Patient leaflet - Prednisolone Sodium Phosphate 0.5% w/v eye and ear drops solution

1. What Prednisolone Sodium Phosphate Drops is and what it is used for

Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution (referred to as Prednisolone Sodium Phosphate drops in this leaﬂet) contains 0.5% w/v of Prednisolone Sodium Phosphate. It belongs to a group of medicines called corticosteroids (‘steroids’ for short).

Prednisolone Sodium Phosphate Drops work by reducing inﬂammation (redness, itching and soreness).

Prednisolone Sodium Phosphate Drops is used to treat inﬂammation of the eye or ear where there is no infection.

2. What you need to know before you use Prednisolone Sodium Phosphate Drops

Do not use Prednisolone Sodium Phosphate Drops:

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.

Warnings and precautions

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.

Children

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

Other medicines and Prednisolone Sodium Phosphate Drops

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)

Pregnancy, breast-feeding and fertility

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.

Driving and using machines

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.

Warnings about visual problems when using Prednisolone Sodium Phosphate Drops

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

3. How to use Prednisolone Sodium Phosphate 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.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it is not, or you are not sure, ask your doctor or pharmacist.

Remember:

Always use Prednisolone Sodium Phosphate 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.
If there is no improvement in your symptoms after 7 days, stop using the drops and see your doctor again. Check that the seal on the bottle is not broken before using Prednisolone Sodium Phosphate Drops for the ﬁrst time. Wash and dry your hands. Do not breathe on or touch the dropper nozzle.

Eyes

The recommended dose is 1 or 2 drops put into the eye every one or two hours

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10 mm

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5 mm

Once the redness, itching and soreness starts to feel better, apply the drops less often.
Tilt your head back
Gently pull your lower eyelid downwards
and outwards
Place drops in the gap between the eyelid and
eye (squeeze bottle very gently if necessary)
Blink a few times to spread out the drops
Repeat for the other eye if needed.

Ears

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

Medical check-ups

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 use more Prednisolone Sodium Phosphate Drops than you should

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.

If you forget to use Prednisolone Sodium Phosphate Drops

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

If you stop using Prednisolone Sodium Phosphate Drops

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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Effects on your eyes

Very rare: may affect up to 1 in 10,000 people

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

Frequency not known (cannot be estimated from the available data)

Ulcers on the surface of the eye (cornea). Tell your doctor if your eye becomes painful and if you have blurred vision which does not improve after a few minutes
Increased pressure in the eye (glaucoma) which can lead to problems with your sight
- A hole in the eyeball (if you have a disease which causes thinning of the surface of the eye)
- Cataracts (clouding of the lens of the eye)
- Enlarged pupils
- Drooping of the eyelid
- Swelling and redness of the outer surface of the eye
- Blurred vision and other alterations to your sight.

Effects on the skin around your eyes Frequency not known (cannot be estimated from the available data)

These may not appear until some time after you have started to use the medicine.

Irritation
Burning
Stinging
Itching
Redness.

5. How to store Prednisolone Sodium Phosphate Drops

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

Do not use this medicine after the expiry date which is stated on the label. Do not use for longer than 28 days after the seal on the bottle has been broken.

Store below 25°C. Do not Freeze.

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Prednisolone Sodium Phosphate Drops contains

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.

What Prednisolone Sodium Phosphate Drops looks like and contents of the pack

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.

Marketing Authorisation Holder

RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden.

Manufacturer

Excelvision, 27, rue de la Lombardière, ZI La Lombardière, 07100 Annonay

This leaﬂet was last revised in 11/2020.

If this leaﬂet is difﬁcult to see or read or you would like it in a different format, please contact RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden.

Reporting of side effects

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.