Teva-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 TEVA-MONTELUKAST to treat your asthma or your child’s asthma, including preventing your asthma symptoms during the day and night.

TEVA-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.

Seasonal Allergic Rhinitis (for adults and adolescents 15 years and older):

Your physician has prescribed TEVA-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 and children 2 years and older with asthma): When taken as prescribed, TEVA-MONTELUKAST also prevents the narrowing of airways triggered by exercise.

What it does:

TEVA-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 TEVA-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 as Montelukast sodium

What the non-medicinal ingredients are:

Each 4 mg and 5 mg chewable tablet contains the following non-medicinal ingredients: aspartame, flavour cherry Permaseal PHS-143671, hydroxypropylcellulose, magnesium stearate, mannitol, red iron oxide, sodium lauryl sulfate and sodium starch glycolate.

Each 10 mg film-coated tablet contains the following non-medicinal ingredients: hydroxypropylcellulose, lactose monohydrate (128.6 mg), magnesium stearate, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate and colour coating containing the following: hydroxypropylcellulose, hydroxypropyl methylcellulose, iron oxide yellow, iron oxide red and titanium dioxide.

Phenylketonurics: TEVA-MONTELUKAST 4 mg and 5 mg chewable tablets contain 0.28 mg phenylalanine each.

What dosage forms it comes in:

TEVA-MONTELUKAST film-coated tablet 10 mg and TEVA-MONTELUKAST chewable tablet 4 mg, 5 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

TEVA-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.

Serious behavior and mood-related changes have been reported in patients taking montelukast. If you or your child experience these changes while taking TEVA-MONTELUKAST (see "SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM"), tell your physician.

BEFORE using TEVA-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 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 TEVA-MONTELUKAST.

Use in breast-feeding

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

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

Take one 10 mg TEVA-MONTELUKAST tablet once a day in the evening with or without food, as your physician has prescribed.

Patients 6 to 14 years of age:

Take one 5 mg TEVA-MONTELUKAST chewable tablet 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 TEVA-MONTELUKAST chewable tablet once a day in the evening with or without food, as your physician has prescribed.

Take TEVA-MONTELUKAST daily for as long as your physician prescribes it in order to maintain control of your or your child’s asthma. TEVA-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 TEVA-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 TEVA-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 TEVA-MONTELUKAST 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 or your child. Never give it to anyone else.

Follow up with your physician to ensure your continued health and safety.

Overdose:

Missed Dose:

Try to take TEVA-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. TEVA-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
  • 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 TEVA-MONTELUKAST, contact your physician or pharmacist.

HOW TO STORE IT

Store the 10 mg film-coated tablets, and the 4 mg and 5 mg chewable tablets at room temperature (15°C-30°C), protected from moisture and light. For blister package keep tablets in original package.

Keep all medicines safely away from children.

Reporting Side Effects

MORE INFORMATION

If you want more information about TEVA-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), www.tevacanada.ca or contacting Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3

E-mail: druginfo@tevacanada.com or

Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

www.tevacanada.com

Last revised: December 3, 2020

* Aspirin^® is a Registered Trademark