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MINIMS DEXAMETHASONE SODIUM PHOSPHATE 0.1% W/V EYE DROPS SOLUTION.

Active substance(s): DEXAMETHASONE SODIUM PHOSPHATE

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Art.76886 P1UK02

Minims® Dexamethasone Sodium Phosphate 0.1% w/v
Eye Drops, solution
Dexamethasone 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. What Minims® Dexamethasone Sodium Phosphate eye drops are and what they are used for
2. What you need to know 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. Contents of the pack and other 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. What you need to know 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 of this medicine (listed in section 6).
•• 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.
Other medicines and your eye drops
Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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).
Pregnancy, breast-feeding and fertility
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
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The drops are for single use only and provided in 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.

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Art.76886 P1UK02

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. Twist and pull cap to separate from the Minims body (Diagram 1).
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
Diagram 1
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.
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.
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.
•• 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.
•• 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.
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 side effects directly via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store your eye 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 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 for single use only and provided in single use Minims units, to treat both eyes if necessary. Once opened, use immediately.
Discard any unused portion.
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.
By reporting side effects you can help provide more information on the safety of this medicine.
6. Contents of the pack and other information
What do your eye drops contain
•• The active substance 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 dihydrate, anhydrous disodium hydrogen phosphate
and purified water.
This medicine does not contain a preservative as it is a sterile single use unit.
What your eye drops look like and contents of the pack
Your eye drops are a colourless solution.
Each carton contains 20 units.
Marketing Authorisation Holder:
Bausch & Lomb UK 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 03468/0072 (UK)
This leaflet was last revised in: June 2015

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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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