Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
CLEAN PROFESSIONAL INFORMATION FOR MONTRAHET  
SCHEDULING STATUS  
S3  
1 NAME OF THE MEDICINE  
MONTRAHET 4 mg chewable tablets  
MONTRAHET 5 mg chewable tablets  
2 QUALITATIVE AND QUANTITATIVE COMPOSITION  
Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.  
Each tablet contains montelukast sodium equivalent to 5 mg of montelukast.  
Contains sugar ‘mannitol & aspartame’  
Each 4 mg tablet contains 168,720 mg of mannitol and 1,2 mg aspartame  
Each 5 mg contains 210,900 mg mannitol and 1,5 mg aspartame  
‘for full list of excipients, see section 6.1’  
3 PHARMACEUTICAL FORM  
Chewable tablets  
MONTRAHET 4 mg is light pink coloured, speckled, oval, biconvex shaped, chewable tablets  
debossed with 'I' on one side and '112' on the other side.  
MONTRAHET 5 mg is light pink coloured, speckled, round, biconvex shaped, chewable tablets  
debossed with T on one side and '113' on the other side.  
4 CLINICAL PARTICULARS  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
4.1 Therapeutic indications  
MONTRAHET 4 mg chewable tablets are indicated in paediatric patients 2 to 5 years of age for the  
prophylaxis and chronic treatment of atopic asthma.  
MONTRAHET 5 mg chewable tablets are indicated in paediatric patients over 6 years of age for  
prophylaxis and chronic the treatment of atopic asthma.  
4.2 Posology and method of administration  
MONTRAHET 4 mg & 5 mg should be taken once daily in the evening.  
Paediatric Patients 2 to 5 Years of Age with Atopic asthma  
The dosage for paediatric patients 2 to 5 years of age is one MONTRAHET 4 mg chewable tablet  
daily to be taken at bedtime.  
Paediatric Patients 6 to 14 Years of Age with Atopic Asthma:  
The dosage for paediatric patients 6 to 14 years of age is one MONTRAHET 5 mg chewable tablet  
daily.  
General Recommendations:  
A therapeutic effect of MONTRAHET 4 mg & 5 mg on parameters of asthma control occurs within  
one day.  
MONTRAHET 4 mg & 5 mg may be taken with or without food. If taken with food Montelukast  
should be taken 1 hour before or 2 hours after food. Patients should be advised to continue taking  
MONTRAHET 4 mg & 5 mg while their asthma is controlled, as well as during periods of worsening  
asthma.  
Therapy with MONTRAHET 4 mg & 5 mg chewable tablets in Relation to Other Treatments for  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
Asthma:  
MONTRAHET 4 mg & 5 mg can be added to a patient’s existing treatment regimen.  
Special populations  
Elderly population:  
No dosage adjustment is necessary for the elderly.  
Renal impairment:  
No dosage adjustment is necessary for patients with renal insufficiency.  
Hepatic impairment:  
No dosage adjustment is necessary for patients with mild-to-moderate hepatic impairment.  
No dosage adjustment is necessary for patients of either gender.  
Paediatric population  
Montelukast 4 mg and 5 mg chewable tablets formulations are not recommended for paediatrics  
below 2 years of age (see section 4.3).  
Method of administration  
Orally  
4.3 Contraindications  
•
•
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  
MONTRAHET 4 mg chewable tablets are contraindicated in children under the age of 2  
years, as safety and efficacy have not been demonstrated.  
•
MONTRAHET 5 mg chewable tablets are contraindicated in children under the age of 6  
years, as safety and efficacy have not been demonstrated.  
September 2024  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
4.4 Special warnings and precautions for use  
General  
The efficacy of oral HETELUKST 4 mg & 5 mg for the treatment of acute asthma attacks has not  
been established.  
MONTRAHET 4 mg & 5 mg 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.  
MONTRAHET 4 mg & 5 mg is not indicated for use in the reversal of bronchospasm in acute  
asthma attacks, including status asthmaticus. Patients should be advised to have appropriate  
rescue medication available.  
Therapy with MONTRAHET 4 mg & 5 mg can be continued during acute exacerbations of asthma.  
While the dose of inhaled corticosteroid may be reduced gradually under medical supervision,  
MONTRAHET 4 mg & 5 mg should not be abruptly substituted for inhaled or oral corticosteroids.  
Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-  
inflammatory medicines while taking MONTRAHET 4 mg & 5 mg. Although MONTRAHET 4 mg &  
5 mg is effective in improving airway function in asthmatics with documented aspirin sensitivity, it  
has not been shown to truncate bronchoconstrictor response to aspirin and other non-steroidal  
anti-inflammatory medicines in aspirin-sensitive asthmatic patients.  
