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Patient Information 9628414

SINGULAIR^® (SING-u-lair) Tablets, Chewable Tablets, and Oral Granules

Generic name: montelukast (mon-te-LOO-kast) sodium

Read this information before you start taking treatment of exercise-induced asthma. seizures (convulsions or fits)

SINGULAIR^®. Also, read the leaflet you get each time • Do not take an additional dose of SINGULAIR • palpitations you refill SINGULAIR, since there may be new information within 24 hours of a previous dose. • nose bleed in the leaflet since the last time you saw it. This leaflet _does _not _take _the _place _of _talking _with _your _doctor _For _adults _and _children ₂ _years _of _age _and _older • diarrhea, indigestion, inflammation of the _about _your _medical _condition _and/or _your _treatment. _with _seasonal _allergic _rhinitis, _or _for _adults _and _pancreas, _nausea, _vomiting_children ₆ _months _of _age _and _older _with _perennial _• _hepatitis_What _is _SINGULAIR*_allergic _rhinitis_: _• _{bruising •} _joint _pain, _muscle _aches _and _muscle _cramps

• SINGULAIR is a medicine called a leukotriene • Take SINGULAIR once a day, at about the same • swelling
^receptor ^antagonist. ^It ^works ^by ^blocking ^time ^each ^{day. substances} ⁱⁿ ^the ^body ^called ^{leukotrienes.} ^• ^Take ^SINGULAIR ^every ^day ^for ^as ^long ^as ^your ^Rarely, ^asthmatic ^patients ^taking ^SINGULAIR ^{have Blocking} ^leukotrienes ^improves ^asthma ^and ^allergic ^doctor ^prescribes ^{it. experienced} ^a ^condition ^that ^includes ^certainrhinitis. SINGULAIR is not a steroid. Studies have • You may take SINGULAIR with food or without food. ^symptoms ^that ^do ^not ^go ^away ^or ^that ^get ^worse._{sho wn} _that _SINGULAIR _does _not _affect _the _growth _These _occur _usually, _but _not _{al ways,} _in _patients _{who rate} _of _children. _(See _the _end _of _this _leaflet _for _more _How _should _I _give _SINGULAIR _oral _granules _to _my _child?_were _taking _steroid _pills _by _mouth _for _asthma _{and information} _about _asthma _and _allergic _{rhinitis.) Do} _not _open _the _packet _until _ready _to _{use. those} _steroids _were _being _slowly _lowered _or _{stopped. Although} _SINGULAIR _has _not _been _shown _to _causeSINGULAIR is prescribed for the treatment of asthma, SINGULAIR 4-mg oral granules can be given: this condition, you must tell your doctor right away if
the prevention of exercise-induced asthma, and • directly in the mouth; you get one or more of these symptoms:
allergic rhinitis: • dissolved in 1 teaspoonful ( 5 mL) of cold or room • a feeling of pins and needles or numbness of
¹^. ^Asthma.^temperature ^baby ^formula ^or ^breast ^{milk; arms} ^or ^{legs SINGULAIR} ^should ^be ^used ^for ^the ^long-term ^• ^mixed ^with ^a ^spoonful ^of ^one ^of ^the ^following ^soft ^• ^a ^flu-like ^{illness management} ^of ^asthma ⁱⁿ ^adults ^and ^children ^foods ^at ^cold ^or ^room ^temperature: ^applesauce, ^• ^rash_ages ₁₂ _months _and _older.mashed carrots, rice, or ice cream. • severe inflammation (pain and swelling) of the _Be _sure _that _the _entire _dose _is _mixed _with _the _food, _sinuses _(sinusitis)^Do ^not ^take ^SINGULAIR ^for ^the ^immediate ^relief ^baby ^formula, ^or ^breast ^milk ^and ^that ^the ^child ^isof an asthma attack. If you get an asthma attack, given the entire spoonful of the food, baby formula, or ^These ^are ^not ^all ^the ^possible ^side ^effects ^of ^SINGULAIR._you _should _{follo w} _the _instructions _your _doctor _breast _milk _mixture _right _away _(within ₁₅ _{minutes). For} _more _information _ask _your _doctor _or _pharmacist.^gave ^you ^for ^treating ^asthma ^attacks.^{IMPOR TAN T:} ^Never ^store ^any ^oral ^granules ^mixed ^Talk ^to ^your ^doctor ^if ^you ^think ^you ^have ^side ^effects 2. Prevention of exercise-induced asthma. with food, baby formula, or breast milk for use at a ^from ^taking ^SINGULAIR.SINGULAIR is used for the prevention of exercise- later time. Throw away any unused portion. General Information about the safe and effective use
induced asthma in patients 15 years of age and older. _Do _not _put _SINGULAIR _oral _granules _in _any of SINGULAIR
3. Allergic Rhinitis. liquid drink other than baby formula or breast Medicines are sometimes prescribed for conditions
SINGULAIR is used to help control the symptoms milk. However, your child may drink liquids after that are not mentioned in patient information leaflets.
of allergic rhinitis (sneezing, stuffy nose, runny s wallo wing the SINGULAIR oral granules. Do not use SINGULAIR for a condition for which it
nose, itching of the nose). SINGULAIR is used to _treat _seasonal _allergic _rhinitis _(outdoor _allergies _What _is _the _dose _of _SINGULAIR?was not prescribed. Do not give SINGULAIR to other _people _even _if _they _have _the _same _symptoms _youthat happen part of the year) in adults and children For asthma—Take once daily in the evening: have. It may harm them. Keep SINGULAIR and all
ages 2 years and older, and perennial allergic • One 10-mg tablet for adults and adolescents medicines out of the reach of children.
^rhinitis ^(indoor ^allergies ^that ^happen ^all ^year) ⁱⁿ ¹⁵ ^years ^of ^age ^and ^{older, adults} ^and ^children ^ages ⁶ ^months ^and ^older. ^• ^One ^5-mg ^{che wable} ^tablet ^for ^children ⁶ ^to ^Store ^SINGULAIR ^at ²⁵^˚^C ^{( 77}^˚^F). ^Protect ^from ^moisture^Who ^should ^not ^take ^SINGULAIR?¹⁴ ^years ^of ^age, ^and ^light. ^Store ⁱⁿ ^original ^package.• One 4-mg che wable tablet or one packet of 4-mg This leaflet summarizes information about
Do not take SINGULAIR if you are allergic to SINGULAIR oral granules for children 2 to 5 years of age, or SINGULAIR. If you would like more information, talk
or any of its ingredients. • One packet of 4-mg oral granules for children to your doctor. You can ask your pharmacist or doctor
_The _active _ingredient _in _SINGULAIR _is _montelukast 12 to 23 months of age. for information about SINGULAIR that is written for _sodium. _For _{exercise-induced} _{asthma—Take} _at _least ₂ _hours _health _{professionals.
See} _the _end _of _this _leaflet _for _a _list _of _all _the _ingredients before exercise, but not more than once daily: What are the ingredients in SINGULAIR? _in _SINGULAIR. _• _One _10-mg _tablet _for _adults _and _{adolescents 15} _years _of _age _and _{older Active} _ingredient: _montelukast _sodium

