Betnesol Eye, Ear and Nose Drops Solution 0.1% w/v

• 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.
• In this leaflet, Betnesol Eye, Ear & Nose Drops will be called Betnesol Drops.

1. What Betnesol Drops are for
2. Before you use Betnesol Drops
3. How to use Betnesol Drops
4. Possible side effects
5. How to store Betnesol Drops
6. Further information.

• You have been treated with Betnesol or similar corticosteroid drops recently. You should not use corticosteroids for a long time without regular medical check-ups from your doctor
• You have redness in your eyes for which you do not know the cause. Steroid treatment must not be given unless the cause of the redness is known
• You have an infection of the lining of your nose, which is not being treated
• You have recently had surgery on your nose which has not yet healed
• You have tuberculosis (TB).
• You have thinning of the cornea or sclera (the tissues which cover the outer surface of the eye). Using these drops could lead to a hole in the eyeball.
• You are giving this medicine to a baby. Using this medicine for a long time in babies may cause the adrenal gland to stop working properly.

If any of the above applies to you, talk to your doctor or pharmacist.

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

Some medicines may increase the effects of Betnesol Drops and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)

If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before using Betnesol Drops. If you use this medicine while pregnant, there may be a small risk of cleft palate or retarded growth in the foetus.

Betnesol Drops may cause temporary blurred vision and lightheadedness. If this happens to you, do not drive or use machinery until you return to normal.

This medicine contains benzalkonium chloride as a preservative which may cause skin reactions or eye irritation.

Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.

Contact your doctor if you experience blurred vision or other visual disturbances.

Check that the seal on the bottle is not broken before using Betnesol Drops for the first time. Wash and dry your hands. Do not breathe on or touch the dropper nozzle.

If there is no improvement in your symptoms after 7 days, stop using the drops and see your doctor again.

Eyes

• The usual dose is 1 or 2 drops put into the eye every one or two hours
• Once the redness, itching and soreness starts to feel better, apply the drops less often.

1. Tilt the head back
2. Gently pull lower eyelid downwards and outwards
3. Place drops in the gap between the lid and eye (squeeze bottle very gently if necessary)
4. Blink a few times to spread out the drops
5. Repeat for the other eye if needed.

If you are using this medicine for your eyes and you use it for a number of weeks, your doctor may ask you to have check-ups.

These are to make sure that your medicine is working properly and that the dose you are taking is right for you. Your doctor will check your eyes for:

• An increase in pressure
• Cataracts
• Infection.

• The usual dose is 2 or 3 drops put into the ear every two or three hours
• Once the redness, itching and soreness starts to feel better, apply the drops less often.

1. Tilt the head to one side
2. Place drops in the ear canal (squeeze bottle gently if necessary)
3. Keep head tilted for a minute or two to let the drops soak in
4. Repeat for the other ear if needed.

The usual dose is 2 or 3 drops put into each nostril two or three times each day.

1. Tilt head backwards
2. Place drops in nostril (squeeze bottle gently if necessary)
3. Keep head tilted and sniff gently to let the drops soak in
4. Repeat for other nostril if needed.

Your doctor will regularly check the growth of children who are taking Betnesol by nose over a long period of time.

If you accidentally use too much Betnesol Drops it is unlikely to lead to any serious side effects. However, if you are concerned, contact the nearest hospital casualty department or your doctor.

It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You should use only as much as your doctor recommends; using more or less may make your symptoms worse.

Do not use a double dose to make up for a missed dose. Simply use the next dose as planned.

Do not stop using Betnesol Drops without first talking to your doctor.

If you have been using Betnesol Drops for a long period of time (around 6 to 8 weeks), then you should stop using it gradually, to avoid the inflammation coming back.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is betamethasone sodium phosphate at a concentration of 0.1%.

The other ingredients are benzalkonium chloride solution, disodium hydrogen phosphate anhydrous, sodium chloride, disodium edetate, sodium hydroxide (E524), phosphoric acid and water for injections.

Betnesol Drops is an eye, ear and nose drops solution. It is a clear, colourless liquid.

Betnesol Drops come in 5 ml or 10 ml plastic bottles with a built-in nozzle and a tamper-evident plastic cap.