4.1. Therapeutic indications

Mometasone Furoate Nasal Spray is indicated for use in adults and children 3 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis.

Mometasone Furoate Nasal Spray is indicated for the treatment of nasal polyps in adults aged 18 years and older.

4.2. Posology and method of administration

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

Posology

Seasonal Allergic or Perennial Rhinitis

Adults (including older patients) and children aged 12 years 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 3 and 11 years:

The usual recommended dose is one actuation (50 micrograms/actuation) in each nostril once daily (total dose 100 micrograms).

Mometasone furoate nasal spray 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.

Treatment with mometasone furoate nasal spray may need to be initiated some days before the expected start of the pollen season in patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis.

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 of mometasone furoate nasal spray for the treatment of nasal polyposis were four months in duration.

Paediatric population

Seasonal Allergic Rhinitis and Perennial Rhinitis

The safety and efficacy of mometasone furoate nasal spray in children under 3 years of age have not been established.

Nasal Polyposis

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

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.

Mometasone furoate nasal spray 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.

4.4. Special warnings and precautions for use

Immunosuppression

Mometasone furoate nasal spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial or systemic viral infections.

Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs..

Local Nasal Effects

Following 12 months of treatment with mometasone furoate nasal spray in a study of patients with perennial rhinitis, there was no evidence of atrophy of the nasal mucosa; also, mometasone furoate tended to reverse the nasal mucosa closer to a normal histologic phenotype. Nevertheless, patients using mometasone furoate nasal spray over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localised fungal infection of the nose or pharynx develops, discontinuation of mometasone furoate nasal spray therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing mometasone furoate nasal spray.

Mometasone furoate is not recommended in case of nasal septum perforation (see section 4.8).

In clinical studies, epistaxis occurred at a higher incidence compared with placebo. Epistaxis was generally self-limiting and mild in severity (see section 4.8).

Systemic Effects of Corticosteroids

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Following the use of intranasal corticosteroids, instances of increased intraocular pressure have been reported (see section 4.8).

Visual disturbance may be reported with systemic and topical (including intranasal, inhaled and intraocular corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Patients who are transferred from long-term administration of systemically active corticosteroids to mometasone furoate nasal spray require careful attention. Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of Hypothalamus-Pituitary-Adrenal (HPA) axis function. If these patients exhibit signs and symptoms of adrenal insufficiency or symptoms of withdrawal (e.g., joint and/or muscular pain, lassitude and depression initially), despite relief from nasal symptoms, systemic corticosteroid administration should be resumed and other modes of therapy and appropriate measures instituted. Such transfer may also unmask pre-existing allergic conditions, such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.

Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Nasal Polyps

The safety and efficacy of mometasone furoate nasal spray has not been studied for use in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities.

Unilateral polyps that are unusual or irregular in appearance, especially if ulcerating or bleeding, should be further evaluated.

Effect on Growth in Paediatric Population

It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring the patient to a paediatric specialist.

Non-nasal Symptoms

Although mometasone furoate nasal spray will control the nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of other symptoms, particularly ocular symptoms.

Mometasone Furoate Nasal Spray contains benzalkonium chlorideBenzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

Mometasone Furoate Nasal Spray contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per actuation, that is to say essentially `sodium-free´.

4.5. Interaction with other medicinal products and other forms of interaction

(See 4.4 “Systemic Effects of Corticosteroids”

A clinical interaction study was conducted with loratadine. No interactions were observed.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of mometasone furoate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). As with other nasal corticosteroid preparations, mometasone furoate nasal spray should not be used in pregnancy unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.

Breast-feeding

It is unknown whether mometasone furoate nasal spray is excreted in human milk. As with other nasal corticosteroid preparations, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from mometasone furoate therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There are no clinical data concerning the effect of mometasone furoate on fertility. Animal studies have shown reproductive toxicity, but no effects on fertility (see section 5.3).

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Summary of the safety profile

Epistaxis was generally self-limiting and mild in severity, and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence when compared to the active control nasal corticosteroids studied (up to 15%) as reported in clinical studies for allergic rhinitis. The incidence of all other adverse events was comparable with that of placebo. In patients treated for nasal polyposis, the overall incidence of adverse events was similar to that observed for patients with allergic rhinitis.

Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.

Tabulated list of adverse reactions

Treatment-related adverse reactions (≥1%) reported in clinical trials in patients with allergic rhinitis or nasal polyposis and post-marketing regardless of indication are presented in Table 1. Adverse reactions are listed according to MedDRA primary system organ class. Within each system organ class, adverse reactions are ranked by frequency. Frequencies were defined as follows: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100). The frequency of post-marketing adverse events are considered as “not known (cannot be estimated from the available data)”.

Table 1: Treatment-related adverse reactions reported by system organ class and frequency

Very common

Common

Not known

Infections and infestations

Pharyngitis

Upper respiratory tract infection**

Immune system disorders

Hypersensitivity including anaphylactic reactions, angioedema, bronchospasm, and dyspnoea

Nervous system disorders

Headache

Eye disorders

Glaucoma

Increased intraocular pressure

Cataracts

Vision, blurred (see also section 4.4)

Respiratory, thoracic and mediastinal disorders

Epistaxis*

Epistaxis

Nasal burning

Nasal irritation

Nasal ulceration

Nasal septum perforation

Gastrointestinal disorders

Throat irritation*

Disturbances of taste and smell

*recorded for twice daily dosing for nasal polyposis

**recorded at uncommon frequency for twice daily dosing for nasal polyposis

Paediatric population

In the paediatric population, the incidence of recorded adverse events in clinical studies, e.g., epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function.

Management

Because the systemic bioavailability of Mometasone Furoate Nasal Spray is <1%,, overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage..