Dexafree 1 mg/ml eye drops solution in single-dose container
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
DEXAFREE 1 mg/ml, eye drops solution in single-dose container
Dexamethasone phosphate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Dexafree is and what it is used for
- What you need to know before using Dexafree
- How to use Dexafree
- Possible adverse effects
- How to store Dexafree
- Contents of the pack and other information
1. What Dexafree is and what it is used for
Dexafree is a solution for ophthalmic use supplied in single-dose containers containing a substance called dexamethasone. This substance is a corticosteroid that suppresses inflammatory symptoms.
Dexafree is indicated for the treatment of inflammation of the eye(s).
The eye must not be infected (red eye, discharge, tearing, etc.); otherwise, this medicine should be combined with specific treatment for the infection (see section 2).
2. What you need to know before using Dexafree
Do not use Dexafree:
• If you have an eye infection that may be bacterial (acute purulent infection), fungal, viral (herpes virus, vaccinia virus, varicella-zoster virus), or amoebic.
• If you have corneal damage (perforation, ulcers, or lesions associated with incomplete healing).
• If you have elevated intraocular pressure caused by glucocorticosteroids (a family of corticosteroids).
• If you are allergic (hypersensitive) to dexamethasone sodium phosphate or to any of the other components of Dexafree.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Dexafree.
DO NOT INJECT, DO NOT INGEST
Avoid contact between the tip of the dispenser container and the eye or eyelids.
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If you use Dexafree, you must have strict monitoring by your ophthalmologist in all cases, and particularly:
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For children and elderly patients, more frequent ophthalmological monitoring is recommended.
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If you have an ocular infection, Dexafree should only be used if the infection is controlled with an anti-infective treatment.
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If you have corneal ulcers, do not use local treatment with dexamethasone or Dexafree unless inflammation is the cause of delayed healing.
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If you have elevated intraocular pressure or have previously experienced increased intraocular pressure after steroid treatment, you are at risk of increased intraocular pressure if treated with Dexafree.
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If you have glaucoma.
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Children: Prolonged treatment should be avoided.
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Severe allergic conjunctivitis: If you have severe allergic conjunctivitis unresponsive to standard therapy, Dexafree should be used only for short periods.
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Diabetes: If you are diabetic, inform your ophthalmologist.
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Red eye: Dexafree should not be used in cases of undiagnosed red eye.
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Contact lenses: You should avoid wearing contact lenses during treatment with Dexafree.
Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may occur after discontinuing intensive or long-term treatment with Dexafree. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and patients treated with a medicine called ritonavir or cobicistat.
Contact your doctor if you experience blurred vision or other visual disturbances.
Use of Dexafree with other medicines:
If you are using another eye drop solution, separate the instillations by 15 minutes.
Inform your doctor if you are taking ritonavir or cobicistat, as this may lead to increased levels of dexamethasone in the blood. Calcium phosphate deposits in the cornea have been reported during combined use of corticosteroids and topical beta-blockers.
Tell your doctor or pharmacist if you are using or have recently used, or might need to use, any other medicines.
Pregnancy and breastfeeding
There are insufficient data on the use of Dexafree in pregnant women to assess potential harmful effects.
For this reason, the use of Dexafree during pregnancy is not recommended.
It is not known whether this medicine is excreted in breast milk. However, the total dose of dexamethasone is low.
Therefore, Dexafree may be used during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines:
As with all eye drops, transient blurred vision or other visual disturbances may affect your ability to drive or operate machinery. If blurred vision occurs, patients should wait until vision is clear before driving or using machinery.
Athletes
Athletes should be informed that this medicine contains a component that may result in a positive analytical finding in doping control tests.
Dexafree contains phosphates
This medicine contains 80 micrograms of phosphates per drop.
3. How to use DEXAFREE
Dosage
Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is 1 drop, 4 to 6 times a day in the affected eye. In severe cases, treatment may be initiated with 1 drop per hour and should be reduced to 1 drop every 4 hours once a favorable response is observed. Gradual discontinuation of treatment is recommended to avoid relapse.
Use in elderly patients
In elderly patients, dose adjustment is not required.
Use in children and adolescents
In children, prolonged use should be avoided.
Method of administration
Ophthalmic use: this medicine is intended for administration into the eye.
