WAXSOL EAR DROPS DUCOSATE SODIUM BP 0.5% W/V
Active substance(s): DOCUSATE SODIUM
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0120403107
PACKAGE LEAFLET:
INFORMATION FOR
THE USER
EAR DROPS
Docusate Sodium BP 0.5% w/v
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
0516_GI_Waxsol_Drops_10ml_56UK2061110-02.indd 1
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.
01.07.16 13:10
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
0516_GI_Waxsol_Drops_10ml_56UK2061110-02.indd 2
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.
Manufacturer:
Norgine Pharma
29 rue Ethé Virton
28100 Dreux
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
approved in July 2016.
56UK2061110-02
01.07.16 13:10
PACKAGE LEAFLET:
INFORMATION FOR
THE USER
EAR DROPS
Docusate Sodium BP 0.5% w/v
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
0516_GI_Waxsol_Drops_10ml_56UK2061110-02.indd 1
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.
01.07.16 13:10
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
0516_GI_Waxsol_Drops_10ml_56UK2061110-02.indd 2
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.
Manufacturer:
Norgine Pharma
29 rue Ethé Virton
28100 Dreux
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
approved in July 2016.
56UK2061110-02
01.07.16 13:10
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
