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

Active substance: DEXAMETHASONE SODIUM PHOSPHATE

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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

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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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