Patient leaflet - Montelukast 10 mg film-coated tablets
1. What Montelukast is and what it is used for
What Montelukast is
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast works
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).
When Montelukast should be used
Your doctor has prescribed Montelukast to treat asthma, preventing your asthma symptoms during the day and night.
- Montelukast is 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 also helps prevent the narrowing of airways triggered by exercise.
- In those asthmatic patients in whom Montelukast is indicated in asthma, Montelukast 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.
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
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Montelukast
- 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 or pharmacist before taking Montelukast:
- If your asthma or breathing gets worse, tell your doctor immediately.
- Oral 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.
- It is important that you or your child 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 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.
| Various neuropsychiatric events (for example behaviour and mood-related changes, depression and suicidality) have been reported in patients of all ages treated with montelukast (see section 4). There have also been reports of these symptoms continuing after treatment is stopped. If you develop such symptoms while taking montelukast or if these symptoms do not resolve after montelukast is stopped, you should contact your prescriber. |
Children and adolescents
Do not give Montelukast to children and adolescents under 15 years of age for whom alternative products available in lower strengths are recommended.
Other medicines and Montelukast
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.
Some medicines may affect how Montelukast works or Montelukast may affect how other medicines work.
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).
Montelukast with food and drink
Montelukast may be taken with or without food.
Pregnancy and breast-feeding
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.
Pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast. 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 consult 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 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 patients’ ability to drive or operate machinery.
Montelukast 10 mg film-coated tablets contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
3. How to take Montelukast
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- The recommended dose is 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.
- To be taken by mouth.
This medicine is for oral use.
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. Montelukast may be taken with or without food.
Use in children and adolescents younger than 15 years
This product is not suitable for children and adolescents under 15 years of age for whom alternative products available in lower strengths are recommended.
If you are taking Montelukast, be sure that you do not take any other products that contain the same active ingredient, montelukast.
If you take more Montelukast 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
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
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.
In clinical studies with montelukast, the most commonly reported side effects (may affect up to 1 of 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 (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 (may affect up to 1 in 1,000 people)
- increased bleeding tendency
- tremor
- palpitations
Very rare (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) (see Section 2)
- low blood platelet count
- behaviour and mood related changes: hallucinations, disorientation, suicidal thoughts and actions
- swelling (inflammation) of the lungs
- hepatitis (inflammation of the liver)
- severe skin reactions (erythema multiforme) that may occur without warning
Additionally, while the medicine has been on the market, the following 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)
- diarrhoea, nausea, vomiting
- rash
- fever
- elevated liver enzymes
Uncommon (may affect up to 1 in 100 people)
- behaviour and mood related changes: dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness
- dizziness, drowsiness, pins and needles/numbness
- nose bleed
- dry mouth, indigestion
- bruising, itching, hives
- joint or muscle pain, muscle cramps
- bedwetting in children
- weakness/tiredness, feeling unwell, swelling
Rare (may affect up to 1 to 1,000 people)
- behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements
Very rare (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
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Montelukast
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 carton and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Store in the original package in order to protect from light and moisture.
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 protect the environment.
6. Contents of the pack and other information
What Montelukast contains
- The active substance is montelukast. Each film-coated tablet contains montelukast sodium which corresponds to 10 mg of montelukast.
The other ingredients are: cellulose, microcrystalline (E460), lactose monohydrate, hydroxypropylcellulose, low substituted (E463), croscarmellose sodium (E468), magnesium stearate (E572).
Film coating: hypromellose, type 2910 (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), carnauba wax (E903), iron oxide yellow (E172), iron oxide red (E172).
What Montelukast looks like and contents of the pack
Montelukast 10 mg film-coated tablets are beige coloured, rounded square, film coated, biconvex tablets, plain on both sides.
Packaged in OPA-Al-PVC/Al blister in following pack sizes 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Indoco Remedies UK Limited, Alpha House, 296 Kenton Road, Harrow, Middlesex, HA3 8DD, United Kingdom
Manufacturer
Rivopharm UK Ltd
100 Bishopsgate
London
EC2N 4AG
United Kingdom