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PREDSOL 0.5% W/V EYE AND EAR DROPS SOLUTION

Active substance(s): PREDNISOLONE SODIUM PHOSPHATE

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Package leaflet: Information for the patient
Predsol 0.5% w/v Eye and Ear Drops, Solution
Prednisolone Sodium Phosphate
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
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.
What is in this leaflet
1.
2.
3.
4.
5.
6.

1.

What Predsol Drops is and what it is used for
What you need to know before you use Predsol Drops
How to use Predsol Drops
Possible side effects
How to store Predsol Drops
Contents of the pack and other information

What Predsol Drops is and what it is used for

Predsol 0.5% w/v Eye and Ear Drops, Solution (referred to as Predsol drops in this leaflet) contains 0.5%
w/v of Prednisolone Sodim Phosphate. It belongs to a group of medicines called corticosteroids (‘steroids’
for short).
Predsol Drops work by reducing inflammation (redness, itching and soreness).
Predsol 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 Predsol Drops

Do not use Predsol 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 Predsol Drops
- if you have been treated with Predsol 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 Predsol Drops below)

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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 Predsol Drops
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
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.
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
Predsol Drops may cause temporary blurred vision. If this happens to you, do not drive or use machinery
until your sight returns to normal.

3.

How to use Predsol 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 Predsol 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 Predsol 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
- 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.
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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.
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.
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 Predsol Drops than you should
If you accidentally use too much Predsol 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 Predsol 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 Predsol Drops
Do not stop using Predsol Drops without first talking to your doctor.
If you have been using Predsol 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)
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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.

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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.

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 via the internet at
www.mhra.gov.uk/yellowcard; or you can report via Freephone 0808 100 3352 (available from 10 a.m. to 2
p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side
effects you can help provide more information on the safety of this medicine.

5.

How to store Predsol 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 Predsol 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 Predsol Drops looks like and contents of the pack
Predsol 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, Lagervägen 7, 136 50 Haninge, Sweden.
Manufacturer
Excelvision, 27, rue de la Lombardière, ZI La Lombardière, 07100 Annonay
This leaflet was last revised in June 2014.
If this leaflet is difficult to see or read or you would like it in a different format, please contact RPH
Pharmaceuticals AB, Haninge, Sweden.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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