Minims Dexamethasone sodium phosphate 0.1% w/v, Eye drops solution

• 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 in this medicine (listed in section 6).
• you currently have conditions affecting your cornea (the clear part at the front of your eye) such as damage to the cornea, or an ulcer (open sore/inflammation) on the cornea.
• you have any type of eye infection which you are not currently having treatment for, unless your doctor prescribed other medicines to treat the infection at the same time.
• it is intended for long term continuous treatment in children.

Talk to your doctor if you or your family have or have had a history of glaucoma (an increased pressure in your eye(s).

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 (a disorder that occurs when your body makes too much of the hormone cortisol over a long period of time). Suppression of the adrenal gland function may develop after stopping a long-term 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.

If you a have pre-existing eye infection you can receive Minims^® Dexamethasone Sodium Phosphate eye drops only while using specific medicines to treat infection at the same time.

You should avoid treatment with Minims^® Dexamethasone Sodium Phosphate for longer than 10 days except under medical supervision. Long-term treatment with dexamethasone may increase the risk of Cushing’s syndrome, fungal infection and glaucoma development.

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. If you use more than one type of eye medicine, take them at least 5 minutes apart. Eye ointments should be used last.

Minims^® Dexamethasone Sodium Phosphate used together with anticholinergics used for pupil dilatation during eye examinations (such as atropine) may increase the risk of increased pressure in your eye(s).

Use of Minims^® Dexamethasone Sodium Phosphate together with topical anti-inflammatory medicines (NSAIDs) may increase the potential for corneal healing problems.

Minims^® Dexamethasone Sodium Phosphate may be less effective if you are taking:

• medicine used to treat epilepsy (phenytoin, phenobarbitone)
• medicine used to make breathing easier by widening the airways during cold or flu (ephedrine)
• medicine used to treat tuberculosis (a serious illness that mainly affects the lungs) (rifampicin).

Minims^® Dexamethasone Sodium Phosphate can decrease the effects of medicines similar to aspirin called salicylates (indicated for inflammation, pain, fever and blood thinning).

Tell your doctor if you are using ritonavir or cobicistat (which are used to treat HIV/AIDS), 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 use 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 contact lenses may increase the risk of eye infection.

As with all eye drops, your vision may be blurred and you may have other visual disturbances after putting the drops in. Wait until your vision is clear before driving or using machines.

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 a minute. 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:

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.