Patient leaflet - Montelukast Tillomed 10 mg film-coated tablets
1. What Montelukast Tablets is and what it is used for
What Montelukast Tablets is
Montelukast Tablets is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast Tablets 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 Tablets should be used
Your doctor has prescribed Montelukast Tablets to treat asthma, preventing your asthma symptoms during the day and night.
- Montelukast Tablets 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 Tablets also helps prevent the narrowing of airways triggered by exercise.
- In those asthmatic patients in whom montelukast is indicated in asthma, Montelukast Tablets 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 Tablets
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 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.
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 Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines. 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 Tablets with food and drink
Montelukast Tablets 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
Your doctor will assess whether you can take Montelukast Tablets during this time.
Breast-feeding
It is not known if this medicine appears in breast milk. You should consult your doctor before taking Montelukast Tablets 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 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.
Montelukast Tablets contain sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Montelukast 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.
- This medicine is for oral use.
- 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.
- If you are taking this medicine, be sure that you do not take any other products that contain the same active ingredient, montelukast.
Adults and adolescents 15 years of age and older:
The recommended dose is one 10 mg tablet to be taken daily in the evening.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Montelukast Tillomed 10 mg
Film-coated Tablets Montelukast sodium
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.
Shanay-PIL 100726
Montelukast 10 mg FCT
510522544GB01
Nat app
UK
[All]
NA
9 points (Reg text)
NA
Black C
If you take more Montelukast Tablets than you should
If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.
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 this medicine 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 can treat your asthma only if you continue to take it.
It is important to continue taking this medicine 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, 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: (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
- severe skin reactions (erythema multiforme) that may occur without warning
- inflammation of the liver (hepatitis)
Other side effects
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, 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: (may affect up to 1 in 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 Yellow Card Scheme at www.mhra.gov.co.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 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 blister label and the carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicine you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Montelukast Tablets contains
The active substance is montelukast sodium. Each tablet contains montelukast sodium equivalent to 10 mg montelukast.
The other ingredients are:
Tablet core:
Lactose monohydrate
Microcrystalline cellulose
Corscarmellose sodium
Magnesium stearate
Film-coating:
HPMC 2910/Hypromellose 6cp
Hydroxypropyl cellulose
Titanium dioxide
Iron oxide yellow
Carnauba wax
Iron oxide red
What Montelukast Tablets looks like and contents of the pack
Montelukast Tillomed 10 mg are beige coloured, round, bi-convex, film-coated tablets, debossed with “M10” on one side and plain on other side. The tablets are available in pack sizes containing 3 x 10 tablets in aluminium/aluminium blister pack.
Marketing Authorisation Holder
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
Manufacturer
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
Tillomed Malta Limited
Malta Life Sciences Park
LS2.01.06 Industrial Estate
San Gwann, SGN 3000, Malta
This leaflet was last revised in July 2026
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To get this information in large print or another format, please email medical.information@tillomed.com or call 0800 970 6115.