Montelukast Unicorn 4 mg/5 mg Chewable Tablets

MONTELUKAST UNICORN 4 chewable tablets are indicated in paediatric patients 2 to 5 years of age for the prophylaxis and chronic treatment of atopic asthma.

MONTELUKAST UNICORN 5 chewable tablets are indicated in paediatric patients from 6 years of age for the prophylaxis and chronic treatment of atopic asthma.

This medicinal product is to be given to a child under adult supervision.

MONTELUKAST UNICORN 4: The dosage for paediatric patients 2 to 5 years of age is one 4 mg chewable tablet daily to be taken in the evening.

MONTELUKAST UNICORN 5: The dosage for paediatric patients 6 to 14 years of age is one 5 mg tablet daily to be taken in the evening.

MONTELUKAST UNICORN may be taken with or without food.

MONTELUKAST UNICORN can be added to a patientu2019s existing treatment regimen. No dosage adjustment is necessary for the elderly, patients with renal insufficiency or mild to moderate hepatic impairment.

• Hypersensitivity to montelukast or any other component of MONTELUKAST UNICORN listed in section 6.1.
• MONTELUKAST UNICORN 4: Safety and efficacy have not been established in children under the age of 2 years.
• MONTELUKAST UNICORN 5: Safety and efficacy have not been established in children under the age of 6 years.
• Pregnancy and lactation.

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 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 UNICORN should be taken once daily in the evening. Patients should be advised to take MONTELUKAST UNICORN exactly as prescribed, even if they are asymptomatic. MONTELUKAST UNICORN should also be used during periods of worsening asthma and patients should contact their healthcare practitioner if their asthma is not well controlled.

MONTELUKAST UNICORN should not be abruptly substituted for inhaled or oral corticosteroids. If appropriate, the dose of corticosteroids should be tapered gradually under medical supervision.

There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.

Eosinophilic conditions: 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.

MONTELUKAST UNICORN should not be used as monotherapy for the treatment or management of exercise-induced bronchospasm. Patients should be advised to continue with the usual regimen of an inhaled beta-agonist for prophylaxis of exercise-induced bronchospasm and to have a short-acting inhaled beta-agonist available for rescue treatment.

While using MONTELUKAST UNICORN, patients must seek medical attention if short-acting 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 is needed.

Precautions relating to excipients: MONTELUKAST UNICORN 4 and 5 chewable tablets contain aspartame, which is metabolised to phenylalanine. MONTELUKAST UNICORN should be used with caution in patients with phenylketonuria. Patients with known hypersensitivity to aspirin should continue avoiding the use of aspirin or NSAIDs (non-steroidal anti-inflammatory agents) while taking MONTELUKAST UNICORN. Neuropsychiatric events have been reported in adults, adolescents, and children taking MONTELUKAST UNICORN (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 UNICORN if such events occur.

Renal insufficiency: Since montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast was not evaluated in patients with renal insufficiency. No dosage adjustment is recommended in these patients.

MONTELUKAST UNICORN may be administered together with other medicines used for the prophylaxis and chronic treatment of asthma. MONTELUKAST UNICORN does not significantly change the pharmacokinetics of theophylline, warfarin, digoxin, fexofenadine, oral contraceptives (containing 1 mg norethindrone and 35 u03bcg ethinyl estradiol), prednisone or prednisolone.

Concurrent use of MONTELUKAST UNICORN and phenobarbital results in significant decreases (approximately 40 %) in the area under the curve (AUC) for MONTELUKAST UNICORN, as a result of induction of hepatic metabolism. No dosage adjustment is necessary. However, clinical monitoring is required when potent hepatic enzyme inducers such as phenytoin, phenobarbital and rifampicin are given with montelukast.

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 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 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.

The safety of the use of MONTELUKAST UNICORN in pregnant and lactating women has not yet been established. It is not known if MONTELUKAST UNICORN is excreted in human milk. MONTELUKAST UNICORN should not be used in pregnant and lactating women (see u201cCONTRAINDICATIONSu201d).

MONTELUKAST UNICORN may cause side effects such as drowsiness and dizziness which may affect your ability to drive or operate machinery.

Infections and infestations: Frequent: upper respiratory infection u2020

Blood and lymphatic system disorders: Less frequent: Increased bleeding tendency, thrombocytopenia.

The following has been reported but frequency is unknown: bruising, agranulocytosis.

Immune system disorders: Less frequent: Anaphylaxis, angioedema, allergy, hypersensitivity reactions, hepatic eosinophilic infiltration.

Endocrine disorders: The following has been reported but frequency is unknown: Pancreatitis.

Psychiatric disorders: The following has been reported but frequency is unknown: Aggressive behaviour or hostility, agitation, hallucinations, disorientation, dream abnormalities including nightmares, insomnia, drowsiness, irritability, restlessness, depression, suicidal thinking and behaviour (suicidality), somnambulism, anxiety, psychomotor hyperactivity (including irritability, restlessness, tremor u00a7), disturbance in attention, memory impairment, tic, obsessive-compulsive symptoms, dysphemia.

Nervous system disorders: Frequent: Headache. Less frequent: dizziness, drowsiness, paraesthesia/hypoesthesia, seizure.

Cardiac disorders: Less frequent: Palpitations.

Respiratory, thoracic and mediastinal disorders: Less frequent: Churg-Strauss Syndrome (see section 4.4), Nasal congestion, cough, influenza, increased incidence of respiratory tract infections, epistaxis, pulmonary eosinophilia.

Gastrointestinal disorders: Frequent: Abdominal pain, diarrhoea u2021, nausea u2021, vomiting u2021. Less frequent: Dyspepsia, gastroenteritis, dry mouth.

Hepato-biliary disorders: Frequent: Elevated levels of serum transaminases (AST, ALT). Less frequent: Hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury). The following has been reported but frequency is unknown: Cholestatic hepatitis, symptomatic hepatitis, hyperbilirubinaemia.

Skin and subcutaneous tissue disorders: Frequent: Skin rash u2021. Less frequent: Pruritus, urticaria, bruising, angioedema, erythema nodosum, erythema multiforme.

Musculoskeletal, connective tissue and bone disorders: Less frequent: arthralgia, myalgia including muscle cramps.

Renal and urinary disorders: Less frequent: enuresis in children. The following has been reported but frequency is unknown: pyuria.

General disorders and administration site conditions: Less frequent: Asthenia, fatigue, dental pain, pyrexia u2021, malaise, oedema, thirst. The following has been reported but frequency is unknown: generalised pain, fatalities.

u2020This 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.

u2021This 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.

u00a7 Frequency Category: Rare

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: 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 overdose with montelukast. It is not known whether montelukast is dialysable by peritoneal- or haemo-dialysis.