P a tie n tin fo rm a tio n
9989618
S IN G U L A IR
(S IN G -u *la ir) (m o n te lu k a s t s o d iu m ) T a b le ts
S IN G U L A IR
(m o n te lu k a s t s o d iu m ) C h e w a b le T a b le ts
S IN G U L A IR - (m o n te lu k a s t s o d iu m ) O ra l G ra n u le s
Read the Patient Information Leaflet that comes with
SINGULAIR before you start taking it and each time you
get a refill. There may be new information. This leaflet
does not take the place of talking with your healthcare
provider about your medical condition or your treatment.
What is SINGULAIR?
• SINGULAIR is a prescription medicine that blocks
substances in the body called leukotrienes. This may
help to improve sym ptom s of asthma and allergic
rhinitis. SINGULAIR does not contain a steroid.
SINGULAIR is used to:
1. Prevent asthma attacks and for the long-term
treatment of asthma in adults and children ages
12 months and older.
Do not take SINGULAIR if you need relief right away
for a sudden asthma attack. If you get an asthma attack,
you should follow the instructions your healthcare
provider gave you for treating asthma attacks.
2. Prevent exercise-induced asthma in people 15 years
of age and older.
3. Help control the sym ptom s of allergic rhinitis
(sneezing, stuffy nose, runny nose, itching of the
nose). SINGULAIR is used to treat:
• outdoor allergies that happen part of the year
(seasonal allergic rhinitis) in adults and children
ages 2 years and older, and
• indoor allergies that happen all year (perennial
allergic rhinitis) in adults and children ages 6
months and older.
• Tell your healthcare provider right away if your
asthma sym ptom s get worse, or if you need to use
your rescue inhaler medicine more often for asthma
attacks.
• Do not take SINGULAIR if you need relief right away
from a sudden asthm a attack. If you get an asthma
attack, you should follow the instructions your
healthcare provider gave you for treating asthma
attacks.
• Alw ays have your rescue inhaler medicine with you
for asthma attacks.
• Do not stop taking or lower the dose of your other
asthma m edicines unless your healthcare provider
tells you to.
For patients 15 years of age and older for the
prevention of exercise-induced asthma:
• Take SINGULAIR at least 2 hours before exercise.
• Alw ays have your rescue inhaler medicine with you
for asthma attacks.
• If you take SINGULAIR every day for chronic
asthma or allergic rhinitis, do not take another
dose to prevent exercise-induced asthma. Talk to
your healthcare provider about your treatment for
exercise-induced asthma.
• Do not take 2 doses of SINGULAIR w ithin 24 hours
(1 day).
For adults and children 2 years of age and older w ith
seasonal allergic rhinitis, or for adults and children
6 m onths of age and older w ith perennial allergic
rhinitis:
• Take SINGULAIR 1 time each day, at about the same
time each day.
How should I give SINGULAIR oral granules to my child?
Tell your healthcare provider right away if you get
one or more of these symptoms:
• a feeling of pins and needles or numbness of arms
or legs
• a flu-like illness
• rash
• severe inflammation (pain and swelling) of the
sinuses (sinusitis)
The most common side effects w ith SINGULAIR include:
upper respiratory infection
fever
headache
sore throat
cough
stomach pain
diarrhea
earache or ear
infection
flu
runny nose
sinus infection
Other side effects w ith SINGULAIR include:
• increased bleeding tendency
• allergic reactions (including swelling of the face, lips,
tongue, and/or throat (which may cause trouble
breathing or swallowing), hives and itching)
• dizziness, drowsiness, pins and needles/numbness,
seizures (convulsions or fits)
• palpitations
• nose bleed, stuffy nose
• diarrhea, heartburn, indigestion, inflammation of
the pancreas, nausea, stomach or intestinal upset,
vomiting
• hepatitis
• bruising, rash
• joint pain, muscle aches and muscle cramps
• tiredness, swelling
Tell your healthcare provider if you have any side effect
that bothers you or that does not go away.
W ho should not take SINGULAIR?
Do not take SINGULAIR if you are allergic to any of its
ingredients.
See the end of this leaflet for a complete list of the
ingredients in SINGULAIR.
What should I tell my healthcare provider before taking
SINGULAIR?
Before taking SINGULAIR, tell your healthcare provider
if you:
• are allergic to aspirin
• have phenylketonuria. SINGULAIR chewable tablets
contain aspartame, a source of phenylalanine
• have any other medical conditions
• are pregnant or plan to become pregnant. If you are
pregnant or plan to become pregnant, SINGULAIR
may not be right for you. If you become pregnant
while taking SINGULAIR, talk to your healthcare
provider about reporting your pregnancy to the
Pregnancy Registry for SINGULAIR, or you can enroll
in this registry by calling 1-800-986-8999.
• are breast-feeding or plan to breast-feed. It is not
known if SINGULAIR passes into your breast milk.
Talk to your healthcare provider about the best way
to feed your baby while taking SINGULAIR.
Tell your healthcare provider about all the m edicines
you take, including prescription and non-prescription
medicines, vitamins, and herbal supplements. Some
m edicines may affect how SINGULAIR works, or
SINGULAIR may affect how your other m edicines work.
Give SINGULAIR oral granules to your child exactly as
instructed by your healthcare provider.
Do not open the packet until ready to use.