?Wash your hands thoroughly before using the product.
? Tilt your head slightly backward, looking upward.
With the index finger of your free hand, gently pull down the lower eyelid of the affected eye.
Carefully administer one drop into the lower conjunctival sac.
? After administration, gently press with your finger on the tear duct for several minutes (to reduce the risk of systemic reactions and increase penetration of the active substance into the eye).
?Discard each single-dose container after use. Do not save it for later use.
Frequency of administration
4 to 6 times a day.
Duration of treatment
Treatment duration may vary from several days up to a maximum of 14 days.
If you use more Dexafree than you should:
If too much product has been instilled into your eye and you experience persistent irritation, rinse the eye with sterile water.
Contact your doctor or pharmacist immediately.
If you forget to use Dexafree:
Do not use a double dose to make up for the missed dose.
If you stop using Dexafree:
Do not stop treatment abruptly. Always consult your doctor if you decide to discontinue treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Endocrine disorders
- Frequency not known: cannot be estimated from available data.
- Hormonal problems: excessive growth of body hair (particularly in women), muscle weakness and wasting, purple stretch marks on the skin of the body, increased blood pressure, irregular or absent menstruation, changes in body protein and calcium levels, growth delay in children and adolescents, and swelling and weight gain in the body and face (Cushing's syndrome) (see section 2, "Warnings and precautions").
Eye disorders
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Very common: may affect more than 1 in 10 people
- Increased intraocular pressure after 2 weeks of treatment.
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Common: may affect up to 1 in 10 people
- Discomfort, irritation, burning, itching, stinging, and blurred vision after instillation.
These symptoms are usually transient and mild.
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Uncommon: may affect up to 1 in 100 people
- Allergic and hypersensitivity reactions to any component of the eye drops,
- Delayed wound healing,
- Clouding of the lens (cataract),
- Infections,
- Glaucoma.
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Very rare: may affect up to 1 in 10,000 people
- Inflammation of the eye membranes (conjunctivitis),
- Pupil dilation (mydriasis),
- Swelling (facial edema),
- Drooping of the eyelid (ptosis),
- Inflammation of the pigmented membrane of the iris (uveitis),
- Calcification of the cornea,
- Inflammation of the cornea (crystalline keratopathy),
- Changes in corneal thickness,
- Corneal edema,
- Corneal ulceration,
- Corneal perforation.
If you have severe damage to the transparent layer at the front of the eye (cornea), treatment with phosphates, in very rare cases, may lead to cloudy patches in the cornea due to calcium deposits.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Dexafree
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on each single-dose unit after EXP. The expiry date refers to the last day of the month indicated.
After first opening of the blister: Use the single-dose unit within 15 days of opening the blister.
After opening the single-dose unit: Use immediately and discard the single-dose unit after use.
Store the single-dose units in the blister to protect them from light.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dexafree
The active substance is dexamethasone sodium phosphate.
Each ml of solution contains 1 mg of dexamethasone phosphate (as dexamethasone phosphate and sodium).
The other components are disodium edetate, disodium hydrogen phosphate dodecahydrate, sodium chloride and water for injections.
Appearance of the product and contents of the pack
Dexafree is an eye drop solution which is colourless or slightly brown, presented in single-dose units.
Each single-dose unit contains 0.4 ml of solution. The carton contains 10, 20, 30, 50 or 100 single-dose units packed in blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Laboratoires Théa S.A.
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
(France)
Local Representative:
Laboratorios Thea S.A.
C/ Enric Granados, nº 86-88, 2nd floor
08008 Barcelona
(Spain)
Manufacturer:
EXCELVISION
Rue de la Lombardière, 07100 Annonay
(France)
OR
Laboratoires UNITHER
1 rue de l’Arquerie
50200 Coutances
(France)
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria, Cyprus, France, Greece, Ireland, Poland, Portugal, Spain and United Kingdom………………………………………………………………DEXAFREE
Belgium, Netherlands and Luxembourg….............MONOFREE DEXAMETHASON
Germany and Austria…………….…………………………………MONODEX
Italy and Slovenia………………………………………................DEXAMONO
Denmark, Finland, Norway and Sweden…………….……………..MONOPEX
Date of the most recent revision of this leaflet: August 2018
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):
http://www.aemps.es