Patient Medication Information: uses, side effects, how to take - SPC-Montelukast
ABOUT THIS MEDICATION
What the medication is used for:
Asthma (for adults 15 years of age and older):
Your physician has prescribed SPC-Montelukast to treat your asthma, including preventing your asthma symptoms during the day and night.
SPC-Montelukast can be used alone or together with other medications to help with the treatment and prevention of your asthma. Your physician will decide which combination of medicines will work best for you.
Seasonal Allergic Rhinitis (for adults and adolescents 15 years and older):
Your physician has prescribed SPC-Montelukast to treat your seasonal allergies, including daytime and nighttime symptoms, including nasal congestion, runny nose, nasal itching, and sneezing; nasal congestion upon awakening; tearing, itchy, red, and puffy eyes.
Exercise-induced bronchoconstriction (for adults, adolescents 15 years and older with asthma): When taken as prescribed, SPC-Montelukast also prevents the narrowing of airways triggered by exercise.
What it does:
SPC-Montelukast is a leukotriene receptor antagonist that blocks substances in your lungs called leukotrienes. Leukotrienes cause narrowing and swelling of airways in your lungs. Blocking leukotrienes improves asthma symptoms and helps prevent asthma attacks. Leukotrienes also can contribute to the development of allergy symptoms. Blocking leukotrienes improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
When it should not be used:
Do not take SPC-Montelukast if you are allergic to any of its ingredients. See what the non-medicinal ingredients are.
What the medicinal ingredient is:
montelukast sodium
What the non-medicinal ingredients are:
10 mg film-coated tablet: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, PEG 400, and titanium dioxide.
What dosage forms it comes in:
SPC-Montelukast film-coated tablet 10 mg.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Serious mental health problems have happened in people taking SPC-Montelukast or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking SPC-Montelukast and tell your healthcare provider right away if you have any unusual changes in behavior or thinking, including any of these symptoms:
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SPC-Montelukast is not for the treatment of acute asthma attacks. If an attack occurs, you should follow the instructions your physician has given you for that situation.
Serious behavior and mood-related changes have been reported in patients taking montelukast sodium. If you experience these changes while taking SPC-Montelukast (see “SIDE EFFECTS AND WHAT TO DO ABOUT THEM”), tell your physician.
BEFORE using SPC-Montelukast, tell your physician if you:
- suffer from liver problems;
- are using any other medicines;
- have or have had any medical problems or allergies.
You should immediately inform your doctor if you start to have any:
- agitation, including aggressive behavior or hostility,
- suicidal thoughts and actions,
- anxiousness, depression (sad mood), • disorientation (inability to know correct time, place or person), dream abnormalities, hallucinations (seeing or hearing things that are not there),
- insomnia, irritability, restlessness, sleep walking,
- tremors,
- disturbance in attention, memory problems,
- stuttering.
Use in pregnancy
Women who are pregnant or intend to become pregnant should consult their physician before taking SPC-Montelukast.
Use in breast-feeding
It is not known if montelukast sodium appears in breast milk. You should consult your physician before taking SPC-Montelukast if you are breast-feeding or intend to breast-feed.
SPC-Montelukast is not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with montelukast sodium may affect some patients' ability to drive or operate machinery.
If your asthma symptoms get worse, you should contact your physician immediately.
If your asthma is made worse by exercise, you should continue to use the medicines your physician has prescribed for you to use before exercise, unless your physician tells you otherwise.
You should always have your inhaled rescue medicine for asthma attacks with you in case you need it.
If your asthma is made worse by acetylsalicylic acid (ASA) (e.g., Aspirin®), you should continue to avoid ASA or other non-steroidal anti-inflammatory drugs.
INTERACTIONS WITH THIS MEDICATION
In general, SPC-Montelukast does not interfere with other medicines that you may be taking. However, some medicines may affect how SPC-Montelukast works, or SPC-Montelukast may affect how your other medicines work. It is important to tell your physician about all drugs that you are using or plan to use, including those obtained without a prescription.
