Montelukast 10mg Film-Coated Tablets
Montelukast 10mg Film-coated Tablets
For adolescents and adults from 15 years of age
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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• The full name of this medicine is Montelukast 10mg Film-coated Tablets but within the leaflet it will be referred to as Montelukast tablets
What is in this leaflet: j What Montelukast tablets are and what they are used for
^ What you need to know before you take Montelukast tablets ^ How to take Montelukast tablets Possible side effects How to store Montelukast tablets Contents of the pack and other information
j What Montelukast tablets are and what they are used for
Montelukast tablets are 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 tablets improves asthma symptoms, help control asthma and improve seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast tablets to treat asthma, preventing your asthma symptoms during the day and night.
• Montelukast tablets are used for the treatment of patients 15 years of age and older who are not adequately controlled on their medication and need additional therapy.
• Montelukast tablets also helps prevent the narrowing of airways triggered by exercise for patients 15 years of age and older.
• In those asthmatic patients 15 years of age and older in whom Montelukast tablets are indicated in asthma, Montelukast tablets can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montelukast tablets should be used depending on the symptoms and severity of your asthma.
^ What you need to know before you take Montelukast tablets
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Montelukast tablets
• if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
• Talk to your doctor, pharmacist or nurse before taking Montelukast tablets
• If your asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast 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 take all asthma medications prescribed by your doctor.
• Montelukast tablets should not be used instead of 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 other non-steroidal anti-inflammatory drugs (NSAIDs) if they make your asthma worse.
Children
5mg chewable tablets are available for paediatric patients 6 to 14 years of age.
4mg chewable tablets are available for paediatric patients 2 to 5 years of age.
4mg granules are available for paediatric patients 6 months to 5 years of age.
Other medicines and Montelukast tablets
Some medicines may affect how Montelukast tablets work, or Montelukast tablets may affect how other medicines work.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking the following medicines before starting Montelukast 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 tablets with food and drink
Montelukast tablets may be taken with or without food.
Pregnancy and breast-feeding
Use in pregnancy
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Use in breast-feeding
It is not known if Montelukast tablets appears in breast milk. You should consult your doctor before taking Montelukast tablets if you are breast-feeding or intend to breast-feed. Your doctor will assess whether you can take Montelukast tablets during this time.
Driving and using machines
Montelukast 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 very rarely with Montelukast tablets may affect some patients' ability to drive or operate machinery.
Montelukast tablets contain 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.
3 How to take Montelukast tablets
• You should take only 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.
• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
Continued over page
Continued top of next column AAAF9614
pharmacist if you are not sure.
• To be taken by mouth.
The recommended dose for patients 15 years of age and older is one 10mg tablet to be taken daily in the evening. Montelukast tablets may be taken with or without food.
If you are taking Montelukast tablets, be sure that you do not take any other products that contain the same active ingredient, montelukast.
If you take more Montelukast tablets than you should
Contact your doctor immediately for advice.
There were no side effects reported in the majority of overdose reports. The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.
If you forget to take Montelukast tablets
Try to take Montelukast tablets 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 tablets
Montelukast tablets can treat your asthma only if you continue to take it.
It is important to continue taking Montelukast tablets 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, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects that have been reported with montelukast, stop taking Montelukast tablets and contact a doctor immediately:
• sudden wheezing, swelling of lips, tongue and throat or body, rash, fainting or difficulties to swallow (severe allergic reaction). This side effect is uncommon (may affect up to 1 in 100 people).
• flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome). This side effect is very rare (may affect up to 1 in 10,000 people).
• suicidal thoughts and actions. This side effect is very rare (may affect up to 1 in 10,000 people).
• severe skin reactions (erythema multiforme) that may occur without warning. This side effect is very rare (may affect up to 1 in 10,000 people).
The following side effects have also been reported with montelukast:
Very common: may affect more than 1 in 10 people
• Colds (upper respiratory infection)
Common: may affect up to 1 in 10 people
• headache
• abdominal pain
• thirst
• diarrhoea, nausea, vomiting
• rash
• fever
• asthma
• hyperactivity
• red, itchy skin (eczema)
• increased amounts of certain substances in the blood (transaminases)
Uncommon: may affect up to 1 in 100 people
• dream abnormalities, including nightmares, irritability, sleepwalking, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression, trouble sleeping
• dizziness, drowsiness, pins and needles/numbness, seizures (fits)
• 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
• shaking
• feeling your heartbeat (palpitations)
• swelling of the skin
Very rare: may affect up to 1 in 10,000 people
• hallucinations, confusion
• hepatitis (inflammation of the liver), liver problems (hepatic eosinophilic infiltration)
• tender red lumps under the skin most commonly on your shins (erythema nodosum)
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.
How to store Montelukast tablets
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
Do not store above 30°C.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
^ Contents of the pack and other information
What Montelukast tablets contain
• The active substance is montelukast. Each film-coated tablet contains montelukast sodium equivalent to 10mg montelukast
• The other ingredients are tablet core: cellulose, microcrystalline, hydroxypropylcellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate; film-coat: lactose monohydrate, hypromellose 15cP, titanium dioxide (E171), macrogol 4000, iron oxide yellow (E172), iron oxide red (E172)
What Montelukast tablets look like and contents of the pack
Film-coated tablet
Beige, square, biconvex film-coated tablets with M engraved on one side
Blister (OPA-Al-PVC/Al):
28 film-coated tablets
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegi 76-78,
220 Hafnarfjordur Iceland
Manufacturer
Actavis Ltd
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000 Malta
This leaflet was last revised in July 2014.
If you would like a f*" leaflet with larger text, please contact 01271 311257.
Continued top of next column AAAF9614
Actavis
Actavis, Barnstaple, EX32 8NS, UK