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

Active substance(s): CLIOQUINOL / FLUMETHASONE PIVALATE

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Package Leaflet: Information for the User

Locorten® Vioform Ear Drops
(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 but will be
referred to as Locorten Vioform Ear Drops or just ear drops throughout
the remainder of this leaflet.

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

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.

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

If any of the above applies 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.

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.
 Do not store above 25oC.
 Do not use this medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
 If your medicine becomes discoloured or shows any sign 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.
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 ingredients in Locorten Vioform Ear Drops are flumetasone
pivalate 0.02% w/v and clioquinol 1% w/v.
Each ml contains 0.02% w/v flumetasone pivalate and 1% w/v clioquinol.
Also contains macrogol.
What Locorten Vioform Ear Drops look like and the contents of the
pack
Locorten Vioform Ear Drops is a clear yellow solution which comes in a
7.5ml plastic bottle.
Manufactured by
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.,
Via Licinio, 11, 22036 Erba, (CO) Italy.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0752

POM

Leaflet dated 27th June 2017
Leaflet coded xxxxxxxxxxxx
Locorten® is a registered trademark of Novartis AG.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

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 but will be referred to as
Flumetasone/Clioquinol Ear Drops or just ear drops throughout the
remainder of this leaflet.
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.

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

Flumetasone/Clioquinol Ear Drops should not be used on children
under 2 years.
If any of the above applies 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.

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.
 Do not store above 25oC.
 Do not use this medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
 If your medicine becomes discoloured or shows any sign 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.
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
The active ingredients in Flumetasone/Clioquinol Ear Drops are
flumetasone pivalate 0.02% w/v and clioquinol 1% w/v.
Each ml contains 0.02% w/v flumetasone pivalate and 1% w/v clioquinol.
Also contains macrogol.
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.
Manufactured by
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.,
Via Licinio, 11, 22036 Erba, (CO) Italy.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0752

POM

Leaflet dated 27th June 2017
Leaflet coded xxxxxxxxxxxx

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

+ 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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