FRIDEX 1 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Fridex 1 mg/ml Eye Drops Solution

dexamethasone phosphate

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fridex and what is it used for
2. What you need to know before you start using Fridex
3. How to use Fridex
4. Possible side effects
5. Storage of Fridex
6. Package Contents and Further Information

1. What is Fridex and what is it used for

This medicine contains the active substance dexamethasone, which is a corticosteroid indicated for the treatment of inflammatory symptoms (such as pain, heat, swelling, and redness).

This medicine is indicated for the treatment of eye inflammation.

If you have an eye infection (red eye, tears, and discharge), you will be given another medicine to use at the same time as Fridex (see section 2).

2. What you need to know before you start using Fridex

Do not use Fridex:

• If you are allergic to dexamethasone phosphate or any of the other ingredients of this medicine (listed in section 6);
• If you have an eye infection that may be caused by bacteria (acute purulent infection), fungi, viruses (herpes virus, vaccinia virus, chickenpox virus) or amoebas (a parasite);
• If you have damage to the surface of the eye (small perforations, ulcers, or lesions that have not healed properly);
• If you have high eye pressure and know it is caused by glucocorticosteroids (a family of corticosteroid medicines)

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Fridex.

Do not inject, do not swallow this medicine.

Avoid contact between the tip of the dispenser and the eye or eyelids.

• A strict eye control is needed during the use of Fridex, particularly:
• • For children and elderly people, more frequent control is recommended.
  • If you have an eye infection. Use this medicine only if you are being treated at the same time with 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 vision loss) do not use this medicine, unless the inflammation is the cause of delayed healing.
  • If you have high eye pressure. If you have already had high eye pressure after an ocular steroid treatment, you are at risk of having it again if you use this medicine.
  • If you have glaucoma, a disease that can cause damage to the optic nerve and can cause vision loss.

• Children: do not use for long-term treatment without a break.
• If you have severe allergic conjunctivitis (redness, swelling, itching, and tears in the eyes) that another medicine has not been able to treat. Use this medicine only for a short period of time.
• If you are diabetic, inform your ophthalmologist or optician about your disease before using this medicine.
• If you have a red eye that has not been diagnosed, do not use Fridex without consulting your doctor first.
• Avoid wearing contact lenses during the use of this medicine.

Talk to your doctor if you notice swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. A decrease in adrenal gland function may occur after stopping long-term or intensive treatment with this medicine. Talk to your doctor before stopping treatment on your own. These risks are especially important in children and patients treated with a medicine called ritonavir or cobicistat (used in the treatment of HIV).

Contact your doctor if you experience blurred vision or other visual disturbances.

Other Medicines and Fridex

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

If you are using other eye drops, wait 15 minutes before instilling the other medicine.

The combined use of eye drops containing steroids and eye drops containing beta-blockers (to treat high eye pressure) may cause calcium phosphate sedimentation on the surface of the eye.

Tell your doctor if you are using ritonavir or cobicistat (used in the treatment of HIV), as these medicines may increase the amount of dexamethasone in the blood.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, 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 assess the possible risks. For this reason, the use of this medicine during pregnancy is not recommended.

It is not known whether this medicine passes into breast milk. However, the dose of this medicine is low, so this medicine can be used during breastfeeding if your doctor considers it appropriate and under medical supervision.

Driving and Using Machines:

You may have blurred vision for a short time after using this eye drop. Wait until your vision is normal before driving or using machines.

Fridex Contains Phosphates

This medicine contains 13.385 mg of phosphates in each bottle, which is equivalent to 2.677 mg/ml. If you have severe corneal damage (the transparent layer on the front of the eye), treatment with phosphates, in very rare cases, can cause blurred vision due to calcium accumulation.

3. How to Use Fridex

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Recommended Dose

The usual recommended dose is 1 drop, 4 to 6 times a day in the affected eye.

In severe cases, treatment may start with 1 drop every hour and should be reduced to 1 drop every 4 hours when a favorable response is observed. Gradual discontinuation of treatment is recommended to avoid relapse.

Use in Elderly People

No dose adjustment of the medicine is needed.

