Patient leaflet - DEXAMETHASONE PHOSPHATE 1 MG / ML (AS SODIUM PHOSPHATE) EYE DROPS SOLUTION IN A SINGLE-DOSE CONTAINER
1. what dexamethasone phosphate is and what it is used for
Dexamethasone phosphate contains the active substance dexamethasone, which is a corticosteroid used to stop inflammatory symptoms (such as pain, heat swelling and redness).
Dexamethasone phosphate is used to treat inflammation of your eyes.
If you have an infected eye (red eye, tears and mucous), you will be given another medicine to take at the same time as Dexamethasone phosphate (see Section 2).
2. what you need to know before you use dexamethasone phosphate
Do not use Dexamethasone phosphate:
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– if you are allergic to dexamethasone sodium phosphate or any of the other ingredients of this medicine (listed in section 6);
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– if you have an eye infection that may be caused by bacteria (acute purulent infection), fungi or viruses (herpes virus, vaccinia virus, varicella virus), or caused by amoebas (a parasite);
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– if you have damage on the surface of the eye (small holes, ulcers or injury which have not healed properly);
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– if you have high pressure in the eye known to be caused by glucocorticoid (family of corticosteroid medicines).
Warnings and precautions
Talk to your doctor or pharmacist before using Dexamethasone phosphate.
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 Dexamethasone phosphate and in particular:
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– for children and the elderly. More frequent monitoring is advised.
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– if you have an eye infection. Use this medicine only if you are treated at the same time with an anti-infective medicine.
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– 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.
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– 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 Dexamethasone phosphate.
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– if you have glaucoma, a condition which can cause damage to the optic nerve and may cause loss of sight.
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– children: do not use for long-term treatment without a break.
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– if you have severe allergic conjunctivitis (redness, swelling, itching and tears in the eye) that another medicine has not been able to treat. Use this medicine only for a short period of time.
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– if you have diabetes. Tell your ophthalmologist or optician about your condition before using Dexamethasone phosphate.
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– if you have a red eye that has not been diagnosed. Do not use Dexamethasone phosphate before talking to your doctor.
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– diabetic: if you are diabetic, tell your ophthalmologist or optician.
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– if you have a red eye that has not been diagnosed, do not use Dexamethasone phosphate
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– for children and the elderly. More frequent monitoring is advised.
Avoid wearing contact lenses while 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 Dexamethasone 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.
Tell your doctor if you have blurred vision or other visual disturbances.
Children
Do not use this medicine in children for long-term treatment without a break.
Other medicines and Dexamethasone phosphate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are using any other eye drops, wait 15 minutes between instilling the other medicine.
Using eye drops containing steroids and eye drops containing beta-blockers (to treat high pressure in the eye) together may cause settling of calcium phosphate on the surface of the eye.
Tell your doctor if you are using ritonavir or cobicistat, as these medicines may increase the amount of dexamethasone in the blood.
Pregnancy and 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.
There is not enough information on the use of Dexamethasone phosphate during pregnancy to evaluate the possible side effects. For this reason, the use of Dexamethasone phosphate during pregnancy is not recommended.
It is not known if this medicine passes into breast milk. However, the dose of Dexamethasone phosphate is low, therefore this medicine can be used when breast-feeding.
Driving and using machines
You may have blurred vision for a short time after using these eye drops. Wait until your vision is normal before you drive or use machines.
Dexamethasone phosphate contains phosphate
Dexamethasone phosphate contains 0.4461 mg phosphates in 0.3 ml which is equivalent to 1.487 mg/ml.
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.
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3. Howto use Dexamethasone phosphate
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dose
The usual recommended 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.
Use in elderly
There is no need to adjust the dose of the medicine.
Use in children
Do not use the medicine for long-term treatment without a break.
Method of administration
This medicine must be instilled in the eye. Do not inject or swallow the medicine.
1) Open the foil sachet which contains 5 single dose containers.
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2) Wash your hands well before using these drops.
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3) Break off one single dose container from the strip and twist open the top of the single dose container (Figure 1).
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4) Tilt your head back and pull the lower eyelid down slightly with your finger (Figure 2). Put one drop into the eye to be treated. Avoid contact between the tip of the container and the eye or eyelids (Figure 3).
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5) 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 few minutes (Figure 4). This helps to stop the eye drops spreading into the rest of your body.
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6) Throw away the single-dose container after use. Do not keep it to use again.
Duration of treatment
You will usually need to use your drops for a few days. Do not use Dexamethasone phosphate for more than 14 days.
If you use more Dexamethasone phosphate than you should
If you have put too much medicine in your eye and your eye feels sore, rinse it with sterile water. Immediately tell your doctor or pharmacist.
If you forget to use Dexamethasone phosphate
Do not use a double dose to make up for a forgotten dose.
If you stop using Dexamethasone phosphate
Do not stop using this medicine suddenly. Inform your doctor if you are thinking about stopping the treatment.
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.
Very common (may affect more than 1 in 10 people)
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– 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
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– healing which takes longer than expected
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– cloudy lens (cataract)
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– eye infections
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– high pressure in the eye (glaucoma)
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– if used often, the kidneys may not produce enough hormones (suppression of corticoadrenal function). This could be shown by low blood sugar, dehydration, weight loss and feeling confused about where you are.
Very rare (may affect up to 1 in 10,000 people)
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– inflamed surface of the eye giving red eye, tears and irritation (conjunctivitis)
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– wide pupil (mydriasis)
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– swelling of the face (facial oedema)
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– drooping eyelids (ptosis)
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– inflammation of the eye which causes pain and redness (uveitis)
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– settling of calcium on the surface of the eye (calcification of the cornea)
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– inflamed surface of the eye giving blurred vision, dry eyes, sensitivity to light, burning, tears and a sandy sensation in your eye (crystalline keratopathy)
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– changes in the thickness of the surface of the eye
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– swelling of the surface of the eye (corneal oedema)
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– ulcer on the surface of the eye causing pain, tears, squinting and vision loss
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– small holes on the surface of the eye (perforation of the cornea)
Reporting of side effects
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 at the website: 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.
5. how to store dexamethasone phosphate
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
After opening of the single-dose container: discard any residual solution remained in the single dose container after instillation.
Keep the single-dose containers in their sachet in order to protect from light and use them within 60 days.
Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw any medicines you no longer use. These measures will help to protect the environment.
6. contents of the pack and other information
What Dexamethasone phosphate contains – The active substance is dexamethasone
sodium phosphate. Each ml of solution contains 1 mg of dexamethasone phosphate (as dexamethasone sodium phosphate), equal to 40 pg of dexamethasone phosphate (with theoretical drop volume of approximately 40 pL).
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– The other ingredients are: disodium edetate, disodium phosphate dodecahydrate, sodium chloride, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH) and water for injections.
What Dexamethasone phosphate looks like and contents of the pack
Dexamethasone phosphate is a clear and colourless solution supplied in single-dose containers.Each single-dose container contains 0.3 ml of solution.
A box contains 20 or 30 single-dose containers packed in sachets.
Marketing Authorization Holder
NTC S.r.l.
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Via Luigi Razza 3 20124 Milan (Italy)