Montelukast belongs to a group of medications known as leukotriene receptor antagonists. It is used to prevent and manage Asthma symptoms and to relieve the symptoms of seasonal Allergies, also known as seasonal Allergic Rhinitis or hay Fever. It may also be used to treat asthma symptoms caused by exercise (exercise-induced bronchoconstriction). It works by blocking the effects of leukotrienes, a substance produced by the body in response to certain "triggers" that cause narrowing and swelling of airways in the lungs. It may be taken alone or in addition to other asthma medications. Montelukast usually starts to work within one day.

When used to prevent and manage asthma, it is important to understand that montelukast should not be used to relieve an asthma attack once it has started. People with asthma should always have their fast-acting asthma relief medication on hand to treat an asthma attack.

Your doctor may have suggested Sandoz Montelukast for conditions other than the ones listed in these drug information articles. As well, some forms of Sandoz Montelukast may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking Sandoz Montelukast, speak to your doctor. Do not stop taking Sandoz Montelukast without consulting your doctor.

Do not give Sandoz Montelukast to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Sandoz Montelukast if their doctor has not prescribed it.

For seasonal allergic rhinitis, the recommended dose of montelukast for adults and adolescents 15 years and older is one 10 mg tablet taken once a day in the evening.

For asthma, the recommended dose of montelukast for adults and adolescents 15 years and older is one 10 mg tablet taken once a day in the evening. For children 6 to 14 years old, the recommended dose is one chewable 5 mg tablet taken once a day in the evening. For children 2 to 5 years old, the recommended dose is one chewable 4 mg tablet or one packet of 4 mg granules taken in the evening.

Montelukast can be taken with or without food.

The oral granules can be given either directly in the mouth, or mixed with a spoonful of cold or room temperature soft food (e.g., apple sauce). The packet should not be opened until ready to use. After opening the packet, the full dose of oral granules must be given within 15 minutes. Do not store any oral granule and food mixture for later use. Do not mix the oral granules in liquid. Children may drink liquids after swallowing the oral granules.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Sandoz Montelukast exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Sandoz Montelukast at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Sandoz Montelukast. If you are concerned about side effects, discuss the risks and benefits of Sandoz Montelukast with your doctor.

The following side effects have been reported by at least 1% of people taking Sandoz Montelukast. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal or stomach pain
• abnormal dreams
• Bedwetting (for children)
• Diarrhea
• dizziness
• drowsiness
• fatigue
• fever
• headache
• muscle aches or cramps
• scaly and itchy skin
• skin rash
• symptoms of a cold (i.e., sore throat, runny nose, nasal congestion)
• thirst
• trouble sleeping
• weakness or unusual tiredness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• aggressive behaviour (such as temper tantrums in children)
• asthma symptoms
• behaviour changes (e.g., anxiety, irritability, aggressiveness, hostility)
• disorientation (not knowing time of day, location)
• hyperactivity
• memory problems
• pounding, fast, or irregular heartbeat
• red lumps under the skin, most commonly on the shins
• respiratory tract infection
• restlessness
• seeing or hearing things that are not there (hallucinations)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• sleepwalking
• swelling
• tremor
• trouble paying attention
• uncontrolled muscle movement

Stop taking the medication and seek immediate medical attention if any of the following occur:

• breathing problems that continue to get worse
• seizures
• signs of a Anaphylaxis (severe allergic reaction) (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• symptoms of Churg-Strauss syndrome (e.g., persistent or worsening flu-like symptoms, rash, pins and needles, numbness of the arms or legs, joint pain, and severe Sinusitis)
• thoughts of self-harm or suicide

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Sandoz Montelukast.

Chewable Tablets

4 mg
Each oval, pink-to-slightly-speckled-pink tablet with cherry odour and embossed with "4" on one side, contains 4 mg of montelukast in the form of montelukast sodium. Nonmedicinal ingredients: aspartame, cellulose microcrystalline, cherry flavour (acacia gum, allura red, fatty acids, flavouring substances, maize maltodextrin, silicon dioxide, sugar), croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, and red ferric oxide.

5 mg
Each round, pink-to-slightly-speckled-pink tablet with cherry odour and embossed with "5" on one side, contains 5 mg of montelukast in the form of montelukast sodium. Nonmedicinal ingredients: aspartame, cellulose microcrystalline, cherry flavour (acacia gum, allura red, fatty acids, flavouring substances, maize maltodextrin, silicon dioxide, sugar), croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, and red ferric oxide.

Granules
Each packet of white, coarse, granular, free-flowing, solid granules contains 4 mg of montelukast in the form of montelukast sodium. Nonmedicinal ingredients: hydroxypropyl cellulose, magnesium stearate, and mannitol.

Tablets
Each beige, square-shaped, biconvex, film-coated tablet, engraved with "10" on one side, contains 10 mg of montelukast in the form of montelukast sodium. Nonmedicinal ingredients: cellulose microcrystalline, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, and titanium dioxide.