• 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.

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

• 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).

Talk to your doctor if you experience swelling and weight gain around the trunk and in the face as these are usually the first manifestations of a syndrome called Cushing’s syndrome. Suppression of the adrenal gland function may develop after stopping a longterm or intensive treatment with Minims® Dexamethasone Sodium Phosphate. Talk to your doctor before stopping the treatment by yourself. These risks are especially important in children and patients treated with a drug called ritonavir or cobicistat.

Contact your doctor if you experience blurred vision or other visual disturbances.

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.

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

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).

Tell your doctor if you are using ritonavir or cobicistat, as this may increase the amount of dexamethasone in the blood.

Tell your doctor or eye specialist, he/she may decide to use these drops or to prescribe you an alternative.

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.

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.

Minims^® Dexamethasone Sodium Phosphate contains sodium dihydrogen phosphate dihydrate and disodium phosphate

This medicine contains 0.16mg phosphates in each drop which is the equivalent of 3.95mg/ml. If you suffer from severe damage to the clear layer at the front (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

• 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.

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 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 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:

Yellow Card Scheme - Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• 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.

Your eye drops are a colourless solution. Each carton contains 20 units.