NEW ZEALAND CONSUMER MEDICINE INFORMATION MONTELUKAST MYLAN montelukast sodium 4 mg and 5 mg chewable tablet montelukast sodium 10 mg film coated tablet
MONTELUKAST MYLAN can be symptoms and helps prevent What is in this leaflet used in children 2 years of age and asthma attacks. Leukotrienes also older, teenagers and adults. cause allergy symptoms. Blocking Please read this leaflet carefully leukotrienes improves allergic before you start taking MONTELUKAST MYLAN tablets rhinitis (seasonal and year-round, MONTELUKAST MYLAN. are not used to treat an acute attack also known as outdoor and indoor of asthma. If an acute attack occurs, nasal allergies). This leaflet answers some common follow your doctor’s instructions for questions about MONTELUKAST that situation. Your doctor may have prescribed MYLAN. this medicine for another reason. Asthma is a lung disease and has It does not contain all the available the following characteristics: Ask your doctor if you have any information. It does not take the • narrowed airways causing questions about why this place of talking to your doctor or breathing to become difficult. medicine has been prescribed for pharmacist. • inflamed airways, which means you. the lining of airways become All medicines have risks and swollen. This medicine is available only with benefits. Your doctor has weighed • sensitive airways that react to a doctor’s prescription. the risks of you taking many things, such as cigarette MONTELUKAST MYLAN against smoke, pollen, or cold air. This medicine is not addictive. the benefits they expect it will have for you. Symptoms of asthma include coughing, wheezing and chest Before you take If you have any concerns about tightness. Not all people with taking this medicine, ask your asthma wheeze. For some, MONTELUKAST doctor or pharmacist. coughing may be the only symptom MYLAN of asthma. Symptoms often occur Keep this leaflet with the during the night or after exercise. medicine. You may need to read it When you must not take again. Seasonal allergies (also known as it hay fever) are triggered by outdoor allergens such as airborne pollens Do not take MONTELUKAST What from trees, grasses and weeds. MYLAN if you have an allergy to: • any medicine containing MONTELUKAST Year-round allergies may occur montelukast sodium. MYLAN is used for year-round and are generally • any of the ingredients listed at triggered by indoor allergens such the end of this leaflet. as dust mites, animal dander, MONTELUKAST MYLAN is used to and/or mould spores. Some of the symptoms of an treat: allergic reaction may include: • asthma, including preventing The daytime and night time shortness of breath; wheezing or asthma symptoms during the symptoms of allergies typically may difficulty breathing; swelling of the day and night. It also prevents include: face, lips, tongue or other parts of the narrowing of airways • stuffy, runny, itchy nose, the body; rash, itching or hives on triggered by exercise. • sneezing, the skin. • seasonal and year-round • watery, swollen, red, itchy eyes. allergies, including daytime and Do not give this medicine to a night time symptoms, including MONTELUKAST MYLAN belongs child under the age of 2 years. nasal congestion, runny nose, to a group of medicines called Safety and effectiveness in children nasal itching, and sneezing; leukotriene receptor antagonists. younger than 2 years have not been nasal congestion upon It works by blocking substances in established. awakening, difficulty going to your lungs called leukotrienes that sleep, and night time cause narrowing and swelling of • 10 mg tablets are awakenings; tearing, itchy, red, airways. Blocking leukotrienes recommended for adults and puffy eyes. improves asthma
Page 1 of 5 and teenagers 15 years and • phenytoin (used for How to take it older treatment of epilepsy) • 5 mg chewable tablets are • phenobarbital (used for MONTELUKAST MYLAN comes as recommended for children treatment of epilepsy) three types of tablets: 6-14 years old • rifampicin (used to treat • 10 mg tablets for adults and • 4 mg chewable tablets are tuberculosis and some teenagers 15 years and older recommended for children 2 other infections) • 5 mg chewable tablets for -5 years old • gemfibrozil (used for children 6-14 years old treatment of high lipid levels • 4 mg chewable tablets for Do not take this medicine after in plasma). children 2 -5 years old the expiry date printed on the pack or if the packaging is torn or These medicines may be affected Swallow the 10 mg tablet whole with shows signs of tampering. by MONTELUKAST MYLAN or may a glass of water. If it has expired or is damaged, affect how well it works. You may return it to your pharmacist for need different amounts of your Chew the 4 mg or 5 mg chewable disposal. medicines, or you may need to take tablet thoroughly and swallow. different medicines. If you are not sure whether you When to take it should start taking this medicine, Your doctor and pharmacist have For patients with asthma, take talk to your doctor. more information on medicines to MONTELUKAST MYLAN once a be careful with or avoid while taking day in the evening. Taking your Before you start to take this medicine. tablet at bedtime each day will have it the best effect. It will also help you remember when to take the tablets. Tell your doctor if you have How to take allergies to any other medicines, For patients with allergic rhinitis, foods, preservatives or dyes. MONTELUKAST take MONTELUKAST MYLAN once Montelukast Mylan chewable tablets MYLAN a day as prescribed by your doctor. contains aspartame. Taking it at the same time each day Follow all directions given to you will help have the best effect. It will Tell your doctor if you are by your doctor or pharmacist also help you remember when to pregnant or plan to become carefully. take it. pregnant or are breast-feeding. They may differ from the information MONTELUKAST MYLAN has not contained in this leaflet. MONTELUKAST MYLAN chewable been studied in pregnant women tablets should be taken on an and it is not known if this medicine If you do not understand the empty stomach, for example, 1 hour passes into breast milk. instructions on the box, ask your before food or 2 hours after food. Your doctor can discuss with you doctor or pharmacist for help. Food can interfere with the the risks and benefits involved. absorption of this medicine.
