Skip to Content

LOCORTEN VIOFORM EAR DROPS SOLUTION

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

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.
The name of your medicine is Locorten Vioform Ear
Drops Solution it will be called Locorten Vioform ear
drops for ease here after.
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).
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.
Reporting of side effects
If you get any side effects talk to your doctor,
pharmacist or nurse. This includes any possible side
effect 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.
• Do not store above 25°C.
• Store in the original package.
• 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
containing 7.5ml 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.
Leaflet date: 24/04/2017

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

Package leaflet: Information for the user

Flumetasone pivalate/Clioquinol 0.02% w/v / 1% w/v Ear Drops Solution
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.
The name of your medicine is Flumetasone
pivalate/Clioquinol 0.02% w/v / 1% w/v Ear Drops
Solution it will be called Flumetasone
pivalate/Clioquinol ear drops for ease here after.
What is in this leaflet:
1. What Flumetasone pivalate/Clioquinol ear drops
are and what they are used for
2. What you need to know before you use
Flumetasone pivalate/Clioquinol ear drops
3. How to use Flumetasone pivalate/Clioquinol ear
drops
4. Possible side effects
5. How to store Flumetasone pivalate/Clioquinol ear
drops
6. Contents of the pack and other information
1. WHAT FLUMETASONE
PIVALATE/CLIOQUINOL EAR DROPS ARE
AND WHAT THEY ARE USED FOR
The name of your medicine is Flumetasone
pivalate/Clioquinol ear drops. Flumetasone
pivalate/Clioquinol ear drops contain the active
ingredients Flumetasone pivalate and Clioquinol.
Flumetasone pivalate/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 PIVALATE/CLIOQUINOL
EAR DROPS
Do not use Flumetasone pivalate/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 pivalate/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 pivalate/Clioquinol ear drops.
Tell the doctor you are using Flumetasone
pivalate/Clioquinol ear drops if you have any thyroid
or urine tests. This is because Flumetasone
pivalate/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
Flumetasone pivalate/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
pivalate/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 pivalate/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
PIVALATE/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 pivalate/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
pivalate/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 pivalate/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.
Reporting of side effects
If you get any side effects talk to your doctor,
pharmacist or nurse. This includes any possible side
effect 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
PIVALATE/CLIOQUINOL EAR DROPS
• Keep out of the sight and reach of children.
• Store your ear drops in a safe place.
• Do not store above 25°C.
• Store in the original package.
• Do not use Flumetasone pivalate/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 pivalate/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 pivalate/Clioquinol ear drops
contain
Contains 0.02%w/v flumetasone pivalate and 1%w/v
clioquinol.
Also contains macrogol 300.
What Flumetasone pivalate/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 7.5ml 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
Leaflet date: 24/04/2017

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.

Hide