Flumetasone Pivalate/Clioquinol 0.02% W/V / 1% W/V Ear Drops Solution
Flumetasone pivalate/Clioquinol 0.02% w/v / 1% w/v Ear Drops solution
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.
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 throughout this leaflet.
In this leaflet:
1. What Flumetasone/Clioquinol ear drops are and what they are used for
2. 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. Further 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. BEFORE YOU USE FLUMETASONE/ CLIOQUINOL EAR DROPS
Do NOT use the eardrops if you:
• are allergic (hypersensitive) to any of the ingredients of Flumetasone/Clioquinol 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.
Flumetasone/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.
Take special care with 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).
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 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 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, Flumetasone/Clioquinol 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.
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.
6. FURTHER INFORMATION
What Flumetasone/Clioquinol ear drops contain
The active ingredients in Flumetasone/Clioquinol ear drops are flumetasone pivalate and clioquinol.
Each ml contains 0.2mg flumethasone pivalate and 10mg clioquinol.
The other ingredient is macrogol 300.
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: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland.
POM
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 25°C. Store in the original package.
- Do not use the ear drops after the expiry date which is stated on the carton and bottle label after 'Exp'. The expiry date refers to the last day of that month.
- If the ear drops become discoloured or show any signs of deterioration, seek the advice of 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.
Procured within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Flumetasone pivalate/Clioquinol 0.02% w/v / 1% w/v Ear Drops solution;
PL 18799/2822
Leaflet date: 31.05.2016