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HSA Approval

EASIFLAM MOUTHWASH 0.15% W/V

SIN16801P

EASIFLAM MOUTHWASH 0.15% W/V

EASIFLAM MOUTHWASH 0.15% W/V

May 31, 2023

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGOLDPLUS UNIVERSAL PTE LTD
Licence HolderGOLDPLUS UNIVERSAL PTE LTD

Product Classification

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

Formulation Information

MOUTHWASH

**HOW TO USE EASIFLAM MOUTHWASH** _– HOW MUCH TO USE_ Follow all directions given to you by your doctor, dentist or pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor, dentist or pharmacist for help. Do not swallow the mouthwash. Easiflam Mouthwash is for use in the throat or mouth. It should be rinsed around the mouth or used as a gargle according to the following instructions: Adult and Elderly When used as a gargle, the dose is 15ml (approximately one tablespoon) which should be gargled for at least 30 seconds every 1½ to 3 hours, as needed. When used as a rinse for oral lesions, the dose is 15ml (approximately 1 tablespoon) which should be held in the mouth and swirled around for at least 30 seconds, repeat every 1½ to 3 hours. **Children** Easiflam mouthwash is not recommended in children under 6 years of age 5–15ml as a gargle if able to do so, or as an oral rinse. **With Impaired Renal Function** Since absorbed benzydamine and its metabolites are excreted in the urine, the possibility of systemic effects should be considered in patients with severe renal impairment. **With Impaired Liver Function** Since absorbed benzydamine is highly metabolized in the liver, the possibility of systemic effects should be considered in severe liver impairment. _– WHEN TO USE IT_ Use every 1½ to 3 hours as directed by your doctor, dentist or pharmacist. _– HOW LONG TO USE IT_ You are advised not to use the mouthwash continuously for more than 7 days, unless your doctor, dentist or pharmacist tells you to. _– IF YOU FORGET TO USE IT_ If you forget to use your mouthwash, do not worry. Use it as soon as you remember and then carry on using it every 1½ to 3 hours as before. Do not use double the amount of mouthwash to make up for a forgotten dose. _– IF YOU USE TOO MUCH (OVERDOSE)_ If you use too much Easiflam Mouthwash, or if you accidentally swallow it, contact your doctor, dentist or pharmacist for advice.

ORAL

Medical Information

**WHAT EASIFLAM MOUTHWASH IS USED FOR** - For the temporary relief of painful conditions of the oral cavity including: tonsillitis, sore throat, radiation mucositis, aphthous ulcers, post-orosurgical and periodontal procedures.

**BEFORE YOU USE EASIFLAM MOUTHWASH** _– WHEN YOU MUST NOT USE IT_ Do not take this mouthwash if: - you are allergic to Benzydamine Hydrochloride or any of the ingredients listed at the end of this leaflet. If you are not sure whether you should start taking this medicine, talk to your doctor, dentist or pharmacist. Be careful not to splash the mouthwash in your eyes. If you get it in your eyes accidentally, wash them immediately with cold water.

A01AD02

benzydamine

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

Hovid Berhad

Active Ingredients

Benzydamine Hydrochloride

0.15% w/v

Benzydamine

Documents

Patient Information Leaflets

Easiflam Mouthwash 0.15% PIL.pdf

Approved: May 31, 2023

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