Patient Medication Information: uses, side effects, how to take - Jamp Montelukast Chewable Tablets
What the medication is used for:
Asthma (children 2 to 14 years old):
Your physician has prescribed JAMP Montelukast Chewable Tablets to treat your child’s asthma, including preventing your asthma symptoms during the day and night.
JAMP Montelukast Chewable Tablets 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 (children 2 to 14 years old with asthma): When taken as prescribed, JAMP Montelukast Chewable Tablets also prevents the narrowing of airways triggered by exercise.
What it does:
JAMP Montelukast Chewable Tablets 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.
When it should not be used:
Your child should not take JAMP Montelukast Chewable Tablets 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:
Aspartame, cherry flavor, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide red and disodium edetate.
Phenylketonurics: JAMP Montelukast Chewable Tablets 4 mg and 5 mg contain 0.674 and 0.842 mg phenylalanine, respectively.
What dosage forms it comes in:
JAMP Montelukast Chewable Tablets 4 mg, 5 mg.
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 your child from taking JAMP Montelukast Chewable Tablets and tell your healthcare provider right away if your child has any unusual changes in behavior or thinking, including any of these symptoms:
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JAMP Montelukast Chewable Tablets 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 montelukast sodium. If your child experiences these changes while taking JAMP Montelukast Chewable Tablets (see “SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM”), tell your physician.
BEFORE using JAMP Montelukast Chewable Tablets, tell your physician if your child:
- have phenylketonuria;
- suffer from liver problems;
- are using any other medicines;
WARNINGS AND PRECAUTIONS
ABOUT THIS MEDICATION
- have or have had any medical problems or allergies.
You should immediately inform your doctor if your child starts 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 Chewable Tablets.
Use in breast-feeding
It is not known if montelukast sodium appears in breast milk. You should consult your physician before taking JAMP Montelukast Chewable Tablets if you are breast-feeding or intend to breast-feed.
JAMP Montelukast Chewable Tablets 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 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 your physician has prescribed to use before exercise, unless the physician tells you otherwise. You should always have your child’s inhaled rescue medicine for asthma attacks with you in case they 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.
In general, JAMP Montelukast Chewable Tablets does not interfere with other medicines that your child may be taking. However, some medicines may affect how JAMP Montelukast Chewable Tablets works, or JAMP Montelukast Chewable Tablets 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.
Usual dose: Asthma:
Patients 6 to 14 years of age:
Take one 5 mg JAMP Montelukast Chewable Tablets 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 JAMP Montelukast Chewable Tablets once a day in the evening with or without food, as your physician has prescribed.
Your child should take JAMP Montelukast Chewable Tablets daily for as long as your physician prescribes it in order to maintain control of your child’s asthma. JAMP Montelukast Chewable Tablets can treat your child’s asthma only if your child continues to take it.
It is important that your child continue taking JAMP Montelukast Chewable Tablets daily as prescribed by your physician, even when your child has no symptoms or your child has an asthma attack.
If your child is taking other medications along with JAMP Montelukast Chewable Tablets your physician will instruct you how and when your child should take each medication. Your physician will increase or decrease the doses of these medications as needed.
Remember that your physician has prescribed this medicine only for your child. Never give it to anyone else.
Follow up with your physician to ensure your child’s continued health and safety.
Overdose:
| If you think you have taken too much JAMP Montelukast Chewable Tablets, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
Your child should try to take JAMP Montelukast Chewable Tablets as prescribed. However, if your child misses a dose, your child should take the next dose when it is due. Your child should 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. JAMP Montelukast Chewable Tablets is
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptoms / Effects | Talk with your physician or pharmacist | Stop taking drug and seek immediate emergency medical attention | |
| Only if severe | In all cases | ||
| 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, obsessive-compulsive 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 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 JAMP Montelukast Chewable Tablets, contact your physician or pharmacist.
Store the 4 mg and 5 mg chewable tablets at room temperature (15°C–30°C). Protect from moisture and light.
Keep all medicines safely away from children.
HOW TO STORE IT
If you want more information about JAMP Montelukast Chewable Tablets:
- 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.jamppharma.com), or by calling 1-866-399-9091.
Last Revised: April 12, 2021
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.