Actamone 5mg chewable Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MONTELUKAST

Available from:

Sigillata Limited (Ireland) Inniscarra, Main Street, Rathcoole, Co. Dublin D24 E029 , Ireland

ATC code:

R03DC03

INN (International Name):

MONTELUKAST 5 mg

Pharmaceutical form:

CHEWABLE TABLET

Composition:

MONTELUKAST 5 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Authorised

Authorization date:

2010-09-22

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTAMONE 5 MG CHEWABLE TABLETS
FOR CHILDREN 6 TO 14 YEARS OF AGE
montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU OR YOUR CHILD.
•
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 or your child only. Do not
pass it on to others. It may harm
them, even if their signs of illness are the same as your or your
child’s.
•
If you or your child 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 Actamone is and what it is used for
2.
What you need to know before you or your child take Actamone
3.
How to take Actamone
4.
Possible side effects
5.
How to store Actamone
6.
Contents of the pack and other information
1.
WHAT ACTAMONE IS AND WHAT IT IS USED FOR
WHAT ACTAMONE IS
Actamone is a leukotriene receptor antagonist that blocks substances
called leukotrienes.
HOW ACTAMONE WORKS
Leukotrienes cause narrowing and swelling of airways in the lungs. By
blocking leukotrienes, Actamone
improves asthma symptoms and helps control asthma.
WHEN ACTAMONE SHOULD BE USED
Your doctor has prescribed Actamone to treat asthma, preventing your
asthma symptoms during the day and
night.
•
Actamone is used for the treatment of paediatric patients 6 to 14
years of age who are not adequately
controlled on their medication and need additional therapy.
•
Actamone 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.
•
Actamone also helps prevent the narrowing of airways triggered by
exercise.
Your doctor will determine how Actamone should be used depending on
the symptoms and severit

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Actamone 5 mg chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Actamone 5 mg chewable tablet contains montelukast sodium
equivalent to 5 mg montelukast
_Excipients with known effect: _
Each Actamone 5 mg chewable tablet contains 4.5 mg lactose monohydrate
and 1.5 mg aspartame.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
Pink, mottled, round, biconvex tablet, diameter 9.5 mm with M5
engraved on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Actamone 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.
Actamone 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).
Actamone 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: _
The recommended dose 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, Actamone
should be taken 1 hour before or 2 hours
after food. No dosage adjustment within this age group is necessary.
_General recommendations: _
_ _
The therapeutic effect of Actamone on parameters of asthma control
occurs within one day. Patients should
be advised to continue taking Actamone even if their asthma is under
control, as well as during periods of
worsening asthma.
2
No dosage adjustment is necessary for patients with renal
insufficiency, or mild to moderate hepatic
impairm