Package leaflet: Information for the user

Fridex 1 mg/ml eye drops, solution

Dexamethasone phosphate
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. 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. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Fridex is and what it is used for
What you need to know before using Fridex
How to use Fridex
Possible side effects
How to store Fridex
Contents of the pack and other information

1. What Fridex is and what it is used for

Fridex is an eye drop that contains a substance called dexamethasone, a corticosteroid indicated for the treatment of inflammatory symptoms (such as pain, swelling and redness).
Fridex is indicated for the treatment of eye inflammation. The eye must not be infected (red eye, discharge, tearing); otherwise, specific treatment for the infection must be added (see section 2).
This medicine is a multi-dose eye drop solution without preservatives.

2. What you need to know before using Fridex

Do not use Fridex:

if you are allergic to dexamethasone phosphate or to any of the excipients in Fridex (see section 6).
if you have an ocular infection, such as bacterial infections (including acute purulent infections), fungal infections, viral infections (e.g. Herpes simplex, vaccinia virus, varicella-zoster) or those caused by amoebae (parasites).
if you have damage to the surface of the eye (perforation, ulceration, or lesions with incomplete re-epithelialization).
if you have known ocular hypertension induced by glucocorticoids (a family of corticosteroids).

Warnings and precautions
Talk to your doctor or pharmacist before using Fridex.
DO NOT INJECT, DO NOT INGEST.
Avoid contact between the tip of the container and the eye or eyelids.

If you use Fridex, you must always have regular ophthalmological check-ups, particularly:
In children and elderly patients, more frequent ophthalmological examinations are recommended.
If you have an ocular infection. You may use Fridex only if you are simultaneously receiving anti-infective treatment.
If you have corneal ulceration (an open wound on the eye surface with pain, tearing, squinting, and vision loss). You should not use topical dexamethasone treatment, or Fridex, unless inflammation is the main cause of delayed healing.
If you suffer from elevated intraocular pressure. If you previously experienced an increase in intraocular pressure during topical steroid treatment, you are at risk of developing increased intraocular pressure again when treated with Fridex.
If you have glaucoma, a condition that can damage the optic nerve and may lead to vision loss.
Children: Long-term, uninterrupted therapy should be avoided.
Severe allergic conjunctivitis: If you have severe allergic conjunctivitis (redness, swelling, itching, and tearing) unresponsive to standard therapy, Fridex may be used only for a short period.
Diabetes: If you are diabetic, inform your ophthalmologist or optometrist before using Fridex.
Red eye: Do not use Fridex if you have a red eye without a confirmed diagnosis.
Contact lenses: Do not wear contact lenses during treatment with Fridex. Contact your doctor if you experience swelling and weight gain in the trunk and face, as these are often the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may occur after discontinuation of prolonged or intensive treatment with Fridex. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and in patients treated with ritonavir- or cobicistat-containing medicines (used in HIV treatment).

Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Fridex
Contact your doctor or pharmacist if you are taking, or have recently taken, any other medicines.
If you are using another eye drop at the same time, wait at least 15 minutes between applications.
Calcium phosphate precipitations on the corneal surface have been reported during concomitant topical therapy with steroids and beta-blockers.
Inform your doctor if you are taking medicines containing ritonavir or cobicistat (used in the treatment of HIV), as they may increase the amount of dexamethasone in your blood.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is insufficient data on the use of Fridex during pregnancy to assess potential harmful effects. For this reason, the use of Fridex 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, so Fridex may be used during breastfeeding when strictly necessary and under direct medical supervision.
Driving and using machines
After using this product, temporary blurred vision or other visual disturbances may occur.
If this happens, do not drive or operate machinery until your vision is clear again.
Fridex contains phosphates
This medicine contains 13.385 mg of phosphates per vial, equivalent to 2.677 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, in very rare cases, cause corneal opacities due to calcium accumulation during treatment.

3. How to use Fridex

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose is 1 drop administered 4 to 6 times daily into the affected eye. In severe cases, treatment should begin with 1 drop every hour, then reduced to 1 drop every 4 hours once a favorable response is observed. A gradual reduction of the dosage is recommended to avoid relapse.

