Fridex 1 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fridex 1 mg/ml eye drops, solution

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 other people, even if they have the same symptoms as you, because it may 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

1. What Fridex is and what it is used for
2. What you need to know before using Fridex
3. How to use Fridex
4. Possible side effects
5. How to store Fridex
6. Contents of the pack and other information

1. What Fridex is and what it is used for

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

This medicine is indicated for the treatment of inflammation in your eyes.

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

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 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, varicella virus) or amoebae (a parasite);
• If you have damage to the surface of the eye (micro-perforations, ulcers, or lesions that have not healed properly);
• If you have high intraocular pressure and know it is caused by glucocorticosteroids (a family of corticosteroid medicines).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Fridex.

Do not inject, do not ingest this medicine.

Avoid contact between the tip of the dispensing container and the eye or eyelids.

• Strict eye monitoring is required during use of Fridex, particularly:

  • For children and elderly patients, more frequent monitoring is recommended.
  • If you have an eye infection. Use this medicine only if you are also being treated with an anti-infective medicine.
  • If you have corneal ulceration (an open sore on the eye surface causing sometimes severe pain, tearing, eyelid closure, and vision loss), do not use this medicine unless inflammation is delaying healing.
  • If you suffer from high intraocular pressure. If you have previously experienced high eye pressure after treatment with ocular steroids, you are at risk of experiencing it again when using this medicine.
  • If you have glaucoma, a condition that can damage the optic nerve and may lead to vision loss.

• Children: do not use for long-term continuous treatment.

• If you have severe allergic conjunctivitis (eye redness, swelling, itching, and tearing) not controlled by other medicines, use this medicine only for a short period.

• If you are diabetic, inform your ophthalmologist or optician about your condition before using this medicine.

• If you have a red eye that has not been diagnosed, do not use Fridex without first consulting your doctor.

• Avoid wearing contact lenses during use of this medicine.

Contact 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. Adrenal gland suppression may occur after stopping long-term or intensive treatment with this medicine. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and patients taking a medicine called ritonavir or cobicistat (used in HIV treatment).

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

Other medicines and Fridex

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 (used to treat high eye pressure) may cause calcium phosphate precipitation on the eye surface.

Inform your doctor if you are taking ritonavir or cobicistat (used in HIV treatment), 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is insufficient information on the use of this medicine during pregnancy to evaluate possible adverse effects. For this reason, 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; therefore, it may be used during breastfeeding if your doctor considers it appropriate and under medical supervision.

Driving and using machines:

You may experience blurred vision for a short period after using this eye drop. Wait until your vision returns to normal before driving or operating machinery.

Fridex contains phosphates

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

3. How to use Fridex

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose

The usual recommended dose is 1 drop, 4 to 6 times daily 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 in order to avoid relapse.

Use in elderly patients

No dose adjustment of the medicine is required.

Use in children

Do not use this medicine in children for long-term continuous treatment.

Method of administration

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

1. Wash your hands thoroughly before use (Figure 1).
2. Remove the cap.
3. Hold the bottle pointing downwards with your thumb and fingers.
4. Look upwards and gently pull down the lower eyelid with your finger until a "pocket" forms between the eyelid and the eye (Figure 2).
5. Tilt your head backwards and place one drop into the affected eye (Figure 3).
6. Do not touch the eye or eyelid, surrounding areas, or other surfaces with the dropper tip. This could contaminate the eye drops.
7. Immediately after instilling the drop, gently press with your finger on the tear duct (the inner corner of the eye near the nose) for a few minutes. This helps prevent the medicine from draining out of the eye (Figure 4).
8. Close the cap tightly immediately after use.

Duration of treatment

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

If you use more Fridex than you should

If you have applied too much medicine to your eye and experience persistent irritation, rinse the eye with sterile water.

Inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 considering 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 everyone gets them.

Very common: may affect more than 1 in 10 people

• Increased eye pressure occurring 2 weeks after starting 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

• Increased eye pressure (glaucoma)

• With frequent use, the adrenal glands may not produce enough hormones (adrenal suppression). This could lead to low blood sugar levels, dehydration, weight loss, and confusion.

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

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

Frequency not known: cannot be estimated from the available data.

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

Very rarely, some people with severe damage to the transparent layer at the front of the eye (cornea) have developed cloudy patches in the cornea due to calcium buildup during treatment.

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Fridex Storage

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

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 must not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fridex

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

The other components are: disodium edetate, anhydrous disodium hydrogen phosphate, sodium chloride, and water for injections.

Appearance of the product and contents of the container

It is a clear, colourless solution free from visible particles, 5 ml in a white LDPE bottle of 5 ml with a white Novelia nozzle (HDPE and silicone) and a white HDPE cap.

Marketing Authorisation 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.Box 37

Greece

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

NTC Ophthalmics Iberica, S.L.

Calle Pinar, 5

28006 Madrid

Spain

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

Italy: Fridex
Spain: Fridex

Date of the most recent review of this leaflet: June 2020

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

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