Montelukast 4mg chewable tablets sugar free

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Montelukast sodium

Commercializzato da:

Milpharm Ltd

Codice ATC:

R03DC03

INN (Nome Internazionale):

Montelukast sodium

Dosaggio:

4mg

Forma farmaceutica:

Chewable tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 03030200; GTIN: 8901175013845

Foglio illustrativo

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 is and what it is used for
2.
What you need to know before you take Montelukast
3.
How to take Montelukast
4.
Possible side effects
5.
How to store Montelukast
6.
Contents of the pack and other information
Montelukast is a leukotriene receptor antagonist that blocks
substances called leukotrienes. Leukotrienes cause narrowing and
swelling of airways in your lungs. By blocking leukotrienes,
Montelukast improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast to treat your child’s
asthma, preventing asthma symptoms during the day and night.
•
Montelukast is used for the treatment of 2 to 5 year old patients
who are not adequately controlled on their medication and need
additional therapy.
•
Montelukast may also be used as an alternative treatment to
inhaled corticosteroids for 2 to 5 year old patients who have not
recently taken oral corticosteroids for their asthma and have
shown that they are unable to use inhaled corticosteroids.
•
Montelukast also helps prevent the narrowing of airways
triggered by exercise for patients 2 years of age and older.
Your doctor will determine how Montelukast should be used
depending on the symptoms and severity of your child’s asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
•
difficulty breathing because of narrowed airways. This
narrowing of airways worsens and improves in response to
various conditions.
•
sensitive airways that react

Scheda tecnica

OBJECT 1
MONTELUKAST 4 MG CHEWABLE TABLETS
Summary of Product Characteristics Updated 02-Aug-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Montelukast 4 mg chewable tablets
2. Qualitative and quantitative composition
One chewable tablet contains montelukast sodium, which is equivalent
to 4 mg montelukast.
_Excipient with known effect_: Aspartame (E 951) 1.2 mg per tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Chewable tablet
Pink colored, mottled, oval, biconvex, uncoated tablets debossed with
'X' on one side and '52' on other
side. The size is 11.0 mm X 8.0 mm.
4. Clinical particulars
4.1 Therapeutic indications
Montelukast is indicated in the treatment of asthma as add-on therapy
in those 2 to 5 year old patients
with mild to moderate persistent asthma who are inadequately
controlled on inhaled corticosteroids and in
whom “as-needed” short acting beta agonists provide inadequate
clinical control of asthma.
Montelukast may also be an alternative treatment option to low-dose
inhaled corticosteroids for 2 to 5
year old 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 is also indicated in the prophylaxis of asthma from 2
years of age and older in which the
predominant component is exercise-induced bronchoconstriction.
4.2 Posology and method of administration
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 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 4 mg