Jamp-Montelukast (Jamp Pharma, 4 mg, 5 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Asthma (for children 2 to 14 years old):

Your physician has prescribed Jamp-MONTELUKAST to treat your asthma or your child’s asthma, including preventing your or your child’s asthma symptoms during the day and night. When taken as prescribed, Jamp-MONTELUKAST also prevents the narrowing of airways triggered by exercise.

Jamp-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.

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).

When it should not be used:

Do not take Jamp-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 important non-medicinal ingredients are: Each 4 mg and 5 mg chewable tablet contains the following non-medicinal ingredients: aspartame, flavour cherry, hydroxypropylcellulose, magnesium stearate, mannitol, microcrystalline cellulose, croscarmellose sodium and red iron oxide.

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

What dosage forms it comes in:

Jamp-MONTELUKAST, chewable tablet 4 mg, 5 mg.

WARNINGS AND PRECAUTIONS

Jamp-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 Jamp-MONTELUKAST. If you or your child 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 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 starts 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 IMPORTANT: PLEASE READ

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 s h o u l d c o n s u l t y o u r p h y s i c i a n b e f o r e t a k i n g 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 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, 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 or your child are using or plan to use, including those obtained without a prescription.

PROPER USE OF THIS MEDICATION

Usual dose:

Asthma (for children 2 to 14 years old):

Take Jamp-MONTELUKAST once a day in the evening with or without food, as your or your child’s physician has prescribed.

Take Jamp-MONTELUKAST daily for as long as your or your child’s physician prescribes it in order to maintain control of your or your child’s asthma. Jamp-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 Jamp-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 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.

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:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. Missed Dose:

Try to take Jamp-MONTELUKAST as prescribed. However, if you miss a dose, just resume the usual schedule of one tablet or packet once daily.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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, disturbance in attention, memory impairment, restlessness, sleep walking, sleep disorders including dream abnormalities and insomnia
• 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.

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

HOW TO STORE IT

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

Keep all medicines safely away from children

REPORTING SUSPECTED 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: -------------------------------------------------------------

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

This document plus the full monograph, prepared for health professionals can be found by contacting JAMP Pharma Corporation

JAMP Pharma Corporation

1380-203 rue Newton

Boucherville, QC

J4B 5H2

Canada

Date of preparation: March 14, 2016