Tell your doctor if you have liver How much to take MONTELUKAST MYLAN film disease. Take MONTELUKAST MYLAN only coated tablets can be taken with our when prescribed by your doctor. without food. If you have not told your doctor For adults and teenagers 15 years about any of the above, tell them How long to take it before you start taking and older, for the treatment of MONTELUKAST MYLAN. asthma, seasonal and year-round Continue taking your medicine allergies, the dose is one 10 mg for as long as your doctor tells tablet taken daily. Taking other medicines you. For children 6 to 14 years old, for This medicine helps to control your Tell your doctor or pharmacist if the treatment of asthma, seasonal condition but does not cure it. It is you are taking any other and year-round allergies, the dose important to keep taking your medicines, including medicines is one 5 mg chewable tablet taken MONTELUKAST MYLAN that you buy without a daily. prescription from your pharmacy, If you forget to take it supermarket or health food shop. For children 2 to 5 years old, for the treatment of asthma, seasonal and Skip the dose you missed and You should also tell any health year-round allergies, the dose is take your next dose as usual. professional who is prescribing a one 4 mg chewable tablet taken new medication for you that you are daily. Do not take a double dose to taking MONTELUKAST MYLAN. Studies have shown that make up for the dose that you MONTELUKAST MYLAN does not missed. Some medicines may interfere with affect the growth rate of children. This may increase the chance of MONTELUKAST MYLAN. These you getting an unwanted side effect. include:
Page 2 of 5 If you have trouble remembering to Keep all of your doctor’s take your medicine, ask your appointments so that your Side effects pharmacist for some hints. progress can be checked. Tell your doctor or pharmacist as Things you must not do soon as possible if you do not While you are taking feel well while you are taking Do not take MONTELUKAST MONTELUKAST MYLAN. MONTELUKAST MYLAN to treat any other This medicine helps most people, MYLAN complaints unless your doctor but it may have unwanted side tells you to. effects in a few people.
Things you must do Do not give your medicine to All medicines can have side Continue taking MONTELUKAST anyone else, even if they have effects. Sometimes they are MYLAN every day as directed by the same condition as you. serious, most of the time they are your doctor, even if you have no not. You may need medical asthma symptoms or if you have Do not stop taking your medicine treatment if you get some of the an asthma attack. or lower the dosage without side effects. checking with your doctor. If your or your child’s asthma Ask your doctor or pharmacist to gets worse while taking Things to be careful of answer any questions you may MONTELUKAST MYLAN, tell your have. Be careful driving or operating doctor immediately. machinery until you know how Tell your doctor or pharmacist if MONTELUKAST MYLAN affects you notice any of the following If an acute attack of asthma you. This medicine may cause occurs, follow your or your drowsiness or dizziness in some and they worry you: child’s doctor’s instructions on people. If you have any of these • headache, what medicines to use to relieve symptoms, do not drive, operate • stomach pain, the attack. machinery or do anything else that • thirst, could be dangerous. Children • If you or your child experience bedwetting in children, should be careful when riding • weakness/tiredness, behaviour and mood-related bicycles or climbing trees changes while taking • diarrhoea, • an uncomfortable feeling in the MONTELUKAST MYLAN, tell your Be careful when drinking alcohol doctor immediately. stomach or belching after while you are taking this medicine. If eating, you drink alcohol, drowsiness or • indigestion, If you or your child is on anti- dizziness may be worse. asthma medicines, be aware that • nausea or vomiting, if he/she develops a combination • dry mouth, of symptoms such as flu-like • dizziness, drowsiness, illness, pins and needles or In case of overdose • pins and needles/numbness, numbness of arms or legs, • nose bleed; worsening of pulmonary If you take too much • bruising, symptoms, and/or rash, you (overdose) • joint pain, muscle aches or should consult your doctor. muscle cramps, Immediately telephone your • feeling weak or a lack of If you become pregnant while doctor or the National Poisons energy, taking MONTELUKAST MYLAN, Centre (telephone 0800 POISON • restlessness, tell your doctor immediately. or 0800 764 766) or go to accident • tremor, and emergency at your nearest • strange dreams including hospital, if you think that you or If you are about to be started on nightmares, anyone else may have taken too any new medicine, tell your • trouble sleeping (insomnia), doctor and pharmacist that you much MONTELUKAST MYLAN. • disorientation, are taking MONTELUKAST Do this even if there are no signs • irritability, MYLAN. of discomfort or poisoning. You may need urgent medical attention. • stuttering. Tell any other doctors, dentists, and pharmacists who treat you Symptoms of an overdose may Tell your doctor as soon as that you are taking this medicine. include: possible if you notice any of the • abdominal pain, following: If you are going to have surgery, • sleepiness or drowsiness, • upper respiratory infection, tell the surgeon or anaesthetist • thirst, symptoms may include that you are taking this medicine. • headache, coughing, nasal congestion, It may affect other medicines used • vomiting, runny nose, excess mucus or during surgery. • hyperactivity. scratchy sore throat,
