Details for: ACH-MONTELUKAST
Company: ACCORD HEALTHCARE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02379236 | ACH-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 and adolescents 15 years and older)
Your physician has prescribed ACH-Montelukast to treat
your asthma, including preventing your asthma symptoms
during the day and night.
ACH-Montelukast can be used alone or together with other
medications to help with the treatment and prevention of
your asthma. Your physician will decide which
combination of medicines will work best for you.
Seasonal Allergic Rhinitis for (adults and adolescents 15 years and older)
Your physician has prescribed ACH-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 15 years and older with asthma): When
taken as prescribed, ACH-Montelukast also prevents the
narrowing of airways triggered by exercise.
What it does
ACH-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 ACH-Montelukast if you 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: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, iron oxide red, iron oxide yellow, magnesium stearate, microcelac100 (co-precipitated product of lactose monohydrate 75% w/w and microcrystalline cellulose 25% w/w), polyethylene glycol and titanium dioxide.
What dosage form it comes in
ACH-Montelukast is available as film-coated tablet 10 mg.
Warnings and precautions
Serious Warnings and Precautions
Serious mental health problems have happened in people taking montelukast sodium or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking ACH-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
ACH-Montelukast is not for the treatment of acute
asthma attacks. If an attack occurs, you should follow the
instructions your physician has given you for that situation.
Serious behavior and mood-related changes have been
reported in patients taking montelukast sodium. If you experience these changes while taking
ACH-Montelukast
(see "SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM"), tell
your physician.
BEFORE using ACH-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 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 problems
- stuttering
Use in pregnancy
Women who are pregnant or intend to become pregnant should consult their physician before taking ACHMontelukast.
Use in breast-feeding
It is not known if ACH-Montelukast appears in breast
milk. You should consult your physician before taking
ACH-Montelukast if you are breastfeeding or intend to
breast-feed.
ACH-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 montelukast sodium may affect some
patients' ability to drive or operate machinery.
If your 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, ACH-Montelukast does not interfere with other medicines that you may be taking. However, some medicines may affect how ACH-Montelukast works, or ACH-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 and adolescents 15 years and older:
Take one 10 mg ACH-Montelukast tablet once a day in the
evening with or without food, as your physician has
prescribed.
Take ACH-Montelukast daily for as long as your physician
prescribes it in order to maintain control of your asthma.
ACH-Montelukast can treat your asthma only if you
continue to take it.
It is important that you continue taking ACHMontelukast daily as prescribed by your physician, even
when you have no symptoms or if you have an asthma
attack.
If you are taking other medications along with ACHMontelukast 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 ACH-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. Never give it to anyone else.
Follow up with your physician to ensure your continued
health and safety.
Overdose
If you think you have taken too much ACH-Montelukast, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose
Try to take ACH-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.
Side effects and what to do about them
Any medicine may have unintended or undesirable effects,
so-called side effects. Montelukast sodium 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
Tell your physician or pharmacist if you develop any of the above symptoms, any unusual symptom, or if any known symptom continues or worsens.
| Symptoms / Effects | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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 | |||
| sleep disorders including dream abnormalities and insomnia | ✔ | ||
| sleep walking | ✔ | ||
| disturbance in attention, memory problems | ✔ | ||
| 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), irritability, restlessness, obsessivecompulsive symptoms, anxiousness, depression (sad mood) | ✔ | ||
| disorientation (inability to know correct time, place or person) | ✔ | ||
| suicidal thoughts and actions | ✔ | ||
| stuttering | ✔ | ||
| tremor | ✔ | ||
| hallucinations (seeing or hearing things that are not there) | ✔ | ||
| seizure (convulsions or fits) | ✔ | ||
| palpitations (heart skips a beat) | ✔ | ||
| eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as ChurgStrauss syndrome: a flulike 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 ACH-Montelukast, contact your physician or pharmacist.
How to store
Store at room temperature (15°C - 30°C) in a dry place and protected from light.
Keep out of reach and sight of children.
Reporting side effects
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 ACH-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 website ( https://health-products.canada.ca/dpd-bdpp/index-eng.jsp ); or by calling the sponsor Accord Healthcare Inc. at 1- 866-296-0354.
This leaflet was prepared by:
Accord Healthcare Inc.
3535 boul. St-Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Last revised: April 8, 2021
Aspirin® is a Registered Trademark of Bayer AG, used
under license.