WAXSOL 0.5% w/v Ear Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Docusate sodium

Available from:

Mylan IRE Healthcare Limited

ATC code:

S02DC

INN (International Name):

Docusate sodium

Dosage:

0.5 percent weight/volume

Pharmaceutical form:

Ear drops, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Indifferent preparations

Authorization status:

Marketed

Authorization date:

2011-05-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
WAXSOL 0.5% W/V EAR DROPS SOLUTION
DOCUSATE SODIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects
not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1. WHAT WAXSOL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE WAXSOL
3. HOW TO USE WAXSOL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE WAXSOL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT WAXSOL IS AND WHAT IT IS USED FOR
WAXSOL contains the active substance docusate sodium. WAXSOL is used
to help remove ear wax
in adults, the elderly and children. The drops help to clear your ear
canal if it is blocked with wax by
softening it and breaking it up.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE WAXSOL
DO NOT USE WAXSOL:
• If you are allergic (hypersensitive) to docusate sodium or any of
the other ingredients of WAXSOL
(listed in section 6).
• if you have a perforated (burst) ear drum
• if your ear is sore inside
WARNINGS AND PRECAUTIONS
If you have pain or inflammation while using WAXSOL, treatment should
be stopped.
OTHER MEDICINES AND WAXSOL
Please tell your doctor or pharmacist if you are taking, have recently
taken or might take any other
medicines, including medicines obtained without a prescription.
PREGNANCY AND BREAST-FEEDING
Ask your doctor or pharmacist for advice before taking this medicine
•
WAXSOL can be used if you are pregnant or thinking of becoming
pregnant
•
WAXSOL can be used if you are breastfeeding
DRIVING AND USING MACHINES
WAXSOL should not affect your ability to drive or use machi

Summary of Product characteristics

Health Products Regulatory Authority
29 September 2022
CRN00D155
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
WAXSOL 0.5% w/v Ear Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
WAXSOL Ear Drops contain the following active ingredient:
Docusate Sodium 0.5% w/v.
Excipients with known effect: parahydroxybenzoates max 0.6% w/v.
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Ear drops, solution (Ear Drops)
A clear colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
WAXSOL Ear Drops are indicated as an aid in the removal of ear wax.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For aural use only.
Posology:
_ADULTS (INCLUDING THE ELDERLY):_ The application of ear drops
sufficient to fill the affected ear, e.g. usually 10 drops.
_CHILDREN: (6-12 YEARS):_ As for adult dose.
Method of Administration:
Apply before going to bed, tilt the head and fill the ear canal with
WAXSOL Ear Drops. Plug the ear using cotton wool, leaving
in the ear overnight. The softened earwax should come out of the ear
without requiring syringing. If the problem persists
patients should consult their doctor.
Do not apply for more than 2 consecutive nights.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Perforation of the ear drum or inflammation of the ear.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If pain or inflammation is experienced, treatment should be
discontinued.
WAXSOL Ear Drops contains parahydroxybenzoates, which may cause
allergic reactions (possibly delayed).
Health Products Regulatory Authority
29 September 2022
CRN00D155
Page 2 of 4
The dropper applicator of this medicinal product contains latex
rubber. May cause severe allergic reactions.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
There is no evidence to suggest that WAXSOL Ear Drops should not be
used during pregnancy and lactation.
4.7 EFFECTS ON A