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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
(flumetasone pivalate and clioquinol)
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 but will be referred to as
Flumetasone/Clioquinol ear drops throughout this
leaflet.
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

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.

1. WHAT FLUMETASONE/CLIOQUINOL EAR
DROPS ARE AND WHAT THEY ARE USED FOR

The usual dose is 2 or 3 drops twice a day, for up to
7–10 days.

The name of your medicine is Flumetasone/Clioquinol
ear drops. Flumetasone/Clioquinol ear drops contain
the active ingredients Flumetasone pivalate and
Clioquinol.

Your specific dosage will be given on the carton label.

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.

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 accidentally swallowed, contact
your doctor or go to your nearest hospital emergency
department immediately.

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.

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
The active ingredients in Flumetasone/Clioquinol ear
drops are flumetason pivalate and clioquinol.
The other inactive ingredient is macrogol.

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.

Each ml contains 0.2mg flumethasone pivalate and
10mg clioquinol.

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.

What Flumetasone/Clioquinol ear drops look like
and the contents of the pack
Flumetasone/Clioquinol ear drops is a clear-yellow
solution, which comes in a 7.5ml plastic bottle.

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 out of the sight and reach of children.
Do not store above 25°C.
Do not take the medicine after the expiry date
which is stated on the carton and bottle label after
‘Exp’. The expiry date refers to the last day of that
month.
If the medicine becomes discoloured or shows any
signs of deterioration, return it to your pharmacist.
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.

Manufactured by: Laboratorio Italiano Biochimico
Farmaceutico Lisapharma S.P.A., Via Licinio,
11-22036 Erba, (CO), Italy.
Procured within the EU and repackaged by the
licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA40NU, UK.
Flumetasone Pivalate/Clioquinol 0.02% w/v /
1% w/v Ear Drops solution;
POM

PL 18799/2821
Leaflet date: 14.04.2016

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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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