Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution

• 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.

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

• if you are allergic to Prednisolone Sodium Phosphate or any of the other ingredients of this medicine (listed in section 6)
• if you have an infection in the eye, or it is producing pus and is sticky
• if you have glaucoma (increased pressure in the eye)
• if you have ulcers in your eye (shingles)
• if you have a fungal disease in your ear
• if you have a perforated ear drum.

Important: Never use this medicine in your eye without first checking with your doctor. If it is used for the wrong condition, it could lead to blindness.

Talk to your doctor or pharmacist before using Prednisolone Sodium Phosphate Drops

• if you have been treated with Prednisolone Sodium Phosphate or similar corticosteroid drops recently. Do not have repeated or prolonged treatment without regular checkups from your doctor
• if you have tuberculosis (TB)
• if you wear soft contact lenses (see other medicines and Prednisolone Sodium Phosphate Drops below)

Systemic effects of nasal corticosteroids: Prolonged use at high doses may cause:

• Cushing’s syndrome (a hormonal disorder caused by high levels of cortisol), Cushingoid features such as facial roundness or puffiness, adrenal suppression, cataract and glaucoma.
• Rarely, a range of psychological effects including psychomotor hyperactivity (a feeling of restlessness, muscle spasms, twitches), sleep disorders, anxiety.

• prolonged use may lead to the risk of adrenal suppression in infants
• growth retardation in children and adolescents
• depression or aggression (particularly in children)

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

This medicine contains benzalkonium chloride as a preservative which may cause 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.

Some medicines may increase the effects of Prednisolone Sodium Phosphate 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 or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is a small risk of cleft palate or retarded growth in the foetus.

Prednisolone Sodium Phosphate Drops may cause temporary blurred vision. If this happens to you, do not drive or use machinery until your sight returns to normal.

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

• The recommended 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 your head back
2. Gently pull your lower eyelid downwards and outwards
3. Place drops in the gap between the eyelid 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.

• The recommended 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 your 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.

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.

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

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 forgotten dose. Simply use the next dose as planned.

Do not stop using Prednisolone Sodium Phosphate Drops without first talking to your doctor.

If you have been using Prednisolone Sodium Phosphate 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 any side effects directly to the national reporting system 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 Prednisolone sodium phosphate (0.5 %)
• The other ingredients are benzalkonium chloride solution, sodium chloride, sodium acid phosphate, disodium edetate, sodium hydroxide, phosphoric acid, purified water.

Prednisolone Sodium Phosphate Drops is clear, colourless solution. It comes in 5 ml or 10 ml plastic bottles with a built in nozzle and a tamper evident plastic cap.