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LOCORTEN VIOFORM EAR DROPS

Active substance(s): CLIOQUINOL / FLUMETHASONE PIVALATE

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Assessed against UK
PIL dated May 2017

Final draft mock up
By Ibrahim Karir at 10:40 am, Oct 13, 2017

Locorten® Vioform® Ear Drops solution
(flumetasone pivalate/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
Locorten 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 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 LOCORTEN VIOFORM EAR
DROPS
• Keep out of the sight and reach of children.
• Store your ear drops in a safe place.
• Store in original package. Do not store above
25°C.
• Do not use Locorten Vioform Ear Drops after the
“expiry date” which is stated on the carton and
bottle. The expiry date refers to the last day of that
month.





Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.
If your medicine have become discoloured or
show any other signs of deterioration, consult your
doctor or pharmacist who will tell you what to do.

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
Contains 0.02% w/v flumetasone pivalate
and 1% w/v clioquinol. Also contains macrogol 300.
What Locorten Vioform Ear Drops looks like and
the contents of the pack.
Clear, yellowish to brownish-yellow solution in a
yellow plastic dropper bottle with a black cap and
containing 7.5 ml solution.
Manufacturer: Amdipharm Limited, Temple
Chambers, 3 Burlington Road, Dublin 4, Ireland.
Procured from within the EU & repackaged by
PL holder: Kosei Pharma UK Limited.,
956 Buckingham Avenue, Slough, SL1 4NL, UK

Locorten® Vioform® Ear Drops solution
PL 39352/0377
Locorten® and Vioform® are trademarks of Novartis
AG.
POM
Leaflet date: 08/09/2017

To listen to or request a
copy of this leaflet in
Braille, large print or
audio please call:
01753515054 (UK only)

Flumetasone pivalate/Clioquinol 0.02% w/v/1% w/v Ear Drops,
solution
(flumetasone pivalate/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; it will be called Flumetasone/Clioquinol Ear
Drops for ease here after.
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
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. WHAT YOU NEED TO KNOW BEFORE YOU
USE FLUMETASONE/CLIOQUINOL EAR
DROPS
Do not use Flumetasone/Clioquinol 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.

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).
Contact your doctor if you experience blurred vision
or other visual disturbances.
Other medicines and Flumetasone/Clioquinol
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 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 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
Flumetasone/Clioquinol 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 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.
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.
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.
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 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.
• Store your ear drops in a safe place.
• Store in original package. Do not store above
25°C.
• Do not use Flumetasone/Clioquinol Ear Drops
after the expiry date which is stated on the carton
and bottle. The expiry date refers to the last day of
that month.
• Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.
• If your medicine have become discoloured or
show any other signs of deterioration, consult your
doctor or pharmacist who will tell you what to do.
6.

CONTENTS OF THE PACK AND OTHER
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 macrogol 300.
What Flumetasone/Clioquinol Ear Drops looks
like and the contents of the pack.
Clear, yellowish to brownish-yellow solution in a
yellow plastic dropper bottle with a black cap
containing 7.5 ml solution.
Manufacturer: Amdipharm Limited, Temple
Chambers, 3 Burlington Road, Dublin 4, Ireland.
Procured from within the EU & repackaged by
PL holder: Kosei Pharma UK Limited,
956 Buckingham Avenue, Slough, SL1 4NL, UK

Flumetasone pivalate/Clioquinol 0.02% w/v/
1% w/v Ear Drops, solution
PL 39352/0377
POM
Leaflet date: 08/09/2017

To listen to or request a
copy of this leaflet in
Braille, large print or
audio please call:
01753515054 (UK only)

+ Expand Transcript

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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