No dosage adjustment is required in elderly patients.
In children, long-term continuous therapy should be avoided.

Method of administration
Ophthalmic use: this medicine is for use in the eyes only.

Wash your hands thoroughly before application (Figure 1).
Unscrew the cap of the bottle.
Hold the bottle pointing downwards, grasping it between your thumb and other fingers.
Look upwards and pull down the lower eyelid with one finger to form a "pocket" between the eyelid and the eye (Figure 2).
Tilt your head backwards and instill one drop into the eye (Figure 3).
The tip of the dropper must not touch the eye, the area around the eye, or any other surfaces.
After applying Fridex, press with one finger on the inner corner of the eye near the nose for a few minutes. This prevents the medicine from being absorbed into the rest of the body (Figure 4).
Close the bottle tightly immediately after use.

Sequence of four numbered illustrations showing hand washing, the

Duration of treatment
The duration of treatment generally ranges from several days up to a maximum of 14 days.

If you use more Fridex than you should
If you have instilled an excessive amount of the product into the eye and experience persistent irritation, rinse the eye with sterile water. Contact your doctor or pharmacist immediately.

If you forget to use Fridex
Do not use a double dose to make up for the missed dose.

If you stop using Fridex
Do not stop treatment abruptly. Always consult your doctor before deciding to discontinue treatment.

If you have any questions about the use of this medicine, consult 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):

increased intraocular pressure after 2 weeks of treatment.

Common (may affect up to 1 in 10 people):

eye discomfort, irritation, burning, stinging pain, itching, and blurred vision after instillation. These effects are usually mild and do not last long.

Uncommon (may affect up to 1 in 100 people):

allergic or hypersensitivity reactions to one of the components of the eye drops,
delayed wound healing,
clouding of the lens (cataract),
eye infections,
increased eye pressure (glaucoma),
if used frequently, the adrenal glands might not produce enough hormones (suppression of adrenal cortical function). This condition may present as low blood sugar levels, dehydration, weight loss, and confusion.

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

inflammation of the surface of the eye characterized by redness, tearing, and irritation (conjunctivitis),
dilation of the pupil (mydriasis),
swelling of the face (facial edema),
drooping of the eyelids (ptosis),
inflammation inside the eye causing pain and redness (uveitis),
calcium deposits on the eye surface (corneal calcification),
inflammation of the surface of the eye causing blurred vision, light sensitivity, burning, tearing, and a gritty sensation in the eye (crystalline keratopathy),
changes in the thickness of the eye surface,
swelling of the surface of the eye (corneal edema),
ulceration on the surface of the eye causing pain, tearing, squinting, and vision loss,
small holes in the surface of the eye (corneal perforation).

Frequency not known
Hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and body and facial swelling with weight gain (called “Cushing's syndrome”) (see section 2, “Warnings and precautions”).
In very rare cases, patients with severe damage to the transparent layer at the front of the eye (cornea) have developed areas of corneal opacity due to calcium accumulation during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fridex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Fridex must be used within 28 days of first opening the bottle.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fridex contains

The active substance is dexamethasone phosphate. 1 ml of solution contains 1 mg of dexamethasone phosphate (as sodium dexamethasone phosphate).
The other components of Fridex are: disodium edetate, sodium chloride, anhydrous disodium phosphate, water for injections.

Description of the appearance of Fridex and contents of the pack
Clear, colourless aqueous solution in a 5 ml white LDPE (low-density polyethylene) vial,
fitted with a Novelia® delivery system made of HDPE (high-density polyethylene) and silicone, white, and with a white HDPE cap.
Marketing Authorisation Holder
NTC S.r.l. - Via Luigi Razza, 3 – 20124 - Milan, Italy
Exclusive Distributor for Sales
NTC Italia S.r.l. - Via dei Gracchi, 35 - 20146 Milan, Italy
Manufacturer
Rafarm S.A., Thesi Pousi-Xatzi Agiou Louka, 19002 Paiania, Attiki, Greece
This medicinal product is authorised in the European Economic Area countries under the following
names:
Italy: Fridex
Spain: Fridex