Montelukast 10 Mg Film-Coated Tablets
Package leaflet: Information for the patient
Montelukast 10 mg Film-coated tablets
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Montelukast 10 mg Film-coated Tablets are and what they are used for
2. What you need to know before you take Montelukast 10 mg Film-coated Tablets
3. How to take Montelukast 10 mg Film-coated Tablets
4. Possible side effects
5. How to store Montelukast 10 mg Film-coated Tablets
6. Contents of the pack and other information
1. What Montelukast 10 mg Film-coated Tablets are and what they are used for
Montelukast contains montelukast, which is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Montelukast improves asthma symptoms, helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast to treat asthma, preventing your asthma symptoms during the day and night.
• Montelukast is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast also helps prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom Montelukast is indicated in asthma, it can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montelukast should be used depending on the symptoms and severity of your asthma.
Montelukast 10mg Film-coated Tablets are used in adults and adolescents 15 years of age and over only.
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 the 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.
2. What you need to know before you take Montelukast 10 mg Film-coated Tablets
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 (listed in section 6).
Warnings and precautions
• If your asthma or breathing gets worse, tell your doctor immediately.
• Montelukast is 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.
Talk to your doctor if you need more inhaled rescue medicine than usual for the acute asthma attacks.
• It is important that you take all asthma medications prescribed by your doctor.
Montelukast 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 lung (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 nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
Children and adolescents
For children 2 to 5 years of age, montelukast 4 mg chewable tablets are available.
For children and adolescents 6 to 14 years old, montelukast 5 mg chewable tablets are available.
Other medicines and Montelukast
Some medicines may affect how Montelukast works, or Montelukast may affect how other medicines work.
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:
• 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)
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will assess whether you can take Montelukast during this time.
Breast-feeding
It is not known if Montelukast appears in breast milk. You should talk to your doctor before taking Montelukast if you are breast-feeding or intend to breast-feed.
Driving and using machines
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 with Montelukast may affect some patient's ability to drive or operate machinery.
Montelukast 10 mg Film-coated Tablets contains sunset yellow (E110)
The tablets also contain sunset yellow (E110), which may cause allergic reactions.
3. How to take Montelukast 10 mg Film-coated Tablets
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 only take one tablet of Montelukast once a day as prescribed by your doctor.
• It should be taken even when you have no symptoms or have an acute asthma attack.
• To be taken by mouth
For adults (including the elderly) and adolescents of 15 years of age and older:
The recommended dose is:
• One 10 mg tablet to be taken daily in the evening. Montelukast 10 mg Film-coated Tablets may be taken with or without food.
Use in children and adolescents
Montelukast 10mg Film-coated Tablets are not appropriate for children and adolescents under 15 years of age. Further pharmaceutical forms/ strengths of the active substance montelukast are available. 4 mg and 5 mg chewable tablets can be used to treat patients from 2 to 14 years of age.
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.
If you take more Montelukast 10 mg Film-coated Tablets than you should
Contact your doctor immediately for advice.
50059539
There were no side effects reported in the majority of overdosage reports. The most frequently occurring symptoms reported with overdosage included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.
If you forget to take Montelukast 10 mg Film-coated Tablets
Try to take Montelukast as prescribed. However, if you miss a dose, just resume the usual schedule of one tablet once daily.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Montelukast 10 mg Film-coated Tablets
Montelukast can treat your asthma only if you continue to take it.
It is important to continue taking Montelukast for as long as your doctor prescribes. It will help control your asthma.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects that have been reported with montelukast, stop taking Montelukast Film-coated tablets and contact a doctor right away:
• Allergic reactions including rash, swelling of the face, lips tongue or throat which may cause difficulty in breathing or swallowing, sudden wheezing, collapse.
• In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flulike illness, pins and needles or numbness of arms and legs, worsening of lung (pulmonary)symptoms and/or rash (Churg-Strauss syndrome) have been reported.
• Suicidal thoughts and actions
• Seizure (fits)
• Yellowing of the skin or eyes which may be caused by hepatitis (inflammation of the liver), or other liver problems (hepatic eosinophilic infiltration)
• Chest pain with a dry cough, fever, shortness of breath and wheezing due to an inflammation of the lungs caused by an increase in the numbers of a certain type of white blood cell (pulmonary eosinophilia)
In clinical studies with montelukast, the most commonly reported side effects (occurring in 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).
Additionally, while the medicine has been on the market, the following side effects have been reported:
Very common (may affect more than 1 in 10 people)
• Upper respiratory infection
Common (may affect up to 1 in 10 people)
• Diarrheoa
• Nausea, vomiting
• Rash
• Fever
• Raised liver enzymes
Uncommon (may affect up to 1 in 100 people)
• Behaviour and mood related changes e.g. dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression, shaking (tremor)
• Dizziness, drowsiness
• Pins and needles, numbness
• Nosebleed
• Dry mouth
• Indigestion
• Bruising, itching, hives
• Joint or muscle pain, muscle cramps
• Tiredness, feeling unwell
• Swelling
Rare (may affect up to 1 in 1,000 people)
• Increased bleeding tendency
• Fast or irregular heartbeats (Palpitations)
• Disturbance in attention,
• Memory impairment
Very rare (may affect up to 1 in 10,000 people)
• Hallucinations (seeing, feeling or hearing things that are not there), disorientation
• Tender red lumps under the skin most commonly on your shins (erythema nodosum)
• Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) called erythema multiforme
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Montelukast 10 mg Film-coated Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Montelukast 10 mg Film-coated Tablets contain:
• The active substance is montelukast.
• Each tablet contains 10 mg of montelukast as montelukast sodium.
• The other ingredients are:
Core:
Cellulose, microcrystalline Mannitol, granular,
Croscarmellose sodium,
Magnesium stearate Sodium laurilsulfate,
Silica colloidal anhydrous.
Film-coating:
Polydextrose,
Titanium dioxide,
Hypromellose,
Triacetin,
Indigo Carmine Aluminium Lake (E132),
Macrogol 400,
Sunset Yellow Aluminium Lake (E110) (see section 2 "Montelukast 10 mg Film-coated Tablets contains sunset yellow (E110)")
Macrogol 8000.
What Montelukast 10 mg Tablets look like and contents of the pack:
Montelukast 10 mg are blue film coated, round tablets with sides that curve outwards and sloping edges marked with 'MO' over '10' on one side and 'M' on the reverse.
Montelukast are available in blisters of: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90 and 100 tablets or in perforated unit dose blisters of 28 x 1 or in polypropylene tablet containers with polyethylene caps containing 28, 30, 56, 60, 84, 90, 100, 112, 120, 180 and 500 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary
This leaflet was last revised in: April 2015
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