What should I tell my doctor before I start taking _SINGULAIR? _For _allergic _{rhinitis—Take} _once _daily _at _about _the SINGULAIR chewable tablets contain aspartame, _same _time _each _{day: a} _source _of _{phenylalanine.}_Tell _your _doctor _about: _• _One _10-mg _tablet _for _adults _and _adolescents _{Phenylketonurics:} _SINGULAIR _4-mg _and _{5-mg •} _Pregnancy: _If _you _are _pregnant _or _plan _to _become ₁₅ _years _of _age _and _{older, chewable} _tablets _contain _0.674 _and _0.842 _{mg pregnant,} _SINGULAIR _may _not _be _right _for _you. _• _One _5-mg _{che wable} _tablet _for _children ₆ _to _{phenylalanine,} _{respectively.}

• Breast-feeding: If you are breast-feeding, 14 years of age, Inactive ingredients:

SINGULAIR may be passed in your milk to your • One 4-mg che wable tablet for children 2 to • 4-mg oral granules: mannitol, hydroxypropyl baby. You should consult your doctor before 5 years of age, or cellulose, and magnesium stearate. taking SINGULAIR if you are breast-feeding or • One packet of 4-mg oral granules for children • 4-mg and 5-mg che wable tablets: mannitol, intend to breast-feed. 2 to 5 years of age with seasonal allergic rhinitis, microcrystalline cellulose, hydroxypropyl

• Medical Problems or Allergies: Talk about any or for children 6 months to 5 years of age with cellulose, red ferric oxide, croscarmellose
medical problems or allergies you have now or perennial allergic rhinitis. sodium, cherry flavor, aspartame, and
^had ⁱⁿ ^the ^past.• Other Medicines: Tell your doctor about all ^What ^should ^I ^avoid ^while ^taking ^SINGULAIR?^magnesium ^stearate.• 10-mg tablet: microcrystalline cellulose, lactose
the medicines you take, including prescription If you have asthma and if your asthma is made monohydrate, croscarmellose sodium, hydroxypropyl
and non-prescription medicines, and herbal worse by aspirin, continue to avoid aspirin or other cellulose, magnesium stearate, hydroxypropyl
supplements. Some medicines may affect ho w medicines called non-steroidal anti-inflammatory methylcellulose, titanium dioxide, red ferric
SINGULAIR works, or SINGULAIR may affect drugs while taking SINGULAIR. oxide, yellow ferric oxide, and carnauba wax.
^{ho w} ^your ^other ^medicines ^work.What are the possible side effects of SINGULAIR? What is asthma?

