Montelukast Sodium Tablet 5mg Taj Pharma

Montelukast Sodium Tablet 5mg Taj Pharma

  1. Name of the medicinal product

Montelukast Sodium 5 mg film-coated tablets
Montelukast Sodium 10 mg film-coated tablets

  1. Qualitative and quantitative composition

a) Each film-coated tablet contains montelukast sodium
Montelukast sodium USP
Equivalent to montelukast                              5mg
Excipients                                                         q.s
Colours: Titanium Dioxide USP

b) Each film-coated tablet contains montelukast sodium
Montelukast sodium USP
Equivalent to montelukast                              10mg
Excipients                                                          q.s
Colours: Titanium Dioxide USP

For a full list of excipients, see section 6.1.

  1. Pharmaceutical form

Film-coated tablet

  1. Clinical particulars

4.1 Therapeutic indications

Montelukast 5mg film-coated tablets 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 5mg film-coated tablets is indicated in asthma, Montelukast 5mg film-coated tablets can also provide symptomatic relief of seasonal allergic rhinitis.

Montelukast 5mg film-coated tablets is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.

4.2 Posology and method of administration

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 5mg tablet daily to be taken in the evening.

General recommendations:

The therapeutic effect of Montelukast 5mg film-coated tablets on parameters of asthma control occurs within one day. Montelukast 5mg film-coated tablets may be taken with or without food. Patients should be advised to continue taking Montelukast 5mg film-coated tablets even if their asthma is under control, as well as during periods of worsening asthma. Montelukast 5mg film-coated tablets 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 5mg film-coated tablets in relation to other treatments for asthma

Montelukast 5mg film-coated tablets can be added to a patient’s existing treatment regimen.

Inhaled corticosteroids:

Treatment with Montelukast 5mg film-coated tablets can be used as add-on therapy in patients when inhaled corticosteroids plus “as needed” short acting β-agonists provide inadequate clinical control. Montelukast 5mg film-coated tablets should not be abruptly substituted for inhaled corticosteroids (see section 4.4).

Paediatric population

Do not give Montelukast 5mg film-coated tablets to children less than 15 years of age. The safety and efficacy of Montelukast 5mg film-coated tablets in children less than 15 years has not been established.

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.

Method of administration:

Oral use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

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.

This medicinal product contains lactose monohydrate.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Neuropsychiatric events have been reported in adults, adolescents, and children taking Montelukast 5mg film-coated tablets (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 5mg film-coated tablets if such events occur.

4.5 Interaction with other medicinal products and other forms of interaction

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.

4.6 Fertility, pregnancy and lactation

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 5mg film-coated tablets and malformations (i.e. limb defects) that have been rarely reported in worldwide post marketing experience.

Montelukast 5mg film-coated tablets may be used during pregnancy only if it is considered to be clearly essential.

Breastfeeding

It is unknown whether montelukast is excreted in human milk. Studies in rats have shown that montelukast is excreted in milk (see section 5.3).

Montelukast 5mg film-coated tablets may be used in breast-feeding only if it is considered to be clearly essential

4.7 Effects on ability to drive and use machines

Montelukast has no or negligible influence on the ability to drive and use machines. However, individuals have reported drowsiness or dizziness.

4.8 Undesirable effects

Montelukast has been evaluated in clinical studies as follows:

  • 5mg film-coated tablets in approximately 4000 adult and adolescent asthmatic patients 15 years of age and older.
  • 5mg film-coated tablets in approximately 400 adult and adolescent asthmatic patients with seasonal allergic rhinitis 15 years of age and older.
  • 5mg chewable tablets in approximately 1750 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:

Body system 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 Experience Term, in the table below. Frequency Categories were estimated based on relevant clinical trials.

