MedPath
HSA Approval

FLIXONASE AQUEOUS NASAL SPRAY 0.05% w/w

SIN07090P

FLIXONASE AQUEOUS NASAL SPRAY 0.05% w/w

FLIXONASE AQUEOUS NASAL SPRAY 0.05% w/w

June 22, 1992

GSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.

GSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.
Licence HolderGSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Pharmacy Only
HSA Singapore Classification

Formulation Information

SPRAY

**HOW TO USE FLIXONASE** **How much to use** To be sprayed into the nose only. If your Flixonase is new and you have not used it before, or if you have not used it for one week or more, you should activate a few sprays into the air before use. For adults above 18 years old, the usual dose is two sprays into each nostril once a day, preferably in the morning. In some cases, two sprays twice daily may be required. The maximum daily dose should not exceed four sprays per nostril. Flixonase should not be used in children under 18 years of age unless on the advice of a doctor. Flixonase quickly starts to reduce inflammation and swelling in your nose, although it may take a few days to significantly improve symptoms. Therefore to prevent the onset of symptoms, start to use Flixonase a few days before expected exposure to one of your 'usual' triggers. It may take a few days for this medicine to work and it is VERY IMPORTANT THAT YOU USE IT REGULARLY for the recommended treatment duration. If you stop the treatment when you feel better, your symptoms may return as the medication wears off. If your symptoms include itchy watery eyes and they trouble you, inform your pharmacist or doctor. If after seven days of continuous use: - your symptoms have not improved, stop using the spray and speak to your doctor. - your symptoms have improved but not enough, speak to your doctor or pharmacist for advice. Do not use for more than 3 months without the advice of a doctor or pharmacist. **If you use too much (overdose)** If you or someone else accidentally uses too much Flixonase on one occasion, there is nothing to worry about. However, if you use too much of it over a long time (months or years) you may start to get unwanted side effects inside your nose and body. It is important that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should use only as much as your doctor recommends; using more or less may make your symptoms worse. Discuss any worries you may have about this with your doctor or pharmacist. **USING THE SPRAY** ![Flixonase Dosage Image 1](https://cdn.medpath.com/drug/dosage/20240520/8d8127f54eb1230abe9c494c0244cd05.png) **HOW LONG TO USE THE SPRAY** Your pharmacist or doctor will tell you how long to use your Flixonase for. Do not use the spray for more than 3 months without the advice of your doctor or pharmacist. **If you forget to use the spray** If you miss a dose, just use the next one when it is due.

NASAL

Medical Information

**WHAT FLIXONASE IS USED FOR** Flixonase contains a corticosteroid called fluticasone propionate, which treats inflamed tissue. The tiny amounts sprayed into your nose help to reduce swelling and irritation. Flixonase is used to prevent and treat allergic rhinitis (including allergic symptoms due to dust mites, moulds and pet hair) in adults aged 18 years and over. When you have rhinitis, the inside of your nose becomes swollen and itchy. This usually occurs when people breathe in allergens from house dust mites or mould or fur from animals such as cats or dogs. When you spray Flixonase into your nose, it helps to relieve the itching, sneezing, and blocked or runny nose. Ask your pharmacist or doctor if you have any questions or if you aren't sure why Flixonase has been recommended for you. Flixonase is non-drowsy, and is not addictive.

**BEFORE YOU USE FLIXONASE** **When you must not use it** - Do not use Flixonase if you have ever had an allergic reaction to fluticasone propionate, an allergic reaction to any other corticosteroid or any of the ingredients listed at the end of this leaflet. Read the side effects section to find out the symptoms of an allergic reaction – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Do not use Flixonase after the expiry date (EXP) printed on the pack. If you use it after the expiry date has passed, it might not work as well. - Do not use Flixonase if the packaging is torn or shows signs of tampering. If you're not sure whether you should be using Flixonase, talk to your pharmacist or doctor.

R01AD08

fluticasone

Manufacturer Information

gsk consumer healthcare singapore pte. ltd.

GLAXO WELLCOME SA

Active Ingredients

FLUTICASONE PROPIONATE

0.05% w/w

Documents

Patient Information Leaflets

Flixonase 150D Clean - Leaflet.pdf

Approved: April 27, 2020

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