The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: dexamethasone sodium phosphateOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Dexafree

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Dexamethasone sodium phosphate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Dexamethasone sodium phosphate

Equivalent medicines (same active substance, strength and form)

→ Maxidex brand

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

FOR

Warnings and precautions Tell your doctor, pharmacist or nurse before using Dexafree. 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 Dexafree and in particular:
for children and the elderly. More frequent monitoring is advised,
if you have an eye infection. Only use Dexafree 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 Dexafree, 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 Dexafree,
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 Dexafree 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 Dexafree.
contact lenses: do not wear contact lenses when you are using Dexafree.

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).

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 Dexafree. 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.

Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected]

Tell your doctor if you have blurred vision or other visual disturbances. Other medicines and Dexafree 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. Pregnancy and breast feeding There is not enough information on the use of Dexafree during pregnancy to know the possible side effects. For this reason, the use of Dexafree during pregnancy is not recommended. It is not known if this medicine is present in breast milk. However, the dose of Dexafree is low. Dexafree can be used when breast feeding.

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 national reporting system: United Kingdom 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.

What you need to know before you take it

E DEXAFREE

high pressure in the eye after 2 weeks of using the drops. Do not use Dexafree Common (may affect up to 1 in 10 people):
if you are suffering from an eye infection that you are not using a
discomfort, irritation, burning, stinging, itching and blurred vision medicine for, after use. These are usually mild and do not last long.
if you have damage on the surface of the eye (small holes, ulcers Uncommon (may affect up to 1 in 100 people): or injury which have not healed properly),
signs of an allergic reaction,
if you have high pressure in the eye known to be caused by
healing which takes longer than expected, glucosteroids (family of corticosteroid medicines),
cloudy lens (cataract),
if you are allergic (hypersensitive) to dexamethasone sodium phosphate, or any of the other ingredients of this medicine (listed • infections,
high pressure in the eye (glaucoma). in section 6).

How to take it

DEXAFREE supplied in single-dose containers. Each single-dose container contains 0.4 ml of solution. A pack Dose Always use this medicine exactly as your doctor has told you. Check contains 10, 20, 30, 50 or 100 single-dose containers packed in sachets. 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 Not all pack sizes may be marketed. treated. If your condition is more serious, you may be told to start Marketing Authorisation Holder with 1 drop every hour and then change to 1 drop every 4 hours, Laboratoires Théa after the medicine has started to work. It is important to lower the 12, rue Louis Blériot dose slowly to stop the condition getting worse again. 63017 Clermont-Ferrand Cedex 2

In elderly people: there is no need to adjust the dose. France
In children: do not use for long-term treatment without a break. Manufacturer Method of administration Laboratoire UNITHER Ocular use: this medicine is eye drops to be used in the eye. 1 rue de l'Arquerie  Wash your hands well before using these drops. 50200 Coutances  Look upwards and pull the lower eyelid down with your finger. Put France one drop into the eye to be treated. This medicine is authorised in the Member States of the EEA  Immediately after you have put the eye drop in, press lightly with under the following names: your finger on the inside corner of your eye, nearest your nose for Bulgaria, Cyprus, France, Greece, few minutes. This helps to stop the eye drops spreading into the Ireland, Poland, Portugal, Spain, rest of your body. Sweden and United Kingdom…………………………………………… DEXAFREE  Throw away the single-dose container after use. Do not keep it to Belgium, Luxembourg and the Netherlands……………………………………… use again. ……………………………………………………………. MONOFREE DEXAMETHASON Frequency of use Austria and Germany………………………………………………………….MONODEX 4 to 6 times a day. Italy and Slovenia ……………………………………………………………..DEXAMONO Denmark, Finland and Norway ………………………………………… MONOPEX Duration of treatment You will usually need to use your drops for a few days and no longer This leaflet was last revised in 11/2021. than 14 days. If you would like any more information, or would like the leaflet If you use more Dexafree than you should in a different format, please contact Medical Information at THEA Rinse the eye with sterile water if you have put too much medicine Pharmaceuticals Ltd, telephone number from UK 0345 521 1290, in your eye and your eye feels sore. from Ireland +44 (0) 345 521 1290 Immediately tell your doctor or pharmacist.

65NOTXXXX/X

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them:

Endocrine conditions: Not known: frequency cannot be estimated from the available data

Hormone problems: growth of extra body hair (particularly in Dexafree contains dexamethasone, which is a corticosteroid used women), muscle weakness and wasting, purple stretch marks on to stop inflammatory symptoms (such as pain, heat swelling and body skin, increased blood pressure, irregular or missing periods, redness). changes in the levels of protein and calcium in your body, stunted Dexafree is used to treat inflammation of your eyes. growth in children and teenagers and swelling and weight gain of If you have an infected eye (red eye, tears and mucous), you will be the body and face (called 'Cushing's syndrome') (see section 2, given another medicine to take at the same time as Dexafree. See "Warnings and precautions"). Section 2. Eye conditions: Very common (may affect more than 1 in 10 people):

How to store it

DEXAFREE 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 single-dose container after EXP. The expiry date refers to the last day of that month. Keep the single-dose containers in their sachet to protect them from light. After first opening the sachet, use the single-dose containers within 15 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 any medicines you no longer use. These measures will help protect the environment.