Renal Insufficiency  
Since montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of  
montelukast were not evaluated in patients with renal insufficiency. No dosage adjustment is  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
recommended in these patients (see section 4.2)  
Eosinophilic Conditions  
In rare cases, patients on therapy with MONTRAHET 4 mg & 5 mg 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 events  
usually, but not always, have been associated with the reduction of oral corticosteroid therapy.  
Medical practitioners should be alert to eosinophilia, vasculitic rash, worsening pulmonary  
symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal  
association between MONTRAHET 4 mg & 5 mg and these underlying conditions has not been  
established (see section 4.8).  
Information for Patients  
Patients should be advised to take MONTRAHET 4 mg & 5 mg daily as prescribed, even when  
they are asymptomatic, as well as during periods of worsening asthma, and to contact their  
physicians if their asthma is not well controlled.  
Patients should be advised that oral tablets of MONTRAHET 4 mg & 5 mg are not for the treatment  
of acute asthma attacks. They should have appropriate short-acting inhaled beta-agonist  
medication available to treat asthma exacerbations.  
Patients should be advised that, while using MONTRAHET 4 mg & 5 mg 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 24-hour  
period are needed.  
Patients receiving MONTRAHET 4 mg & 5 mg should be instructed not to decrease the dose or  
stop taking any other anti-asthma medications unless instructed by a medical practitioner.  
September 2024  
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Page 5 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
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.  
Patients with known aspirin sensitivity should be advised to continue avoidance of aspirin or non-  
steroidal anti-inflammatory medicines while taking MONTRAHET 4 mg & 5 mg tablets.  
Phenylketonurics: Phenylketonuric patients should be informed that the chewable tablets contain  
phenylalanine (a component of aspartame) 1,200 mg per 4 mg and 1,500 mg per 5 mg tablet.  
MONTRAHET contains mannitol that may have a mild laxative effect.  
4.5 Interaction with other medicines and other forms of interaction  
Montelukast may be administered with other therapies routinely used in the prophylaxis and  
chronic treatment of asthma. In drug-medicines, the recommended dose of montelukast did not  
have clinically important effects on the pharmacokinetics of the following medicines: 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 patients 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 coadministered with inducers of CYP 3A4, 2C8, and 2C9, such as phenytoin,  
phenobarbitone and rifampicin.  
In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8. However, data from  
September 2024  
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Page 6 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate  
representative of medicines primarily metabolised by CYP2C8) demonstrated that montelukast  
does not inhibit CYP2C8 in vivo. Therefore  
montelukast is not anticipated to alter the metabolism of medicines metabolised by this enzyme  
(e.g. paclitaxel, rosiglitazone and repaglinide).  
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.  
4.6 Fertility, pregnancy and lactation Women of childbearing potential/ contraception in  
males and females  
In drug-medicines, the recommended dose of montelukast did not have important effects on the  
pharmacokinetics of the oral contraceptives (ethinyl estradiol/norethindrone 35/1).  
Pregnancy  
The safety of this medicine in pregnant women has not been established.  
Since there are no controlled studies in pregnant women montelukast should not be used during  
pregnancy.  
During worldwide marketing experience, congenital limb defects have been reported in offspring of  
women treated with montelukast during pregnancy. A causal relationship between these events  
and montelukast has not been established.  
September 2024  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
Breastfeeding  
The safety of this medicine in lactating women has not been established.  
Since there are no controlled studies in nursing women, montelukast should not be used during by  
nursing mothers. It is not known if montelukast is excreted in human milk.  
Montelukast may be used in breast-feeding mothers only if it is considered to be clearly essential.  
Fertility  
No information has been provided.  
4.7 Effects on ability to drive and use machines  
Montelukast may cause headache, drowsiness and dizziness. Patients should be advised not to  
drive or operate machinery if any of these symptoms.  
