Patient leaflet - Dexamethasone 1 mg/ml eye drops, solution in single-dose Container
1. What Dexamethasone is and what it is used for
This medicine is an eye drop, solution in single-dose containers. It contains dexamethasone phosphate, which belongs to the group of corticosteroids that suppress certain inflammatory symptoms.
This medicine is used to treat inflammation of your eye(s).
If you have an infected eye (red eye, secretions and tears), you will be given specific treatment at the same time as this medicine (see section 2).
2. What you need to know before you take Dexamethasone
Do not take this medicine
if you are suffering from an eye infection caused by bacteria (such as acute pyogenic bacterial infection), fungal diseases, viral diseases (e.g. Herpes simplex, vaccinia, varicella zoster), or amebiasis,
- 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 corticosteroid medicines),
- if you are allergic to dexamethasone phosphate, or any of the other ingredients in this medicine (listed in section 6).
Warnings and precautions
Tell your doctor or pharmacist 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 treatment,
- if you have a corneal ulcer. Do not use topical dexamethasone treatment or 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 a topical steroid treatment, you are at risk of having this again if you use this medicine,
- if you have glaucoma.
- Children: do not use for long-term treatment without a break.
- Severe allergic conjunctivitis: if you have severe allergic conjunctivitis that another treatment has not been able to treat, only use this medicine for a short period of time.
- Diabetes: if you have diabetes, tell your ophthalmologist or optician.
- Red eye: If you have an undiagnosed red eye, do not use this medicine.
- Contact lenses: you should avoid wearing contact lenses during treatment 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 medicine called ritonavir or cobicistat.
Tell your doctor if you have blurred vision or other visual disturbances.
Other medicines and Dexamethasone.
If you are using any other eye drops, solution at the same time, you should wait 15 minutes between each instillation.
Tell your doctor if you are using ritonavir or cobicistat, as these medicines may increase the amount of dexamethasone in the blood.
Concomitant topical use of corticosteroids and beta-blockers 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.
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 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 this medicine is low. This medicine can be used when breast-feeding.
Driving and using machines
As with all eye drops, 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 phosphates
This medicine contains 18 micrograms phosphates in each drop. 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.
3. How to take Dexamethasone
Dose
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 1 drop, to be instilled into the affected eye 4 to 6 times a day. If your condition is more serious, you may be told to start with 1 drop every hour. 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 the elderly: there is no need to adjust the dose.
- In children: do not use for long-term treatment without a break.
Method of administration
Ocular use: this medicine is eye drops to be used 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 few minutes (to stop the eye drops spreading into the rest of your body and to give the active ingredient the best possible chance to enter the eye).
- 4. Throw away the single-dose container after use. Do not keep it to use again.
Frequency of use
4 to 6 times per day.
Duration of treatment
The duration of the treatment will generally vary from a few days to a maximum of 14 days.
If you use more of this medicine than you should
Rinse the eye with sterile water if you have put too much medicine in your eye and have prolonged irritation.
Contact your doctor or pharmacist immediately.
If you forget to use this medicine
Do not use a double dose to make up for a forgotten dose.
If you stop using this medicine
Do not stop using this medicine suddenly. Always tell 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.
Endocrine disorders
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”).
Eye disorders
Very common (may affect more than 1 in 10 people)
- high pressure in the eye after 2 weeks of treatment.
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)
- allergic and hypersensitivity reactions to any of the ingredients in the eye drops,
- healing which takes longer than expected,
- cloudy lens of the eye (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.
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: 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.
5. How to store Dexamethasone
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 carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
After first opening the sachet, keep the single-dose containers in the sachet and use them within 30 days.
After opening of the single-dose container: use immediately and throw away the single-dose container after use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What this medicine contains
- The active substance is dexamethasone phosphate. Each ml of eye drops, solution contains 1mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
- The other ingredients are disodium edetate (E386), sodium chloride, disodium hydrogen phosphate dihydrate (for pH-adjustment) (E339) and water for injections.
What this medicine looks like and contents of the pack
This medicine is a clear, colourless solution.
Each cardboard box contains single-dose containers (LDPE) filled with 0.4ml solution. The containers are presented in aluminium sachets of 5 or 10 containers, along with a Patient Information Leaflet.
Packages of 10, 20, 30, 50 or 100 single dose containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
14th km National Road 1
GR-145 64 Kifisia
Greece