SINTRINE Film-coated tablet Ref.[115334] Active ingredients: Montelukast

SINTRINE 10 film-coated tablets should only be used in adults and children 15 years of age and older.

Prophylaxis and treatment of atopic asthma

1 tablet (10 mg) to be taken daily in the evening.

SINTRINE 10 tablets may be taken with or without food.

Patients should be advised to continue taking SINTRINE 10 while their asthma is controlled, as well as during periods of worsening asthma.

No dosage adjustment is necessary for the elderly, patients with renal insufficiency, mild to moderate hepatic impairment, or for patients of either gender.

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 haemodialysis.

24 months.

Store at or below 25°C. Store in the original package. The product is sensitive to light and moisture.

Container: Keep the bottle tightly closed.

KEEP OUT OF THE REACH OF CHILDREN.

Sintrine 10 film-coated tablets are packed as 10, 14, 20, 28, 30, 35 or 50 tablets in: OPA/Al/PVC/Aluminium blisters or white, opaque polyethylene containers and tamper evident polypropylene closures with desiccant insert.

Not all packs may be marketed.