MOMETASONE SANDOZ NASAL SPRAY 0.05% [SIN15328P]

Product Info

MOMETASONE SANDOZ NASAL SPRAY 0.05%

[SIN15328P]

4.1 Therapeutic indications
Mometasone nasal spray is indicated for use in adults and children 2 years of age and older to treat the symptoms of seasonal or perennial rhinitis.

In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with Mometasone nasal spray is recommended two to four weeks prior to the anticipated start of the pollen season.

Mometasone nasal spray is also indicated for the treatment of nasal polyps in patients 18 years of age and older. Treatment of nasal polyps in pediatric patients less than 18 years of age has not been established.

Mometasone nasal spray is indicated for the treatment of symptoms associated with mild to moderate uncomplicated acute rhinosinusitis in patients 12 years of age and older without signs and symptoms of severe bacterial infection.

4.2 Posology and method of administration
Posology
Adults (including geriatric patients) and children 12 years of age and older:
The usual recommended dose for prophylaxis and treatment is two sprays (50 micrograms/spray) in each nostril once daily (total dose 200 micrograms). Once symptoms are controlled, dose reduction to one spray in each nostril (total dose 100 micrograms) may be effective for maintenance.

If symptoms are inadequately controlled, the dose may be increased to a maximum daily dose of four sprays in each nostril once daily (total dose 400 micrograms). Dose reduction is recommended following control of symptoms.

Clinically significant onset of action occurs as early as 12 hours after the first dose.

Children between the ages of 2 and 11 years:
The usual recommended dose is one spray (50 micrograms/spray) in each nostril once daily (total dose 100 micrograms).

Administration to young children should be aided by an adult.

Nasal Polyposis: Adults (including geriatric patients) and adolescents 18 years of age and older:
The usual recommended dose for polyposis is two sprays (50 micrograms/spray) in each nostril once daily (total daily dose of 200 mcg). If symptoms are inadequately controlled, the dose may be increased to a daily dose of two sprays in each nostril twice daily (total daily dose of 400 mcg).

Dose reduction is recommended following control of symptoms.

Acute rhinosinusitis: The usual recommended dose for acute rhinosinusitis is two sprays (50 micrograms/spray) in each nostril twice daily (total daily dose of 400 mcg). If no improvement is seen after 15 days of twice daily administration, alternative therapies should be considered. If symptoms worsen during treatment, the patients should be advised to consult their physician.

Method of administration
Mometasone nasal spray is intended only for nasal use.

After initial priming of the Mometasone nasal spray pump (10 actuations, until a uniform spray is observed), each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate.
If the spray pump has not been used for 14 days or longer, it should be re-primed with 2 actuations, until a uniform spray is observed, before next use.

Shake container well before each use.
Cleaning: It is important to clean the nasal spray regularly, otherwise it may not work properly.
Remove the dust cap and gently pull off the nozzle. Wash the nozzle and dust cap in warm water and then rinse under a running tap. Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine. Allow the dust cap and nozzle to dry in a warm place. Push the nozzle back onto the bottle and replace the dust cap. The spray will need to be primed again with 2 sprays when first used after cleaning.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.