Nasonex 50 mikrogram/dos Nässpray, suspension

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

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Bipacksedel Bipacksedel (PIL)

27-03-2020

Produktens egenskaper Produktens egenskaper (SPC)

19-12-2017

Aktiva substanser:
mometasonfuroatmonohydrat
Tillgänglig från:
Orifarm AB
ATC-kod:
R01AD09
INN (International namn):
mometasone furoate monohydrate
Dos:
50 mikrogram/dos
Läkemedelsform:
Nässpray, suspension
Sammansättning:
mometasonfuroatmonohydrat 52 mikrog Aktiv substans; bensalkoniumklorid Hjälpämne; glycerol Hjälpämne
Receptbelagda typ:
Receptbelagt
Bemyndigande status:
Avregistrerad
Godkännandenummer:
56386
Tillstånd datum:
2018-02-14

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Bipacksedel Bipacksedel - engelska

27-03-2020

Produktens egenskaper Produktens egenskaper - engelska

27-03-2020

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PACKAGE LEAFLET

Package leaflet: Information for the user

Nasonex and associated names strength pharmaceutical form

[See Annex I - To be completed nationally]

Mometasone Furoate

Please read this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even

if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Nasonex is and what it is used for

What you need to know before you use Nasonex

How to use Nasonex

Possible side effects

How to store Nasonex

Contents of the pack and other information

1.

What Nasonex is and what it is used for

What is Nasonex?

Nasonex Nasal Spray contains mometasone furoate, one of a group of medicines called

corticosteroids. When mometasone furoate is sprayed into the nose, it can help to relieve

inflammation (swelling and irritation of the nose), sneezing, itching and a blocked up or runny nose.

What is Nasonex used for?

Hay fever and perennial rhinitis

Nasonex is used to treat the symptoms of hayfever (also called seasonal allergic rhinitis) and perennial

rhinitis in adults and children aged 3 and older.

Hayfever, which occurs at certain times of the year, is an allergic reaction caused by breathing in

pollen from trees, grasses, weeds and also moulds and fungal spores. Perennial rhinitis occurs

throughout the year and symptoms can be caused by a sensitivity to a variety of things including house

dust mite, animal hair (or dander), feathers and certain foods. Nasonex reduces the swelling and

irritation in your nose and thereby relieving sneezing, itching and a blocked-up or runny nose caused

by hay fever or perennial rhinitis.

Nasal polyps

Nasonex is used to treat nasal polyps in adults aged 18 and over.

Nasal polyps are small growths on the lining of the nose and usually affect both nostrils. Nasonex

reduces the inflammation in the nose, causing the polyps to gradually shrink, thereby relieving a

blocked feeling in the nose which may affect breathing through the nose.

2.

What you need to know before you use Nasonex

Do not use Nasonex

if you are allergic (hypersensitive) to mometasone furoate or any of the other ingredients of this

medicine (listed in section 6).

if you have an untreated infection in your nose. Use of Nasonex during an untreated infection in

your nose, such as herpes, can worsen the infection. You should wait until the infection is

resolved before you start using the nasal spray.

if you have recently had an operation on your nose or you have injured your nose. You should

not use the nasal spray until your nose has healed.

Warnings and precautions

Talk to your doctor or pharmacist before using Nasonex

if you have or have ever had tuberculosis.

if you have any other infection.

if you are taking other corticosteroid medicines, either by mouth or by injection.

if you have cystic fibrosis.

While you are using Nasonex, talk to your doctor

if your immune system is not functioning well (if you have difficulty in fighting infection) and

you come into contact with anyone with measles or chickenpox. You should avoid coming into

contact with anyone who has these infections.

if you have an infection of the nose or throat.

if you are using the medicine for several months or longer.

if you have persistent irritation to the nose or throat.

When corticosteroid nasal sprays are used at high doses for long periods of time, side effects may

occur due to the drug being absorbed in the body.

