Montelukast 5mg chewable tablets sugar free

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Montelukast sodium

Prieinama:

Milpharm Ltd

ATC kodas:

R03DC03

INN (Tarptautinis Pavadinimas):

Montelukast sodium

Dozė:

5mg

Vaisto forma:

Chewable tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 03030200; GTIN: 8901175013852

Pakuotės lapelis

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 the lungs. By blocking leukotrienes,
Montelukast improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast to treat asthma, preventing
your asthma symptoms during the day and night.
•
Montelukast is used for the treatment of 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 6 to14 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.
Your doctor will determine how Montelukast 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:
•
difficulty breathing because of narrowed airways. This
narrowing of airways worsens and improves in response to
various conditions.
•
sensitive airways that react to many things, such as cigarette
smoke, pollen, cold air,

Prekės savybės

OBJECT 1
MONTELUKAST 5 MG CHEWABLE TABLETS
Summary of Product Characteristics Updated 02-Aug-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Montelukast 5 mg Chewable Tablets
2. Qualitative and quantitative composition
One chewable tablet contains montelukast sodium, which is equivalent
to 5 mg montelukast.
_Excipient with known effect_:Aspartame (E 951) 1.5 mg per tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Chewable tablet
Pink colored, mottled, round (diameter 9.5 mm), biconvex, uncoated
tablets debossed with 'X' on one side
and '53' on other side.
4. Clinical particulars
4.1 Therapeutic indications
Montelukast is indicated in the treatment of asthma as add-on therapy
in those 6 to 14 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 6 to 14
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 for 6 to 14
year old patients in which the
predominant component is exerciseinduced 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, Montelukast 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 Montelukast on parameters of asthma control
occurs within one day. Patients
should be advised to continue taking Montelukast even if their asthma
is under control, as well as during
periods