Montelukast Oral Granules Unicorn 4.15 mg Granules

MONTELUKAST ORAL GRANULES UNICORN is indicated in paediatric patients 2 to 5 years of age for the prophylaxis and chronic treatment of atopic asthma.

Posology
This medicine is to be given to a child under adult supervision. The recommended dose for paediatric patients 2 to 5 years of age is one sachet of 4 mg oral granules daily to be taken in the evening.
Administration of MONTELUKAST ORAL GRANULES UNICORN
MONTELUKAST ORAL GRANULES UNICORN can be administered either directly in the mouth or mixed with a spoonful of cold or room temperature soft food (e.g., applesauce, ice cream, carrots and rice). The sachet should not be opened until ready to use. After opening the sachet, the full dose of MONTELUKAST ORAL GRANULES UNICORN must be administered immediately (within 15 minutes). If mixed with food, MONTELUKAST ORAL GRANULES UNICORN must not be stored for future use. MONTELUKAST ORAL GRANULES UNICORN are not intended to be dissolved in liquid for administration. However, liquids may be taken subsequent to administration. MONTELUKAST ORAL GRANULES UNICORN can be administered without regard to the timing of food ingestion.
General recommendations
The therapeutic effect of MONTELUKAST ORAL GRANULES UNICORN on parameters of asthma control occurs within one day. Patients should be advised to continue taking MONTELUKAST ORAL GRANULES UNICORN even if their asthma is under control, as well as during periods of worsening asthma. No dosage adjustment is necessary 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 ORAL GRANULES UNICORN in relation to other treatments for asthma MONTELUKAST ORAL GRANULES UNICORN can be added to a patientu2019s existing treatment regimen.
Method of administration
Oral use as described above.

• Known sensitivity to montelukast or to any of the excipients in MONTELUKAST ORAL GRANULES UNICORN (see sections 2 and 6.1).
• Children under the age of 2 years, as safety and efficacy of MONTELUKAST ORAL GRANULES UNICORN oral granules have not been demonstrated.

Patients should be advised never to use oral montelukast to treat acute asthma attacks, including status asthmaticus and to keep their usual appropriate rescue medication for this purpose readily available. MONTELUKAST ORAL GRANULES UNICORN is not indicated for use in the reversal of bronchospasm in acute asthma attacks. If an acute attack occurs, a short-acting inhaled u03b2 -agonist should be used. Patients should seek their doctors' advice as soon as possible if they need more inhalations of short-acting u03b2 -agonists than usual.
MONTELUKAST ORAL GRANULES UNICORN should not be used as monotherapy for the treatment and management of exercise-induced bronchospasm. Patients who have exacerbations of asthma after exercise should continue to use their usual regimen of inhaled beta-agonists as prophylaxis and have available for rescue a short-acting inhaled beta-agonist.
Montelukast should not be abruptly substituted for inhaled or oral corticosteroids. There are no data demonstrating that oral corticosteroids can be reduced when MONTELUKAST ORAL GRANULES UNICORN is given concomitantly.
Renal Insufficiency
Since MONTELUKAST ORAL GRANULES UNICORN and its metabolites are not excreted in the urine, the pharmacokinetics of MONTELUKAST ORAL GRANULES UNICORN were not evaluated in patients with renal insufficiency. No dosage adjustment is recommended in these patients.
Patients on therapy with anti-asthma medicines including MONTELUKAST ORAL GRANULES UNICORN 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, medical practitioners 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 medicines.
MONTELUKAST ORAL GRANULES UNICORN as an alternative treatment option to low-dose inhaled corticosteroids for mild, persistent asthma
Montelukast is not recommended as monotherapy in patients with moderate persistent asthma. The use of montelukast as an alternative treatment option to low-dose inhaled corticosteroids for children 2 to 5 years old with mild persistent asthma should only be considered for patients who do not have a recent history of serious asthma attacks that required oral corticosteroid use and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.1). Mild persistent asthma is defined as asthma symptoms more than once a week but less than once a day, nocturnal symptoms more than twice a month but less than once a week, normal lung function between episodes. If satisfactory control of asthma is not achieved at follow-up (usually within one month), the need for an additional or different anti-inflammatory therapy based on the step system for asthma therapy should be evaluated. Patients should be periodically evaluated for their asthma control.
Information for Patients:
u2022 Patients should be advised to take MONTELUKAST ORAL GRANULES UNICORN daily as prescribed, even when they are symptomatic, as well as during periods of worsening asthma, and to contact their physicians if their asthma is not well controlled.
Neuropsychiatric events such as behavioural changes, depression and suicidality have been reported in all age groups taking montelukast (see section 4.8). The symptoms may be serious and continue if the treatment is not withdrawn. Therefore the treatment with montelukast should be discontinued if neuropsychiatric symptoms occur during treatment. Advise patients and/or caregivers to be alert for neuropsychiatric events and instruct them to notify their physician if these changes in behaviour occur.
u2022 Patients should be advised that MONTELUKAST ORAL GRANULES UNICORN are not for the treatment of acute asthma attacks. They should have appropriate short-acting inhaled beta-agonist medication available to treat asthma exacerbations.
u2022 Patients should be advised that, while using MONTELUKAST ORAL GRANULES UNICORN, medical attention should be sought if short-acting inhaled bronchodilators are needed more often than usual, or if more than the maximum number of inhalations of short-acting bronchodilator treatment prescribed for a 24-hour period are needed.
u2022 Patients receiving MONTELUKAST ORAL GRANULES UNICORN should be instructed not to decrease the dose or stop taking any other anti-asthma medications unless instructed by a physician.
u2022 Patients who have exacerbations of asthma after exercise should be instructed to continue to use their usual regimen of inhaled beta-agonists as prophylaxis unless otherwise instructed by their medical practitioner. All patients should have available for rescue a short-acting inhaled beta-agonist.
u2022 Patients with known aspirin sensitivity should be advised to continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking MONTELUKAST ORAL GRANULES UNICORN.

Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. In medicine-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 medicine interaction study involving montelukast and rosiglitazone (a probe substrate representative of medicinal products primarily metabolised 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 medical practitioner should be aware of the potential for an increase in adverse reactions. Based on in vitro data, clinically important medicine 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
The safety of montelukast in pregnant and lactating women has not been established. MONTELUKAST ORAL GRANULES UNICORN should not be used during pregnancy. During worldwide marketing experience, congenital limb defects have been reported in offspring of women treated with MONTELUKAST ORAL GRANULES UNICORN during pregnancy. A causal relationship between these events and MONTELUKAST ORAL GRANULES UNICORN has not been established.
Lactation
Studies in rats have shown that montelukast is excreted in milk (see section 5.3). It is unknown whether montelukast/metabolites are excreted in human milk. MONTELUKAST ORAL GRANULES UNICORN should not be used in breastfeeding mothers.

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

Tabulated list of Adverse Reactions:
System organ class Adverse reactions Frequency category
Infections and infestations upper respiratory infection Frequent
Blood and lymphatic system Disorders increased bleeding tendency, thrombocytopenia Less frequent
Immune system disorders hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration Less frequent
Psychiatric disorders dream abnormalities including nightmares, insomnia, somnambulism, anxiety, agitation including aggressive behaviour or hostility, depression, psychomotor hyperactivity (including irritability, restlessness, tremor) disturbance in attention, memory impairment, tic hallucinations, disorientation, suicidal thinking and behaviour (suicidality), obsessive-compulsive symptoms, dysphemia Less frequent
Nervous system disorders Headache, hyperkinesia Frequent
dizziness, drowsiness, paraesthesia/hypoesthesia, seizure Less frequent
Cardiac disorders Palpitations Less frequent
Respiratory, thoracic and mediastinal disorders Epistaxis, Churg-Strauss Syndrome (CSS) (see section 4.4), pulmonary eosinophilia, asthma Less frequent
Gastro-intestinal disorders diarrhoea, nausea, vomiting, abdominal pain Frequent
dry mouth, dyspepsia Less frequent
Hepatobiliary disorders elevated levels of serum transaminases (ALT, AST) Frequent
hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury). Less frequent
Skin and subcutaneous tissue Disorders Rash Frequent
Bruising, urticaria, pruritus, angioedema, erythema nodosum, erythema multiforme, eczematous, dermatitis, rash Less frequent
Musculoskeletal and connective tissue disorders Arthralgia, myalgia including muscle cramps Less frequent
Renal and urinary disorders Enuresis in children Less frequent
General disorders and administration site conditions Pyrexia, thirst Frequent
Asthenia/fatigue, malaise, oedema Less frequent
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. Suspected adverse reactions can also be reported directly to the HCR via the website: https://pvi1j.solutions.iqvia.com or the e-mail address, [email protected].

No specific information is available on the treatment of overdosage with MONTELUKAST ORAL GRANULES UNICORN. 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 1000 mg. 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 overdose with montelukast. It is not known whether montelukast is dialysable by peritoneal- or haemo-dialysis.