If your eyes are itching or irritated, your doctor may recommend that you use other treatments with

Nasonex.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children

When used at high doses for long periods of time, corticosteroid nasal sprays may cause certain side-

effects, such as slowed growth rate in children.

It is recommended that the height of children receiving long-term treatment with nasal corticosteroids

is regularly monitored and if any changes are noted, their doctor should be notified.

Other medicines and Nasonex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription.

If you are taking other corticosteroid medicines for allergy, either by mouth or injection, your doctor

may advise you to stop taking them once you begin using Nasonex. A few people may find that once

they discontinue oral or injected corticosteroids they suffer from some undesirable effects, such as

joint or muscular pain, weakness and depression. You may also seem to develop other allergies, such

as itchy, watering eyes or patches of red and itchy skin. If you develop any of these effects, you should

contact your doctor.

Some medicines may increase the effects of Nasonex and your doctor may wish to monitor you

carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

Pregnancy and breast-feeding

There is little or no information on the use of Nasonex in pregnant women. It is not known if

mometasone furoate is found in breast milk.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

There is no known information on the effect of Nasonex on the ability to drive or use machinery.

Nasonex contains benzalkonium chloride

Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3.

How to use Nasonex

Always use Nasonex exactly as your doctor has told you. You should check with your doctor or

pharmacist if you are not sure. Do not use a larger dose or use the spray more often or for longer than

your doctor tells you to.

Treatment of Hayfever and Perennial Rhinitis

Use in adults and children over 12 years old

The usual dose is two sprays into each nostril once a day.

Once your symptoms are under control, your doctor may advise you to decrease the dose.

If you do not start to feel any better, you should see your doctor and he or she may tell you to

increase the dose; the maximum daily dose is four sprays into each nostril once a day.

Use in children aged 3 to 11 years

The usual dose is one spray into each nostril once daily.

In some patients Nasonex begins to relieve symptoms within 12 hours after the first dose; however full

benefit of treatment may not be seen in the first two days. Therefore, you should continue regular use

to achieve full benefit of treatment.

If you or your child suffer badly from hayfever, your doctor may tell you to start using Nasonex some

days before the start of the pollen season, as this will help to prevent your hayfever symptoms from

occurring.

Nasal Polyps

Use in adults over 18 years old

The usual starting dose is two sprays into each nostril once daily.

If symptoms are not controlled after 5 to 6 weeks, the dose may be increased to two sprays in

each nostril twice daily. Once symptoms are under control, your doctor may advise you to

decrease your dose.

If no improvement in symptoms is seen after 5 to 6 weeks of twice daily administration, you

should contact your doctor.

Preparing your nasal spray for use

Your Nasonex Nasal Spray has a dust cap which protects the nozzle and keeps it clean. Remember to

take this off before using the spray and to replace it after use.

If you are using the spray for the first time you need to ‘prime’ the bottle by pumping the spray 10

times until a fine mist is produced:

Gently shake the bottle.

Put your forefinger and middle finger either side of the nozzle and your thumb underneath the

bottle.

Do Not

pierce the nasal applicator.

Point the nozzle away from you and then press down with your fingers to pump the spray 10

times until a fine mist is produced.

If you have not used the spray for 14 days or more, you need to “re-prime” the bottle by pumping the

spray 2 times until a fine mist is produced.

How to use your nasal spray

Shake the bottle gently and remove the dust cap. (Figure 1)

Gently blow your nose.

Close one nostril and put the nozzle into the other nostril as shown. (Figure 2)

Tilt your head forward slightly, keeping the bottle upright.

Start to breathe in gently or slowly through your nose and whilst you are

breathing in squirt a spray of fine mist into your nose by pressing down ONCE

with your fingers.

Breathe out through your mouth. Repeat step 4 to inhale a second spray in the

same nostril if applicable.

Remove the nozzle from this nostril and breathe out through the mouth.

Repeat steps 3 to 6 for the other nostril (Figure 3).

