day-time and night-time
symptoms and the prevention of exercise-induced bronchospasm.
Montelukast Viatris tablets are indicated in paediatric patients 2
years of age and older for the relief
of day-time and night-time symptoms of seasonal allergic rhinitis and
perennial allergic rhinitis.
Page 2 of 15
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
Montelukast Viatris tablets should be taken once daily. For asthma,
the dose should be taken in the
evening. For allergic rhinitis, the time