Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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 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.
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.
• Patients should be aware that various neuropsychiatric events (for example behaviour and mood-related changes) have been reported in adults, adolescents and children treated with Montelukast (see section 4). If you develop such symptoms while taking Montelukast, you should consult your doctor.
Children Do not give this medicine to children less than 15 years of age. There are different forms of this medicine available for paediatric patients under 18 years of age based on age range.
Other medicines and Montelukast Tell your doctor or pharmacist if you are taking, 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).
Taking Montelukast with food Montelukast 10 mg 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 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 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 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 medicine.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially "sodium-free".
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 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.
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.
If you are taking Montelukast, be sure that you do not take any other products that contain the same active ingredient, montelukast.
This medicine is for oral use.
You can take Montelukast 10 mg with or without food.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with montelukast 10 mg film-coated tablets, 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 to 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: the following 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,
• behavioural 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 reported while the medicine has been on the market 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: the following may affect up to 1 in 100 people
• behavioural 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
• behavioural 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),
• behavioural 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 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.
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 and carton after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
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.
What Montelukast tablets contain • The active substance is montelukast. Each film-coated tablet contains 10 mg montelukast (as montelukast sodium).
• The other ingredients are lactose monohydrate, powdered cellulose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E171), talc, propylene glycol, red iron oxide (E172) and yellow iron oxide (E172) in the film coating. See section 2 "Montelukast contains lactose and sodium".
What Montelukast looks like and contents of the pack The film-coated tablets are apricot-coloured, round, slightly biconvex, with bevelled edges.
Boxes of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 or 200 film-coated tablets in blisters are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder KRKA, d.d.
Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Manufacturer KRKA, d.d.
Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
KRKA Polska Sp. z o.o
ul. Równoległa 5
02-235 Warsaw
Poland
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany
This leaflet was last revised in March 2023.
Krka UK Ltd
Address
KRKA UK Ltd, Thames House, Waterside Drive, Langley, Slough, SL3 6EZ, UK
Telephone
+44 (0)207 164 6156
Medical Information Direct Line
+44 (0)7572 410 233
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)7894 980 624
Stock Availability
[email protected]
WWW
www.krka.co.uk
• Contact us
• Links
• Accessibility
• Legal and privacy notice
• Cookie notice
• Cookie Settings
• Glossary
• Site Maps
Delivered to you by
Montelukast 10 mg film-coated tablets comes as tablet containing 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Montelukast 10 mg film-coated tablets is montelukast sodium.
Medicines with the same active substance, strength and form include: Singulair 10 mg film-coated tablets, Montelukast 10 mg Film-coated Tablets, Montelukast 10 mg film-coated tablets. In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Montelukast 10 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Montelukast is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short-acting β-agonists provide inadequate clinical control of asthma. In those asthmatic patients in whom Montelukast is indicated in asthma, Montelukast can also provide symptomatic relief of seasonal allergic rhinitis.
Montelukast is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.
Posology
The recommended dose for adults and adolescents 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis, is one 10 mg tablet daily to be taken in the evening.
General recommendations
The therapeutic effect of Montelukast on parameters of asthma control occurs within one day.
Montelukast may be taken with or without food.
Patients should be advised to continue taking Montelukast even if their asthma is under control, as well as during periods of worsening asthma.
Montelukast should not be used concomitantly with other products containing the same active ingredient, montelukast.
No dosage adjustment is necessary for the elderly, or for patients with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients.
Therapy with Montelukast in relation to other treatments for asthma Montelukast can be added to a patient's existing treatment regimen.
Inhaled corticosteroids: Treatment with Montelukast can be used as add-on therapy in patients when inhaled corticosteroids plus “as-needed” short-acting β-agonists, provide inadequate clinical control. Montelukast should not be abruptly substituted for inhaled corticosteroids (See Section 4.4).
Paediatric population
Do not give Montelukast 10 mg film-coated tablets to children less than 15 years of age. The safety and efficacy of montelukast 10 mg film-coated tablets in children less than 15 years has not been established.
5 mg chewable tablets are available for paediatric patients 6 to 14 years of age.
4-mg chewable tablets are available for paediatric patients 2 to 5 years of age.
Method of administration
Oral use
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available. If an acute attack occurs, a short-acting inhaled β-agonist should be used. Patients should seek their doctor's advice as soon as possible if they need more inhalations of short-acting β-agonists than usual.
Montelukast should not be substituted abruptly for inhaled or oral corticosteroids.
There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.
In rare cases, patients on therapy with anti-asthma agents including montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These cases have been sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. Although a causal relationship with leukotriene receptor antagonism has not been established, physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. Patients who develop these symptoms should be reassessed and their treatment regimens evaluated.
Treatment with montelukast does not alter the need for patients with aspirin-sensitive asthma to avoid taking aspirin and other non-steroidal anti-inflammatory drugs.
Neuropsychiatric events have been reported in adults, adolescents, and children taking Montelukast (see section 4.8). Patients and physicians should be alert for neuropsychiatric events. Patients and/or caregivers should be instructed to notify their physician if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Montelukast if such events occur.
Special information about some of the ingredients
Montelukast contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially "sodium-free".
Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following medicinal products: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
The area under the plasma concentration curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of phenobarbital. Since montelukast is metabolised by CYP 3A4, 2C8 and 2C9, caution should be exercised, particularly in children, when montelukast is co-administered with inducers of CYP 3A4, 2C8 and 2C9, such as phenytoin, phenobarbital and rifampicin.
In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8. However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of medicinal products primarily metabolized by CYP 2C8) demonstrated that montelukast does not inhibit CYP 2C8 in vivo. Therefore, montelukast is not anticipated to markedly alter the metabolism of medicinal products metabolised by this enzyme (e.g., paclitaxel, rosiglitazone, and repaglinide).
