NTP-Montelukast: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Asthma (for adults, adolescents and children 2 to 14 years old):

Your physician has prescribed NTP-MONTELUKAST to treat your asthma or your child’s asthma, including preventing your asthma symptoms during the day and night. When taken as prescribed, NTP-MONTELUKAST also prevents the narrowing of airways triggered by exercise.

Seasonal Allergic Rhinitis (for adults and adolescents 15 years and older):

Your physician has prescribed NTP-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:

NTP-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 NTP-MONTELUKAST

if you or your child is allergic to any of its ingredients. See what the non-medicinal ingredients are.

What the medicinal ingredient is:

Montelukast as Montelukast sodium

What the important non-medicinal ingredients are: Each 4 mg and 5 mg chewable tablet contains the following non-medicinal ingredients: aspartame, flavour cherry Permaseal PHS-143671, hydroxypropylcellulose, magnesium stearate, mannitol, red iron oxide, sodium lauryl sulfate and sodium starch glycolate.

Each 10 mg film-coated tablet contains the following non-medicinal ingredients: hydroxypropylcellulose, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate and colour coating containing the following: hydroxypropylcellulose, hydroxypropyl methylcellulose, iron oxide yellow, iron oxide red and titanium dioxide.

Phenylketonurics: NTP-MONTELUKAST

4 mg and 5 mg chewable tablets contain 0.28 mg phenylalanine each.

What dosage forms it comes in:

NTP-MONTELUKAST

film-coated tablet 10 mg and NTP-MONTELUKAST

chewable tablet 4 mg, 5 mg.

WARNINGS AND PRECAUTIONS

NTP-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.

BEFORE using NTP-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 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.

Use in pregnancy

Women who are pregnant or intend to become pregnant should consult their physician before taking NTP-

MONTELUKAST.

Use in breast-feeding

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

NTP-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 NTP-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, NTP-MONTELUKAST does not interfere with other medicines that you or your child may be taking. However, some medicines may affect how NTP-MONTELUKAST works, or NTP-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 NTP-MONTELUKAST once a day in the evening with or without food, as your physician has prescribed.

Take NTP-MONTELUKAST

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

It is important that you or your child continue taking NTP-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.

Seasonal Allergic Rhinitis (for adults and adolescents 15 years and older):

Take NTP-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 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 NTP-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. NTP-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
• palpitations (heart skips a beat)
• 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.

* A condition, which includes a combination of certain persistent or worsening symptoms, has been reported very rarely in patients given NTP-MONTELUKAST. These symptoms may include: a flu-like illness, rash, pins and needles or numbness of arms or legs, joint pain and severe sinusitis. These have occurred usually, but not always, in patients whose oral corticosteroid medicine for asthma is being reduced. Although NTP-MONTELUKAST

has not been shown to cause this condition, you must tell your physician immediately if you experience a combination of these symptoms.

This is not a complete list of side effects. For any unexpected effects while taking NTP-MONTELUKAST, contact your physician or pharmacist.

HOW TO STORE IT

Store the 10 mg film-coated tablets, and the 4 mg and 5 mg chewable tablets at room temperature (15°C-30°C), protected from moisture and light. For blister package keep tablets in original package.

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, ON 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 can be found by contacting Teva Canada Ltd. at: 1-800-268-4127 ext. 5005 (English Canada) or druginfo@tevacanada.com

or 1-877-777-9117 (French Canada)

Teva Canada Ltd.

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Last revised: September 27, 2013

Aspirin^® is a Registered Trademark of Bayer AG