Montelukast Biotech 4 mg, 5 mg, 10 mg Chewable tablets

MONTELUKAST CHEW BIOTECH 4 Tablets are indicated in paediatric patients 2 u2013 5 years of age for the prophylaxis and chronic treatment of atopic asthma. MONTELUKAST CHEW BIOTECH 5 Chewable tablets are indicated in paediatric patients over 6 years of age for the prophylaxis and chronic treatment of atopic asthma. MONTELUKAST BIOTECH 10 Film-coated tablets are indicated for adults and children 15 years of age and older for the prophylaxis and chronic treatment of atopic asthma. In those adult asthmatic patients, in whom MONTELUKAST BIOTECH is indicated for asthma, MONTELUKAST BIOTECH may also provide some symptomatic relief of seasonal allergic rhinitis.

Posology MONTELUKAST BIOTECH should be taken once daily in the evening. MONTELUKAST CHEW BIOTECH 4: Paediatric patients 2 to 5 years of age with atopic asthma: The dosage for paediatric patients 2 to 5 years of age is one 4 mg MONTELUKAST CHEW BIOTECH 4 chewable tablet daily. MONTELUKAST CHEW BIOTECH 5: Paediatric patients 6 to 14 years of age with atopic asthma: The dosage for paediatric patients 6 to 14 years of age is one 5 mg MONTELUKAST CHEW BIOTECH 5 chewable tablet daily. MONTELUKAST CHEW BIOTECH 5 has not been studied in seasonal allergic rhinitis in children with asthma. MONTELUKAST BIOTECH 10 Film-Coated Tablet: Adults and children 15 years of age and older with atopic asthma with or without seasonal allergic rhinitis: The dosage for adults 15 years of age and older is one 10 mg MONTELUKAST BIOTECH 10 film-coated tablet daily. The 10 mg MONTELUKAST BIOTECH 10 film-coated tablet should be swallowed whole. Therapy with MONTELUKAST BIOTECH in relation to other treatments for asthma: MONTELUKAST BIOTECH can be added to a patientu2019s existing treatment regimen. Patients should be advised to take MONTELUKAST BIOTECH every day even while their asthma is controlled, as well as during periods of worsening asthma. Special populations No dosage adjustment is necessary for the elderly, for patients with renal insufficiency, mild to moderate hepatic impairment or for patients of either gender. Method of administration For oral use. MONTELUKAST BIOTECH can be taken with or without food.

• Hypersensitivity to montelukast or to any of the excipients of MONTELUKAST BIOTECH listed in section 6.1.
• MONTELUKAST CHEW BIOTECH 4 is contraindicated in children under the age of 2 years as safety and efficacy of the 4 mg tablets have not been demonstrated.
• MONTELUKAST CHEW BIOTECH 5 is contraindicated in children under the age of 6 years, as safety and efficacy of 5 mg tablets have not been demonstrated.
• MONTELUKAST BIOTECH 10 is contraindicated in children under the age of 15 years.
• Pregnancy and lactation.
• MONTELUKAST BIOTECH 10 contains soy lecithin (E-322) (peanut oil). If you are allergic to peanut or soya, do not use MONTELUKAST BIOTECH 10.

MONTELUKAST BIOTECH is not indicated in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. MONTELUKAST BIOTECH should not be used for the treatment of acute asthma attacks as efficacy has not been established. Eosinophilic conditions Patients on therapy with MONTELUKAST BIOTECH may present with eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg- Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Medical practitioners should be on the alert for patients presenting with eosinophilia, vasculitic rash, worsening of pulmonary symptoms, cardiac complications, and/or neuropathy.

Neuropsychiatric events Neuropsychiatric events have been reported in adult, adolescent and paediatric patients taking MONTELUKAST BIOTECH. These include agitation, aggression, hostility, anxiousness, dream abnormalities, hallucinations, depression, disorientation, disturbance in attention, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behaviour (including suicide), tic and tremor. Patients and medical practitioners should be aware of the potential for neuropsychiatric events. Patients should be instructed to inform their medical practitioners if these events occur. Medical practitioners should carefully evaluate the risks and benefits of continuing treatment with MONTELUKAST BIOTECH if such events occur.

Hypersensitivity to aspirin Patients with a known hypersensitivity to aspirin should continue avoiding aspirin and NSAIDs while taking MONTELUKAST BIOTECH. Although MONTELUKAST BIOTECH is effective in improving airway function in asthmatics, it has not been shown to reduce the bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) in aspirin-sensitive asthmatic patients.

Hepatic impairment The metabolism of montelukast may be decreased in patients with mild to moderate hepatic function impairment and clinical evidence of cirrhosis. The half-life may be slightly prolonged; however, dosage adjustment is not necessary. Data are not available in patients with severe hepatic function impairment.

MONTELUKAST BIOTECH may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma, and seasonal allergic rhinitis. In medicine interaction studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following medicines: Theophylline, prednisone, prednisolone, oral contraceptives (ethinyl oestradiol/norethindrone 35 mcg /1 mg), digoxin and warfarin. Patients sensitive to aspirin should avoid the use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) while using MONTELUKAST BIOTECH (see section 4.4). Clinical monitoring is recommended during co-administration of MONTELUKAST BIOTECH with potent cytochrome P450 enzyme inducers, such as ritonavir, rifampicin, phenytoin and phenobarbital (phenobarbitone) or St Johnu2019s wort. Phenobarbital (phenobarbitone) induces the hepatic metabolism of MONTELUKAST BIOTECH resulting in significant decreases of approximately 40 % in the area under the curve (AUC) for MONTELUKAST BIOTECH. No dosage adjustment for MONTELUKAST BIOTECH is recommended. MONTELUKAST BIOTECH may potentiate sodium and fluid retention caused by prednisone which could result in severe peripheral oedema. In vitro studies have shown that montelukast is an inhibitor of isoenzyme CYP2C8. However, data from an interaction study involving montelukast and rosiglitazone (a substrate representative of medicines primarily metabolised by isoenzyme CYP2C8) demonstrated that montelukast did not significantly inhibit isoenzyme CYP2C8 in vivo. Therefore, MONTELUKAST BIOTECH is not anticipated to alter the metabolism of medicines metabolised by isoenzyme (CYP2C8) (e.g., paclitaxel, rosiglitazone, and repaglinide.) In vitro studies have shown that montelukast is a substrate of CYP2C8, CYP2C9, and CYP3A4. Data from an interaction study involving montelukast and gemfibrozil (an inhibitor of both CYP2C8 and CYP2C9) demonstrated that gemfibrozil increased the systemic exposure of montelukast by 4,4-fold. Co-administration of itraconazole, a strong CYP3A4 inhibitor, with gemfibrozil and montelukast did not further increase the systemic exposure of montelukast. The effect of gemfibrozil on systemic exposure of montelukast is not considered to be clinically meaningful based on clinical safety data with doses greater than the 10 mg approved dose in adults (e.g., 200 mg/day to adult patients for 22 weeks, and up to 900 mg/day to patients for approximately one week) where clinically important adverse experiences were not observed. Therefore, no dosage adjustment of MONTELUKAST BIOTECH is required upon co-administration with gemfibrozil.

Pregnancy The safety of MONTELUKAST BIOTECH in pregnant and lactating women has not been established. MONTELUKAST BIOTECH should not be used during pregnancy (see section 4.3). Breastfeeding MONTELUKAST BIOTECH should not be used during breastfeeding (see section 4.3). It is not known if MONTELUKAST BIOTECH is excreted in human breastmilk. Fertility No data available.

MONTELUKAST BIOTECH may cause side effects such as dizziness or drowsiness, which may affect the ability to drive. Patients should therefore be advised not to drive or operate machinery until their individual susceptibility is known.

Tabulated summary of adverse reactions Infections and infestations Frequent Upper respiratory infection Blood and lymphatic system disorders Less frequent Increased bleeding tendency, agranulocytosis, thrombocytopenia, systemic eosinophilia, vasculitis consistent with Churg-Strauss syndrome (see section 4.4), porphyria. Immune system disorders Less frequent Hypersensitivity reactions including anaphylaxis, angioedema, hepatic eosinophilic infiltration, decreased immune responsiveness. Psychiatric disorders Less frequent Abnormal dreams including nightmares, and insomnia, somnambulism, hallucinations, agitation including aggressive behaviour or hostility, anxiousness, depression, psychomotor hyperactivity (including irritability, restlessness, tremor) suicidal thinking and behaviour (suicidality), disturbance in attention, memory impairment, tic, disorientation, obsessive-compulsive symptoms, dysphemia Nervous system disorders Frequent Headache, dizziness. Less frequent Drowsiness, paraesthesia/ hypoesthesia, seizure Cardiac disorders Less frequent Palpitations, chest pain Eye disorders Less frequent Blepharospasm, mydriasis Respiratory, thoracic and mediastinal disorders Less frequent Congestion (nasal), cough, influenza, epistaxis, pulmonary eosinophilia. Gastrointestinal disorders Frequent Dyspepsia, gastroenteritis (infectious), pain (dental), diarrhoea, thirst, abdominal pain Less frequent Nausea, vomiting, bowel movement irregularity, dry mouth, flatulence, salivary hypersecretion Hepato-biliary disorders Less frequent Hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury), increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) Skin and subcutaneous tissue disorders Frequent Rash Less frequent Pruritus, urticaria, erythema nodosum, bruising, erythema multiforme Musculoskeletal, connective tissue and bone disorders Less frequent Arthralgia, myalgia, including muscle cramps Renal and urinary disorders Less frequent Enuresis in children General disorders and administration site conditions Frequent Asthenia/fatigue, trauma Less frequent Oedema, pyrexia and increased sweating Ear and labyrinth disorders Frequent Vertigo Investigations Less frequent Alanine aminotransferase increased, Aspartate aminotransferase increased, white blood cell count decreased, eosinophil count increased, haematocrit decreased, haemoglobin decreased 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. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Symptoms 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 No specific information is available on the treatment of overdosage with MONTELUKAST BIOTECH. Treatment may include removal of unabsorbed material from the gastro-intestinal tract, clinical monitoring and supportive therapy if required. It is not known whether montelukast is dialysable by peritoneal or haemodialysis.