Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Choline salicylate; Glycerol
LanesHealth (Ireland) Limited
S02DA
Choline salicylate; Glycerol
20 %w/v +12.6 percent weight/volume
Ear drops, solution
Analgesics and anesthetics
Not marketed
1983-04-01
Common Technical Document Audax Ear Drops Module 1 – Administrative and Prescribing Information Module 1.3 – Product Information February 2019 -GCW Text to appear on the Patient Information Leaflet AUDAX Ear drops Choline salicylate solution 43.22% w/v and Glycerol 12.62% w/v PATIENT INFORMATION LEAFLET Please read this leaflet carefully before using Audax Ear Drops. • Keep this leaflet, you may wish to read it again. • Ask your pharmacist if you need more information or advice. IN THIS LEAFLET: 1. What Audax Ear Drops are and what they are used for? 2. Before you use Audax Ear Drops 3. How to use Audax Ear Drops 4. Possible side effects 5. How to store Audax Ear Drops 6. Further information 1. WHAT AUDAX EAR DROPS ARE AND WHAT THEY ARE USED FOR? These drops should be used for the relief of EAR PAIN in acute and chronic internal and external earache. IF YOU HAVE EAR PAIN YOU SHOULD ALWAYS SPEAK TO YOUR DOCTOR OR PHARMACIST. They are also used for the SOFTENING OF EAR WAX as an aid to ear wax removal. 2. BEFORE YOU USE AUDAX EAR DROPS DO NOT USE AUDAX EAR DROPS • If you are allergic to active ingredient choline salicylate or glycerol or any of the other ingredients in this product. See 'What these drops contain' for the full list of ingredients. • If you have a perforated or bleeding ear drum. • If you are pregnant or think you may be pregnant or are planning to have a baby • On children under 1 year of age, unless advised by your doctor. TAKE SPECIAL CARE... • Make sure Audax Ear Drops are suitable for you to use - ask your doctor or pharmacist. PREGNANCY AND BREASTFEEDING.... If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine. Speak to your doctor… • If symptoms persist beyond 4 days or get worse, talk to your doctor or pharmacist. •Audax ear drops contains propylene glycol this may cause skin irritation Common Technical Document Audax Ear Drops Module 1 – Administrative and Prescribing Information Module 1.3 – Product Information February Les hele dokumentet
Health Products Regulatory Authority 11 June 2019 CRN008ZPS Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Audax Ear Drops Solution Choline Salicylate 20%w/v Glycerol 12.6%w/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Choline Salicylate 20.0%w/v. Glycerol 12.6%w/v. Excipients: also contains 1.25%w/v ethylene oxide polyoxypropylene glycol and up to 66.6%w/v propylene glycol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ear drops solution Clear, faintly tan solution, with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For relief of pain in otitis externa and media, furuncles and other local inflammation, softening of earwax and aid to earwax removal. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Topical into ear. Place the head on one side with the affected ear uppermost. Completely fill the external auditory canal with drops. The ear should be plugged with cotton wool soaked with the eardrops or a wick may be inserted if preferred. Audax Ear Drops should be instilled every 3 to 4 hours until permanent relief of symptoms is obtained. 4.3 CONTRAINDICATIONS 1. Use in patients hypersensitive to salicylates. 2. Perforated ear drum. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. If symptoms persist, the doctor should be consulted. 2. If the patient is under the doctor’s care or is on any medication, the doctor should be consulted before using. 3. Contains propylene glycol and esters which may cause skin irritation. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None stated. 4.6 FERTILITY, PREGNANCY AND LACTATION There is no known hazard with the use of this product during pregnancy and lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Health Products Regulatory Authority 11 June 2019 CRN008ZPS Page 2 of 3 None stated. 4.8 UNDESIRABLE EFFECTS None stated. 4.9 OVERDOSE Each bottle of Audax Ear Drops contains 1.6g of choline salicylate equivalent to 1.2g of aspirin. Accidental or deliberate ingestio Les hele dokumentet