Page 3 of 5 • bleeding or bruising more easily • chest pain, pharmacist what to do with any than normal, • shortness of breath, medicine that is left over. • behaviour and mood related • rapid breathing or wheezing, changes including agitation • combination of symptoms such including aggressive behaviour as flu-like illness, pins and Product description or hostility, depression, needles or numbness of arms • hyperactivity, and legs, worsening of What it looks like • disturbances in attention, pulmonary symptoms and/or • feeling anxious, rash (Churg-Strauss 4 mg chewable tablet: A white to • hallucinations, syndrome). off-white coloured, oval, biconvex • trouble remembering (memory tablet debossed with “M” on one impairment), The above list includes very serious side and “MS1” on the other side. • obsessive-compulsive side effects. You may need urgent symptoms, medical attention or hospitalisation. 5 mg chewable tablet: A white to • sleep walking, off-white coloured, round, biconvex • uncontrolled muscle Tell your doctor or pharmacist if tablet debossed with “M” on one movements, you notice anything that is side and “MS2” on the other side. • symptoms of liver disease making you feel unwell. which includes nausea, 10 mg film coated tablet: A blue vomiting, loss of appetite, Other side effects not listed above film-coated, round bi-convex feeling generally unwell, fever, may also occur in some people. Tell beveled edge shaped tablet itching, yellowing of the skin your doctor if you notice any other debossed with “MO” over “10” on and eyes, light coloured bowel effects. one side and “M” on the reverse. motions, and dark coloured urine, Do not be alarmed by this list of Ingredients • swelling of hands, ankles, feet possible side effects. You may Active ingredient(s): or other body parts due to fluid not experience any of them.
build-up, • MONTELUKAST MYLAN 4 mg • fever, chewable tablet contains • tender red lumps under the After taking montelukast sodium which skin, most commonly on your MONTELUKAST corresponds to 4 mg shins (erythema nodosum). montelukast.
MYLAN • MONTELUKAST MYLAN 5 mg Tell your doctor immediately if chewable tablet contains have suicidal thoughts and Storage montelukast sodium which actions corresponds to 5 mg Keep your tablets in the bottle montelukast. The above list includes serious side until it is time to take them. • MONTELUKAST MYLAN 10 effects that may require medical If you take the tablets out of the mg film coated tablet contains attention. pack they may not keep well. montelukast sodium which corresponds to 10 mg If any of the following happen, Keep your tablets in a cool dry montelukast. tell your doctor immediately or dark place where the temperature go to Accident and Emergency at stays below 25°C. Inactive ingredient(s): your nearest hospital:
Do not store MONTELUKAST • palpitations, MONTELUKAST MYLAN 4 mg and MYLAN or any other medicine in the • 5 mg chewable tablets also seizures, bathroom or near a sink. Do not • contains: swelling (inflammation) of the leave it on a window sill or in the • lungs, car. mannitol, • • allergic reactions: Heat and dampness can destroy microcrystalline cellulose, o including swelling of the some medicines. • croscarmellose sodium, face, lips, tongue, and/or • aspartame (E951), throat (which may cause Keep it where children cannot • colloidal anhydrous silica, trouble breathing or reach it. • magnesium stearate, swallowing), A locked cupboard at least one-and- • sodium lauryl sulfate, o hives (severe and sudden a half metres above the ground is a • The cherry flavour (501027 AP onset of pinkish itchy good place to store medicines. 0551) contains: swellings on the skin, also maize maltodextrin, called nettle rash), o o benzyl alcohol (E1519), • severe skin reactions that may Disposal o triethyl citrate (E1505). occur without warning such as If your doctor tells you to stop rash, and itching, taking this medicine or the expiry MONTELUKAST MYLAN 10 mg • rash on the body where each date has passed, ask your film coated tablets also contains: mark resembles a bull’s eye, • microcrystalline cellulose,
Page 4 of 5 • mannitol, • croscarmellose sodium, • magnesium stearate, • sodium laurylsulfate • silica colloidal anhydrous. • The film coating consists of: o polydextrose, o titanium dioxide, o hypromellose, o triacetin, o indigo carmine aluminium lake (E132), o macrogol 400, o sunset yellow aluminium lake (E110), o macrogol 8000. This medicine does not contain lactose or gluten.
If you want to know more
Should you have any questions regarding this product, please contact your pharmacist or doctor. Who supplies this medicine MONTELUKAST MYLAN is supplied in New Zealand by:
Mylan New Zealand Ltd, PO Box 11183, Ellerslie, Auckland NEW ZEALAND
Telephone: (09) 579 2792
Date of Preparation
24 August 2020 (Based on datasheet dated 24 August 2020)
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