Puradex 1mg/ml eye drops, solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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 Puradex is and what it is used for
2 What you need to know before you use Puradex
3 How to use Puradex
4 Possible side effects
5 How to store Puradex
6 Contents of the pack and other information

• if you are suffering from an eye infection that you are not using a medicine for,
• if you have damage on the surface of the eye (small holes, ulcers or injury which have not healed properly),
• if you have high pressure in the eye known to be caused by glucosteroids (family of corticosteriod medicines),
• if you are allergic (hypersensitive) to dexamethasone sodium phosphate or any of the other ingredients of this medicine (listed in section 6).

Tell your doctor, pharmacist or nurse before using this medicine.

DO NOT INJECT, DO NOT SWALLOW.

Avoid contact between the dispenser tip and the eye or eyelids.

• Close monitoring of the eye is needed during the use of this medicine and in particular:
  • for children and the elderly. More frequent monitoring is advised,
  • if you have an eye infection. Only use this medicine if you are using an anti-infective medicine,
  • if you have a corneal ulcer, an open sore on the surface of the eye with sometimes extreme pain, tears, squinting and loss of vision. Do not use this medicine, unless inflammation is the main cause of delayed healing,
  • if you suffer from high pressure in the eye. If you have already had high pressure in the eye after using an eye steroid medicine, you are at risk of having this again if you use this medicine,
  • if you have glaucoma, a condition which can cause damage to the optic nerve and may cause loss of sight.
• Children: do not use for long-term treatment without a break.
• If you have severe allergic conjunctivitis (redness, swelling, itching and tears in the eye) that another medicine has not been able to treat, only use this medicine for a short period of time.
• Diabetic: if you are diabetic, tell your ophthalmologist or optician.
• If you have a red eye that has not been diagnosed, do not use this medicine.
• Contact lenses: do not wear contact lenses when you are using this medicine.

Talk to your doctor if you notice swelling and weight gain around your middle and in your face as these are usually the first signs of a condition called Cushing’s syndrome. Decrease in the function of the adrenal gland may develop after stopping a long-term or intensive treatment with this medicine. 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.

Tell your doctor if you have blurred vision or other visual disturbances.

If you are using any other eye medicine, wait 15 minutes between using each medicine.

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

Using eye drops containing steroids and eye drops containing betablockers (to treat high pressure in the eye) together may cause settling of calcium phosphate on the surface of the eye.

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

• There is not enough information on the use of this medicine during pregnancy to know the possible side effects. For this reason, the use of this medicine during pregnancy is not recommended.
• It is not known if this medicine is present in breast milk. However, the dose of dexamethasone in this medicine is low. This medicine can be used when breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You may have blurred vision for a short time after using your drops. Wait until your vision is normal before you drive or use machines.

This medicine contains 104 micrograms phosphates in each drop.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is 1 drop, 4 to 6 times a day in the eye to be treated. If your condition is more serious, you may be told to start with 1 drop every hour and then change to 1 drop every 4 hours, after the medicine has started to work. It is important to lower the dose slowly to stop the condition getting worse again.

• In elderly people: there is no need to adjust the dose.
• In children: do not use for long-term treatment without a break.

This medicine should be administered in the eye.

1. Wash your hands well before using these drops.
2. Look upwards and pull the lower eyelid down with your finger. Put one drop into the eye to be treated.
3. Immediately after you have put the eye drop in, press lightly with your finger on the inside corner of your eye, nearest your nose for a few minutes. This helps to stop the eye drops spreading into the rest of your body.
4. Avoid contact between the tip of the dispenser and the eye or eyelids.

4 to 6 times a day.

You will usually need to use your drops for a few days and no longer than 14 days.

Rinse the eye with sterile water if you have put too much medicine in your eye and your eye feels sore.

Immediately tell your doctor or pharmacist.

Do not use a double dose to make up for a forgotten dose.

Do not stop using this medicine suddenly. Always tell your doctor if you are thinking about stopping the treatment.

Not known (frequency cannot be estimated from the available data):

• Hormone problems: growth of extra body hair (particularly in women), muscle weakness and wasting, purple stretch marks on body skin, increased blood pressure, irregular or missing periods, changes in the levels of protein and calcium in your body, stunted growth in children and teenagers and swelling and weight gain of the body and face (called ‘Cushing’s syndrome’) (see section 2, “Warnings and precautions”).

Very common (may affect more than 1 in 10 people)

• high pressure in the eye after 2 weeks of using the drops.

Common (may affect up to 1 in 10 people)

• discomfort, irritation, burning, stinging, itching and blurred vision after use. These are usually mild and do not last long.

Uncommon (may affect up to 1 in 100 people)

• signs of an allergic reaction,
• healing which takes longer than expected,
• cloudy lens (cataract),
• infections,
• high pressure in the eye (glaucoma).

Very rare (may affect up to 1 in 10,000 people)

• inflamed surface of the eye giving red eye, tears and irritation (conjunctivitis),
• wide pupil (mydriasis),
• swelling of the face (facial oedema),
• drooping eyelids (ptosis),
• inflammation of the eye which causes pain and redness (uveitis),
• settling of calcium on the surface of the eye (calcification of the cornea),
• inflamed surface of the eye giving blurred vision, dry eyes, sensitivity to light, burning, tears and a sandy sensation in your eye (crystalline keratopathy),
• changes in the thickness of the surface of the eye,
• swelling of the surface of the eye (corneal oedema),
• ulcer on the surface of the eye causing pain, tears, squinting and vision loss,
• small holes on the surface of the eye (perforation of the cornea).

If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

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 the 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 millilitre of solution contains 1mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
• The other excipients are disodium edetate, sodium chloride, disodium hydrogen phosphate anhydrous, water for injection.

6ml solution in a white opaque 11ml LDPE bottle with white Novelia nozzle (HDPE and silicone) and a white HDPE cap, clear colourless solution, with no visible particles.