Use in Children

Do not use this medicine in children for long-term treatment without a break.

Method of Administration

This medicine should be instilled into the eye. Do not inject or swallow the medicine.

1. Wash your hands well before use (Figure 1).
2. Remove the cap.
3. Hold the bottle, pointing downwards, with your thumb and fingers.
4. Look up and gently pull your lower eyelid down until a "pocket" forms between the eyelid and the eye (Figure 2).
5. Tilt your head back and place one drop into the affected eye (Figure 3).
6. Do not touch the dropper to the eye or eyelids, surrounding areas, or other surfaces. You could infect the eye drops.
7. Immediately after placing the drop in the eye, gently press the tear duct (the edge of the eye that meets the nose) for a few minutes with your finger. This helps the medicine not to come out of the eye. (Figure 4).
8. Close the bottle cap firmly immediately after use.

Duration of Treatment

You will need to use your drops for several days. Do not use this medicine for more than 14 days.

If You Use More Fridex Than You Should

If you have put too much medicine in your eye and notice lasting irritation, rinse your eye with sterile water.

Talk to your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If You Forget to Use Fridex

Do not use a double dose to make up for the forgotten dose.

If You Stop Using Fridex

Do not stop using this medicine abruptly. Inform your doctor if you are thinking of stopping treatment.

If you have any further questions about 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

• High eye pressure after 2 weeks of using the drops.

Common: may affect up to 1 in 10 people

• Eye 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
• Delayed wound healing
• Cloudy lens (cataract)
• Eye infections
• High eye pressure (glaucoma)

• If used frequently, it is possible that the kidneys may not produce enough hormones (suppression of adrenal function). This could lead to low blood sugar levels, dehydration, weight loss, and disorientation.

Rare: may affect up to 1 in 10,000 people.

• Inflammation on the surface of the eye that produces red eyes, tears, and irritation (conjunctivitis)
• Dilated pupil (mydriasis)
• Facial swelling (facial edema)
• Drooping eyelids (ptosis)
• Inflammation of the eye that causes pain and redness (uveitis)
• Calcium deposits on the surface of the eye (corneal calcification)
• Inflamed surface of the eye that provides blurred vision, dry eyes, sensitivity to light, burning, tears, and a gritty sensation in the eye (crystalline keratopathy)
• Changes in the thickness of the surface of the eye
• Swelling on the surface of the eye (corneal edema)
• Ulceration on the surface of the eye that causes pain, tears, squinting, and vision loss
• Small perforations on the surface of the eye (corneal perforation)

Frequency Not Known: cannot be estimated from the available data.

Hormonal problems: excessive body hair growth (particularly in women), weakness and muscle wasting, purple streaks on the skin, increased blood pressure, irregular or absent menstrual periods, changes in body protein and calcium levels, delayed growth in children and adolescents, and swelling and weight gain of the body and face (called "Cushing's syndrome") (see section 2, "Warnings and Precautions").

In very rare cases, some people with severe damage to the transparent layer on the front of the eye (cornea) have developed cloudy patches on the cornea due to calcium accumulation during treatment.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month stated.

Do not use the eye drops more than 28 days after first opening the bottle.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Further Information

Composition of Fridex

• The active substance is dexamethasone phosphate.
• Each ml of solution contains 1 mg of dexamethasone phosphate (as sodium dexamethasone phosphate).

The other ingredients are: disodium edetate, anhydrous disodium hydrogen phosphate, sodium chloride, and water for injectable preparations.

Appearance of the Product and Package Contents

It is a clear, colorless solution of 5 ml without visible particles in a 5 ml white LDPE bottle with a white Novelia nozzle (HDPE and silicone) and a white HDPE cap.

Marketing Authorization Holder

NTC S.r.l.

Via Luigi Razza, 3

20124

Milan - Italy

Manufacturer

Rafarm S.A.

Thesi Pousi-Xatzi Agiou Louka

Paiania Attiki 19002, P.O.Box37

Greece

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

NTC Ophthalmics Iberica, S.L.

Calle Pinar, 5

28006 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Italy: Fridex

Spain: Fridex

Date of Last Revision of this Package Leaflet:June 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/