After using the spray, wipe the nozzle carefully with a clean handkerchief or tissue and

replace the dust cap.

Cleaning your nasal spray

It is important to clean your 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.

If you use more Nasonex than you should

Tell your doctor if you accidentally use more than you were told.

If you use steroids for a long time or in large amounts they may, rarely, affect some of your hormones.

In children this may affect growth and development.

If you forget to use

Nasonex

If you forget to use your nasal spray at the right time, use it as soon as you remember, then carry on as

before. Do not take a double dose to make up for a forgotten dose.

If you stop using Nasonex

In some patients Nasonex should begin to relieve symptoms 12 hours after the first dose; however full

benefit of treatment may not be seen for up to two days. It is very important that you use your nasal

spray regularly. Do not stop your treatment even if you feel better unless told to do so by your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediate hypersensitivity (allergic) reactions may occur after use of this product. These reactions

may be severe. You should stop taking Nasonex and get immediate medical help if you experience

symptoms such as:

swollen face, tongue or pharynx

trouble swallowing

hives

wheezing or trouble breathing

When corticosteroid nasal sprays are used at high doses for long periods of time, side effects may

occur due to the drug being absorbed in the body.

Other side effects

Most people do not have any problems after using the nasal spray. However, some people, after using

Nasonex or other corticosteroid nasal sprays, may find that they suffer from:

Common side effects (may affect up to 1 in 10 people):

headache

sneezing

nose bleeds [occurred very commonly (may affect more than 1 in 10 people) in people with

nasal polyps receiving Nasonex two sprays in each nostril twice a day]

sore nose or throat

ulcers in the nose

respiratory tract infection

Not known (frequency

cannot be estimated from the available data):

increase in pressure in the eye (glaucoma) and/or cataracts causing visual disturbances,

damage to the partition in the nose which separates the nostrils

changes in taste and smell

difficulty in breathing and/or wheezing

blurred vision

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V. By

reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Nasonex

Keep this medicine out of the sight and reach of children.

Do not store the bottle above 25°C. Do not freeze.

Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.

The expiry date refers to the last day of that month.

The bottle should be used within 2 months of first opening. Only open one bottle at a time.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Nasonex contains

The active substance is mometasone furoate. Each spray contains 50 micrograms of

mometasone furoate, as the monohydrate.

The other ingredients are dispersible cellulose, glycerol, sodium citrate, citric acid monohydrate,

polysorbate 80, benzalkonium chloride, purified water.

This medicine contains 0.02 mg of benzalkonium chloride per spray.

What Nasonex looks like and contents of the pack

Nasonex is a nasal spray suspension.

Each bottle contains 60 sprays or 140 sprays.

Bottles containing 60 sprays are supplied in single packs.

Bottles containing 140 sprays are supplied in packs of 1, 2, or 3 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[See Annex I - To be completed nationally]

The manufacturer is:

Schering-Plough Labo NV,

Heist-op-den Berg, Belgium

This medicinal product is authorised in the Member States of the EEA under the following

names:

Austria: Nasonex aquosum – Nasenspray

Belgium, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Slovenia, Sweden, UK : Nasonex

Bulgaria, Czech Republic, Romania, Slovak Republic: NASONEX

Latvia: Nasonex 50 mikrogrami/deva deguna aerosols,suspensija

Portugal: Nasomet

Spain: NASONEX 50 microgramos suspensión para pulverización nasal

This leaflet was last approved in

13 March 2020

[To be completed nationally]

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SUMMARY OF PRODUCT CHARACTERISTICS

1.

N

AME OF THE

M

EDICINAL

P

RODUCT

NASONEX and associated names strength pharmaceutical form

[See Annex I - To be completed nationally]

2.

Q

UALITATIVE AND

Q

UANTITATIVE

C

OMPOSITION

Mometasone furoate (as the monohydrate) 50 micrograms/actuation.

Excipient with known effect

This medicinal product contains 0.02 mg of benzalkonium chloride per actuation.

