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FLUMETASONE PIVALATE/CLIOQUINOL 0.02% W/V / 1% W/V EAR DROPS SOLUTION

Active substance(s): CLIOQUINOL / FLUMETHASONE PIVALATE

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Flumetasone pivalate/
Clioquinol 0.02%w/v / 1%w/v
Ear Drops Solution
Read all of this leaflet carefully before you start
taking 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 severe, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
The name of your medicine is Flumetasone pivalate/
Clioquinol 0.02%w/v / 1%w/v Ear Drops Solution; it
will be called Flumetasone/Clioquinol Ear Drops for
ease here after.
In this leaflet:
1. What Flumetasone/Clioquinol Ear Drops are and
what they are used for
2. Before you use Flumetasone/Clioquinol Ear Drops
3. How to use Flumetasone/Clioquinol Ear Drops
4. Possible side effects
5. How to store Flumetasone/Clioquinol Ear Drops
6. Further information

1. WHAT FLUMETASONE/CLIOQUINOL EAR
DROPS ARE AND WHAT THEY ARE USED
FOR
The name of your medicine is Flumetasone/Clioquinol
Ear Drops. Flumetasone/Clioquinol Ear Drops contain
the active ingredients flumetasone pivalate and
clioquinol.
Flumetasone/Clioquinol Ear Drops are used to treat
infection and inflammation of the external ear.
The drops contain an antibacterial and antifungal
ingredient to combat infection and a steroid which
acts to reduce inflammation.

2. BEFORE YOU USE
FLUMETASONE/CLIOQUINOL EAR DROPS
Do NOT use the ear drops if you:
are allergic (hypersensitive) to any of the
ingredients of Flumetasone/Clioquinol Ear Drops,
or to iodine (allergic reactions include mild
symptoms such as itching and/or rash. More
severe symptoms include swelling of the face, lips,
tongue and/or throat with difficulty in swallowing or
breathing)
have a perforated or burst ear drum
have an infection of the outer ear.

Flumetasone/Clioquinol Ear Drops should not be
used on children under 2 years.
If any of the above apply to you, or if you are not
sure, tell your doctor or pharmacist before using
the ear drops.
Take special care with Flumetasone/Clioquinol Ear
Drops
Tell the doctor you are using Flumetasone/Clioquinol
Ear Drops if you have any thyroid or urine tests. This
is because Flumetasone/Clioquinol Ear Drops may
affect the results.
Long term-continuous use should be avoided
because it can lead to hormonal suppression (the
maximum duration of therapy recommended is 7-10
days).
Taking other medicines
Please tell your doctor if you are taking or have
recently taken any other medicines including those
you have obtained without a prescription.
Pregnancy and Breast-feeding
You should not use Flumetasone/Clioquinol Ear
Drops if you are pregnant, planning to become
pregnant or if you are breast-feeding unless your
doctor feels it is necessary.

3. HOW TO USE
FLUMETASONE/CLIOQUINOL EAR DROPS
Always use the ear drops exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose is 2 or 3 drops twice a day, for up to
7-10 days.
Your specific dosage will be given on the carton label.
To administer the ear drops
Sit or lie down with the affected ear uppermost. Place
the nozzle of the bottle near the ear opening and
squeeze the middle of the bottle with your fingers.
(You may find it easier to ask someone else to do this
for you).
Remain with your head tilted for a few minutes; it may
be helpful to place a piece of cotton wool loosely in
the ear opening for a short period to stop any drops
running out.
Be careful not to get the ear drops in or near the eye.
Wash your hands after applying the ear drops.
If you forget a dose
If you forget to use a dose, put in the drops as soon
as you remember, and then continue as before.
If the ear drops are accidently swallowed, contact
your doctor or go to your nearest hospital emergency
department immediately.
(continued overleaf)

4. POSSIBLE SIDE EFFECTS
Like all medicines, Flumetasone/Clioquinol Ear Drops
can cause side effects, although not everybody gets
them.
If you notice;
itching or skin rashes
swelling of the face, lips or throat
difficulty in breathing or wheeziness
Stop using the ear drops and tell your doctor
immediately. These may be signs of an allergic
reaction.
Flumetasone/Clioquinol Ear Drops can cause irritation
in or on the ear. Signs of this might be: burning;
itching or rash. The drops may also cause
discolouration of the skin or hair.
If any of the side effects becomes severe or, if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist immediately.
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 FLUMETASONE/
CLIOQUINOL EAR DROPS
KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN
Do not store above 25ºC. Store in the original
packaging.
Do not use after the “use by” date shown on the pack.
If your medicine shows any signs of deterioration,
seek the advice of your pharmacist.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. FURTHER INFORMATION
Flumetasone/Clioquinol Ear Drops may stain clothing
and bed clothes yellow. If this occurs, then the items
should be washed within 24 hours, if possible. Fabrics
suitable for soaking should be soaked overnight. After
soaking, boil, or if not suitable for boiling, wash at the
temperature recommended for the fabric (see the
fabric label). It is advisable to use a soap based
powder. The drops may also discolour jewellery if they
come into contact.

What Flumetasone/Clioquinol Ear Drops
Contains 0.02%w/v flumetasone pivalate and 1%w/v
clioquinol.
Also contains polyethylene glycol 300.
What Flumetasone/Clioquinol Ear Drops looks like
and the contents of the pack
Clear, yellowish to brownish-yellow ear drops solution
in a yellow plastic dropper bottle with a black tamper
evident screw cap. Each pack contains 1 x 7.5ml
bottle.
PL holder: Manx Healthcare Ltd, Taylor Group House,
Wedgnock Lane, Warwick, CV34 5YA
PL 14251/0045
Procured from within the EU
POM
Manufacturer: Amdipharm Ltd, Temple Chambers,
3 Burlington Road, Dublin 4, Ireland
To request a copy of this leaflet in large print, audio or
Braille, please call 01926 482511
This leaflet was last revised in September 2016
WIP URN: 150916-XXXX-PIL-01

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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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