Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Mometasone furoate 50 micrograms/actuation nasal spray, suspension
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
for
Mometasone Furoate nasal spray, suspension contains the active ingredient mometasone furoate (as the monohydrate). Mometasone furoate is a corticosteroid (steroid for short) which has an anti-inflammatory action, reducing swelling and irritation which causes sneezing, itching and a blocked or runny nose. What is Mometasone Furoate nasal spray, suspension used for? Hay fever and perennial rhinitis. This medicine 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. This medicine 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 This medicine 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. This medicine 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 take it
e Mometasone Furoate nasal spray, suspension
Do not use Mometasone Furoate nasal spray, suspension
- if you are allergic (hypersensitive) to mometasone furoate or to any of the other ingredients of this medicine (listed in section 6).
- if you have an untreated infection in your nose. Use of this medicine during an untreated infection in your nose, such as herpes, can worsen the infection. You should wait until the infection is resolved 1
PLGB 36390/0366 –
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, pharmacist or nurse before using Mometasone Furoate nasal spray, suspension if you:
- have or have ever had tuberculosis.
- have any other type of infection.
- are taking other corticosteroid medicines, either by mouth or by injection.
- have cystic fibroisis. While you are using Mometasone Furoate nasal spray, suspension, 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 this medicine. 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, you should notify your doctor. Other medicines and Mometasone Furoate nasal spray, suspension Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Some medicines may increase the effects of Mometasone Furoate nasal spray, suspension and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). 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 Mometasone Furoate nasal spray, suspension. 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. Pregnancy and breast-feeding and fertility There is little or no information on the use of Mometasone Furoate nasal spray, suspension 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. 2
PLGB 36390/0366 Driving and using machines There is no known information on the effect of this medicine on the ability to drive or use machinery. Mometasone Furoate nasal spray, suspension contains benzalkonium chloride This medicine contains benzalkonium chloride which and may cause irritation or swelling inside the nose, especially if used for a long time. 3.
How to use Mometasone Furoate nasal spray, suspension
Always use this medicine exactly as your doctor or pharmacist has told you. 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 recommended 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 3 – 11 years of age The recommended dose is ONE spray into each nostril ONCE a day. In some patients Mometasone Furoate nasal spray, suspension 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 Mometasone Furoate nasal spray, suspension before the start of the pollen season, as this will help to prevent your hayfever symptoms from occurring. At the end of the pollen season your hayfever symptoms should get better and treatment may then not be needed. For Nasal Polyps Use in adults over 18 years old The recommended 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 3
PLGB 36390/0366 If you are using the nasal spray for the first time, you should prime the pump by pumping the spray 10 times until a fine mist is produced. To do this: 1. Gently shake the bottle 2. Put your forefinger and middle finger on the collar either side of the nozzle and your thumb underneath the bottle. 3. Keep the thumb still and press down with your fingers to pump the spray, holding the nozzle away from you. If you have not used the nasal spray for 14 days or longer, you should re-prime the pump by pumping the spray 2 times until a fine mist is produced. If there is no spray and you think the nozzle may be blocked, clean it. (Refer to cleaning instructions below). DO NOT try to unblock the spray hole with a pin or other sharp object as this will destroy the spray mechanism.
How to take it
your nasal spray
1. Shake the bottle gently. 2. Remove the dust cap. 3. Blow your nose gently. 4. Hold the bottle as shown. Place your finger on your nose to close one nostril, and put the nozzle in your other nostril. Tilt your head forward and keep the bottle upright. Start to breathe in slowly through your nose and at the same time press down firmly on the collar of the bottle with your finger, which releases a spray of mometasone furoate. 5. Breathe out through your mouth. Repeat step 4 if more than one spray is required into the same nostril. Remove the nozzle from the nostril and breathe out through your mouth. Repeat steps 4 to 5 for the other nostril. After using the spray, wipe the nozzle carefully with a clean tissue and replace the dust cap. Cleaning your Mometasone Furoate nasal spray, suspension bottle 1. Clean your nasal spray at least once a week as it can become blocked, stopping it from working properly. 2. Remove the dust cap. 3. Gently pull upwards on the white collar to remove the nozzle. 4. Soak the nozzle and dust cap in warm water for a few minutes, and then rinse under a running tap. 5. Allow to dry in a warm place before putting back together. Do not dry near a very hot place. 6. Re-fit the nozzle and 'prime' the bottle if necessary by pumping the spray a few times to produce a fine mist. 7. Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the 4
PLGB 36390/0366 applicator and cause you not to get the right dose of medicine. If you use more Mometasone Furoate nasal spray, suspension than you should If you accidentally use more than your prescribed dose of Mometasone Furoate nasal spray, suspension tell your doctor as soon as possible. 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 Mometasone Furoate nasal spray, suspension If you forget a dose of Mometasone Furoate nasal spray, suspension, use it as soon as you remember, then carry on as before. Do not use an extra dose to make up for the one that you missed. If you stop using Mometasone Furoate nasal spray, suspension In some patients this medicine 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 medicine, ask your doctor, pharmacist or nurse. 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 this medicine 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 this medicine 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 than1 in 10 people) in people with nasal polyps receiving this medicine 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 5
PLGB 36390/0366 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, pharmacist or nurse. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: https://yellowcard.mhra.gov.uk/ 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.
