Details for: AG-MONTELUKAST
Company: ANGITA PHARMA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02482835 | AG-MONTELUKAST | MONTELUKAST (MONTELUKAST SODIUM) | 10 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Asthma (for adults, adolescents and children 2 to 14 years
old):
Your physician has prescribed AG-MONTELUKAST to
treat your asthma or your child’s asthma, including preventing
your asthma symptoms during the day and night. When taken
as prescribed, AG-MONTELUKAST also prevents the
narrowing of airways triggered by exercise.
AG-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 AG-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
AG-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 AG-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
4 mg and 5 mg chewable tablet: aspartame, flavour cherry,
hydroxypropylcellulose, magnesium stearate, mannitol,
microcrystalline cellulose, croscarmellose sodium and red iron
oxide.
Phenylketonurics: AG-MONTELUKAST 4 mg and 5 mg
chewable tablets contain 0.54 and 0.67 mg phenylalanine,
respectively.
10 mg film-coated tablet: lactose monohydrate,
microcrystalline cellulose, croscarmellose sodium, magnesium
stearate, hydroxypropyl methylcellulose, hydroxypropyl
cellulose, titanium dioxide, iron oxide yellow, carnauba wax
and iron oxide red.
What dosage form it comes in
AG-MONTELUKAST film-coated tablet: 10 mg
AG-MONTELUKAST chewable tablet : 4 mg and 5 mg.
Warnings and precautions
AG-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 AG-MONTELUKAST. If you or your child
experience these changes while taking AG-MONTELUKAST
(see “SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM”), tell your
physician.
BEFORE using AG-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 AG-MONTELUKAST.
Use in breast-feeding
It is not known if AG-MONTELUKAST appears in breast
milk. You should consult your physician before taking AG-MONTELUKAST if you are breast-feeding or intend to
breast-feed.
AG-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 AG-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, AG-MONTELUKAST does not interfere with other medicines that you may be taking. However, some medicines may affect how AG-MONTELUKAST works, or AG-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, adolescents and children 2 to 14 years
old):
Take AG-MONTELUKAST once a day in the evening with
or without food, as your physician has prescribed.
Take AG-MONTELUKAST daily for as long as your physician
prescribes it in order to maintain control of your or your child’s
asthma. AG-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 AG-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 AG-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 AG-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
Missed Dose
Try to take AG-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. AG-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.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional 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 | ✔ | ||
| behavior and mood related changes [agitation including aggressive behavior 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 AG-MONTELUKAST, contact your physician or pharmacist.
How to store
Store the 4 mg and 5 mg chewable tablets and the 10 mg filmcoated tablets at room temperature (15°C-30°C). Protect from
moisture and light. For blister package keep tablets in original
package
Keep out of the reach and sight of 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 3 ways:
- 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 AG-MONTELUKAST:
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***
This leaflet was prepared by:
Angita Pharma Inc.
1310 Nobel Street
Boucherville, Québec
J4B 5H3
Date of Revision: November 20, 2018.