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

Active substance(s): CLIOQUINOL / FLUMETHASONE PIVALATE / CLIOQUINOL / FLUMETHASONE PIVALATE

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Flumetasone pivalate/Clioquinol 0.02% w/v /
1% w/v Ear Drops solution
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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
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).
Some medicines may increase the effects of
Flumetasone/Clioquinol Ear Drops and your doctor may
wish to monitor you carefully if you are taking these
medicines (including some medicines for HIV:ritonavir,
cobicistat).
Other medicines and Flumetasone/Clioquinol Ear
Drops
Tell your doctor or pharmacist if you are taking, have
1. WHAT FLUMETASONE/CLIOQUINOL EAR DROPS recently taken or might take any other medicines
including those you have obtained without a prescription.
ARE AND WHAT THEY ARE USED FOR
Pregnancy and breast-feeding
Flumetasone/Clioquinol Ear Drops contain the active
If you are pregnant or breast-feeding,think you may be
ingredients Flumetasone pivalate and Clioquinol.
pregnant or are planning to have a baby, ask your doctor
Flumetasone/Clioquinol Ear Drops are used to treat
or pharmacist for advice before using this medicine.
infection and inflammation of the external ear.
You should not use Flumetasone/Clioquinol Ear Drops
The drops contain an antibacterial and antifungal
if you are pregnant, planning to become pregnant or
ingredient to combat infection and a steroid which acts
if you are breast-feeding unless your doctor feels it is
to reduce inflammation.
necessary.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
3. HOW TO USE FLUMETASONE/CLIOQUINOL EAR
FLUMETASONE/CLIOQUINOL EAR DROPS
DROPS
Do NOT use the ear drops:
Always use this medicine exactly as your doctor or
• if you are allergic to flumetasone pivalate, clioquinol pharmacist has told you. Check with your doctor or
or any of the other ingredients of this medicine
pharmacist if you are not sure.
(listed in section 6). Allergic reactions include mild
The recommended dose is 2 or 3 drops twice a day, for
symptoms such as itching and/or rash.
up to 7–10 days.
More severe symptoms include swelling of the face,
lips, tongue and/or throat with difficulty in swallowing Your specific dosage will be given on the carton label.
or breathing);
Use in children and adolescents
Flumetasone/Clioquinol Ear Drops should not be used
• if you have a perforated or burst ear drum;
in children under the age of two.
• if you have an infection of the outer ear.
Your medicine is known by the above name but will
be referred to as Flumetasone/Clioquinol Ear Drops.
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
-- Keep this leaflet. You may need to read it again.
-- If you have any further questions, ask your doctor,
pharmacist or nurse.
-- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
-- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Flumetasone/Clioquinol Ear Drops are and
what they are used for
2. What you need to know 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. Contents of the pack and other information

Method of administration
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 to use Flumetasone/Clioquinol Ear
Drops
If you forget to use a dose, put in the drops as soon
as you remember and then continue as before. Do not
apply a double dose to make up for a forgotten dose.
If the ear drops are accidentally swallowed, contact
your doctor or go to your nearest hospital emergency
department immediately.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

Do not store above 25°C. Store in the original package.
If your ear drops show signs of discolouration or
deterioration, seek the advice of your pharmacist who
will tell you what to do.
Medicines should not be thrown away in waste water
or in household waste. Please ask your pharmacist
how to throw away any medicine you do not need
anymore. If you do this you 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 contain
Contains 0.02%w/v flumetasone pivalate and 1%w/v
clioquinol.
Also contains polyethylene glycol 300.
4. POSSIBLE SIDE EFFECTS
What Flumetasone/Clioquinol Ear Drops look like
Like all medicines, this medicine can cause side
and the contents of the pack
effects, although not everybody gets them.
Clear-yellow solution in a plastic dropper bottle with a
If you notice;
tamper-evident screw cap.
• itching or skin rashes
Available in bottle containing 7.5ml.
• swelling of the face, lips or throat
• difficulty in breathing or wheeziness.
Who manufactured your medicine
Manufactured by Amdipharm Limited, Temple Chambers,
Stop using the ear drops and tell your doctor
3 Burlington Road, Dublin 4, Ireland. Procured from
immediately. These may be signs of an allergic
within the EU and repackaged by Product Licence
reaction.
Flumetasone/Clioquinol Ear Drops can cause irritation Holder Ennogen Healthcare Ltd, Unit G4 Riverside
in or on the ear. Signs of this might be: burning; itching Industrial Estate, Riverside Way, Dartford, Kent, DA1 5BS.
or rash. The drops may also cause discolouration of the
PL 40739/0113
POM
skin or hair.
Reporting of side effects
Leaflet date: 22 March 2017
Ref: Flu-C/v2
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 out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton.
The expiry date refers to the last day of that month.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 01322 629220 to obtain
the leaflet in a format
suitable for you.

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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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