Skip to Content

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

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Locorten®-Vioform Ear Drops
(flumetasone pivalate/clioquinol)
Patient Information Leaflet
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 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. LocortenVioform 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.

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.

2) What you need to know before you use Locorten-Vioform
Ear Drops

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

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.

Your specific dosage will be given on the carton label.

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.

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 might find it easier to ask someone 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 for a double dose to make up
for a forgotten dose.

What Locorten-Vioform Ear Drops contain:
The active ingredients are flumetasone pivalate 0.02% w/v and clioquinol
1% w/v.
The other ingredient is polyethylene glycol 300.

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.

What Locorten-Vioform Ear Drops look like and contents of the pack
Locorten-Vioform Ear Drops are available as clear, yellowish to brownishyellow solution.
They are available in plastic bottles containing 7.5ml of drops.

4) Possible side effects

PL 10383/2212

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
might 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 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.
Do not store above 25°C.
Store in in the original package.
Do not use this medicine after the expiry date which is stated on the
carton and blister. The expiry date refers to the last day of the month.
• If the medicine becomes discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
• 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.

Locorten-Vioform Ear Drops

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Amdipharm Limited, Temple
Chambers, 3 Burlington Road, Dublin 4, Ireland.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.
Leaflet date: 21.04.2017
Locorten® is a registered trademark of Novartis AG, Switzerland.

Blind or partially sighted? Is this
leaflet hard to see or read? Call
020 8839 3000 to obtain the leaflet
in a format suitable for you.

Flumetasone pivalate/Clioquinol 0.02% w/v / 1% w/v Ear Drops solution
(flumetasone pivalate/clioquinol)
Your medicine is available by the above name but will be referred to as
Flumetasone pivalate/Clioquinol Ear Drops through this leaflet.
Patient Information Leaflet

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Flumetasone
pivalate/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.

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.

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.

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
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 might find it easier to ask someone 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 for a double dose to make up
for a forgotten dose.

What Flumetasone pivalate/Clioquinol Ear Drops contain:
The active ingredients are flumetasone pivalate 0.02% w/v and clioquinol
1% w/v.
The other ingredient is polyethylene glycol 300.

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.

What Flumetasone pivalate/Clioquinol Ear Drops look like and
contents of the pack
Flumetasone pivalate/Clioquinol Ear Drops are available as clear,
yellowish to brownish-yellow solution.
They are available in plastic bottles containing 7.5ml of drops.

4) Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

PL 10383/2212

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
might be signs of an allergic reaction.

Who makes and repackages your medicine?
Your medicine is manufactured by Amdipharm Limited, Temple
Chambers, 3 Burlington Road, Dublin 4, Ireland.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.

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.

Leaflet date: 21.04.2017

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 pivalate/Clioquinol Ear Drops





Keep out of the sight and reach of children.
Do not store above 25°C.
Store in in the original package.
Do not use this medicine after the expiry date which is stated on the
carton and blister. The expiry date refers to the last day of the month.
• If the medicine becomes discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
• 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
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.

Flumetasone pivalate/Clioquinol 0.02% w/v /
1% w/v Ear Drops solution

POM

Blind or partially sighted? Is this
leaflet hard to see or read? Call
020 8839 3000 to obtain the leaflet
in a format suitable for you.

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