Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Mometasone furoate monohydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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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 hay fever (also called seasonal allergic rhinitis) and perennial rhinitis in adults and children aged 3 and older. Hay fever, 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.
e Nasonex
Do not use Nasonex
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 hay fever, 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 hay fever symptoms from occurring. Nasal Polyps Use in adults over 18 years old The usual starting dose is two sprays into each nostril once daily.
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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: 1. Gently shake the bottle. 2. Put your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle. Do Not pierce the nasal applicator. 3. 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.
your nasal spray 1. 2. 3. 4. 5. 6. 7.
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.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
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.
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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.
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 The Marketing Authorisation Holder is: Organon Pharma (UK) Limited, Shotton Lane, Cramlington, United Kingdom, NE23 3JU. The manufacturer is: Organon Heist bv, Industriepark 30, 2220 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 September 2024. © 2024 Organon group of companies. All rights reserved. PIL.NSX.24.UK.0354.IA-MAH_Cram.NoRCN
Nasonex 50 micrograms/actuation Nasal Spray, Suspension comes as oral solution containing 50mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Nasonex 50 micrograms/actuation Nasal Spray, Suspension is mometasone furoate monohydrate.
Medicines with the same active substance, strength and form include: Mometasone furoate 50 microgram Nasal spray suspension, Mometasone furoate 50 micrograms/actuation nasal spray, suspension. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Nasonex 50 micrograms/actuation Nasal Spray, Suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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.
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.
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. Benzalkonium 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.
(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.
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, 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).
None known.
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.
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.
Ask anything about Nasonex 50 micrograms/actuation Nasal Spray, Suspension. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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