Hydrocortisone Eye Drops 1% Bpc 1973
PACKAGE LEAFLET: INFORMATION FOR THE USER C*****
Hydrocortisone Eye Drops 1% BPC 1973
Hydrocortisone Acetate
Read all of this leaflet carefully before you start taking this medicine. It contains important information.
• 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.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Hydrocortisone Eye Drops are and what they are used for
2. Before you use Hydrocortisone Eye Drops
3. How to use Hydrocortisone Eye Drops
4. Possible side effects
5. How to store Hydrocortisone Eye Drops
6. Further information
1. What Hydrocortisone Eye Drops are and what they are used for
Hydrocortisone Eye Drops contain hydrocortisone acetate which belongs to a group of medicines called corticosteroids. These are used to relieve redness and swelling.
Hydrocortisone Eye Drops are used:
• to treat non-infected conditions such as swelling of parts of the eye.
• to treat injury of the cornea (the front of the eye).
• to prevent graft reaction after an operation.
• for treating viral infection (by herpes zoster) of the eye.
2. Before you use Hydrocortisone Eye Drops
Do not use Hydrocortisone Eye Drops if you:
• are allergic (hypersensitive) to hydrocortisone or to any of the other ingredients of this medicine, which are listed in section 6 of this leaflet
• have undiagnosed red eye(s)
• suffer from raised pressure in your eye(s) (glaucoma)
• have a viral infection of the eye
• have a fungal infection of the eye
• have an eye infection that is producing pus
• have tuberculosis of the eye
• are wearing soft contact lenses. These should be removed whilst you are using Hydrocortisone Eye Drops.
If any of the above apply to you or your child please tell your doctor or pharmacist before using this medicine.
Take special care with Hydrocortisone Eye Drops
• Do not use Hydrocortisone Eye Drops for a prolonged period of time (more than 7 days) as this may cause serious side effects (see section 4 of this leaflet).
• You should be aware that your doctor may need to check your eyes frequently during your treatment with Hydrocortisone Eye Drops.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, before you use this medicine.
If you have any doubts about whether this medicine is suitable for you, consult your doctor or pharmacist.
Pregnancy and breast-feeding
This medicine should be avoided if you are pregnant, trying to become pregnant or breast-feeding. Ask your doctor for advice before taking any medicine.
Important information about some of the ingredients of Hydrocortisone Eye Drops
• This medicine contains thiomersal which in rare cases can cause redness, itching and swelling in the eye area. If you are affected stop using Hydrocortisone Eye Drops and contact your doctor or pharmacist as soon as possible.
• It also contains benzalkonium chloride
which is known to discolour soft contact lenses and may cause eye irritation. If you usually wear soft contact lenses they should be removed before you use Hydrocortisone Eye Drops(see below)
3. How to use Hydrocortisone Eye Drops
Always use Hydrocortosine Eye Drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much to use
For adults, the elderly and children
The usual dose is 1 or 2 drops placed in the eye every 30 to 60 minutes until the swelling starts to go down. When this occurs reduce the dose to one drop every 4 hours.
If there is no improvement see your doctor or pharmacist.
Instructions for use
If you wear soft contact lenses they must be removed before treatment with Hydrocortisone Eye Drops and you should wait at least 15 minutes before you put them back in.
1. Before opening a new bottle of Hydrocortisone Eye Drops, please check that the safety strip on the front of the bottle is unbroken.
2. Tear off the safety strip to break the seal.
3. Wash your hands well before use.
4. Remove the outer cap. If you are putting in the drops yourself you should use a mirror.
5. Tilt your head back and look up at the ceiling.
6. Pull the lower lid of the eye out to form a small pocket between your eyelid and your eye.
7. Hold the container between the thumb and middle finger of the other hand, turn the bottle upside down near to your eye, try not to touch your eye with the nozzle.
8. Apply enough pressure to the container to release one to two drops, or as directed by your doctor.
9. Blink your eye a few times.
10. If you think that you have missed your eye, then insert another drop.
11. Repeat steps 5-10 for the other eye, if you have been told to use Hydrocortisone Eye Drops in both eyes.
12. Replace the outer cap on the bottle, trying not to touch the applicator tip with anything, including the eye or your fingers.
13. Wash your hands.
• Do not use for longer than 7 days
• Discard 4 weeks after opening
If you are unsure about how to use Hydrocortisone Eye Drops talk to your doctor or pharmacist.
Drivmg and using machines Continued overleaf
Hydrocortisone Eye Drops can cause
temporary blurring of vision after application
to the eye. Wait until your vision is clear
before driving or using machines.
If you use more Hydrocortisone Eye Drops than you should
If you are at all concerned that you have used too much of this medicine contact your doctor or pharmacist.
Hydrocortisone Eye Drops are for external use only. If you have swallowed or you suspect someone else has swallowed any, contact your doctor or pharmacist.
If you forget to use Hydrocortisone Eye Drops
If you have just missed your dose and it is a long time until your next dose is due, put in the missed dose now and continue the course of treatment. If it is near the time for your next dose wait and use this dose at the correct time. Do not use a double dose to make up for one you have missed.
If you stop using Hydrocortisone Eye Drops
You should keep using Hydrocortisone Eye Drops for as long as your doctor has instructed. Your treatment is helping your condition, even if you have not noticed a difference in how you feel. Should you need to stop your treatment, your doctor will advise you how to do this.
4. Possible side effects
Like all medicines, Hydrocortisone Eye Drops can cause side effects, although not everybody gets them.
If you experience any of the following side effects you should tell your doctor immediately. These are symptoms of an allergic reaction.
• difficulty in breathing with or without swelling of the face, lips, tongue and/or throat
• swelling of the face, lips tongue and/or throat, which may cause difficulty in swallowing
• severe itching of the skin (with raised lumps).
Other possible side effects include:
• raised pressure in the eye which may damage the optic nerve causing poor vision.
• temporary irritation, burning, itching and stinging in the area
• redness or swelling of the eye
• headache
• being sick
• worsening of viral or fungal infections of the eye
• ulcers on the eye which may cause poor vision
Prolonged use of this medicine (for more than 7 days) can lead to cloudiness of the lens of the eye (cataracts); it is therefore advised that the lens of the eye is checked frequently during use of this medicine.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Hydrocortisone Eye Drops
Keep all medicines out of the reach and sight of children.
Make sure the container is properly closed after each use.
Store Hydrocortisone Eye Drops in the original container away from direct light. Store below 25°C.
Do not use Hydrocortisone Eye Drops after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Dispose of this medicine 4 weeks after opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further Information
What Hydrocortisone Eye Drops contain
The active substance is hydrocortisone acetate 1%w/v.
The other ingredients are sodium acid phosphate, sodium phosphate, sodium carboxymethylcellulose, disodium edetate, thiomersal, benzalkonium chloride solution, propylene glycol and purified water.
What Hydrocortisone Eye Drops look like and contents of the pack
Hydrocortisone Eye Drops are a clear, colourless and sterile solution supplied in a plastic dropper bottle with a cap. Each bottle contains 10ml of the solution.
Marketing Authorisation Holder & Manufacturer
Martindale Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
Essex, RM3 8UG
UK
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.
This leaflet was last approved in: 09/2008 PL 00156/0065
Bampton Road Romford, Essex RM3 8UG United Kingdom