 

System Organ Class Adverse Experience Term Frequency Category*
Infections and infestations upper respiratory infection Very Common
Blood and lymphatic system disorders increased bleeding tendency Rare
thrombocytopenia Very Rare
Immune system disorder hypersensitivity reactions including anaphylaxis Uncommon
hepatic eosinophilic infiltration Very Rare
Psychiatric disorders dream abnormalities including nightmares, insomnia, somnambulism, anxiety, agitation including aggressive behaviour or hostility, depression, psychomotor hyperactivity (including irritability, restlessness, tremor§) Uncommon
disturbance in attention, memory impairment , tic Rare
hallucinations, disorientation, suicidal thinking and behaviour (suicidality), Dysphemia Very Rare
Nervous system disorder dizziness, drowsiness paraesthesia/hypoesthesia, seizure Uncommon
Cardiac disorders palpitations Rare
Respiratory, thoracic and mediastinal disorders epistaxis Uncommon
Churg-Strauss Syndrome (CSS) (see section 4.4), pulmonary eosinophilia Very Rare
Gastrointestinal disorders diarrhoea, nausea, vomiting Common
dry mouth, dyspepsia Uncommon
Hepatobiliary disorders elevated levels of serum transaminases (ALT, AST) Common
hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury). Very Rare
Skin and subcutaneous tissue disorders rash Common
bruising, urticaria, pruritus Uncommon
angiooedema Rare
erythema nodosum, erythema multiforme Very Rare
Musculoskeletal, connective tissue and bone disorders arthralgia, myalgia including muscle cramps Uncommon
Renal and urinary disorders enuresis in children Uncommon
General disorders and administration site conditions pyrexia Common
asthenia/fatigue, malaise, oedema, Uncommon
*Frequency Category: Defined for each Adverse Experience Term by the incidence reported in the clinical trials data base: Very Common (≥1/10), Common (≥1/100 to </10), Uncommon (≥1/1000 to </100), Rare (≥1/10,000 to </1000), Very Rare (</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.

4.9 Overdose

In chronic asthma studies, montelukast has been administered at doses up to 200mg/day to adult patients for 22 weeks and in short term studies, up to 900mg/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 1000mg (approximately 61mg/kg in a 42 month old child). The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients.

Symptoms of overdose

There were no adverse experiences in the majority of overdose reports. 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 overdose with montelukast. It is not known whether montelukast is dialysable by peritoneal- or haemo-dialysis.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Leukotriene receptor antagonist

Mechanism of action

The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 (CysLT1) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment. In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both early- and late-phase reactions and are associated with symptoms of allergic rhinitis. Intranasal challenge with CysLTs has been shown to increase nasal airway resistance and symptoms of nasal obstruction.

Pharmacodynamic effects

Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. In clinical studies, montelukast inhibits bronchoconstriction due to inhaled LTD4 at doses as low as 5mg. Bronchodilation was observed within 2 hours of oral administration. The bronchodilation effect caused by a β agonist was additive to that caused by montelukast. Treatment with montelukast inhibited both early- and late phase bronchoconstriction due to antigen challenge. Montelukast, compared with placebo, decreased peripheral blood eosinophils in adult and paediatric patients. In a separate study, treatment with montelukast significantly decreased eosinophils in the airways (as measured in sputum) and in peripheral blood while improving clinical asthma control.

Clinical efficacy and safety

In studies in adults, montelukast, 10mg once daily, compared with placebo, demonstrated significant improvements in morning FEV1 (10.4% vs 2.7% change from baseline), AM peak expiratory flow rate (PEFR) (24.5 L/min vs 3.3 L/min change from baseline), and significant decrease in total β-agonist use ( -26.1% vs -4.6% change from baseline). Improvement in patient-reported daytime and nighttime asthma symptoms scores was significantly better than placebo.

Studies in adults demonstrated the ability of montelukast to add to the clinical effect of inhaled corticosteroid (% change from baseline for inhaled beclometasone plus montelukast vs beclometasone, respectively for FEV1: 5.43% vs 1.04%; β-agonist use: -8.70% vs 2.64%). Compared with inhaled beclometasone (200 µg twice daily with a spacer device), montelukast demonstrated a more rapid initial response, although over the 12-week study, beclometasone provided a greater average treatment effect (% change from baseline for montelukast vs beclometasone, respectively for FEV1: 7.49% vs 13.3%; β agonist use: -28.28% vs -43.89%). However, compared with beclometasone, a high percentage of patients treated with montelukast achieved similar clinical responses (e.g., 50% of patients treated with beclometasone achieved an improvement in FEV1 of approximately 11% or more over baseline while approximately 42% of patients treated with montelukast achieved the same response).