If you forget to use Dexafree Do not use a double dose to make up for a forgotten dose. If you stop using Dexafree Do not stop using this medicine suddenly. Always tell your doctor if you are thinking about stopping the treatment.

N1915U30L05/X0821

6. CONTENTS OF THE PACK AND If you are pregnant or breastfeeding, think you may be pregnant or OTHER INFORMATION are planning to have a baby, ask your doctor or pharmacist for advice What Dexafree contains before using this medicine.

The active substance is dexamethasone sodium phosphate. Each Driving and using machines millilitre of solution contains 1 mg of dexamethasone phosphate You may have blurred vision for a short time after using your drops. (as dexamethasone sodium phosphate). Wait until your vision is normal before you drive or use machines.
The other ingredients are disodium edetate, disodium phosphate Dexafree contains phosphates dodecahydrate, sodium chloride and water for injections. This medicine contains 80 micrograms phosphates in each drop. What Dexafree looks like and contents of the pack Dexafree is a clear colourless to slightly brown eye drops solution

Contents of the pack and other information

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Frequently asked questions about Dexafree

What is the active substance in Dexafree?

The active substance in Dexafree is dexamethasone sodium phosphate.

Are there equivalent medicines to Dexafree?

Medicines with the same active substance, strength and form include: Maxidex. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Dexafree, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Dexafree without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: dexamethasone sodium phosphate
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Dexamethasone sodium phosphate (24 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

For treatment of non-infectious inflammatory conditions affecting the anterior segment of the eye.

4.2. Posology and method of administration

Dexafree 1 mg/ml, eye drops, solution in single-dose container is for ocular use only. This product should be used only under close ophthalmic supervision.

Posology

The usual posology is of 1 drop 4 to 6 times daily in the affected eye.

In severe cases, treatment may be started with 1 drop every hour but dosage should be reduced to one drop every 4 hours when favourable response is observed. Gradual tapering off is recommended in order to avoid a relapse.

The duration of treatment will generally vary from a few days to a maximum of 14 days.

Elderly patients

There has been wide experience with the use of dexamethasone eye drops in elderly patients. The dosage recommendations given above reflect the clinical data derived from this experience.

Paediatric population

Efficacy and safety has not been established in the paediatric population.

In children, long-term continuous corticosteroid therapy should be avoided due to possible adrenal suppression (see section 4.4).

Method of administration

Dexafree is a sterile solution that does not contain a preservative. The solution from one individual single dose container is to be used immediately after opening for administration to the affected eye(s). For single-use only: since sterility cannot be maintained after the individual single dose container is opened, any remaining contents must be discarded immediately after administration.

Patients should be instructed:

- to wash their hands carefully prior to instillation,

- to avoid contact between the tip of the dispenser and the eye or eyelids,

- to throw away the single-dose container after use.

Nasolacrimal occlusion by compression of lacrimal ducts may reduce systemic absorption.

4.3. Contraindications

- Eye infections not controlled by anti-infectious treatment, such as:

Acute purulent bacterial infections including Pseudomonas and mycobacterial infections,

Fungal infections,

Epithelial Herpes simplex keratitis (dendritic keratitis), vaccinia, varicella zoster and most other viral infections of the cornea and conjunctiva,

Amoebic Keratitis,

- Perforation, ulceration and injury of cornea with uncompleted epithelialisation (see also section 4.4),

- Known glucocorticosteroid-induced ocular hypertension,

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Topical steroids should never be given for an undiagnosed red eye.

Patients should be monitored at frequent intervals during treatment with dexamethasone eye drops. Prolonged use of corticosteroid treatment may result in ocular hypertension/glaucoma (especially for patients with previous IOP induced by steroids or with pre-existing high IOP or Glaucoma) and also cataract formation, especially in children and elderly population.

The use of corticosteroids may also result in opportunistic ocular infections due to the suppression of host response or to the delay of their healing. In addition, topical ocular corticosteroids may promote, aggravate or mask signs and symptoms of opportunistic eye infections.

Patients with an eye infection should only receive local steroid treatment when the infection has been controlled by an effective anti-infectious treatment. Such patients should be carefully and regularly monitored by an ophthalmologist.

In some particular inflammatory conditions such as episcleritis, NSAIDS are the first line treatment, Dexamethasone should be used only if NSAIDS are contra-indicated.

