Jamp-Montelukast (Jamp Pharma, 10 mg): Uses, Side Effects and Dosage

When it should not be used:

Do not take JAMP-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 hydroxylpropyl cellulose, magnesium stearate, Microcelac 100, iron oxide red, titanium dioxide, polyethylene glycol and iron oxide yellow.

What dosage forms it comes in:

JAMP-Montelukast film-coated tablet 10 mg

ABOUT THIS MEDICATION WARNINGS AND PRECAUTIONS

What the medication is used for:

Asthma (for adults and adolescents 15 years and older): Your physician has prescribed JAMP-Montelukast to treat your asthma, including preventing your asthma symptoms during the day and night.

JAMP-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 JAMP-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, JAMP-Montelukast also prevents the narrowing of airways triggered by exercise.

What it does:

JAMP-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).

Serious Warnings and Precautions

JAMP-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 JAMP-Montelukast. If you experience these changes while taking JAMP-Montelukast (see “SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM”), tell your physician.

BEFORE using JAMP-Montelukast, tell your physician if you:

• 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 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 JAMP-Montelukast.

Use in breast-feeding

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

JAMP-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 JAMP-Montelukast 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, JAMP-Montelukast does not interfere with other medicines that you may be taking. However, some medicines may affect how JAMP-Montelukast works, or JAMP- 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 and adolescents 15 years and older:

Take JAMP-Montelukast once a day in the evening with or without food, as your physician has prescribed.

Take JAMP-Montelukast daily for as long as your physician prescribes it in order to maintain control of your asthma. JAMP-Montelukast can treat your asthma only if you continue to take it.

It is important that you continue taking JAMP- Montelukast 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 JAMP- 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 JAMP-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:

Missed Dose:

Try to take JAMP-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. JAMP-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
• 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.

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

Store at room temperature (15°C – 30°C) in a dry place protected from light.

Keep all medicines safely away from children.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

HOW TO STORE IT

If you want more information about JAMP-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://www.canada.ca/en/health- canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (www.jamppharma.com), or by calling 1-866-399-9091.

1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada

Last Revised: February 7, 2022

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