Ran-Montelukast: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Asthma (for adults, adolescents and children 2 to 14 years old):

Your physician has prescribed RAN-MONTELUKAST to treat your child’s asthma, including preventing your asthma symptoms during the day and night. When taken as prescribed, RAN-MONTELUKAST also

prevents the narrowing of airways triggered by exercise.

RAN-MONTELUKAST 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 you or your child.

What it does:

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

What dosage forms it comes in:

RAN-MONTELUKAST chewable tablet 4 mg, 5 mg.

WARNINGS AND PRECAUTIONS

RAN-MONTELUKAST 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.

Behavior and mood-related changes have been reported in patients taking RAN-MONTELUKAST. If your child experience these changes while taking RAN-

MONTELUKAST (see “SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM”), tell your physician.

BEFORE using RAN-MONTELUKAST, tell your physician if your child:

• has 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 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

Use in pregnancy

Women who are pregnant or intend to become pregnant should consult their physician before taking RAN-MONTELUKAST.

Use in breast-feeding

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

breast-feed.

RAN-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 RAN-MONTELUKAST 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 asthma is made worse by exercise, your child should continue to use the medicines your physician has prescribed for your child to use before exercise, unless your physician tells you otherwise. You/your child should always have your inhaled rescue medicine for asthma attacks with you in case you need it.

If your child’s 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, RAN-MONTELUKAST does not interfere with other medicines that you may be taking. However, some medicines may affect how RAN- MONTELUKAST works, or RAN-MONTELUKAST may affect how your other medicines work. It is important to tell your physician about all drugs that your child is 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 RAN-MONTELUKAST once a day in the evening with or without food, as your physician has prescribed.

Take RAN-MONTELUKAST daily for as long as your physician prescribes it in order to maintain control of your child’s asthma. RAN-MONTELUKAST can treat your child’s asthma only if your child continues to take it.

It is important that your child continue taking RAN-MONTELUKAST daily as prescribed by your physician, even when your child has no symptoms or if your child has an asthma attack.

If you are taking other medications along with RAN-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 your child. 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 RAN-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 RAN-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. RAN-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 RAN-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 Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect

  (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);

• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

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

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 0701E Ottawa, ON

    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect. (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

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

This document plus the full product monograph, prepared for health professionals can be found by contacting Ranbaxy Pharmaceuticals Canada Inc. at 1-866-840-1340

Ranbaxy Pharmaceuticals Canada Inc.

Date of revision: March 21, 2016