Patients with a corneal ulcer should generally not receive topical dexamethasone except when inflammation is the main cause of healing delay and when the appropriate aetiological treatment has already been prescribed. Such patients should be carefully and regularly monitored by an ophthalmologist.

Thinning of the cornea and sclera may increase the risk of perforations with the use of topical corticosteroids.

This medicine contains 80 micrograms phosphates in each drop. Corneal calcification requiring corneal graft surgery for visual rehabilitation has been reported for patients treated with ophthalmic preparations containing phosphates such as Dexafree. At the first sign of corneal calcification the drug should be withdrawn and the patient should be switched to a phosphate-free preparation.

Posterior subcapsular cataract might occur at cumulative doses of dexamethasone.

Diabetics are also more prone to develop subcapsular cataracts following topical steroid administration.

The use of topical steroids in allergic conjunctivitis is only recommended for severe forms of allergic conjunctivitis not responding to standard therapy and only for a short period.

Cushing's syndrome and/or adrenal suppression associated with systemic absorption of ocular dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat). In these cases, treatment should be progressively discontinued.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Wearing of contact lenses during treatment with corticosteroid eye drops should be avoided.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

In case of concomitant treatment with other eye drops, solution, instillations should be spaced out by 15 minutes.

Superficial stromal corneal precipitations of calcium phosphate have been reported under combined use of corticosteroids and topical beta-blockers.

CYP3A4 inhibitors (including ritonavir and cobicistat): may decrease dexamethasone clearance resulting in increased effects and adrenal suppression/Cushing's syndrome. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid effects.

4.6. Fertility, pregnancy and lactation

Pregnancy

Insufficient data are available on the use of Dexafree 1 mg/ml, eye drops, solution in single-dose container in human pregnancy to assess possible harmful effects.

Corticosteroids cross the placenta. Teratogenic effects have been observed in animals (see section 5.3). However, there is no evidence to date that teratogenic effects are induced in humans. After systemic use of corticosteroids, at higher doses, effects on the unborn/neonate (intrauterine growth inhibition, inhibition of the function of the adrenal cortex) have been reported. However, these effects have not been reported for ocular use.

As a precautionary measure, it is preferable to avoid the use of Dexafree 1 mg/ml, eye drops, solution in single-dose container during pregnancy.

Breastfeeding

It is not known whether this medicine is excreted in breast milk. However the total dose of dexamethasone is low.

Dexafree 1 mg/ml, eye drops, solution in single-dose container can be used during lactation.

Fertility

There are no data on potential effects of Dexamethasone 1 mg/ml on fertility.

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

As with any eye drops, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs, the patient must wait until the vision is clear before driving or using machines.

4.8. Undesirable effects

Endocrine disorders:

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

Cushing's syndrome, adrenal suppression* (see section 4.4)

Eye disorders:

- Very common (≥1/10):

Increase of the intra-ocular pressure*.

- Common (≥1/100 to <1/10):

Discomfort*, irritation*, burning*, stinging*, itching* and blurred vision (see also section 4.4)*.

- Uncommon (≥1/1,000 to <1/100):

Allergic and hypersensitivity reactions, delayed wound healing, posterior capsular cataract*, opportunistic infections, glaucoma*.

- Very rare (<1/10,000, including isolated reports):

Conjunctivitis, mydriasis, facial oedema, ptosis, corticosteroid-induced uveitis, corneal calcifications, crystalline keratopathy, changes in corneal thickness*, corneal oedema, corneal ulceration and corneal perforation.

* see section Description of selected adverse reactions

Description of selected adverse reactions

Increase of the intra-ocular pressure, glaucoma and cataract may occur. Prolonged use of corticosteroid treatment may result in ocular hypertension/glaucoma (especially for patients with previous IOP induced by steroids or with pre-existing high IOP or Glaucoma) and also cataract formation, Children and elderly patients may be particularly susceptible to steroid-induced IOP rise (see section, 4.4).

Increase of the intra-ocular pressure induced by corticosteroid topical treatment has been generally observed within 2 weeks of treatment (see section 4.4.).

Diabetics are also more prone to develop subcapsular cataracts following topical steroid administration.

Discomfort, irritation, burning, stinging, itching and blurred vision frequently may occur immediately after instillation. These events are usually mild and transient and have no consequences.

In diseases causing thinning of the cornea, topical use of steroids could lead to perforation in some cases (see section 4.4).

Depression of adrenal function associated with systemic absorption of the product may occur when the instillations are administered with a frequent dosing schedule (see also sections 4.2 and 4.4).

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.

4.9. Overdose

In the case of topical overdosage, the treatment should be stopped. In case of prolonged irritation, the eye(s) should be rinsed with sterile water.

The symptomatology due to accidental ingestion is not known. As with other corticosteroids however, the physician may consider gastric lavage or emesis.

💬 Ask about this leaflet

Ask anything about Dexafree. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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