Consumer medicine information

Waxsol Ear Drops

Docusate sodium

BRAND INFORMATION

Brand name

Waxsol

Active ingredient

Docusate sodium

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Waxsol Ear Drops.

For easy removal of ear wax

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

Do not share this medicine with others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. What WAXSOL is and what it is used for

WAXSOL is used to help remove ear wax in adults, and the elderly. Use in children under 12 years only on medical advice. The drops help to clear your ear canal if it is blocked with wax by softening it and breaking it up. WAXSOL contains a mild emulsifier which penetrates and helps disperse ear wax.

What is ear wax?

Ear wax is produced by the glands in the skin lining the ear canal, and its purpose appears to be protective.

Ear Care

The shape of the ear canal makes it difficult to clean. Because of the delicate nature of the ear, cotton buds and other instruments should never be inserted into it. WAXSOL is used to soften and remove ear wax.

2. Before you use WAXSOL

Do not use WAXSOL

  • If you have hypersensitivity to the active substance, to any of the excipients, or components that form the finished product. (see list in Section 6 Further Information)
  • if you have a perforated eardrum (a hole in your eardrum).
  • if your ear is sore or inflamed.

Pregnancy and breastfeeding

WAXSOL can be used if you are pregnant or breast-feeding.

3. How to use WAXSOL

Always use WAXSOL exactly as directed. You should check with your doctor or pharmacist if you are not sure.

How to use the drops:

  • Fill the dropper from the bottle.
  • Tilt your head to one side.
  • Gently drip WAXSOL into your blocked ear until it is full.
  • Place a cotton wool plug in the ear. The best time to do this is before you go to bed.

Only use the drops for 2 nights at a time. If you feel that the drops are not working after this time, or the problem continues to exist, please contact your doctor or pharmacist.

If you use more WAXSOL than you should, this may seep from the ear.

It is unlikely that you will notice any problems but if you do have any, (such as skin irritation), you should tell your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, WAXSOL can cause side effects, although not everybody gets them.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Some people may have an allergic reaction (possibly delayed) which may include but is not limited to the following:

  • redness of the skin area and/or a rash or
  • allergic reaction to the latex in the dropper applicator, which can be severe including e.g. difficulty in breathing or fainting

Seek urgent medical advice if you experience an allergic reaction.

Tell your doctor as soon as possible if you notice any of the following:

  • Application site reactions e,g, pain, irritation, redness, itching, inflammation or peeling of the skin
  • Infection of the outer ear and ear canal involving a lot of pain and redness
  • Dizziness, reducing hearing ability or ear discomfort

WAXSOL has no or negligible influence on the ability to drive and use machines. However, if dizziness occurs, driving and using machines should be avoided.

Do not use WAXSOL if you have an injury or swelling of the ear canal as this may result in painful symptoms. Always tell your doctor or pharmacist if you think the drops are causing you a problem.

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store WAXSOL

Keep all medicines out of reach of children.

Store the bottle below 25°C. Do not use WAXSOL after the expiry date which is printed or embossed on the carton and label.

6.Further Information

What WAXSOL contains

WAXSOL is a clear colourless liquid. It contains 10 mL of docusate sodium 0.5 % w/v in a water miscible base containing glycerine and water. It contains a mixture of hydroxybenzoate esters 1.7 mg/mL and phenoxyethanol 4.3 mg/mL as preservatives.

This leaflet was last revised in March 2021

AUST R 18662

Mylan Health Pty Ltd
Level 1, 30-34 Hickson Road
Millers Point, NSW 2000
Phone: 1800 314 527

Mylan New Zealand Limited
Auckland NZ
Phone: 0800 168 169

WAXSOL® is a Mylan company trade mark

WAXSOL_cmi\Mar21/01

Published by MIMS May 2021

BRAND INFORMATION

Brand name

Waxsol

Active ingredient

Docusate sodium

Schedule

Unscheduled

 

Name of the medicine

Docusate sodium BP 0.5%.

Excipients

Water miscible base containing glycerine 10%.

Actions

Because of its low surface tension and its water miscibility, Waxsol rapidly penetrates the dry matrix of the ceruminous mass, reducing the solid material to a semisolid debris which can be syringed away readily or, in less severe and in chronic cases, is ejected by normal physiological processes.

Indications

Facilitation of the removal of ear wax.

Contraindications

Ear drum perforation or inflammation.

Precautions

Discontinue use if inflammation or any pain is experienced.

Adverse Effects

Occasional cases of inflammation have been reported after the use of Waxsol. This has subsided on discontinuation of therapy.

Directions For Use

For aural use only. The patient should be directed to fill the ear with Waxsol for two consecutive nights before attending for syringing.

Presentation

Ear drops: 10 mL.

Storage

Store below 30°C.

Poison Schedule

Unscheduled.