Montelukast Bluefish 5 mg chewable tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Montelukast sodium

Available from:

Bluefish Pharmaceuticals AB

ATC code:

R03DC03

INN (International Name):

Montelukast sodium

Dosage:

5 milligram(s)

Pharmaceutical form:

Chewable tablet

Therapeutic area:

montelukast

Authorization status:

Marketed

Authorization date:

2021-09-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST BLUEFISH 4 MG/ 5 MG CHEWABLE TABLETS
montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Montelukast Bluefish is and what it is used for
2.
What you need to know before you take Montelukast Bluefish
3.
How to take Montelukast Bluefish
4.
Possible side effects
5.
How to store Montelukast Bluefish
6.
Contents of the pack and other information
1.
WHAT MONTELUKAST BLUEFISH IS AND WHAT IT IS USED FOR
WHAT MONTELUKAST BLUEFISH IS
Montelukast Bluefish is a leukotriene receptor antagonist that blocks
substances called leukotrienes.
HOW MONTELUKAST BLUEFISH WORKS
Leukotrienes cause narrowing and swelling of airways in the lungs and
also cause allergy symptoms.
By blocking leukotrienes, Montelukast Bluefish improve asthma
symptoms, help control asthma and
improve seasonal allergy symptoms (also known as hay fever or seasonal
allergic rhinitis).
WHEN MONTELUKAST BLUEFISH SHOULD BE USED
Your doctor has prescribed Montelukast
_ _
Bluefish to treat your child’s asthma, preventing asthma
symptoms during the day and night.
-
Montelukast
_ _
Bluefish is used for the treatment of children from 2 to 5 years (4 mg
dose) and
6 to 14 years (5 mg dose) who are not adequately controlled on their
medication and need
ADDITIONAL THERAPY
.
-
Montelukast
_ _
Bluefish may also be used as an
ALTERNATIVE TREATMENT TO INHALED CORTICOSTEROIDS
for
children from 2 to 5 year/6-14 years who have not recently taken oral
corticosteroids for their
asthma and have s

Summary of Product characteristics

Health Products Regulatory Authority
13 September 2021
CRN009R47
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Montelukast Bluefish 5 mg chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains montelukast sodium, which is equivalent
to 5 mg montelukast.
Excipient with known effect:
This medicine contains aspartame (E 951) 1.5 mg per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Light pink coloured, speckled, round, biconvex shaped, chewable
tablets debossed with 'I' on one side and '113' on the other
side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Montelukast Bluefish is indicated in the treatment of asthma as add-on
therapy in those patients with mild to moderate
persistent asthma who are inadequately controlled on inhaled
corticosteroids and in whom 'asneeded' short-acting β-agonists
provide inadequate clinical control of asthma.
Montelukast Bluefish may also be an alternative treatment option to
low-dose inhaled corticosteroids for patients with mild
persistent asthma who do not have a recent history of serious asthma
attacks that required oral corticosteroid use, and who
have demonstrated that they are not capable of using inhaled
corticosteroids (see section 4.2).
Montelukast Bluefish is also indicated in the prophylaxis of asthma in
which the predominant component is exercise-induced
bronchoconstriction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This medicinal product is to be given to a child under adult
supervision. The dosage for paediatric patients 2-5 years of age is
one 4 mg chewable tablet daily to be taken in the evening. If taken in
connection with food, Montelukast Bluefish should be
taken 1 hour before or 2 hours after food. No dosage adjustment within
this age group is necessary. For children who have
problems consuming a chewable tablet, a granule formulation is
available (see montelukast sodium 4 mg granule SPC). The
Montelukast Bluefish 4 mg chewable tablet