Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: Sandoz SA (Pty) Ltd<sup>1</sup>, Waterfall 5-lr, Magwa Crescent West, Waterfall City, Jukskei View, 2090 Marketed by sanofi aventis south africa (pty) ltd. 1 Company Reg. No.: 1990/001979/07
SINTRINE 4 chewable tablets are indicated in paediatric patients 2 to 5 years of age for the prophylaxis and chronic treatment of atopic asthma.
SINTRINE 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.
SINTRINE 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.
SINTRINE 5: The dosage for paediatric patients 6 to 14 years of age is one 5 mg tablet daily to be taken in the evening.
SINTRINE may be taken with or without food.
SINTRINE can be added to a patient’s existing treatment regimen.
No dosage adjustment is necessary for the elderly, patients with renal insufficiency or mild to moderate hepatic impairment.
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.
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.
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.
24 months.
Store in the original package. The product is sensitive to light and moisture. Store at or below 25°C.
Keep the container tightly closed.
KEEP OUT OF THE REACH OF CHILDREN.
OPA/Al/PVC/Aluminium blisters, or White, opaque polyethylene containers and tamper evident polypropylene closures with desiccant insert.
Not all packs may be marketed.
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