MONASAL NASAL SPRAY 50 MCG/SPRAY [SIN15932P]

Product Info

MONASAL NASAL SPRAY 50 MCG/SPRAY

[SIN15932P]

4.1 Therapeutic indications

MONASAL® is indicated for use in adults and children 2 years of age and older to treat the symptoms of seasonal or perennial allergic rhinitis.

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

MONASAL® is indicated for the treatment of nasal polyps in adults 18 years of age and older. Treatment of nasal polyps in paediatric patients less than 18 years of age has not been established.

MONASAL® 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

After initial priming of the MONASAL® nasal spray pump, each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate.

Posology
Seasonal or perennial allergic rhinitis
Adults (including older patients) and children 12 years of age and older: The usual recommended dose is two actuations (50 micrograms/actuation) in each nostril once daily (total dose 200 micrograms). Once symptoms are controlled, dose reduction to one actuation 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 actuations in each nostril once daily (total dose 400 micrograms). Dose reduction is recommended following control of symptoms.

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

Mometasone furoate demonstrated a clinically significant onset of action within 12 hours after the first dose in some patients with seasonal allergic rhinitis; however, full benefit of treatment may not be achieved in the first 48 hours. Therefore, the patient should continue regular use to achieve full therapeutic benefit.

Nasal polyposis
The usual recommended starting dose for polyposis is two actuations (50 micrograms/actuation) in each nostril once daily (total daily dose of 200 micrograms). If after 5 to 6 weeks 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 micrograms). The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. If no improvement in symptoms is seen after 5 to 6 weeks of twice daily administration, the patient should be re-evaluated and treatment strategy reconsidered.

Efficacy and safety studies mometasone furoate for the treatment of nasal polyposis were four months in duration.

Paediatric population
Seasonal or perennial allergic rhinitis
The safety and efficacy of mometasone furoate in children under 2 years of age have not been established.

Nasal polyposis
The safety and efficacy of mometasone furoate in children and adolescents under 18 years of age have not been established.

Treatment of acute rhinosinusitis:

Use in adults and children 12 years of age and older: The usual recommended dose is two sprays (50 micrograms/spray) into each nostril twice daily (total daily dose of 400 micrograms). If no improvement in symptoms is seen after 15 days of twice daily administration, you should contact your doctor to discuss other treatments to replace MONASAL®. If symptoms get worse during treatment you should contact your doctor.

Method of administration
Prior to administration of the first dose, shake container well and actuate the pump 10 times (until a uniform spray is obtained). If the pump is not used for 14 days or longer, reprime the pump with 2 actuations until a uniform spray is observed, before next use.

Shake container well before each use. The bottle should be discarded after the labelled number of actuations or within 2 months of first use.

4.3 Contraindications

Hypersensitivity to the active substance, mometasone furoate, 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.

MONASAL® should not be used in the presence of untreated localised infection involving the nasal mucosa, such as herpes simplex.

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.