Package leaflet: Information for the user

Dropodex* 0.1%w/v Eye Drops, solution

Dexamethasone phosphate (as dexamethasone sodium phosphate)

What is in this leaflet:

1.    What Dropodex® Eye Drops are and what it is used for

2.    What you need to know before you use Dropodex®

3.    How to use Dropodex®

4.    Possible side effects

5.    How to store Dropodex®

6.    Contents of the pack and other information

1. WHAT DROPODEX® EYE DROPS ARE AND WHAT IT IS USED FOR

Every Dropodex® single-dose unit contains the active ingredient Dexamethasone phosphate (as dexamethasone sodium phosphate) at a concentration of 0.1% w/v (1mg/ml). Each Dropodex® sterile, single-dose unit holds approximately 0.4 ml of solution. Dropodex® belongs to the group of corticosteroids that suppresses inflammation.

Dropodex® is used for:

•    Certain cases of inflammation in the front of the eye such as the inflammation of the cornea, conjunctiva and iris and connective tissue.

•    Hypersensitive reaction of the conjunctiva not responding to standard treatments.

•    Treatment of inflammation of the eye, as long as the eye is not infected.

Your doctor may sometimes use other drugs at the same time as Dropodex® to make sure that your eye is treated effectively.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DROPODEX®

Do not use Dropodex®:

•    If you are allergic (hypersensitive) to Dexamethasone sodium phosphate or any of the other ingredients of Dropodex® (listed in section 6).

•    In case of bacterial eye infections (such as: acute purulent bacterial infections), fungal infections, viral diseases (for example: Herpes simplex, vaccinia, varicella zoster), or amoebiasis.

•    In case of tuberculosis.

•    In cases of damaged cornea (such as: perforation of the cornea), ulceration, lesions with incomplete formation of the covering tissue.

•    In cases of increased intraocular pressure caused by glucocorticosteroids (these belong to the group of corticosteroids).

Warnings and precautions:

If any of the following apply to you then inform your doctor or

eye specialist before starting treatment:

•    If you have an eye infection.

•    If you have increased pressure within the eye (glaucoma), or are at risk of developing glaucoma. Your doctor will check for this.

•    If you are using any other eye drops.

•    Wearing of contact lenses during treatment with corticosteroid eye drops must be avoided.

Long-term, frequent use of corticosteroids can lead to the formation of

cataracts (clouding of the lens in the eye).

Children and adolescents

Use of Dropodex 0.1 % w/v eye drops solution in children and adolescents must be restricted. In children, continuous, long term use of corticosteroid eye drops should be avoided.

Other medicines and Dropodex®

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

If you are already using eye drops to treat glaucoma it is possible that the dose may need to be adjusted if you are prescribed Dropodex®.

If you are using more than one sort of eye drops leave five minutes between applications.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or eye specialist for advice before taking this medicine. There is insufficient information available to determine the potential harmful effects on pregnancy. Dropodex® should not be used during pregnancy and breast-feeding unless considered appropriate by your doctor or eye specialist.

Driving and using machines

Your eyesight may become blurred for a short time following the use of Dropodex®. You must not drive or operate hazardous machinery until your eyesight has returned to normal.

3. HOW TO USE DROPODEX®

Always use Dropodex® exactly as your doctor has told you. If your eye problem is severe, you may be asked to use this eye drop more frequently at first. The frequency can then be reduced as the eye gets better. More detailed instructions will be given to you by your doctor or pharmacist. Make sure you follow these instructions carefully.

Usual Dose

The recommended dose is 1 drop in one or both eyes, 4 to 6 times a day in the affected eye. In severe cases, treatment may be started with 1 drop every hour at the start of the therapy but dosage should be reduced to 1 drop every 4 hours when a favourable response is observed. Do not stop using the treatment abruptly. Gradual tapering off is recommended in order to avoid a relapse. The duration of treatment will generally vary from a few days to a maximum of 14 days.

