Audax Ear Drops Solution Choline Salicylate 20%w/v Glycerol 12.6%w/v

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Choline salicylate; Glycerol

Available from:

LanesHealth (Ireland) Limited

ATC code:

S02DA

INN (International Name):

Choline salicylate; Glycerol

Dosage:

20 %w/v +12.6 percent weight/volume

Pharmaceutical form:

Ear drops, solution

Therapeutic area:

Analgesics and anesthetics

Authorization status:

Not marketed

Authorization date:

1983-04-01

Patient Information leaflet

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

Summary of Product characteristics

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