For the full list of excipients, see section 6.1.

3.

P

HARMACEUTICAL

F

ORM

Nasal Spray, Suspension.

White to off-white opaque suspension.

4.

C

LINICAL

P

ARTICULARS

4.1

Therapeutic indications

NASONEX 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.

NASONEX Nasal Spray is indicated for the treatment of nasal polyps in adults 18 years of age and older.

4.2

Posology and method of administration

After initial priming of the NASONEX 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 Allergic or Perennial 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 3 and 11 years: The usual recommended dose is one actuation

(50 micrograms/actuation) in each nostril once daily (total dose 100 micrograms).

NASONEX 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 NASONEX 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 NASONEX 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 NASONEX Nasal Spray in children under 3 years of age have not been

established.

Nasal Polyposis

The safety and efficacy of NASONEX 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.

NASONEX 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

NASONEX 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 NASONEX 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 NASONEX 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, discontinuance of NASONEX

Nasal Spray therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation

may be an indication for discontinuing NASONEX Nasal Spray.

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

In clinical studies, epistaxis occurred at a higher incidence compared to placebo. Epistaxis was

generally self-limiting and mild in severity (see section 4.8).

NASONEX Nasal Spray contains benzalkonium chloride.

enzalkonium chloride may cause irritation

or swelling inside the nose, especially if used for a long time.

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

NASONEX Nasal Spray require careful attention. Systemic corticosteroid withdrawal in such patients

may result in adrenal insufficiency for a number of months until recovery of 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 NASONEX 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 NASONEX 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.

4.5

Interactions with other medicaments and other forms of interaction

(See 4.4 Special warnings and special precautions for use with systemic 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

animals

have

shown

reproductive

toxicity

(see

section 5.3).

with

other

nasal

corticosteroid preparations, NASONEX 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.

Lactation

It is unknown whether mometasone furoate 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 NASONEX Nasal Spray 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 national reporting system

listed in Appendix V.

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 NASONEX Nasal Spray is <1%, overdose is unlikely to require

any therapy other than observation, followed by initiation of the appropriate prescribed dosage.

5.

P

HARMACOLOGICAL

P

ROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Decongestants and Other Nasal Preparations for Topical Use-

Corticosteroids, ATC code: R01A D09

Mechanism of action

Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that

are not systemically active.

It is likely that much of the mechanism for the anti-allergic and anti-inflammatory effects of mometasone

furoate lies in its ability to inhibit the release of mediators of allergic reactions. Mometasone furoate

significantly inhibits the release of leukotrienes from leucocytes of allergic patients. In cell culture,

mometasone furoate demonstrated high potency in inhibition of synthesis and release of IL-1, IL-5, IL-6

and TNF

; it is also a potent inhibitor of leukotriene production. In addition, it is an extremely potent

inhibitor of the production of the Th2 cytokines, IL-4 and IL-5, from human CD4+ T-cells.

Pharmacodynamic effects

In studies utilising nasal antigen challenge, NASONEX Nasal Spray has shown anti-inflammatory activity

in both the early- and late- phase allergic responses. This has been demonstrated by decreases (vs placebo)

in histamine and eosinophil activity and reductions (vs baseline) in eosinophils, neutrophils, and epithelial

cell adhesion proteins.

In 28% of the patients with seasonal allergic rhinitis, NASONEX Nasal Spray demonstrated a clinically

significant onset of action within 12 hours after the first dose. The median (50%) onset time of relief was

35.9 hours.

Paediatric population

In a placebo-controlled clinical trial in which paediatric patients (n=49/group) were administered

NASONEX Nasal Spray 100 micrograms daily for one year, no reduction in growth velocity was

observed.

There are limited data available on the safety and efficacy of NASONEX Nasal Spray in the paediatric

population aged 3 to 5 years, and an appropriate dosage range cannot be established. In a study involving

48 children aged 3 to 5 years treated with intranasal mometasone furoate 50, 100 or 200

g/day for 14

days, there was no significant differences from placebo in the mean change in plasma cortisol level in

response to the tetracosactrin stimulation test.