4.8 Undesirable effects  
a. Summary of the safety profile  
Immune system disorder:  
Less frequent:  
•
systemic eosinophilia (including Churg-Strauss syndrome)  
Nervous system disorder  
Frequent:  
•
headache  
Gastrointestinal disorders  
Frequent:  
•
abdominal pain  
General disorders and administration site  
conditions  
Frequent:  
•
thirst  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
b. Tabulated list of adverse reactions  
Infections and infestations  
Frequent:  
Upper respiratory infection  
Increased bleeding tendency  
Blood and lymphatic system disorders  
Less frequent:  
Immune system disorder  
Less frequent:  
Hypersensitivity reactions including anaphylaxis,  
hepatic eosinophilic infiltration  
Psychiatric disorders  
Less frequent:  
Abnormal dreams (including nightmares) and  
hallucinations, agitation including aggressive  
behaviour, anxiousness, depression, insomnia,  
irritability, restlessness, suicidal thinking and  
behaviour (suicidality), tremor, anxiety,  
somnambulism, disturbance in attention, memory  
impairment  
Nervous system disorder  
Less frequent  
Dizziness, drowsiness, paraesthesia/hypoesthesia,  
seizure  
Cardiac disorders  
Less frequent:  
Palpitations  
Respiratory, thoracic and mediastinal disorders  
Less frequent:  
Epistaxis Churg-Strauss Syndrome (CSS) (see  
section 4.4)  
Gastrointestinal disorders  
Frequent:  
Diarrhoea, nausea, vomiting  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
Less frequent:  
Dry mouth, dyspepsia  
Hepato-biliary disorders  
Frequent:  
Elevated levels of serum transaminases (ALT,  
AST)  
Less frequent:  
Hepatitis (including cholestatic, hepatocellular, and  
mixed-pattern liver injury),  
Skin and subcutaneous tissue disorders  
Frequent:  
Rash  
Less frequent:  
Bruising, urticaria, pruritus, angioedema, erythema  
nodosum, erythema multiforme  
Musculoskeletal, connective tissue and bone disorders  
Less frequent:  
Arthralgia, myalgia including muscle cramps  
General disorders and administration site conditions  
Frequent:  
Pyrexia  
Less frequent:  
Asthenia/fatigue, malaise, oedema  
c. Description of selected adverse reactions  
No information has been provided  
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 asked  
to report any suspected adverse to report any suspected adverse reactions to SAHPRA via  
the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s  
publications: https://www.sahpra.org.za/publications/Index/8 or to the Holder of certificate of  
registration through the mail: pvg.cdma@heterogroups.com  
September 2024  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
4.9 Overdose  
No specific information is available on the treatment of overdose with montelukast.  
There have been reports of acute overdosage in post- marketing experience and clinical studies  
with montelukast. These include reports in adults and children with a dose as high as 1000 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 overdosage 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. It is not known whether  
montelukast is dialysable by peritoneal- or hemo-dialysis.  
5 PHARMACOLOGICAL PROPERTIES  
5.1 Pharmacodynamic properties  
Pharmacotherapeutic group: Other systemic drugs for obstructive airways diseases, Leukotriene  
receptor antagonists  
ATC-code: R03D C03  
Pharmacological classification  
A.10.2.2 Other anti-asthmatics Leukotriene receptor antagonist  
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 receptors (CysLT) found in the human airway and cause a number of airway  
actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil  
recruitment.  
Montelukast binds with high affinity and selectivity to the CysLT1 receptor (in preference to other  
pharmacologically important airway receptors such as the prostanoid, cholinergic, or beta-  
adrenergic receptor). Montelukast inhibits physiological actions of LTC4, LTD4, and LTE4 at the  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
CysLT1 receptor without agonist activity.  
Montelukast causes potent inhibition of airway cysteinyl leukotriene receptors as demonstrated by  
the ability to inhibit bronchoconstriction due to inhaled LTD4 in asthmatic patients. Doses as low as  
5 mg cause substantial blockage of LTD4-induced bronchoconstriction.  
5.2 Pharmacokinetic properties  
Absorption  
Montelukast is absorbed following oral administration. For the 4 mg chewable tablet, Cmax is  
achieved 2 hours after administration in paediatric patients 2 to 5 years of age in the fasted state.  
The mean Cmaxn is 66 % higher while mean Cmin is lower than in adults receiving a 10 mg tablet.  
Safety and efficacy were demonstrated in clinical studies where the 4 mg chewable tablet was  
administered without regard to the timing of food ingestion.  
For the 5 mg chewable tablet, the Cmax is achieved 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 liters. Studies in rats with radiolabeled montelukast indicate minimal  
distribution across the blood-brain barrier. In addition, concentrations of radiolabeled material at 24  
hours post-dose were minimal in all other tissues.  
Biotransformation  
Montelukast is extensively metabolized in the liver. In studies with therapeutic doses, plasma  
concentrations of metabolites of montelukast are undetectable at steady state in adults and  
paediatric patients.  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
Cytochrome P450 2C8 is the major enzyme in the metabolism of montelukast. Additionally, CYP  
3A4 and2C9 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 10  
mg montelukast daily.  