A clinical study was conducted to evaluate montelukast for the symptomatic treatment of seasonal allergic rhinitis in adult and adolescent asthmatic patients 15 years of age and older with concomitant seasonal allergic rhinitis. In this study, montelukast 10mg tablets administered once daily demonstrated a statistically significant improvement in the Daily Rhinitis Symptoms score, compared with placebo. The Daily Rhinitis Symptoms score is the average of the Daytime Nasal Symptoms score (mean of nasal congestion, rhinorrhea, sneezing, nasal itching) and the Nighttime Symptoms score (mean of nasal congestion upon awakening, difficulty going to sleep, and nighttime awakenings scores). Global evaluations of allergic rhinitis by patients and physicians were significantly improved, compared with placebo. The evaluation of asthma efficacy was not a primary objective in this study.

In an 8-week study in paediatric patients 6 to 14 years of age, montelukast 5mg once daily, compared with placebo, significantly improved respiratory function (FEV1 8.71% vs 4.16% change from baseline; AM PEFR 27.9 L/min vs 17.8 L/min change from baseline) and decreased “as-needed” β-agonist use (-11.7% vs +8.2% change from baseline).

Significant reduction of exercise-induced bronchoconstriction (EIB) was demonstrated in a 12-week study in adults (maximal fall in FEV22.33% for montelukast vs 32.40% for placebo; time to recovery to within 5% of baseline FEV1 44.22 min vs 60.64 min). This effect was consistent throughout the 12-week study period. Reduction in EIB was also demonstrated in a short term study in paediatric patients (maximal fall in FEV1 18.27% vs 26.11%; time to recovery to within 5% of baseline FEV1 17.76 min vs 27.98 min). The effect in both studies was demonstrated at the end of the once-daily dosing interval.

In aspirin-sensitive asthmatic patients receiving concomitant inhaled and/or oral corticosteroids, treatment with montelukast, compared with placebo, resulted in significant improvement in asthma control (FEV1 8.55% vs -1.74% change from baseline and decrease in total β-agonist use -27.78% vs 2.09% change from baseline).

5.2 Pharmacokinetic properties

Absorption

Montelukast is rapidly absorbed following oral administration. For the 10mg film-coated tablet, the mean peak plasma concentration (Cmax) is achieved 3 hours (Tmax) after administration in adults in the fasted state. The mean oral bioavailability is 64%. The oral bioavailability and Cmax are not influenced by a standard meal. Safety and efficacy were demonstrated in clinical trials where the 10mg film-coated tablet was administered without regard to the timing of food ingestion.

For the 5mg chewable tablet, the Cmax is achieved in 2 hours after administration in adults in the fasted state. The mean oral bioavailability is 73% and is decreased to 63% by a standard meal.

Distribution

Montelukast is more than 99% bound to plasma proteins. The steady-state volume of distribution of montelukast averages 8-11 litres. Studies in rats with radiolabelled montelukast indicate minimal distribution across the blood-brain barrier. In addition, concentrations of radiolabelled material at 24 hours post-dose were minimal in all other tissues.

Biotransformation

Montelukast is extensively metabolised. In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and children.

Cytochrome P450 2C8 is the major enzyme in the metabolism of montelukast. Additionally CYP 3A4 and 2C9 may have a minor contribution, although itraconazole, an inhibitor of CYP 3A4, was shown not to change pharmacokinetic variables of montelukast in healthy subjects that received 10mg montelukast daily. Based on in vitro results in human liver microsomes, therapeutic plasma concentrations of montelukast do not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6. The contribution of metabolites to the therapeutic effect of montelukast is minimal.

Elimination

The plasma clearance of montelukast averages 45 ml/min in healthy adults. Following an oral dose of radiolabelled montelukast, 86% of the radioactivity was recovered in 5-day faecal collections and <0.2% was recovered in urine. Coupled with estimates of montelukast oral bioavailability, this indicates that montelukast and its metabolites are excreted almost exclusively via the bile.

Characteristics in patients

No dosage adjustment is necessary for the elderly or mild to moderate hepatic insufficiency. Studies in patients with renal impairment have not been undertaken. Because montelukast and its metabolites are eliminated by the biliary route, no dose adjustment is anticipated to be necessary in patients with renal impairment. There are no data on the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (Child-Pugh score>9).

With high doses of montelukast (20- and 60-fold the recommended adult dose), decrease in plasma theophylline concentration was observed. This effect was not seen at the recommended dose of 10mg once daily.