The European Medicines Agency has waived the obligation to submit the results of studies with

NASONEX Nasal Spray and associated names in all subsets of the paediatric population in seasonal

and perennial allergic rhinitis (see section 4.2 for information on paediatric use).

5.2

Pharmacokinetic properties

Absorption

Mometasone furoate, administered as an aqueous nasal spray, has a systemic bioavailability of <1% in

plasma, using a sensitive assay with a lower quantitation limit of 0.25 pg/ml.

Distribution

Not applicable as mometasone is poorly absorbed via the nasal route.

Biotransformation

The small amount that may be swallowed and absorbed undergoes extensive first-pass hepatic

metabolism.

Elimination

Absorbed mometasone furoate is extensively metabolized and the metabolites are excreted in urine and

bile.

5.3

Preclinical safety data

No toxicological effects unique to mometasone furoate exposure were demonstrated. All observed effects

are typical of this class of compounds and are related to exaggerated pharmacologic effects of

glucocorticoids.

Preclinical studies demonstrate that mometasone furoate is devoid of androgenic, antiandrogenic,

estrogenic or antiestrogenic activity but, like other glucocorticoids, it exhibits some antiuterotrophic

activity and delays vaginal opening in animal models at high oral doses of 56 mg/kg/day and

280 mg/kg/day.

Like other glucocorticoids, mometasone furoate showed a clastogenic potential in-vitro at high

concentrations. However, no mutagenic effects can be expected at therapeutically relevant doses.

In studies of reproductive function, subcutaneous mometasone furoate, at 15 micrograms/kg prolonged

gestation and prolonged and difficult labour occurred with a reduction in offspring survival and body

weight or body weight gain. There was no effect on fertility.

Like other glucocorticoids, mometasone furoate is a teratogen in rodents and rabbits. Effects noted were

umbilical hernia in rats, cleft palate in mice and gallbladder agenesis, umbilical hernia, and flexed front

paws in rabbits. There were also reductions in maternal body weight gains, effects on foetal growth (lower

foetal body weight and/or delayed ossification) in rats, rabbits and mice, and reduced offspring survival in

mice.

The carcinogenicity potential of inhaled mometasone furoate (aerosol with CFC propellant and surfactant)

at concentrations of 0.25 to 2.0 micrograms/l was investigated in 24-month studies in mice and rats.

Typical glucocorticoid-related effects, including several non-neoplastic lesions, were observed. No

statistically significant dose-response relationship was detected for any of the tumour types.

6.

P

HARMACEUTICAL

P

ARTICULARS

6.1

List of excipients

Dispersable cellulose (microcrystalline cellulose and carmellose sodium)

Glycerol

Sodium citrate

Citric acid monohydrate

Polysorbate 80

Benzalkonium chloride

Purified water

6.2

Incompatibilities

Not applicable

6.3

Shelf life

3 years

Use within 2 months of first use.

6.4

Special precautions for storage

Do not store above 25°C.

Do not freeze.

6.5

Nature and contents of container

NASONEX Nasal Spray is contained in a white, high density polyethylene bottle, that contains 10 g

(60 actuations) or 18 g (140 actuations) of product formulation, supplied with a metered-dose, manual

polypropylene spray pump actuator.

Pack sizes :

10 g, 1 bottle

18 g, 1, 2 or 3 bottles

Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

7.

M

ARKETING

A

UTHORISATION

H

OLDER

[See Annex I - To be completed nationally]

8.

M

ARKETING

A

UTHORISATION

N

UMBER

[To be completed nationally]

9.

D

ATE OF

F

IRST

A

UTHORISATION

/R

ENEWAL OF THE AUTHORISATION

[To be completed nationally]

10.

D

ATE OF

R

EVISION OF THE

T

EXT

13 March 2020

[To be completed nationally]

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