Montol

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

montelukast (montelukast sodium)

Available from:

Delorbis Pharmaceuticals Ltd.

INN (International Name):

montelukast (montelukast sodium)

Dosage:

5mg

Pharmaceutical form:

tablets chewable

Prescription type:

Prescription

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTOL 5 MG CHEWABLE TABLETS
Montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
TAKING THIS MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or
pharmacist.
•
This medicine has been prescribed for you or your child. Do not pass
it on to others. It may
harm them, even if their symptoms are the same as yours or your
child’s.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. See section 4.
IN THIS LEAFLET:
1. What Montol 5 mg is and what it is used for
2. Before you take Montol 5 mg
3. How to take Montol 5 mg
4. Possible side effects
5. How to store Montol 5 mg
6. Further information
1.
WHAT MONTOL 5 MG IS AND WHAT IT IS USED FOR
Montol 5 mg is a leukotriene receptor antagonist that blocks
substances called leukotrienes.
Leukotrienes cause narrowing and swelling of airways in the lungs. By
blocking leukotrienes,
Montol 5 mg improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montol 5 mg to treat asthma, preventing
your asthma symptoms
during the day and night.
•
Montol 5 mg is used for the treatment of patients who are not
adequately controlled on
their medication and need additional therapy.
•
Montol 5 mg may also be used as an alternative treatment to inhaled
corticosteroids for 6
to 14 year old patients who have not recently taken oral
corticosteroids for their asthma
and have shown that they are unable to use inhaled corticosteroids.
•
Montol 5 mg also helps prevent the narrowing of airways triggered by
exercise.
Your doctor will determine how Montol 5 mg should be used depending on
the symptoms and
severity of you or your child’s asthma.
WHAT IS ASTHMA?
Asthma is a long-term disease.
Asthma includes:
2
•
difficulty breathing because of narrowed airways. This narrowing of
airways worsens and
improves in response to various conditions.

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Montol 5 mg Chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains montelukast sodium equivalent to 5 mg of
montelukast.
Excipient(s) with known effect: Aspartame 6.00 mg per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablets
Pink, round, biconvex tablets with “M5” engraved on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Montol 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 “as-needed” short-acting β-agonists provide inadequate
clinical control of asthma.
Montol 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).
Montol is also indicated in the prophylaxis of asthma in which the
predominant component is
exercise-induced bronchoconstriction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage for paediatric patients 6-14 years of age is one 5 mg
chewable tablet daily to be taken
in the evening. If taken in connection with food, Montol should be
taken 1 hour before or 2 hours
after food. No dosage adjustment within this age group is necessary.
_General recommendations_
:
SUMMARY OF PRODUCT CHARACTERISTICS
2
The therapeutic effect of Montol on parameters of asthma control
occurs within one day. Patients
should be advised to continue taking Montol even if their asthma is
under control, as well as
during periods of worsening asthma.
No dosage adjustment is necessary for patients with renal
insufficiency, or mild to moderate
hepatic impairment. There are no data on patients with severe hepatic
impairment. The dosage is
the same for both male and female patients.
_Montol as