How to store it
Mometasone Furoate nasal spray, suspension
Keep this medicine out of sight and reach of children. Do not store above 25°C. Do not freeze. Store in the original container. 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. 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. Use within 2 months of first use 6.
Contents of the pack and other information
What Mometasone Furoate nasal spray, suspension contains
- The active substance is mometasone furoate. Each actuation delivers 50 micrograms of mometasone furoate (as the monohydrate) as delivered dose (ex actuator). The other ingredients are glycerol, microcrystalline cellulose, carmellose sodium, citric acid monohydrate, polysorbate 80, benzalkonium chloride, sodium citrate dihydrate, water for injection. What Mometasone Furoate nasal spray, suspension looks like and contents of the pack One white opaque plastic vial, fitted with a white-metered atomising pump, white nasal adaptor and a translucent dust cap for nozzle. Each bottle of Mometasone furoate 50 micrograms/actuation nasal spray, suspension provides 140 sprays. Each actuation delivers a dose of 50 micrograms of mometasone furoate (as the monohydrate) Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom Manufacturer: Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola, PLA 3000, Malta S&D Pharma CZ, spol. s r.o, Theodor 28, Pchery (Pharmos a.s. facility), 273 08, Czech Republic Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, 6
PLGB 36390/0366 United Kingdom Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium Amring Farma S.R.L. Bulevardul Mircea Eliade Nr. 7, Bloc 1, Etaj 1, Ap. 3, Sectorul 1, Bucureşti, Romania Generis Farmacêutica, S.A., Rua João de Deus, n.o 19, Venda Nova, 2700-487 Amadora, Portugal This leaflet was last revised in 05/2024.
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Frequently asked questions about Mometasone furoate 50 micrograms/actuation nasal spray, suspension
How do I take Mometasone furoate 50 micrograms/actuation nasal spray, suspension?
Mometasone furoate 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.
What is the active substance in Mometasone furoate 50 micrograms/actuation nasal spray, suspension?
The active substance in Mometasone furoate 50 micrograms/actuation nasal spray, suspension is mometasone furoate monohydrate.
Are there equivalent medicines to Mometasone furoate 50 micrograms/actuation nasal spray, suspension?
Medicines with the same active substance, strength and form include: Nasonex 50 micrograms/actuation Nasal Spray, Suspension, Mometasone furoate 50 microgram Nasal spray suspension. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Mometasone furoate 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.
Can I get Mometasone furoate 50 micrograms/actuation nasal spray, suspension without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: mometasone furoate monohydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Mometasone furoate nasal spray, suspension is indicated for use in adults and children 3 years of age and older to treat the symptoms of seasonal allergic or perennial allergic rhinitis.
Mometasone furoate nasal spray, suspension is indicated for the treatment of nasal polyps in adults 18 years of age and older.
4.2. Posology and method of administration
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.
Paediatric population
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, suspension 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, suspension 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 to the first dose, shake container well.
After initial priming of the Mometasone furoate nasal spray, suspension pump (usually 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 pump is not used for 14 days or longer, reprime the pump with 2 actuations, 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 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 localized 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, suspension 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, suspension 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, suspension 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 mometasone furoate nasal spray, suspension therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing mometasone furoate nasal spray, suspension.
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 to placebo. Epistaxis was generally self-limiting and mild in severity (see section 4.8).
Mometasone furoate nasal spray, suspension contains benzalkonium chloride which 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 behavioral 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).
Patients who are transferred from long-term administration of systemically active corticosteroids to mometasone furoate nasal spray, suspension 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 mometasone furoate nasal spray, suspension 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, suspension 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.
Visual disturbance
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 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.
4.5. Interaction with other medicinal products and other forms of interaction
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.
(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.
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, suspension 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 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 nasal spray, suspension 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
No studies on the effects on the ability to drive and use machines have been performed.
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 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 website: https://yellowcard.mhra.gov.uk/ 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 of the negligible ≤( 0.1%) systemic bioavailability of mometasone furoate nasal spray, suspension overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage.
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Ask anything about Mometasone furoate 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.