^{Ho w} ^should ^I ^take ^SINGULAIR?The side effects of SINGULAIR are usually mild, and Asthma is a continuing (chronic) inflammation of the For adults and children 12 months of age and older generally did not cause patients to stop taking their bronchial passageways which are the tubes that carry with asthma: medicine. The side effects in patients treated with air from outside the body to the lungs.

^• ^Take ^SINGULAIR ^once ^a ^day ⁱⁿ ^the ^{evening. SINGULAIR} ^were ^similar ⁱⁿ ^type ^and ^frequency ^to ^side• Take SINGULAIR every day for as long as your effects in patients who were given a placebo (a pill ^Symptoms ^of ^asthma ^include:_doctor _prescribes _it, _even _if _you _have _no _asthma _containing _no _medicine). _• _{coughing symptoms.} _• _{wheezing •} _You _may _take _SINGULAIR _with _food _or _without _{food. The} _most _common _side _effects _with _SINGULAIR _• _chest _{tightness •} _If _your _asthma _symptoms _get _worse, _or _if _you _include: _• _shortness _of _{breath need} _to _increase _the _use _of _your _inhaled _rescue _• _stomach _{pain medicine} _for _asthma _attacks, _call _your _doctor _• _stomach _or _intestinal _upset_What _is _{exercise-induced} _asthma?_right _away. _• _{heartburn Exercise-induced} _asthma, _more _accurately _{called •} _Do _not _take _SINGULAIR _for _the _immediate _relief _• _{tiredness exercise-induced} _{bronchoconstriction} _occurs _when_of _an _asthma _attack. _If _you _get _an _asthma _attack, _• _{fever exercise} _triggers _symptoms _of _{asthma. you} _should _{follo w} _the _instructions _your _doctor _• _stuffy _{nose gave} _you _for _treating _asthma _attacks. _• _cough_What _is _allergic _rhinitis?_• _{Al ways} _have _your _inhaled _rescue _medicine _for _• _{flu •} _Seasonal _allergic _rhinitis, _also _{kno wn} _as _hay _{fever, asthma} _attacks _with _you. _• _upper _respiratory _{infection is} _triggered _by _outdoor _allergens _such _as _{pollens •} _Do _not _stop _taking _or _{lo wer} _the _dose _of _your _other _• _{dizziness from} _trees, _grasses, _and _{weeds. asthma} _medicines _unless _your _doctor _tells _you _to. _• _{headache •} _Perennial _allergic _rhinitis _may _occur _year-round _{and •} _{rash is} _generally _triggered _by _indoor _allergens _such _asFor patients 15 years of age and older for the _prevention _of _{exercise-induced} _asthma:_Less _common _side _effects _that _have _happened _with dust mites, animal dander, and/or mold spores. _• _Take _SINGULAIR _at _least ₂ _hours _before _{exercise. SINGULAIR} _{include: •} _Symptoms _of _allergic _rhinitis _may _{include: •} _{Al ways} _have _your _inhaled _rescue _medicine _for _• _increased _bleeding _tendency _• _stuffy, _runny, _and/or _itchy _{nose asthma} _attacks _with _you. _• _allergic _reactions _[including _swelling _of _the _face, _lips, _• _{sneezing •} _If _you _are _taking _SINGULAIR _daily _for _chronic _tongue, _and/or _throat _(which _may _cause _{trouble asthma} _or _allergic _rhinitis, _do _not _take _an _breathing _or _{swallo wing),} _hives _and _{itching] Rx} _{only additional} _dose _to _prevent _{exercise-induced} _• _behavior _and _mood _related _changes _[agitation _US _Patent _No.: ₅_{,565,473 asthma.} _Speak _to _your _doctor _about _your _including _aggressive _behavior, _bad/vivid _{dreams, depression,} _feeling _anxious, _{hallucinations}

(seeing things that are not there), irritability,

* _Registered _trademark _of _MERCK _& _CO., _Inc. restlessness, suicidal thoughts and actions _{COPYRIGH T} _© _1998-2007 _MERCK _& _CO., _Inc. (including suicide), tremor, trouble sleeping] _All _rights _reserved • drowsiness, pins and needles/numbness,