WAXSOL EAR DROPS DUCOSATE SODIUM BP 0.5% W/V

Active substance: DOCUSATE SODIUM

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PACKAGE LEAFLET:
INFORMATION FOR
THE USER

EAR DROPS

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.
• This medicine has been
prescribed for you. Do not
pass it on to 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.

In this leaflet:
1. What WAXSOL is and what
it is used for
2. Before you use WAXSOL
3. How to use WAXSOL
4. Possible side effects
5. How to store WAXSOL
6. Further information

If you need the
information on this
leaflet in an alternative
format, such as large
text, or Braille please
ring from the UK:
0800 198 5000.

Do not use WAXSOL
• if you have a perforated
(burst) eardrum.
• if your ear is sore inside.
Taking or using other
medicines
Please tell your doctor or
pharmacist if you are taking or

0120403106

Docusate Sodium BP 0.5% w/v

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1. What WAXSOL
is and what it is
used for
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. Before you use
WAXSOL

have recently taken any other
medicines, including medicines
obtained without a prescription.
Pregnancy and breastfeeding
• If you are pregnant or
thinking of becoming
pregnant WAXSOL can be
used.
• If you are breast-feeding
WAXSOL can be used.
Driving and using Machines
WAXSOL should not affect
your ability to drive or use
machines.

3. How to use
WAXSOL
Always use WAXSOL exactly
as your doctor has told you.
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.

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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.
• Some people may have an
allergic reaction which may
include reddness of the skin
area and/or a rash.
• Rarely there is stinging or
soreness, which does not
last long. If it does continue,

do not use the drops on
the next night.
• Injuries or swelling of the
ear canal may result in
painful symptoms.
Reporting of side effects
If you get any side effects, talk
to your doctor, pharmacist
or nurse. This includes any
possible side effects not
listed in this leaflet. You can
also report side effects
directly via the Yellow Card
Scheme at: www.mhra.gov.uk/
yellowcard
By reporting side effects you
can help provide more information on the safety of this
medicine.

5. How to store
WAXSOL
Keep all medicines out of the
reach and sight 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 as month/
year. The expiry date refers

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to the last day of that
month.
Medicines should not be
disposed of via wastewater or
household waste. Ask your
pharmacist how to dispose of
medicines no longer required.
These measures will help to
protect the environment.

6. Further
Information
What WAXSOL contains
The active substance is
Docusate sodium. The liquid
in the bottle contains 0.5%
w/v docusate sodium.
The other ingredients are
glycerin, water and a
preservative called phenonip.
What WAXSOL looks
like and contents of the
bottle
WAXSOL is a clear, colourless liquid and is available in 10
millilitre and 11 millilitre
amber glass bottles which
contain a special dropper.

Marketing Authorisation
Holder
The Marketing Authorisation
Holder is Meda Pharmaceuticals
Ltd, Skyway House, Parsonage
Road, Takeley, Bishop’s Stortford, CM22 6PU. It is made by
Norgine Pharma, 28100 Dreux
Cedex, France.
Ear Care
Your ears normally look after
themselves. Never put cotton
buds or anything else inside
your ear. You could hurt
yourself. The ears make wax
naturally. Sometimes it builds
up and goes hard. When this
happens you may become a
bit deaf or have earache. You
can use WAXSOL on its own
or before the doctor or nurse
washes out your ear. Never
put anything in your ear to try
and clear the wax yourself.
This leaflet was last
a
­pproved in November
2013.

56UK2061110-01

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Studio Oberländer • Rubensstrasse 33 • 60596 Frankfurt am Main • Germany
Tel. +49 69 631520-85 • Fax +49 69 631520-87 • E-Mail: info@studio-oberlaender.de
Gebrauchsinformation
Hersteller:

MEDA Pharma GmbH & Co. KG

Benutzte Farben:

Produkt:

WAXSOL Ear Drops Solution

Black

10 ml
Meda-Nr.

56UK2061110-01

Hersteller-Nr. 0120403106
Land:

United Kingdom

Größe:

157 x 105 mm

Korrektur: 2.

Text:

8,0 pt / 8,5 pt

Datum:

1113_GI_Waxsol_Drops_10ml_56UK2061110-01.indd 3

18. 11. 2013

18.11.13 17:38

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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