Use in children and adolescents

Follow the instructions given by your doctor because the dose may vary. Do not allow the tip of the single-dose unit to touch your eye or areas around your eye. It may become contaminated with bacteria that can cause eye infections leading to serious damage to the eye, even loss of vision. To avoid possible contamination of the single-dose unit, keep the tip of the container away from contact with any surface.

The solution from one individual single-dose unit of Dropodex® is to be used immediately after opening for administration to the affected eye(s). Since sterility cannot be maintained after the individual singledose unit is opened, a new single-dose unit must be opened prior to each use and must be discarded immediately after administration.

How to use Dropodex®:

1.    Wash your hands thoroughly before using the drops. Open the foil sachet if required.

2.    Break off one single-dose unit from the strip.

3.    Open the single-dose unit by bending/twisting the tab. (Figure 1).

4.    Tilt your head backwards.

5.    Gently pull down the lower lid with your other hand to form a pouch. (Figure 2).

6.    Place the dropper tip close to your eye, but do not touch the eye or lid, and gently squeeze the single-dose container to release one drop into your eye. (Figure 3).

7.    Close your eyelid and gently press the corner of your eye with your forefinger for one minute. (Figure 4).

8.    Some drops may roll down your face. This is normal. Wipe away excess solution with a clean tissue. If the drop of Dropodex® is not retained for any reason, another drop should be instilled in the eye.

9.    After instillation, discard the used single-dose unit even if there is solution remaining.

10. Repeat instructions 2-9 for the other eye.

ii.Store the remaining single-dose units in the foil sachet. After opening the sachet, the unopened ampoules can be stored for 28 days.

Follow these instructions carefully. Consult your doctor or pharmacist if there is anything you do not understand.

If you use more Dropodex® than you should

If you put too much Dropodex® into your eye(s), close your eyes and rinse off any excess with warm water.

If the contents of Dropodex® is accidentally swallowed, tell your doctor immediately or go to your nearest hospital casualty department.

Take your medicine with you.

If you forget to use Dropodex®

Do not administer a double dose to make up for a forgotten dose. If you forget to administer a dose of Dropodex®, use it as soon as you remember and then carry on as before.

4. POSSIBLE SIDE EFFECTS

Most people who are treated with these eye drops do not suffer from any unwanted side effects. Occasionally this medicine may cause temporary stinging, burning, redness or watering of the eyes.

Topical corticosteroids should not be used for longer than one week except under ophthalmic supervision. You should consult your doctor if you become aware of any changes in your eyesight.

It is possible that some of the solution may be absorbed into the general circulation of the body following administration to the eye. It is unlikely, however, that this will have any unwanted effect on the body because so little of the eye drop is absorbed through the eye. The action of pressing on the inner part of the eye when adding the drops will also help to reduce this absorption even further.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5.    HOW TO STORE DROPODEX®

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 sachet, single-dose units and on the carton. The expiry date can be found after the abbreviation ‘EXP'. The expiry date refers to the last day of that month shown.

Store in original package. After opening the sachet, the unopened ampoules can be stored for 28 days.

Do not store above 25°C. Do not refrigerate or freeze.

The Dropodex® single-dose unit should be discarded immediately after use, even if some solution remains.

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 Dropodex® looks like and contents of the pack

Each single-dose unit contains 0.4 ml Dropodex® Eye Drops, solution without preservative. There are five single-dose units per sachet. Each carton contains four sachets.

Each individual single-dose unit contains 0.4 mg of Dexamethasone phosphate (as dexamethasone sodium phosphate) in 0.4 ml of solution.

Dropodex® Eye Drops, solution also contain sodium chloride, disodium edetate, disodium phosphate dodecahydrate (E339) and purified water.

Marketing Authorisation Holder:

Moorfields Pharmaceuticals, 34 Nile Street, London, Ni 7TP,

United Kingdom.

Tel: 0207 684 9090

Manufacturer:

NOVOCAT FARMA, S.A.

Av. De les Flors, 29 L7. 08191 Rubt Barcelona, Spain.

This leaflet was last revised in 01/2013.

To get this leaflet in large print, braille or as an audio CD, call the RNIB Medicine Leaflet line on 0800 198 5000

MOORFIELDS