Minims Dexamethasone Sodium Phosphate 0.1% W/V Eye Drops Solution.
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Minims® Dexamethasone Sodium Phosphate 0.1% w/v Eye Drops, solution Dexamethasone sodium phosphate
Read all this leaflet carefully before you start using your medicine. It contains a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Remember this medicine is for you. Do not give it to someone else.
In this leaflet:
1. What Minims® Dexamethasone Sodium Phosphate eye drops are and what they are used for
2. Before you use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Further information
1. What Minims® Dexamethasone Sodium Phosphate eye drops are and what they are used for
Minims® Dexamethasone Sodium Phosphate contains a corticosteroid. It is used to treat inflamed eyes (red and painful).
The part of the eye affected will vary depending on the cause of the inflammation.
Your doctor may sometimes prescribe other drugs at the same time to make sure that the inflammation is treated effectively.
This medicine is indicated for children, adults and the elderly.
2. Before you use your eye drops Do not use these drops if
■ you are allergic to the active substance (dexamethasone sodium phosphate) or any of the other ingredients (refer to the end of this leaflet).
■ you have high pressure inside the eye or you are at risk of developing glaucoma. Your doctor will have checked for this.
■ you currently have conditions affecting your cornea.
■ it is intended for long term continuous therapy in children (at the discretion of the physician).
Children
In children, continuous, long term use of these eye drops should be avoided. Check with your doctor if your child has been using this medicine for a long time. The doctor or eye specialist may decide to prescribe an alternative.
Using other medicines
Minims® Dexamethasone Sodium Phosphate can increase the effects of:
■ medicine used to treat epilepsy (barbiturates)
■ medicine used to help you sleep or to relieve anxiety (sedative hypnotics)
■ medicine used to treat depression (tricyclic antidepressants). Minims® Dexamethasone Sodium Phosphate can decrease the effects of:
* medicines such as anticholinesterases (indicated for reduced intestinal movement and for myasthenia gravis (a muscle weakening disease).
■ medicines used to treat infection of the eye caused by a virus
■ medicines similar to aspirin called salicylates (indicated for inflammation, pain, fever and blood thinning).
If you are taking any of these medicines, or if you are unsure, talk to your doctor or pharmacist.
If you are pregnant, may be pregnant, or are breastfeeding
Tell your doctor or eye specialist, he/she may decide to use these drops or to prescribe you an alternative.
Contact lenses
Your doctor will ask you to remove your contact lenses prior to the administration of the drops. There is no information on the effect of this product on contact lenses. Therefore do not wear contact lenses until the effects of the drops have completely worn off.
Driving and using machines
As with all eye drops, your vision may be blurred after putting the drops in. Wait until your vision is clear before driving or using machines.
3. How to use your drops
The drops are in special single use "Minims" units, to treat both eyes if necessary. Once opened, use immediately. Discard any unused portion.
Dosage
■ The normal adult dose is 1 to 2 drops in one or both eyes as often as directed by your doctor.
■ The dose for children will be decided by the doctor or eye specialist.
Method of administration
If you are putting the eye drops in yourself, then follow these instructions carefully:
1. Wash your hands.
2. Use a mirror, this will help you to see what you are doing.
3. Carefully dry your eyes using a tissue, and twist off the cap from the Minims body of the unit.
4. Pull your lower eyelid down gently, and then carefully place 1 or 2 drops inside your lower eyelid.
Make sure the dropper does not touch any parts of your eye.
5. Close your eye and blink a few times to make sure your eye is covered by the liquid.
6. Close the eyelids. It is advisable to press gently on the inner corner of your eyelid for 3 minutes. This will help stop the solution draining into your nose and throat. This is especially advisable in children, the elderly and population at risk.
7. Repeat steps 4, 5 and 6 for the other eye if necessary, then throw away the Minims unit, even if some solution remains.
If your eyes get worse or are not better after a few weeks of using the eye drops, see your doctor or eye specialist or pharmacist.
This medicine should not be used for long term and frequent use without talking to your doctor or pharmacist.
If you use more Minims® Dexamethasone Sodium Phosphate than you should, an overdose is very unlikely to occur. If you suddenly feel unwell after using the drops, tell your doctor or eye specialist or contact the nearest emergency department immediately.
If you forget to use Minims® Dexamethasone Sodium Phosphate, you should take the missed dose as soon as you remember, unless it is nearly time for the next dose, but you should not take a double dose to make up for a missed dose
4. Possible side effects
Most people who are treated with these eye drops do not suffer from any side effects.
■ Minims® Dexamethasone Sodium Phosphate may sting when the drops are first put in and your vision may become blurred. This will gradually wear off.
■ Minims® Dexamethasone Sodium Phosphate may cause rare cases corneal deposits or corneal opacity in patients with diseases of the cornea.
■ Long term, frequent use of corticosteroids can lead to clouding of the lens in the eye (cataract) or to an increase of the pressure inside the eye.
Consult your doctor if you feel any changes in your eyesight.
If any of the side effects gets serious, please seek immediate medical attention. If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store your eye drops
Keep out of the reach and sight of children.
Do not use the eye drops after the expiry date which is stated on the overwrap of each unit and on the carton after the letters "EXP". The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze. Store in original package in order to protect from light.
The drops are in special single use "Minims" units, to treat both eyes if necessary. Once opened, use immediately. Discard any unused portion.
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 do your eye drops contain
■ The active ingredient is dexamethasone sodium phosphate. Each Minims unit contains approximately 0.5 ml eye drops solution of dexamethasone sodium phosphate 0.1% w/v (0.5 mg).
■ The other ingredients are disodium edetate, sodium dihydrogen phosphate dehydrate, sodium chloride, sodium hydroxide solution (for pH adjustment) and purified water.
This medicine does not contain a preservative as it is a sterile single use unit.
Contents of the pack
Each carton contains 20 units.
Marketing Authorisation Holder:
Chauvin Pharmaceuticals Ltd.
106 London Road - Kingston-upon-Thames - KT2 6TN - UK Tel: +44 (0)20 8781 2900 / Fax: +44 (0)20 8781 2901
Manufacturer:
Laboratoire Chauvin - Z.I.Ripotier - 07200 Aubenas - France
Marketing Authorisation Number:
Minims® Dexamethasone Sodium Phosphate 0.1% w/v :
PL 0033/0153 (UK)
DATE OF PREPARATION: November 2008 Art.76548 GB242E01-05.07