In vitro studies have shown that montelukast is a substrate of CYP 2C8, and to a less significant extent, of 2C9, and 3A4. In a clinical drug-drug interaction study involving montelukast and gemfibrozil (an inhibitor of both CYP 2C8 and 2C9) gemfibrozil increased the systemic exposure of montelukast by 4.4-fold. No routine dosage adjustment of montelukast is required upon co-administration with gemfibrozil or other potent inhibitors of CYP 2C8, but the physician should be aware of the potential for an increase in adverse reactions.
Based on in vitro data, clinically important drug interactions with less potent inhibitors of CYP 2C8 (e.g., trimethoprim) are not anticipated. Co-administration of montelukast with itraconazole, a strong inhibitor of CYP 3A4, resulted in no significant increase in the systemic exposure of montelukast.
Pregnancy
Animal studies do not indicate harmful effects with respect to effects on pregnancy or embryonal/foetal development.
Limited data from available pregnancy databases do not suggest a causal relationship between montelukast and malformations (i.e. limb defects) that have been rarely reported in worldwide post marketing experience.
Montelukast may be used during pregnancy only if it is considered to be clearly essential.
Breast-feeding
Studies in rats have shown that montelukast is excreted in milk (see Section 5.3). It is not known whether montelukast metabolites are excreted in human milk.
Montelukast may be used in nursing mothers only if it is considered to be clearly essential.
Montelukast has no or negligible influence on the ability to drive and use machines. However, individuals have reported drowsiness or dizziness.
Montelukast has been evaluated in clinical studies as follows:
- 10 mg film coated tablets in approximately 4,000 adult and adolescent asthmatic patients 15 years of age and older.
- 10 mg film coated tablets in approximately 400 adult and adolescent asthmatic patients with seasonal allergic rhinitis 15 years of age and older.
- 5 mg chewable tablets in approximately 1,750 paediatric asthmatic patients 6 to 14 years of age.
The following drug-related adverse reactions in clinical studies were reported commonly (≥1/100 to <1/10) in asthmatic patients treated with montelukast and at a greater incidence than in patients treated with placebo:
System Organ Class
Adult and Adolescent
Patients 15 years and older (two 12-week studies; n=795)
Paediatric Patients 6 to 14 years old
(one 8-week study; n=201) (two 56-week studies; n=615)
Nervous system disorders
headache
headache
Gastrointestinal disorders
abdominal pain
With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults, and up to 12 months for paediatric patients 6 to 14 years of age, the safety profile did not change.
Tabulated list of Adverse Reactions
Adverse reactions reported in post-marketing use are listed, by System Organ Class and specific Adverse Reactions, in the table below. Frequency Categories were estimated based on relevant clinical trials.
System Organ Class
Frequency Category*
Adverse Reactions
Infections and infestations
Very Common
upper respiratory infection†
Blood and lymphatic system disorders
Rare
increased bleeding tendency
Very Rare
thrombocytopenia
Immune system disorders
Uncommon
hypersensitivity reactions including anaphylaxis
Very Rare
hepatic eosinophilic infiltration
Psychiatric disorders
Uncommon
dream abnormalities including nightmares, insomnia, somnambulism, anxiety, agitation including aggressive behaviour or hostility, depression, psychomotor hyperactivity (including irritability, restlessness, tremor§)
Rare
disturbance in attention, memory impairment, tic
Very Rare
hallucinations, disorientation, suicidal thinking and behaviour (suicidality), obsessive-compulsive symptoms, dysphemia
Nervous system disorders
Uncommon
dizziness, drowsiness,
paraesthesia/hypoesthesia, seizure
Cardiac disorders
Rare
palpitations
Respiratory, thoracic and mediastinal disorders
Uncommon
epistaxis
Very Rare
Churg-Strauss Syndrome (CSS) (see section 4.4)
Very Rare
pulmonary eosinophilia
Gastrointestinal disorders
Common
diarrhoea‡, nausea‡, vomiting‡
Uncommon
dry mouth, dyspepsia
Hepatobiliary disorders
Common
elevated levels of serum transaminases (ALT, AST)
Very Rare
hepatitis (including cholestatic, hepatocellular and mixed-pattern liver injury).
Skin and subcutaneous tissue disorders
Common
rash‡
Uncommon
bruising, urticaria, pruritus
Rare
angiooedema
Very Rare
erythema nodosum, erythema multiforme
Musculoskeletal and connective tissue disorders
Uncommon
arthralgia, myalgia, including muscular cramps
Renal and urinary disorders
Uncommon
enuresis in children
General disorders and
Common
pyrexia‡
administration site conditions
Uncommon
asthenia/fatigue, malaise, oedema
* Frequency Category: Defined for each Adverse Reaction by the incidence reported in the clinical trials data base: Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very Rare (<1/10,000).
†This adverse experience, reported as Very Common in the patients who received montelukast, was also reported as Very Common in the patients who received placebo in clinical trials.
‡This adverse experience, reported as Common in the patients who received montelukast, was also reported as Common in the patients who received placebo in clinical trials.
§ Frequency Category: Rare
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short-term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences.
There have been reports of acute overdose in post-marketing experience and clinical studies with montelukast. These include reports in adults and children with a dose as high as 1,000 mg (approximately 61 mg/kg in a 42 month old child). The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients. There were no adverse experiences in the majority of overdose reports.
Symptoms of overdose
The most frequently occurring adverse experiences were consistent with the safety profile of montelukast and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity.
Management of overdose
No specific information is available on the treatment of overdosage with montelukast. It is not known whether montelukast is dialysable by peritoneal- or haemo-dialysis.
Ask anything about Montelukast 10 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.