SINGULAIR 4-mg oral granules can be given:
• right in the mouth; or
• dissolved in 1 teaspoonful (5 mL) of cold or room
temperature baby formula or breast milk; or
• mixed with 1 spoonful of one of the following soft
foods at cold or room temperature: applesauce,
mashed carrots, rice, or ice cream.
Give the child all of the mixture right away, within
15 minutes.
Do not store any leftover SINGULAIR m ixture (oral
granules mixed w ith food, baby formula, or breast milk)
for use at a later time. Throw away any unused portion.
Do not mix SINGULAIR oral granules w ith any liquid drink
other than baby formula or breast milk. Your child may
drink other liquids after swallowing the mixture.
What is the dose of SINGULAIR?
The dose of SINGULAIR prescribed for your or your child's
condition is based on age:
• 6 to 23 months: one packet of 4-mg oral granules.
• 2 to 5 years: one 4-mg chewable tablet or one packet
of 4-mg oral granules.
• 6 to 14 years: one 5-mg chewable tablet.
• 15yearsand older:one 10-mg tablet.
What should I avoid w hile taking SINGULAIR?
How should I take SINGULAIR?
For anyone who takes SINGULAIR:
• Take SINGULAIR exactly as prescribed by your
healthcare provider. Your healthcare provider will
tell you how much SINGULAIR to take, and when to
take it.
• Do not stop taking SINGULAIR or change when you
take it without talking with your healthcare provider.
• You can take SINGULAIR with food or without food.
See the information below in the section "How
should I give SINGULAIR oral granules to my child?"
for information about what foods and liquids can be
taken with SINGULAIR oral granules.
• If you or your child m isses a dose of SINGULAIR, just
take the next dose at your regular time. Do not take
2 doses at the same time.
• If you take too much SINGULAIR, call your doctor.
For adults and children 12 months of age and older
w ith asthma:
• Take SINGULAIR 1 time each day, in the evening.
Continue to take SINGULAIR every day for as long
as your healthcare provider prescribes it, even if you
have no asthma symptoms.
SINGULAIR is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck 8t Co., Inc.
Copyright © 1998-2010 Merck Sharp & Dohme Corp.
.
a subsidiary of Merck & Co.
. Inc.
All rights reserved
If you have asthma and aspirin makes your asthma
symptoms worse, continue to avoid taking aspirin or other
medicines called non-steroidal anti-inflammatory drugs
(NSAIDs) w hile taking SINGULAIR.
What are the possible side effects of SINGULAIR?
SINGULAIR may cause serious side effects.
Behavior and mood-related changes. Tell your
healthcare provider right away if you or your
child have any of these symptoms while taking
SINGULAIR:
• agitation including aggressive
behavior or hostility
• bad or vivid dreams
• depression
• disorientation
• feeling anxious
• hallucinations (seeing or
hearing things that are not
really there)
• irritability
• restlessness
• sleepw alking
• suicidal thoughts
and actions
(including suicide)
• tremor
• trouble sleeping
• Increase in certain w hite blood cells (eosinophils)
and possible inflamed blood vessels throughout the
body (systemic vasculitis). Rarely, this can happen
in people with asthma who take SINGULAIR. This
usually, but not always, happens in people who
also take a steroid medicine by mouth that is being
stopped or the dose is being lowered.
These are not all the possible side effects of SINGULAIR.
For more information ask your healthcare provider or
pharmacist.
Call your healthcare provider for medical advice about
side effects. You may report side effects to FDA at
1-800-FDA-1088.
How should I store SINGULAIR?
• Store SINGULAIR at 59°F to 86°F (15°C to 30°C).
• Keep SINGULAIR in the container it com es in.
• Keep SINGULAIR in a dry place and away from light.
General Information about the safe and effective use of
SINGULAIR
Medicines are som etim es prescribed for purposes other
than those mentioned in Patient Information Leaflets. Do
not use SINGULAIR for a condition for which it was not
prescribed. Do not give SINGULAIR toother people even
if they have the same sym ptom s you have. It may harm
them. Keep SINGULAIR and all medicines out of the reach
of children.
This leaflet summarizes information about SINGULAIR.
If you would like more information, talk to your healthcare
provider. You can ask your pharmacist or healthcare
provider for information about SINGULAIR that is written
for health professionals. For more information, go to
www.singulair.com or call the Merck National Service
Center at 1-800-NSC-Merck (1-800-672-6372).
What are the ingredients in SINGULAIR?
Active ingredient: montelukast sodium
Inactive ingredients:
• 4-mq oral granules: mannitol, hvdroxvpropyl
cellulose, and magnesium stearate.
• 4-mq and 5-mq chewable tablets: mannitol,
m icrocrystalline cellulose, hydroxypropyl cellulose,
red ferric oxide, croscarm ellose sodium, cherry
flavor, aspartame, and magnesium stearate.
People with Phenylketonuria: SINGULAIR 4-mg
chewable tablets contain 0.674 mg of phenylalanine,
and SINGULAIR 5-mg chewable tablets contain
0.842 mg of phenylalanine.
•
10-mq tablet: m icrocrvstalline cellulose,
lactose monohydrate, croscarm ellose sodium,
hydroxypropyl cellulose, and magnesium
stearate. The film coating contains: hydroxypropyl
methylcellulose, hydroxypropyl cellulose, titanium
dioxide, red ferric oxide, yellow ferric oxide, and
carnauba wax.
US Patent No.: 5,565,473
Issued M ay 2010
Dist. by:
Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC.
W hitehouse Station, NJ 08889, U SA
21050776(30)(618)-SNG
