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MINIMS PREDNISOLONE SODIUM PHOSPHATE 0.5% W/V EYE DROPS SOLUTION

Active substance(s): PREDNISOLONE SODIUM PHOSPHATE

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Minims® prednisolone sodium phosphate
0.5% w/v eye drops, solution
(prednisolone 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.
The name of your medicine is Minims prednisolone sodium phosphate 0.5% w/v eye drops, solution but it will be referred to
as Minims throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Minims is and what it is used for
What you need to know before you use your eye drops
How to use your eye drops
Possible side effects
How to store your eye drops
Contents of the pack and other information

1. What Minims is and what it is used for
Minims contains a corticosteroid.
It is used to treat inflamed eyes (red and painful) for which the inflammation is not caused by an infection. 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 (prednisolone) 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 have an eye infection.
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 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 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 eye 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.
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.
Diagram 1
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 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, 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.
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.
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.
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, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card Scheme at: http://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 out of the sight and reach of children.
Do not use the eye drops after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date
refers to the last day of that month.
º
Do not store above 25 C. Do not freeze. Store in the original package in order to protect from light.
The eye drops are in special single use ‘Minims’ units, to treat both eyes if necessary. Once opened, use immediately.
Discard any unused portion.
If the medicine becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.
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. Contents of the pack and other information
What Minims contains
Each single dose unit (0.5ml) contains 2.5mg prednisolone sodium phosphate.
The active ingredient is prednisolone sodium phosphate.
The other ingredients are disodium edetate, sodium dihydrogen phosphate dihydrate, 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.
What Minims looks like and contents of the pack
Minims is a clear, colourless, eye drops, solution.
Minims is available in packs containing 20 sterile single-dose units.
Manufactured by: Laboratoire Chauvin, Z.I. Ripotier, 07200 Aubenas, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
®

Minims prednisolone sodium phosphate 0.5% w/v eye drops, solution;
PL 18799/2861
POM
Leaflet date: 20.06.2016

Prednisolone sodium phosphate
0.5% w/v eye drops, solution
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.
The name of your medicine is Prednisolone sodium phosphate 0.5% w/v eye drops, solution but it will be referred to as
Prednisolone throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Prednisolone is and what it is used for
What you need to know before you use your eye drops
How to use your eye drops
Possible side effects
How to store your eye drops
Contents of the pack and other information

1. What Prednisolone is and what it is used for
Prednisolone contains a corticosteroid.
It is used to treat inflamed eyes (red and painful) for which the inflammation is not caused by an infection. 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 (prednisolone) 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 have an eye infection.
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.
Prednisolone 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).
Prednisolone 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 eye 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 Prednisolone 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. Twist and pull cap to separate from the
Prednisolone 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.
Diagram 1
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 Prednisolone 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 Prednisolone 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 Prednisolone, 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.
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.
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.
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, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card Scheme at: http://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 out of the sight and reach of children.
Do not use the eye drops after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date
refers to the last day of that month.
º
Do not store above 25 C. Do not freeze. Store in the original package in order to protect from light.
The eye drops are in special single use ‘Prednisolone’ units, to treat both eyes if necessary. Once opened, use immediately.
Discard any unused portion.
If the medicine becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.
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. Contents of the pack and other information
What Prednisolone contains
Each single dose unit (0.5ml) contains 2.5mg prednisolone sodium phosphate.
The active ingredient is prednisolone sodium phosphate.
The other ingredients are disodium edetate, sodium dihydrogen phosphate dihydrate, 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.
What Prednisolone looks like and contents of the pack
Prednisolone is a clear, colourless, eye drops, solution.
Prednisolone is available in packs containing 20 sterile single-dose units.
Manufactured by: Laboratoire Chauvin, Z.I. Ripotier, 07200 Aubenas, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
Prednisolone sodium phosphate 0.5% w/v eye drops, solution;
PL 18799/2861
POM
Leaflet date: 20.06.2016

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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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