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

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

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LF-102435-01

Package leaflet: Information for the user

Locorten®-Vioform ear drops
Flumetasone pivalate and Clioquinol
Read all of this leaflet carefully before you start
using 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 Locorten Vioform ear drops are and what
they are used for
2. What you need to know before you use Locorten
Vioform ear drops
3. How to use Locorten Vioform ear drops
4. Possible side effects
5. How to store Locorten Vioform ear drops
6. Contents of the pack and other information
1. WHAT LOCORTEN VIOFORM EAR DROPS ARE
AND WHAT THEY ARE USED FOR
The name of your medicine is Locorten Vioform ear
drops. Locorten Vioform ear drops contain the active
ingredients Flumetasone pivalate and Clioquinol.
Locorten Vioform 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. WHAT YOU NEED TO KNOW BEFORE YOU USE
LOCORTEN VIOFORM EAR DROPS
Do not use Locorten Vioform ear drops:
• if you are allergic to flumetasone pivalate,
clioquinol or any of the other ingredients of this
medicine (listed in section 6). 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;
• if you have a perforated or burst ear drum;
• if you have an infection of the outer ear.

Locorten Vioform 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
Locorten Vioform ear drops.
Tell the doctor you are using Locorten Vioform ear drops
if you have any thyroid or urine tests. This is because
Locorten Vioform 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 Locacorten
Vioform ear drops and your doctor may wish to monitor
you carefully if you are taking these medicines
(including some medicines for HIV: ritonavir, cobicistat).
Contact your doctor if you experience blurred vision or
other visual disturbances.
Other medicines and Locorten Vioform ear drops
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines
including those you have obtained without a
prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before using this medicine.
You should not use Locorten Vioform 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 LOCORTEN VIOFORM EAR DROPS
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended 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.

Use in children and adolescents
Locorten Vioform ear drops should not be used in
children under the age of two.
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 Locorten Vioform 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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.
Locorten-Vioform 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.
Not known (frequency cannot be estimated from the
available data):
• Blurred vision.
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 MHRA yellow card
scheme Website: 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 LOCORTEN-VIOFORM EAR
DROPS
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the ‘use before’ date
which is stated on the label and carton. The ‘use
before’ date refers to the last day of that month.
Store your ear drops in a safe place. Do not store
above 25°C.
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. CONTENTS OF THE PACK AND OTHER
INFORMATION
Locorten Vioform 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 Locorten-Vioform ear drops contain
- the active substances are flumetasone pivalate
0.02% w/v and Clioquinol 1% w/v
- the other ingredient is polyethylene glycol.
What Locorten-Vioform ear drops look like and
the contents of the pack.
Locorten Vioform ear Drops is clear, yellowish to
brownish-yellow solution. The drops come in a
plastic dropper bottle containing 7.5 ml or 10 ml of
drops.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Amdipharm UK Limited,
Capital House, 85 King William Street,
London EC4N 7BL, UK
This leaflet was last revised in May 2017.
31036136-02

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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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