SINGULAIR ALLERGY 10mg film-coated tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Montelukast sodium

Dostupné z:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC kód:

R03DC; R03DC03

INN (Medzinárodný Name):

Montelukast sodium

Dávkovanie:

10 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Leukotriene receptor antagonists; montelukast

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2004-03-31

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR® AR 10 MG FILM-COATED 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 Singulair AR is and what it is used for
2.
What you need to know before you take Singulair AR
3.
How to take Singulair AR
4.
Possible side effects
5.
How to store Singulair AR
6.
Contents of the pack and other information
1.
WHAT SINGULAIR AR IS AND WHAT IT IS USED FOR
WHAT SINGULAIR AR IS
Singulair AR is a leukotriene receptor antagonist that blocks
substances called leukotrienes.
HOW SINGULAIR AR WORKS
Leukotrienes cause allergy symptoms. By blocking leukotrienes,
Singulair AR improves seasonal
allergy symptoms (also known as hay fever or seasonal allergic
rhinitis).
WHEN SINGULAIR AR SHOULD BE USED
Your doctor has prescribed Singulair AR for the relief of your
seasonal allergy symptoms.

Singulair AR is used for the treatment of adults and adolescents 15
years of age and older
WHAT ARE SEASONAL ALLERGIES?
Seasonal allergies (also known as hay fever or seasonal allergic
rhinitis) are an allergic response often
caused by airborne pollens from trees, grasses and weeds. The symptoms
of seasonal allergies
typically may include: stuffy, runny, itchy nose; sneezing; watery,
swollen, red, itchy eyes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SINGULAIR AR
Tell your doctor about any medical problems or allergies you have now
or have had.
DO NOT TAKE SINGULAIR AR

if you are allergic to montelukast or any of the other ingredients of
this medicine (li

Súhrn charakteristických

Health Products Regulatory Authority
14 May 2020
CRN009RQ4
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SINGULAIR ALLERGY 10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains montelukast sodium, which is
equivalent to 10 mg montelukast.
Excipients with known effect: This medicine contains 89.3 mg lactose
monohydrate per tablet.
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
that is to say essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Beige, rounded square, film-coated, size 7.9 mm x 7.9 mm with 117
engraved on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The relief of symptoms of seasonal allergic rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for adults and adolescents 15 years of age and
older is one 10 mg tablet daily.
General recommendations
Singulair Allergy contains montelukast, the same active ingredient in
Singulair. Singulair Allergy should not be used
concomitantly with other products containing the same active
ingredient, montelukast. Singulair Allergy may be taken with or
without food. Singulair Allergy should be taken once daily each day
for the duration of prescribed therapy. The time of
administration for seasonal allergic rhinitis may be individualized to
suit patient needs.
No dosage adjustment is necessary for the elderly, or 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.
_Paediatric population_
Do not give Singulair Allergy 10 mg film‑coated tablets to children
and adolescents less than 15 years of age. The safety and
efficacy of Singulair Allergy 10 mg film‑coated tablets in patients
younger than 15 years of age have not been established.
5 mg chewable tablets are available for paediatric patients 6 to 14
years of age.
4