5.3 Preclinical safety data

In animal toxicity studies, minor serum biochemical alterations in ALT, glucose, phosphorus and triglycerides were observed which were transient in nature. The signs of toxicity in animals were increased excretion of saliva, gastro-intestinal symptoms, loose stools and ion imbalance. These occurred at dosages which provided>17-fold the systemic exposure seen at the clinical dosage. In monkeys, the adverse effects appeared at doses from 150mg/kg/day (>232-fold the systemic exposure seen at the clinical dose). In animal studies, montelukast did not affect fertility or reproductive performance at systemic exposure exceeding the clinical systemic exposure by greater than 24-fold. A slight decrease in pup body weight was noted in the female fertility study in rats at 200mg/kg/day (>69fold the clinical systemic exposure). In studies in rabbits, a higher incidence of incomplete ossification, compared with concurrent control animals, was seen at systemic exposure>24-fold the clinical systemic exposure seen at the clinical dose. No abnormalities were seen in rats. Montelukast has been shown to cross the placental barrier and is excreted in breast milk of animals.

No deaths occurred following a single oral administration of montelukast sodium at doses up to 5000mg/kg in mice and rats (15,000mg/m2 and 30,000mg/m2 in mice and rats, respectively), the maximum dose tested. This dose is equivalent to 25,000 times the recommended daily adult human dose (based on an adult patient weight of 50 kg).

Montelukast was determined not to be phototoxic in mice for UVA, UVB or visible light spectra at doses up to 500mg/kg/day (approximately>200-fold based on systemic exposure).

Montelukast was neither mutagenic in in vitro and in vivo tests nor tumorigenic in rodent species.

  1. Pharmaceutical particulars

6.1 List of excipients

Tablet core:

Lactose monohydrate,

Cellulose microcrystalline,

Low substituted hydroxypropylcellulose Croscarmellose sodium,

Magnesium stearate

Film coat:

Hydroxypropylcellulose, Hypromellose 6CPS (A), Titanium dioxide, Macrogol 6000,

Iron oxide yellow,

Iron oxide red

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture.

6.5 Nature and contents of container

Montelukast 5mg tablets are packed in OPA-Al-PVC/Al blister.

Pack size: Packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets in blister.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Manufactured By:
Taj Pharmaceuticals Ltd.
at: Plot. No. 220, Mahagujarat
Industrial Estate, At & Post-Moraiya,
Tal-Sanand, Dist- Ahmedabad Gujarat (India)

 

Package leaflet: Information for the user

 Montelukast Sodium 5 mg film-coated tablets

Montelukast Sodium 10 mg film-coated tablets

 Montelukast

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 5 mg film-coated tablets are and what they are used for
  2. What you need to know before you take Montelukast 5 mg film-coated tablets
  3. How to take Montelukast 5 mg film-coated tablets
  4. Possible side effects
  5. How to store Montelukast 5 mg film-coated tablets
  6. Contents of the pack and other information
  7. What Montelukast 5 mg film-coated tablets are and what they are used for What Montelukast 5 mg film-coated tablets is

Montelukast 5 mg film-coated tablets are leukotriene receptor antagonist that blocks substances called leukotrienes.

 

How Montelukast 5 mg film-coated tablets works

Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Montelukast 5 mg film-coated tablets improves asthma symptoms, helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

 

When Montelukast 5 mg film-coated tablets should be used

Your doctor has prescribed Montelukast 5 mg film-coated tablets to treat asthma, preventing your asthma symptoms during the day and night.

  • Montelukast 5 mg film-coated tablets are 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 5 mg film-coated tablets also helps prevent the narrowing of airways triggered by exercise.
  • In those asthmatic patients in whom Montelukast 5 mg film-coated tablets are indicated in asthma, Montelukast 5 mg film-coated tablets can also provide symptomatic relief of seasonal allergic rhinitis.

 

Your doctor will determine how Montelukast 5 mg film-coated tablets 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
  • sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or
  • swelling (inflammation) in the lining of

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 5 mg film-coated tablets

Tell your doctor about any medical problems or allergies you have now or have had.

