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LOCORTEN VIOFORM EAR DROPS, FLUMETASONE PIVALATE/CLIOQUINOL 0.02% W/V / 1% W/V EAR DROPS SOLUTION - patient leaflet, side effects, dosage

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Patient leaflet - LOCORTEN VIOFORM EAR DROPS, FLUMETASONE PIVALATE/CLIOQUINOL 0.02% W/V / 1% W/V EAR DROPS SOLUTION

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.

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.

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.

5. how to store locorten vioform ear drops

Do not store above 25°C.

Store in the original packaging.

Do not use this medicine after the ‘use before’ date which is stated on the label and carton. The ‘use before’ date refers to the last day of the month.

Keep this medicine out of the sight and reach of children.

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 ear drops contain the active ingredients 0.02% w/v flumetasone pivalate and 1% w/v clioquinol. The other ingredient is polyethylene glycol.

What Locorten Vioform Ear Drops look like and the contents of the pack

A clear, yellowish to brownish-yellow solution in a yellow plastic dropper bottle with a black cap containing 7.5ml.

Manufactured by Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland and procured from within the EU and repackaged in the UK by the Parallel Import Product Licence holder: CD Pharma Ltd, 4 Cairn Court, East Kilbride, G74 4NB.

Locorten Vioform Ear Drops solution PL: 20492/0566

POM

Blind or partially sighted? Is this leaflet hard to see or read? Call 01355 204 448 to obtain a leaflet in a format suitable for you.

Date of Preparation: 18th February 2022

Locorten is a registered trademark