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Flumetasone Pivalate/Clioquinol 0.02% W/V / 1% W/V Ear Drops Solution

Document: leaflet MAH BRAND_PLPI 46245-0018 change

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Locorten® Vioform® Ear Drops

Flumetasone/Clioquinol 0.02% w/v/1% w/v ear drops, solution

(flumetasone pivalate/clioquinol)

The name of your medicine is Locorten Vioform Ear Drops or Flumetasone Pivalate/Clioquinol 0.02% w/v / 1% w/v Ear Drops Solution. It will be referred to as Locorten Vioform Ear Drops throughout the remainder of the leaflet.

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.

In this leaflet:

1.    What Locorten Vioform Ear Drops are and what they are used for

2.    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.    Further 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.    BEFORE YOU USE LOCORTEN VIOFORM EAR DROPS

Do NOT use the ear drops if you:

•    are allergic (hypersensitive) to any of the ingredients of Locorten Vioform Ear Drops, or to iodine (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);

•    have a perforated or burst ear drum;

•    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.

Take special care with 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).

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines including those you have obtained without a prescription.

Pregnancy and Breast-feeding 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 the ear drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual 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.

To administer the ear drops,

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 a dose

If you forget to use a dose, put in the drops as soon as you remember, and then continue as before.

If the ear drops are accidentally swallowed, contact your doctor or go to your nearest hospital emergency department immediately.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Locorten Vioform Ear Drops 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.

If any of the side effects becomes severe or, if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist immediately.

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.

Do not store above 25°C.

Store in the original package.

Do not use after the “use by” date shown on the pack.

6. FURTHER 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 ear drops contain flumetasone pivalate 0.02% w/v and clioquinol BP 1% w/v.

Also contains macrogol.

What Locorten Vioform Ear Drops looks like and the contents of the pack.

The drops come in a plastic bottle containing 7.5 ml of drops.

Manufacturer

Amdipharm Limited,

Temple Chambers,

3 Burlington Road,

Dublin 4,

Ireland

Procured from within the EU.

Repackaged by:

Dr. Fisher Farma B.V.,

Vijzelweg 32,

8243 PM,

Lelystad,

The Netherlands

Product Licence Holder:

Medixl Ltd.,

Maple House,

High Street,

Potters Bar,

EN6 5BS,

UK

PL 46245/0018

Locorten Vioform Ear Drops

Flumetasone Pivalate/Clioquinol 0.02% w/v / 1 % w/v

Ear Drops Solution

|POM|

This leaflet was last revised on 20th September 2016. Locorten® and Vioform® are trademarks of Novartis AG.

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