EASIFLAM MOUTHWASH 0.15% W/V

HOVID BERHAD (MALAYSIA)🇸🇬 Health Sciences Authority

Approval Date: May 31, 2023
Approval ID: 68be07ec60e5fbe9
Company: HOVID BERHAD (MALAYSIA)
Type: Therapeutic

Approval Details

Approval Id: 68be07ec60e5fbe9
Drug Name: EASIFLAM MOUTHWASH 0.15% W/V
Product Name: EASIFLAM MOUTHWASH 0.15% W/V
Approval Number: SIN16801P
Approval Date: 2023-05-31
Registrant: GOLDPLUS UNIVERSAL PTE LTD
Licence Holder: GOLDPLUS UNIVERSAL PTE LTD
Drug Type: Therapeutic
Forensic Classification: PHARMACY ONLY MEDICINES
Dosage Form: MOUTHWASH
Dosage: 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.
Route Of Administration: ORAL
Indication Info: WHAT EASIFLAM MOUTHWASH IS USED FOR <ul> <li>For the temporary relief of painful conditions of the oral cavity including: tonsillitis, sore throat, radiation mucositis, aphthous ulcers, post-orosurgical and periodontal procedures.</li> </ul>
Contraindications: BEFORE YOU USE EASIFLAM MOUTHWASH – WHEN YOU MUST NOT USE IT Do not take this mouthwash if: <ul> <li>you are allergic to Benzydamine Hydrochloride or any of the ingredients listed at the end of this leaflet.</li> </ul> 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.
Atc Code: A01AD02
Atc Item Name: benzydamine
Pharma Manufacturer Name: GOLDPLUS UNIVERSAL PTE LTD

Active Ingredients

Benzydamine Hydrochloride

0.15% w/v

BENZYDAMINE HYDROCHLORIDE

0.15% W/V

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 31, 2023

Approval ID

68be07ec60e5fbe9

Type

Therapeutic

Back to HSA Approvals