PROPER USE OF THIS MEDICATION
Usual dose:
Asthma:
For adults 15 years of age and older
Take SPC-Montelukast once a day in the evening with or without food, as your physician has prescribed.
Take SPC-Montelukast daily for as long as your physician prescribes it in order to maintain control of your asthma. SPC-Montelukast can treat your asthma only if you continue to take it.
It is important that you continue taking SPC-Montelukast daily as prescribed by your physician, even when you have no symptoms or if you have an asthma attack.
If you are taking other medications along with SPC-Montelukast your physician will instruct you how and when to take each medication. Your physician will increase or decrease the doses of these medications as needed.
Seasonal Allergic Rhinitis (for adults and adolescents 15 years and older):
Take SPC-Montelukast once a day in the evening with or without food, as your physician has prescribed.
Remember that your physician has prescribed this medicine only for you. Never give it to anyone else.
Follow up with your physician to ensure your continued health and safety.
Overdose:
| If you think you, or a person you are caring for, have taken too much SPC-Montelukast, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
Try to take SPC-Montelukast as prescribed. However, if you miss a dose take the next dose when it is due. Do not take two doses at the same time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Any medicine may have unintended or undesirable effects, so-called side effects. SPC-Montelukast is generally well-tolerated.
The most common side effects reported were:
- abdominal pain
- headache
- thirst
- diarrhea
- hyperactivity
- asthma
- scaly and itchy skin
- rash
These were usually mild.
Additionally, the following have been reported:
- upper respiratory tract infection (common cold)
- feeling anxious, irritability
- restlessness
- uncontrolled muscle movements
- dizziness, drowsiness, pins and needles/numbness
- nose bleed
- joint pain, muscle aches and muscle cramps
- tender red lumps under the skin, most commonly on your shins
- weakness/tiredness, fatigue
- swelling
- fever • bedwetting in children
Tell your physician or pharmacist if you develop any of the above symptoms, any unusual symptom, or if any known symptom continues or worsens.
Serious side effects and what to do about them
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||||
|---|---|---|---|---|---|---|---|
| Only if severe | In all cases | ||||||
| Rare | |||||||
| symptoms of allergic reactions such as swelling of the face, lips, tongue, and/or throat (which may cause difficulty in breathing or swallowing), hives, rash, and itching | √ | ||||||
| Very Rare | |||||||
| sleep disorders including dream abnormalities and insomnia | √ | ||||||
| sleep walking | √ | ||||||
| disturbance in attention, memory problems | √ | ||||||
| symptoms of liver problems: nausea, vomiting, fatigue, jaundice (yellowing of the skin and eyes), dark urine, flu-like symptoms, loss of appetite, and pain in your abdomen | √ | ||||||
| increased bleeding tendency, bruising, low blood platelet count | √ | ||||||
| severe skin reactions (erythema multiforme) that may occur without warning | √ | ||||||
| behavior and mood related changes: agitation including aggressive behavior or hostility, irritability, restlessness, obsessive-compulsive symptoms, anxiousness, depression (sad mood) | √ | ||||||
| disorientation (inability to know correct time, place or person) | √ | ||||||
| suicidal thoughts and actions | √ | ||||||
| stuttering | √ | ||||||
| tremor | √ | ||||||
| hallucinations (seeing or hearing things that are not there) | √ | ||||||
| seizure (convulsions or fits) | √ | ||||||
| palpitations (heart skips a beat) | √ | ||||||
| eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss syndrome: a flu-like illness, rash, pins and needles | √ | ||||||
| or numbness of arms or legs, joint pain and severe sinusitis | |||
|---|---|---|---|
| swelling (inflammation) of the lungs: breathing problems that continue to get worse | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking SPC-Montelukast, contact your physician or pharmacist.
HOW TO STORE IT
Store tablets at room temperature (15° C to 30° C), protected from moisture and light.
Keep all medicines safely away from children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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MORE INFORMATION
If you want more information about SPC-Montelukast:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), or by calling 1-866-840-1340.
To report an adverse event related to SPC-Montelukast, please contact 1-866-840-1340.
Brampton, ON L6T 1C1
Last revised: APR 15, 2025
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