Do not take Montelukast 5 mg film-coated tablets:
  • if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section ).
Warnings and precautions

Talk to your doctor or pharmacist before taking Montelukast 5 mg film-coated tablets

  • If your asthma or breathing gets worse, tell your doctor
  • Oral Montelukast 5 mg film-coated 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
  • It is important that you or your child take all asthma medications prescribed by your doctor. Montelukast 5 mg film-coated tablets should not be substituted for other asthma medications your doctor has prescribed for
  • 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
  • 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

Patients should be aware that various neuropsychiatric events (for example behaviour and moodrelated changes) have been reported in adults, adolescents and children with Montelukast 5 mg film-coated tablets (see section 4). If you develop such symptoms while taking Montelukast 5 mg film-coated tablets, you should consult your doctor.

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 5 mg film-coated tablets

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 5 mg film-coated 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 5 mg film-coated tablets with food and drink

Montelukast 5 mg film-coated 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 Montelukast 5 mg film-coated tablets.

Pregnancy

Your doctor will assess whether you can take Montelukast 5 mg film-coated tablets during this time.

Breast-feeding

It is not known if montelukast appears in human milk. You should consult your doctor before taking Montelukast 5 mg film-coated tablets if you are breast-feeding or intend to breast-feed.

Driving and using machines

Montelukast 5 mg film-coated 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 with Montelukast 5 mg film-coated tablets may affect some patients’ ability to drive or operate machinery.

Montelukast 5 mg film-coated tablets contain lactose

Montelukast 5 mg film-coated 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 5 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 take only one tablet of Montelukast 5 mg film-coated tablets once a day as prescribed by your doctor.
  • It should be taken even when you have no symptoms or have an acute asthma
For adults and adolescents 15 years of age and older:

The recommended dose is one 5 mg tablet to be taken daily in the evening.

If you are taking Montelukast 5 mg film-coated tablets, be sure that you do not take any other products that contain the same active ingredient, montelukast.

This medicine is for oral use.

Montelukast 5 mg film-coated tablets may be taken with or without food.

If you take more Montelukast 5 mg film-coated 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 5 mg film-coated tablets

Try to take Montelukast 5 mg film-coated 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 5 mg film-coated tablets

Montelukast 5 mg film-coated tablets can treat your asthma only if you continue to take it.

 

It is important to continue taking Montelukast 5 mg film-coated 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 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 5 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 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: 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: the following may affect up to 1 in 1,000 people

  • increased bleeding tendecy
  • tremor
  • palpitations

Very rare: the following 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 while the medicine has been on the mark et

Very common: the following may affect more than 1 in 10 people

upper respiratory infection

Common: the following 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

  • 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: the following may affect up to 1 in 1,000 people

  • behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements

Very rare: the following may affect up to 1 in 10,000 people

  • tender red lumps under the skin, most commonly on your shins (erythema nodosum)
  • Stuttering

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. By reporting side effects you can help provide more information on the safety of this medicine.

5.         How to store Montelukast 5 mg film-coated tablets
  • Keep this medicine out of the sight and reach of
  • Do not use Montelukast 5 mg film-coated tablets after the expiry date which is stated on the label or carton after EXP. The expiry date refers to the last day of that
  • This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light and
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Montelukast 5 mg film-coated tablets contains

The active substance is Montelukast.

a) Each film-coated tablet contains 5 mg of montelukast. The other ingredients are:

Tablet core: Lactose monohydrate, cellulose microcrystalline, low substituted

hydroxypropylcellulose, croscarmellose sodium, magnesium stearate.

Film coat: Hydroxypropylcellulose, hypromellose, titanium dioxide, macrogol 6000, iron oxide yellow and iron oxide red, (see section 2 for Important information about some of the ingredients of Montelukast 5 mg film-coated tablets).

What Montelukast 10 mg film-coated tablets contains

b) Each film-coated tablet contains 10 mg of montelukast. The other ingredients are:

Tablet core: Lactose monohydrate, cellulose microcrystalline, low substituted

hydroxypropylcellulose, croscarmellose sodium, magnesium stearate.

Film coat: Hydroxypropylcellulose, hypromellose, titanium dioxide, macrogol 6000, iron oxide yellow and iron oxide red, (see section 2 for Important information about some of the ingredients of Montelukast 5 mg film-coated tablets).

 

Manufactured By:
Taj Pharmaceuticals Ltd.
at: Plot. No. 220, Mahagujarat
Industrial Estate, At & Post-Moraiya,
Tal-Sanand, Dist- Ahmedabad Gujarat (India)

 

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Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.