IPG-Montelukast: Uses, Side Effects and Dosage

What the medication is used for:

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

Your physician has prescribed IPG-MONTELUKAST to treat your asthma or your child’s asthma, including preventing your asthma symptoms during the day and night.

IPG-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 IPG-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 and children 2 years and older with asthma): When taken as prescribed, IPG-MONTELUKAST also prevents the narrowing of airways triggered by

exercise.

What it does:

IPG-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 IPG-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:

10 mg film-coated tablet: carnauba wax, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and titanium dioxide

4 mg and 5 mg chewable tablet: aspartame, cherry flavour, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, and red iron oxide.

Phenylketonurics: IPG-MONTELUKAST 4 mg and 5 mg chewable tablets contain 0.54 and 0.67 mg phenylalanine, respectively.

What dosage forms it comes in:

IPG-MONTELUKAST film-coated tablet 10 mg.

IPG-MONTELUKAST chewable tablet 4 mg and 5 mg.

ABOUT THIS MEDICATION

IMPORTANT: PLEASE READ

IPG-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.

Serious behavior and mood-related changes have been reported in patients taking IPG-MONTELUKAST. If you or your child experience these changes while taking IPG-MONTELUAST (see “SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM”), tell your physician.

BEFORE using IPG-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 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 IPG-MONTELUKAST.

Use in breast-feeding

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

IPG-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 IPG-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.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Serious mental health problems have happened in people taking IPG-MONTELUKAST or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking IPG-MONTELUKAST 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

  In general, IPG-MONTELUKAST does not interfere with other medicines that you may be taking. However, some medicines may affect how IPG-MONTELUKAST works, or IPG-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.

Usual dose:

Asthma:

For adults 15 years and older:

Take one 10 mg IPG-MONTELUKAST tablet once a day in the evening with or without food, as your physician has prescribed.

Patients 6 to 14 years of age:

Take one 5 mg IPG-MONTELUKAST chewable tablet once a day in the evening with or without food, as your physician has prescribed.

Patients 2 to 5 years old:

Patients can take one 4 mg IPG-MONTELUKAST chewable tablet once a day in the evening with or without food, as your physician has prescribed.

Take IPG-MONTELUKAST daily for as long as your physician prescribes it in order to maintain control of your or your child’s asthma. IPG-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 IPG-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 IPG-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 one 10 mg IPG-MONTELUKAST tablet 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:

Missed Dose:

Try to take IPG-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.

Any medicine may have unintended or undesirable effects, so-called side effects. IPG-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

INTERACTIONS WITH THIS MEDICATION

If you think you, or a person you are caring for, have too much IPG-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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

PROPER USE OF THIS MEDICATION

• 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.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

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

Keep out of reach and sight of children.

HOW TO STORE IT

MORE INFORMATION

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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

If you want more information about IPG-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), the manufacturer’s website www.marcanpharma.com or by calling 1-855-627-2261.

Last revised: DEC 31, 2025