9628415
Patient Information
SINGULAIR® (SING-u-lair) Tablets, ChewableTablets, and Oral Granules
Generic name: montelukast (mon-te-LOO-kast) sodium
Read this information before you start taking
SINGULAIR®. Also, read the leaflet you get each time
you refill SINGULAIR, since there may be new information
in the leaflet since the last time you saw it. This leaflet
does not take the place of talking with your doctor
about your medical condition and/or your treatment.
What is SINGULAIR*?
• SIN G U LA IR is a medicine called a leukotriene
receptor antagonist. It works by blocking
substances in the body called leukotrienes.
Blocking leukotrienes improves asthma and allergic
rhinitis. SIN G U LA IR is not a steroid. Studies have
shown that SIN G U LA IR does not affect the growth
rate of children. (See the end of this leaflet for more
information about asthma and allergic rhinitis.)
SIN G U LA IR is prescribed for the treatment of asthma,
the prevention of exercise-induced asthma, and
allergic rhinitis:
1. Asthma.
SIN G U LA IR should be used for the long-term
management of asthma in adults and children
ages 12 months and older.
Do not take SINGULAIR for the immediate relief
of an asthma attack.
If you get an asthma attack,
you should follow the instructions your doctor
gave you for treating asthma attacks.
2. Prevention of exercise-induced asthma.
SIN G U LA IR is used for the prevention of exercise-
induced asthma in patients 15 years of age and older.
3. Allergic Rhinitis.
SIN G U LA IR is used to help control the symptoms
of allergic rhinitis (sneezing, stuffy nose, runny
nose, itching of the nose). SIN G U LA IR is used to
treat seasonal allergic rhinitis (outdoor allergies
that happen part of the year) in adults and children
ages 2 years and older, and perennial allergic
rhinitis (indoor allergies that happen all year) in
adults and children ages 6 months and older.
Who should not take SINGULAIR?
Do not take SIN GULAIR if you are allergic to SINGULAIR
or any of its ingredients.
The active ingredient in SIN G U LA IR is montelukast
sodium.
See the end of this leaflet for a list of all the ingredients
in SIN GULAIR.
What should I tell my doctor before I start taking
SINGULAIR?
Tell your doctor about:
•
Pregnancy:
If you are pregnant or plan to become
pregnant, SIN G U LA IR may not be right for you.
•
Breast-feeding:
If you are breast-feeding,
SIN G U LA IR may be passed in your milk to your
baby. You should consult your doctor before
taking SIN G U LA IR if you are breast-feeding or
intend to breast-feed.
•
Medical Problems or Allergies:
Talk about any
medical problems or allergies you have now or
had in the past.
•
Other Medicines:
Tell your doctor about all
the medicines you take, including prescription
and non-prescription medicines, and herbal
supplements. Som e medicines may affect how
SIN G U LA IR works, or SIN G U LA IR may affect
how your other medicines work.
How should I take SINGULAIR?
For adults and children
12
months of age and older
with asthma:
• Take SIN G U LA IR once a day in the evening.
• Take SIN G U LA IR every day for as long as your
doctor prescribes it, even if you have no asthma
symptoms.
• You may take SINGULAIR with food or without food.
• If your asthma sym ptom s get worse, or if you
need to increase the use of your inhaled rescue
medicine for asthma attacks, call your doctor
right away.
•
Do not take SINGULAIR for the immediate relief
of an asthma attack.
If you get an asthma attack,
you should follow the instructions your doctor
gave you for treating asthma attacks.
• Alw ays have your inhaled rescue medicine for
asthma attacks with you.
• Do not stop taking or lower the dose of your other
asthma medicines unless your doctor tells you to.
For patients 15 years of age and older for the
prevention of exercise-induced asthma:
• Take SIN G U LA IR at least 2 hours before exercise.
• Alw ays have your inhaled rescue medicine for
asthma attacks with you.
• If you are taking SIN G U LA IR daily for chronic
asthma or allergic rhinitis, do not take an
additional dose to prevent exercise-induced
asthma. Speak to your doctor about your
* Registered trademark of MERCK & CO., Inc.
COPYRIGHT © 1998-2009 MERCK & CO., Inc.
All rights reserved
treatment of exercise-induced asthma.
• Do not take an additional dose of SINGULAIR
within 24 hours of a previous dose.
For adults and children 2 years of age and older
with seasonal allergic rhinitis, or for adults and
children
6
months of age and older with perennial
allergic rhinitis:
• Take SINGULAIR once a day, at about the same
time each day.
• Take SINGULAIR every day for as long as your
doctor prescribes it.
• You may take SINGULAIR with food or without food.
How should I give SINGULAIR oral granules to my child?
Do not open the packet until ready to use.
SINGULAIR 4-mg oral granules can be given:
• directly in the mouth;
• dissolved in 1
teaspoonful (5 mL) of cold or room
temperature baby formula or breast milk;
• mixed with a spoonful of one of the following soft
foods at cold or room temperature: applesauce,
mashed carrots, rice, or ice cream.
Be sure that the entire dose is mixed with the food,
baby formula, or breast milk and that the child is
given the entire spoonful of the food, baby formula, or
breast milk mixture right away (within 15 minutes).
IMPORTANT: Never store any oral granules mixed
with food, baby formula, or breast milk for use at a
later time. Throw away any unused portion.
Do not put SINGULAIR oral granules in any
liquid drink other than baby formula or breast
milk. However, your child may drink liquids after
swallowing the SINGULAIR oral granules.
What is the dose of SINGULAIR?
