Montelukast 10mg Tablet, 14 Tablets

What is Montelukast 10mg Tablet?

Montelukast 10mg Tablet – Montelukast is a leukotriene inhibitor. Leukotrienes are chemicals your body releases when you breathe in an allergen (such as pollen). These chemicals cause swelling in your lungs and tightening of the muscles around your airways, which can result in asthma symptoms. By blocking leukotrienes, Montelukast 10 mg film-coated tablets improve asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

What Montelukast 10mg Tablet is used for

Montelukast 10mg Tablet is used to prevent asthma attacks in adults and children 16 years. Montelukast is also used to prevent exercise-induced bronchospasm in adults and children who are at least 16 years old.

Montelukast 10 mg film-coated tablets to treat asthma, preventing your asthma symptoms during the day and night.
• Montelukast 10 mg film-coated tablets are used for the treatment of adults and adolescents 15 years of age and older who are not adequately controlled on their medication and need additional therapy.
• Montelukast 10 mg film-coated tablets also helps prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom Montelukast 10 mg film-coated tablets are indicated in asthma, Montelukast 10 mg film-coated tablets can also provide symptomatic relief of seasonal allergic rhinitis.

Montelukast Tablet is also used to treat symptoms of year-round (perennial) allergies in adults and children who are at least 16 years. It is also used to treat symptoms of seasonal allergies in adults and children who are at least 16 years old.

To treat younger children with Montelukast, there are lower strengths, 5mg and 4mg, available

What is asthma?

Asthma is a long-term disease.
Asthma includes:
• difficulty breathing because of narrowed airways. This narrowing of airways worsens and improves in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) in the lining of airways.
Symptoms of asthma include Coughing, wheezing, and chest tightness.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollens from trees, grasses and weeds.

The symptoms of seasonal allergies typically may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.

What you need to know before you take Montelukast 10mg Tablet

Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Montelukast 10 mg film-coated tablets:
• if you are allergic to montelukast or any of the other ingredients of this medicine (
Warnings and precautions
Talk to your doctor or pharmacist before taking Montelukast 10 mg film-coated tablets
• If your asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast 10 mg film-coated tablets are not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you. Always have your inhaled rescue medicine for asthma attacks with you.
• It is important that you or your child take all asthma medications prescribed by your doctor.
Montelukast 10 mg film-coated tablets should not be substituted for other asthma medications your doctor has prescribed for you.
• Any patient on anti-asthma medicines should be aware that if you develop a combination of symptoms such as a flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult your doctor.
• You should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
Patients should be aware that various neuropsychiatric events (for example behaviour and mood-related changes) have been reported in adults, adolescents and children with Montelukast 10 mg film-coated tablets (see section 4). If you develop such symptoms while taking Montelukast 10 mg film-coated tablets, you should consult your doctor.
Children and adolescents
Do not give this medicine to children less than 15 years of age.
There are different form(s) of this medicine available for paediatric patients under 18 years of age based on age range.
Other medicines and Montelukast 10 mg film-coated tablets
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines including those obtained without a prescription.
Tell your doctor if you are taking the following medicines before starting Montelukast 10 mg film-coated tablets:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used for treatment of high lipid levels in plasma)
Montelukast 10 mg film-coated tablets with food and drink
Montelukast 10 mg film-coated tablets may be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Montelukast 10 mg film-coated tablets.
Pregnancy
Your doctor will assess whether you can take Montelukast 10 mg film-coated tablets during this time.
Breast-feeding
It is not known if montelukast appears in human milk. You should consult your doctor before taking Montelukast 10 mg film-coated tablets if you are breast-feeding or intend to breast-feed.
Driving and using machines
Montelukast 10 mg film-coated tablets are 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 with Montelukast 10 mg film-coated tablets may affect some patients’ ability to drive or operate machinery.
Montelukast 10 mg film-coated tablets contains lactose
Montelukast 10 mg film-coated tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

How to take Montelukast 10mg Tablet

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• You should take only one tablet of Montelukast 10 mg film-coated tablets once a day as prescribed by your doctor.
• It should be taken even when you have no symptoms or have an acute asthma attack.
For adults and adolescents 15 years of age and older:
The recommended dose is one 10 mg tablet to be taken daily in the evening.
If you are taking Montelukast 10 mg film-coated tablets, be sure that you do not take any other products that contain the same active ingredient, montelukast.
This medicine is for oral use. Montelukast 10 mg film-coated tablets may be taken with or without food.

If you stop taking Montelukast 10 mg film-coated tablets
Montelukast 10 mg film-coated tablets can treat your asthma only if you continue to take it. It is important to continue taking Montelukast 10 mg film-coated tablets for as long as your doctor prescribes. It will help control your asthma.

Montelukast Tablet Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with Montelukast 10 mg film-coated tablets, the most commonly reported side effects (may affect up to 1 in 10 people) thought to be related to Montelukast were:
• abdominal pain
• headache
These were usually mild and occurred at a greater frequency in patients treated with Montelukast than placebo (a pill containing no medication).
Serious side effects
Talk with your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment.
Uncommon: the following may affect up to 1 in 100 people
• allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
• behaviour and mood related changes: agitation including aggressive behaviour or hostility, depression
• seizure
Rare: the following may affect up to 1 in 1,000 people
• increased bleeding tendency
• tremor
• palpitations
Very rare: the following may affect up to 1 in 10,000 people
• combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome)
• low blood platelet count
• behaviour and mood related changes: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that may occur without warning
• inflammation of the liver (hepatitis)
Other side effects while the medicine has been on the market
Very common: the following may affect more than 1 in 10 people
• upper respiratory infection
Common: the following may affect up to 1 in 10 people
• diarrhoea, nausea, vomiting
• rash
• fever
• elevated liver enzymes
Uncommon: the following may affect up to 1 in 100 people
• behaviour and mood-related changes: dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, pins and needles/numbness
• nosebleed
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting in children
• weakness/tiredness, feeling unwell, swelling
Rare: the following may affect up to 1 in 1,000 people
• behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements
Very rare: the following may affect up to 1 in 10,000 people
• tender red lumps under the skin, most commonly on your shins (erythema nodosum)
• behaviour and mood related changes: obsessive-compulsive symptoms, stuttering

Ingredients

The active substance is Montelukast. Each film-coated tablet contains 10 mg of montelukast.
The other ingredients are:
Tablet core: Lactose monohydrate, cellulose microcrystalline, low substituted hydroxypropylcellulose (LH-11) (E 463), croscarmellose sodium, magnesium stearate. Film coat: Hydroxypropylcellulose (LF) (E 463), hypromellose 6CPS (A), titanium dioxide (E 171), macrogol 6000, iron oxide yellow and iron oxide red (E172)

Patient Information leaflet