Consumer Information for: DOM-MONTELUKAST FC

What the medication is used for

Asthma (for adults, adolescents and children 2 to 14 years old):
Your physician has prescribed Dom-MONTELUKAST FC or Dom-MONTELUKAST to treat your asthma or your child’s asthma, including preventing your asthma symptoms during the day and night. When taken as prescribed, Dom-MONTELUKAST FC and Dom-MONTELUKAST also prevents the narrowing of airways triggered by exercise.

Dom-MONTELUKAST FC or Dom-MONTELUKAST can be used alone or together with other medications to help with the treatment and prevention of you or your child’s asthma. Your physician will decide which combination of medicines will work best for you or your child.

Seasonal Allergic Rhinitis (for adults and adolescents 15 years and older):
Your physician has prescribed Dom-MONTELUKAST FC 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 Dom-MONTELUKAST FC or Dom-MONTELUKAST if you or your child 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

Dom-MONTELUKAST FC
10 mg film-coated tablet: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The film-coating consists of: black iron oxide, hydroypropyl cellulose, hypromellose, polyethylene glycol, red iron oxide, talc, titanium dioxide and yellow iron oxide.

Dom-MONTELUKAST
4 mg and 5 mg chewable tablet: aspartame, cherry flavor (artificial), croscarmellose sodium, hydroxypropyl cellulose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose.

Phenylketonurics: Phenylalanine is a component of aspartame. Dom-MONTELUKAST 4 mg and 5 mg chewable tablets contain 1.20 and 1.50 mg aspartame, respectively.

What dosage form it comes in

Dom-MONTELUKAST FC
Film-coated tablet: 10 mg.

Dom-MONTELUKAST
Chewable tablet: 4 mg and 5 mg

Warnings and precautions

Dom-MONTELUKAST FC or Dom-MONTELUKAST is not for the treatment of acute asthma attacks. If an attack occurs, you or your child should follow the instructions your physician has given you for that situation.

Behavior and mood-related changes have been reported in patients taking Dom-MONTELUKAST FC or Dom-MONTELUKAST. If you or your child experience these changes while taking the drug (see "SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM"), tell your physician.

BEFORE using Dom-MONTELUKAST FC or Dom-MONTELUKAST, tell your physician if you or your child:

have phenylketonuria;
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 or your child start to have any:

agitation, including aggressive behaviour or hostility (such as temper tantrums in children),
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 impairment.

Use in pregnancy
Women who are pregnant or intend to become pregnant should consult their physician before taking Dom-MONTELUKAST FC.

Use in breast-feeding
It is not known if montelukast appears in breast milk. You should consult your physician before taking Dom-MONTELUKAST FC if you are breast-feeding or intend to breast-feed.

Dom-MONTELUKAST FC and Dom-MONTELUKAST are 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 Dom-MONTELUKAST FC and Dom-MONTELUKAST may affect some patients' ability to drive or operate machinery.

If your or your child’s 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, Dom-MONTELUKAST FC and Dom-MONTELUKAST do not interfere with other medicines that you or your child may be taking. However, some medicines may affect how Dom-MONTELUKAST FC or Dom-MONTELUKAST works, or Dom-MONTELUKAST FC or Dom-MONTELUKAST may affect how your other medicines work. It is important to tell your physician about all drugs that you or your child are using or plan to use, including those obtained without a prescription.

Proper use of this medication

Usual Dose

Asthma (for adults, adolescents and children 2 to 14 years old):
Take Dom-MONTELUKAST FC or Dom-MONTELUKAST once a day in the evening with or without food, as your physician has prescribed.

Take Dom-MONTELUKAST FC or Dom-MONTELUKAST daily for as long as your physician prescribes it in order to maintain control of your or your child’s asthma. Dom-MONTELUKAST FC or Dom-MONTELUKAST can treat your or your child’s asthma only if you or your child continue to take it.

It is important that you or your child continue taking Dom-MONTELUKAST FC or Dom-MONTELUKAST daily as prescribed by your physician, even when you or your child has no symptoms or if you or your child has an asthma attack.

If you are taking other medications along with Dom-MONTELUKAST FC or Dom-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 Dom-MONTELUKAST FC 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 or your child. 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 Dom-MONTELUKAST FC or Dom-MONTELUKAST as prescribed. However, if you miss a dose, just resume the usual schedule of one tablet or packet once daily.

Side effects and what to do about them

Any medicine may have unintended or undesirable effects, so-called side effects. Dom-MONTELUKAST FC or Dom-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, disturbance in attention
memory impairment, restlessness, sleep walking,
sleep disorders including dream abnormalities and insomnia, 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, how often they happen and what to do about them
Symptom / effect	Talk with your doctor, nurse, or pharmacist only if severe	Talk with your doctor, nurse, or pharmacist in all cases	Stop taking drug and seek immediate emergency medical attention
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, low blood platelet count		✔
severe skin reactions (erythema multiforme) that may occur without warning		✔
behaviour and mood related changes [agitation including aggressive behaviour or hostility (such as temper tantrums in children)]		✔
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			✔
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 Dom-MONTELUKAST FC or Dom-MONTELUKAST, contact your physician or pharmacist.

How to store

Store at room temperature (15°C - 30°C) protected from moisture and light.

Keep all medicines safely away from children.

Reporting 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 three 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 ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM 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, can be obtained by contacting the sponsor, Dominion Pharmacal at, 1-888-550-6060.

This leaflet was prepared by
Dominion Pharmacal
Montréal, Canada
H4P 2T4

Last revised: December 08, 2016

*Aspirin is a trade-mark of Bayer Aktiengesellschaft and not a trade-mark of Dominion Pharmacal. Bayer is not affiliated with and does not endorse Dominion Pharmacal or its products.

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