Betnesol-N Eye, Ear and Nose Drops

• 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• In this leaflet, Betnesol-N Eye, Ear & Nose Drops will be called Betnesol-N Drops.

1. What Betnesol-N Drops is and what it is used for
2. What you need to know before you use Betnesol-N Drops
3. How to use Betnesol-N Drops
4. Possible side effects
5. How to store Betnesol-N Drops
6. Contents of the pack and other information.

• You are allergic to betamethasone
• You are allergic to any of the other ingredients of Betnesol-N Drops (listed in section 6)
• You have not checked your eye condition with your doctor first. If this medicine is used in your eye, for the wrong condition, it could lead to blindness.
• You have an infection in the eye, or it is producing pus and is sticky
• You have an infection in the ear or nose
• You have ulcers in your eye (shingles)
• You have glaucoma (increased pressure in the eye)
• You wear soft contact lenses
• You have a perforated ear drum.

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

Talk to your doctor or pharmacist before using this medicine if:

• You know you have (or think you have) a mitochondrial disease (mutations in the parts of your cells which help make energy); certain mitochondrial diseases may increase your risk of hearing loss with this product.
• You have been treated with Betnesol-N drops or similar corticosteroid medicine recently. You should not use corticosteroids for a long time without regular medical checkups 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 an infant. Prolonged use in babies may cause the adrenal gland to stop working properly
• You are applying these drops to open wounds or damaged skin. The antibiotic component can cause permanent, partial or total deafness if used on open wounds or damaged skin. This possibility should be borne in mind if high doses are given to small children or infants.

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-N 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 breastfeeding ask your doctor or pharmacist for advice before using Betnesol-N Drops. If you use these drops while pregnant there may be small risk of damage to the ear, cleft palate or retarded growth in the foetus.

Betnesol-N 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:

• 0.005% w/v benzalkonium chloride in each dose. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time
• 0.23% w/v phosphates in each dose. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

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

• Always use Betnesol-N exactly as your doctor has told you
• How often you use the drops will depend on how your body responds to the treatment
• Use as few drops as possible for the shortest possible time.

Check that the seal on the bottle is not broken before using Betnesol-N Drops for the first time. Wash and dry your hands. Do not breathe on or touch the dropper nozzle and do not touch the eyes, ear or nose with 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 up to 6 times each day
• 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.

Medical checkups

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:

1. An increase in pressure
2. Cataracts
3. Infection.

Ears

• The usual dose is 2 or 3 drops put into the ear three or four times each day
• 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 other ear if needed.

Nose

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.

Medical checkups

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

If you accidentally use too much Betnesol-N 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. Accidental swallowing of the contents of one bottle (up to 10 ml) is unlikely to lead to any serious adverse events.

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 symptons 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-N Drops without first talking to your doctor.

If you have been using Betnesol-N 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 on the MHRA 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% w/v.

Betnesol-N Drops also contain neomycin sulphate at a concentration on 0.5% w/v. The other ingredients are benzalkonium chloride, disodium edetate, polyethylene glycol 300, sodium formate, anhydrous sodium sulphate, disodium hydrogen phosphate anhydrous, sodium acid phosphate, sodium hydroxide or phosphoric acid and water for injections.

Betnesol-N Drops is a colourless to pale yellow liquid.

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