SINTRINE Oral granules Ref.[115333] Active ingredients: Montelukast

Posology

This medicine is to be given to a child under adult supervision. The recommended dose for paediatric patients 2 to 5 years of age is one sachet of 4 mg oral granules daily to be taken in the evening.

Administration of SINTRINE ORAL GRANULES

SINTRINE ORAL GRANULES can be administered either directly in the mouth or mixed with a spoonful of cold or room temperature soft food (e.g., applesauce, ice cream, carrots and rice). The sachet should not be opened until ready to use. After opening the sachet, the full dose of SINTRINE ORAL GRANULES must be administered immediately (within 15 minutes). If mixed with food, SINTRINE ORAL GRANULES must not be stored for future use. SINTRINE ORAL GRANULES are not intended to be dissolved in liquid for administration. However, liquids may be taken subsequent to administration. SINTRINE ORAL GRANULES can be administered without regard to the timing of food ingestion.

General recommendations

The therapeutic effect of SINTRINE ORAL GRANULES on parameters of asthma control occurs within one day. Patients should be advised to continue taking SINTRINE ORAL GRANULES even if their asthma is under control, as well as during periods of worsening asthma. No dosage adjustment is necessary for patients with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients.

Therapy with SINTRINE ORAL GRANULES in relation to other treatments for asthma

SINTRINE ORAL GRANULES can be added to a patient’s existing treatment regimen.

Method of administration

Oral use as described above.

No specific information is available on the treatment of overdosage with SINTRINE ORAL GRANULES.

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 1000 mg. 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.

24 months.

Store at or below 25°C.

Store in the original package in order to protect from light and moisture.

Do not use after the expiry date stated on the sachet/carton.

KEEP OUT OF REACH OF CHILDREN.

Pouch laminate sachet (PET/Aluminium foil/PE).

The sachets are packed in an outer cardboard carton.

Packs sizes of 7, 10, 14, 20, 28, 30 and 100 sachets.

Not all pack sizes may be marketed.

No special requirements.