In vitro studies using human liver microsomes indicate that cytochrome P450 3A4 and 2C9 are  
involved in the metabolism of montelukast. Based on further 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  
Elimination data are not available for children 2 to 5 years of age. However, the plasma clearance  
of montelukast averages 45 ml/min in healthy adults. Following an oral dose of radiolabeled  
montelukast, 86 % of the radioactivity was recovered in 5-day faecal collections and less than 0,2  
% was recovered in urine. Coupled with estimates of montelukast oral bioavailability, this indicates  
montelukast and its metabolites are excreted almost exclusively via the bile.  
In several studies, the mean plasma half-life of montelukast ranged from 2,7 to 5,5 hours in healthy  
young adults. The pharmacokinetics of montelukast are nearly linear for oral doses up to 50 mg.  
No difference in pharmacokinetics was noted between dosing in the morning or in the evening.  
During once-daily dosing with 10 mg montelukast, there is little accumulation of the parent drug in  
plasma (approximately 14 %). No difference in pharmacokinetics was noted between dosing in the  
morning or in the evening.  
Characteristics in specific groups of subjects or patients  
No dosage adjustment is necessary for the elderly.  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
Hepatic insufficiency  
Patient with mild to moderate hepatic insufficiency and clinical evidence of cirrhosis had evidence  
of decreased metabolism of montelukast resulting in approximately 41 % higher mean montelukast  
area under the plasma concentration curve (AUC) following a single 10 mg dose.  
The elimination of montelukast is slightly prolonged compared with that in healthy subjects (mean  
half-life, 7,4 hours). No dosage adjustment is required in patients with mild-to-moderate hepatic  
insufficiency. There are no clinical data in patients with severe hepatic insufficiency (Child-Pugh  
score greater than 9).  
Renal impairment  
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.  
With high doses of montelukast (20- and 60-fold the recommended adult dose), a decrease in  
plasma theophylline concentration was observed. This effect was not seen at the recommended  
dose of 10 mg once daily.  
5.3 Preclinical safety data  
No information has been provided.  
6. Pharmaceutical Particulars  
6.1 List of excipients  
Mannitol (Pearlitol 25C)  
Croscarmellose sodium  
Hydroxyproyl cellulose  
Ferric oxide  
Cellulose microcrystalline  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
Aspartame  
ART cherry flavour  
Magnesium stearate  
6.2 Incompatibilities  
Not applicable  
6.3 Shelf life  
36 months  
6.4 Special precautions for storage  
Store at or below 25°C  
Protect from light and moisture.  
KEEP OUT OF REACH OF CHILDREN.  
6.5 Nature and contents of container  
MONTRAHET 4 mg is packed in Cold form foil 108 mm (60 microns PVC/ 45 microns aluminum foil  
/ 25 Microns OPA) blister pack and 0,025 x 108 mm plain aluminum foil (Hard tampered) with  
7GSM HSL coating on the bright side packed in the carton.  
MONTRAHET 5 mg is packed in Cold form foil 123 mm (60 microns PVC/ 45 microns aluminum foil  
/ 25 Microns OPA) blister pack and 0,025 x 123 mm plain aluminum foil (Hard tampered) with  
7GSM HSL coating on the bright side packed in the carton.  
Pack sizes: 10’s Alu-Alu blister  
3 X10’s Alu-Alu blister  
MONTRAHET 4 mg and 5 mg is packed in Cold form foil 251 mm (60 microns PVC/ 45 microns  
aluminum foil / 25 Microns OPA) Cold form foil (60μ PVC/45μ Aluminum/25μ OPA)  
September 2024  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
Pack sizes: 14’s Alu-Alu blister  
6.6 Special precautions for disposal and other handling  
No special requirements  
7 HOLDER OF CERTIFICATE OF REGISTRATION  
Hetero Drugs South Africa (Pty) Ltd  
Waterfall Corporate Campus,  
Building No.2, First Floor,  
74 Waterfall Drive,  
Midrand, 2066  
Telephone number: 012 644 1220  
Fax number: 012 644 1564  
e-mail address: nokuthula.n@heterodrugs.com  
8 REGISTRATION NUMBER(S)  
MONTRAHET 4 mg 48/10.4.2/0536  
MONTRAHET 5 mg 48/10.4.2/0537  
9 DATE OF FIRST AUTHORISATION  
19 October 2021  
10 DATE OF REVISION OF THE TEXT  
18 September 2024  
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Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: MONTRAHET 4 mg & MONTRAHET 5 mg  
Dosage form and strength: Each tablet contains montelukast sodium equivalent to 4 mg montelukast  
Each tablet contains montelukast sodium equivalent to 5 mg montelukast  
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