Auro-Montelukast Chewable Tablet: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Asthma (for children 2 to 14 years old):

Your physician has prescribed AURO-

MONTELUKAST CHEWABLE TABLET to treat your child’s asthma, including preventing your asthma symptoms during the day and night.

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

Exercise-induced bronchoconstriction (for adults, adolescents and children 2 years and older with asthma): When taken as prescribed, AURO-MONTELUKAST CHEWABLE TABLET also prevents the narrowing of airways triggered by exercise.

What it does:

AURO-MONTELUKAST CHEWABLE TABLET 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 AURO-MONTELUKAST CHEWABLE TABLET if your child is 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:

Each 4 mg and 5 mg chewable tablet contains the following inactive ingredients: aspartame, cherry flavor, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, and microcrystalline cellulose, and red ferric oxide.

Phenylketonurics: AURO-MONTELUKAST CHEWABLE TABLET 4 mg and 5 mg chewable tablets contain 0.674 and 0.842 mg phenylalanine, respectively.

What dosage forms it comes in:

Chewable tablet 4 mg, 5 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Serious mental health problems have happened in people taking AURO-MONTELUKAST CHEWABLE TABLET or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking AURO-MONTELUKAST CHEWABLE TABLET and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking, including any of these symptoms:

• agitation, including aggressive behavior or hostility
• attention problems
• bad or vivid dreams
• depression
• disorientation (confusion)
• feeling anxious
• irritability
• hallucinations (seeing or hearing things that are not really there)
• memory problems
• obsessive-compulsive symptoms
• restlessness
• sleep walking
• stuttering
• suicidal thoughts and actions (including suicide)
• tremor
• trouble sleeping
• uncontrolled muscle movements

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

Serious behavior and mood-related changes have been reported in patients taking AURO-

MONTELUKAST CHEWABLE TABLET. If your child experience these changes while taking AURO-MONTELUKAST CHEWABLE TABLET (see "SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM"), tell your physician.

BEFORE using AURO-MONTELUKAST CHEWABLE TABLET, tell your physician if 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 your child start to have any:

• agitation, including aggressive behavior 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 problems,
• stuttering.

Use in pregnancy

Women who are pregnant or intend to become pregnant should consult their physician before taking AURO-MONTELUKAST CHEWABLE TABLET.

Use in breast-feeding

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

AURO-MONTELUKAST CHEWABLE TABLET 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 AURO-MONTELUKAST CHEWABLE TABLET may affect some patients' ability to drive or operate machinery.

If your child’s asthma symptoms get worse, you should contact your physician immediately.

If your child’s asthma is made worse by exercise, your child should continue to use the medicines his/her physician has prescribed for him/her to use before exercise, unless the physician says otherwise. Your child should always have his/her inhaled rescue medicine for asthma attacks with you in case you need it.

If your child’s asthma is made worse by acetylsalicylic acid (ASA) (e.g., Aspirin*), your child should continue to avoid ASA or other non-steroidal anti-inflammatory drugs.

INTERACTIONS WITH THIS MEDICATION

In general, AURO-MONTELUKAST CHEWABLE TABLET does not interfere with other medicines that you may be taking. However, some medicines may affect how AURO-MONTELUKAST CHEWABLE TABLET works, or AURO-MONTELUKAST CHEWABLE TABLET may affect how your child’s other medicines work. It is important to tell your physician about all drugs that your child is using or planning to use, including those obtained without a prescription.

PROPER USE OF THIS MEDICATION

Usual dose:

Asthma

Patients 2 to 5 years old:

Patients can take one 4 mg AURO-

MONTELUKAST CHEWABLE TABLET once a day in the evening with or without food, as your physician has prescribed.

AURO-MONTELUKAST CHEWABLE TABLET is taken daily for as long as your child’s physician prescribes it in order to maintain control of your child’s asthma. AURO-MONTELUKAST CHEWABLE TABLET can treat your child’s asthma only if your child continues to take it.

It is important that your child continue taking AURO-MONTELUKAST CHEWABLE TABLET daily as prescribed by his/her physician, even when your child has no symptoms or if your child has an asthma attack.

If your child is taking other medications along with AURO-MONTELUKAST CHEWABLE TABLET

your child’s physician will instruct how and when your child should take each medication. Your child’s physician will increase or decrease the doses of these medications as needed.

Remember that your child’s physician has prescribed this medicine only for your child. Never give it to anyone else.

Follow up with your child’s physician to ensure your continued health and safety.

Overdose:

Missed Dose:

Your child should try to take AURO-

MONTELUKAST CHEWABLE TABLET as prescribed. However, if your child misses a dose, your child 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. AURO-MONTELUKAST CHEWABLE TABLET 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 your child develops any of the above symptoms, any unusual symptom, or if any known symptom continues or worsens.

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If you think you have taken too much AURO-MONTELUKAST CHEWABLE TABLET, contact your health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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

HOW TO STORE IT

Store at room temperature (15°C to 30°C). Protect 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:

• Visiting the Web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-

  products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

  • Calling toll-free at 1-866-234-2345.

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.

MORE INFORMATION

If you want more information about AURO-MONTELUKAST CHEWABLE TABLET:

• 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 website (https://health-

  products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website

  www.auropharma.ca, or by calling 1-855-648-6681.

Auro Pharma Inc.

3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8,

Canada

Date of Revision: November 10, 2020