For asthma—Take once daily in the evening:
• One 10-mg tablet for adults and adolescents
15 years of age and older,
• One 5-mg chewable tablet for children
6
to
14 years of age,
• One 4-mg chewable tablet or one packet of 4-mg
oral granules for children 2 to 5 years of age, or
• One packet of 4-mg oral granules for children
12 to 23 months of age.
For exercise-induced asthma—Take at least 2 hours
before exercise, but not more than once daily:
• One 10-mg tablet for adults and adolescents
15 years of age and older
• joint pain, muscle aches and muscle cramps
• swelling
Behavior and mood-related changes have been
reported: agitation including aggressive behavior or
hostility, bad/vivid dreams, depression, feeling anxious,
hallucinations (seeing things that are not there), irritability,
restlessness, sleep walking, suicidal thoughts and
actions (including suicide), tremor, trouble sleeping.
Tell your doctor if you experience behavior or mood-
related changes while taking SINGULAIR.
Rarely, asthmatic patients taking SINGULAIR have
experienced a condition that includes certain
symptoms that do not go away or that get worse.
These occur usually, but not always, in patients who
were taking steroid pills by mouth for asthma and
those steroids were being slowly lowered or stopped.
Although SINGULAIR has not been shown to cause
this condition, you must tell your doctor 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)
These are not all the possible side effects of SINGULAIR.
For more information ask your doctor or pharmacist.
Talk to your doctor if you think you have side effects
from taking SINGULAIR.
General Information about the safe and effective use
of SINGULAIR
Medicines are sometimes prescribed for conditions
that are not mentioned in patient information leaflets.
Do not use SINGULAIR for a condition for which it
was not prescribed. Do not give SINGULAIR to other
people even if they have the same symptoms you
have. It may harm them. Keep SINGULAIR and all
medicines out of the reach of children.
Store SINGULAIR at 25°C (77°F). Protect from moisture
and light. Store in original package.
This leaflet summarizes information about
SINGULAIR. If you would like more information, talk
to your doctor. You can ask your pharmacist or doctor
for information about SINGULAIR that is written for
health professionals.
What are the ingredients in SINGULAIR?
For allergic rhinitis—Take once daily at about the
same time each day:
• One 10-mg tablet for adults and adolescents
15 years of age and older,
• One 5-mg chewable tablet for children 6 to
14 years of age,
• One 4-mg chewable tablet for children 2 to
5 years of age, or
• One packet of 4-mg oral granules for children
2 to 5 years of age with seasonal allergic rhinitis,
or for children 6 months to 5 years of age with
perennial allergic rhinitis.
What should I avoid while taking SINGULAIR?
If you have asthma and if your asthma is made
worse by aspirin, continue to avoid aspirin or other
medicines called non-steroidal anti-inflammatory
drugs while taking SIN GULA IR.
What are the possible side effects of SINGULAIR?
The side effects of SIN G U LA IR are usually mild, and
generally did not cause patients to stop taking their
medicine. The side effects in patients treated with
SIN G U LA IR w ere similar in type and frequency to side
effects in patients who were given a placebo (a pill
containing no medicine).
The most common side effects with SIN G ULA IR
include:
• stomach pain
• stomach or intestinal upset
• heartburn
• tiredness
• fever
• stuffy nose
• cough
• flu
• upper respiratory infection
• dizziness
• headache
• rash
Less common side effects that have happened with
SIN G U LA IR 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]
• drowsiness, pins and needles/numbness,
seizures (convulsions or fits)
• palpitations
• nose bleed
• diarrhea, indigestion, inflammation of the
pancreas, nausea, vomiting
• hepatitis
• bruising
Active ingredient: montelukast sodium
SINGULAIR chewable tablets contain aspartame,
a source of phenylalanine.
Phenylketonurics: SINGULAIR 4-mg and 5-mg
chewable tablets contain 0.674 and 0.842 mg
phenylalanine, respectively.
Inactive ingredients:
• 4-mg oral granules: mannitol, hydroxypropyl
cellulose, and magnesium stearate.
• 4-mg and 5-mg chewable tablets: mannitol,
microcrystalline cellulose, hydroxypropyl
cellulose, red ferric oxide, croscarmellose
sodium, cherry flavor, aspartame, and
magnesium stearate.
•
10
-mg tablet: microcrystalline cellulose, lactose
monohydrate, croscarmellose sodium, hydroxypropyl
cellulose, magnesium stearate, hydroxypropyl
methylcellulose, titanium dioxide, red ferric
oxide, yellow ferric oxide, and carnauba wax.
What is asthma?
Asthma is a continuing (chronic) inflammation of the
bronchial passageways which are the tubes that carry
air from outside the body to the lungs.
Symptoms of asthma include:
• coughing
• wheezing
• chest tightness
• shortness of breath
What is exercise-induced asthma?
Exercise-induced asthma, more accurately called
exercise-induced bronchoconstriction occurs when
exercise triggers symptoms of asthma.
What is allergic rhinitis?
• Seasonal allergic rhinitis, also known as hay fever,
is triggered by outdoor allergens such as pollens
from trees, grasses, and weeds.
• Perennial allergic rhinitis may occur year-round and
is generally triggered by indoor allergens such as
dust mites, animal dander, and/or mold spores.
• Symptoms of allergic rhinitis may include:
• stuffy, runny, and/or itchy nose
• sneezing
Rx only
US Patent No.: 5,565,473
Issued August 2009
Distributed by:
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA
20952848(3)(415)-SNG-CON
