Patient Medication Information: uses, side effects, how to take - Montelukast (Ranbaxy Pharmaceuticals Canada)
ABOUT THIS MEDICATION
What the medication is used for:
Asthma (for adults 15 years of age and older):
Your physician has prescribed MONTELUKAST to treat your asthma, including preventing your asthma symptoms during the day and night. When taken as prescribed, MONTELUKAST also prevents the narrowing of airways triggered by exercise.
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 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.
What it does:
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 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:
MONTELUKAST film-coated tablet 10 mg.
WARNINGS AND PRECAUTIONS
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.
Behavior and mood-related changes have been reported in patients taking montelukast sodium. If you experience these changes while taking MONTELUKAST (see "SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM"), tell your physician.
BEFORE using 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 behaviour 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.
Use in pregnancy
Women who are pregnant or intend to become pregnant should consult their physician before taking MONTELUKAST.
Use in breast-feeding
It is not known if montelukast sodium appears in breast milk. You should consult your physician before taking MONTELUKAST if you are breast-feeding or intend to breast-feed.
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, MONTELUKAST does not interfere with other medicines that you may be taking. However, some medicines may affect how MONTELUKAST works, or 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 MONTELUKAST once a day in the evening with or without food, as your physician has prescribed.
Take MONTELUKAST daily for as long as your physician prescribes it in order to maintain control of your asthma. MONTELUKAST can treat your asthma only if you continue to take it.
It is important that you continue taking 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 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 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:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
Try to take MONTELUKAST as prescribed. However, if you miss a dose, just resume the usual schedule of one tablet once daily.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Any medicine may have unintended or undesirable effects, so-called side effects. 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, sleep walking, sleep disorders including dream abnormalities and insomnia
- 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
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, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptoms / Effects | Talk with your physician or pharmacist | Stop taking drug and seek immediate emergency medical attention | |||
| 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 | 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 | √ | ||||
| severe skin reactions | √ | ||||
(erythema multiforme) that may occur without warning | ||||
behavior and mood related changes [agitation including aggressive behavior or hostility] | √ | |||
| depression | √ | |||
| disorientation (inability to know correct time, place or person) | √ | |||
| suicidal thoughts and actions | √ | |||
| tremor | √ | |||
hallucinations (seeing or hearing things that are not there) | √ | |||
seizure (convulsions or fits) | √ | |||
| palpitations (heart skips a beat) | √ | |||
| Churg-Strauss syndrome: a flu-like illness, rash, pins and needles or numbness of arms or legs, joint pain and severe sinusitis | √ |
This is not a complete list of side effects. For any unexpected effects while taking MONTELUKAST, contact your physician or pharmacist.
HOW TO STORE IT
Store tablets at room temperature (15° C-30° C), protected from moisture and light.
Keep all medicines safely away from children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E Ottawa, Ontario K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals is available by contacting the sponsor, Ranbaxy Pharmaceuticals Canada Inc. at: 1-866-840-1340.
Date of Revision: August 9, 2013
Aspirin® is a Registered Trademark of Bayer AG, used under license.