Package Insert: Information for the User

Fridex 1 mg/ml Eye Drops in Solution

dexamethasone phosphate

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Fridex and how is it used

2. What you need to know before starting to use Fridex

3. How to use Fridex

4. Possible adverse effects

5. Storage of Fridex

6. Contents of the package and additional information

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

This medication is indicated for the treatment of eye inflammation.

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

No use Fridex:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fridex.

Do not inject, do not ingest this medication.

Avoid contact of the tip of the dispenser container with the eye or eyelids.

• A strict eye control is needed during the use of Fridex, especially:
• • For children and elderly people, a more frequent control is recommended.
  • If you have an eye infection. Use this medication only if you are being treated at the same time with an anti-infective medication.
  • If you have a corneal ulcer (an open wound on the surface of the eye with sometimes extreme pain, tears, squinting and vision loss) do not use this medication, unless the inflammation is the cause of the delayed healing.
  • If you suffer from high eye pressure. If you have already had high eye pressure after a steroid eye treatment, you are at risk of having it again if you use this medication.
  • If you have glaucoma, a disease that can cause damage to the optic nerve and can cause vision loss.

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

Consult 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. You may develop a decrease in adrenal gland function after interrupting a long-term or intensive treatment with this medication. Consult your doctor before stopping treatment on your own. These risks are especially important in children and patients treated with a medication called ritonavir or cobicistat (used in HIV treatment).

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

Other medications and Fridex

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

If you are using other eye drops, wait 15 minutes to instill the other medication.

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is not enough information about the use of this medication during pregnancy to evaluate the possible adverse effects. For this reason, the use of this medication during pregnancy is not recommended.

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

Driving and operating machinery:

You may experience blurry vision for a short period of time after using this eye drop. Wait until your vision is normal before driving or operating machinery.

Fridex contains phosphates

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, 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 begin with 1 drop every hour and should be reduced to 1 drop every 4 hours when a favorable response is observed. It is recommended to gradually discontinue treatment in order to avoid a relapse.

Use in elderly individuals

No dosage adjustment is needed for this medication.

Use in children

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

Administration form

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

1.Wash your handswell 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 with your finger until a "pocket" forms between the eyelid and the eye (Figure 2).

5. Tilt your head back and place one drop in the affected eye (Figure 3).

6. Do not touch the dropper to the eye or eyelid, surrounding areas or other surfaces. It could infect the eye drops.

7. Immediately after placing the drop in your eyes, gently press the lacrimal (the edge of the eye that meets the nose) with your finger for a few minutes. This helps the medication not to come out of the eye. (Figure 4).

8. Close the bottle cap tightly immediately after use.

Treatment duration

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

If you use more Fridex than you should

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

Inform your doctor or pharmacist immediately.

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

If you forgot to use Fridex

Do not use a double dose to compensate for the missed dose.

If you interrupt treatment with Fridex

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience 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

• Allergic reaction symptoms
• Wound healing that takes longer than expected
• Cloudy lens (cataract)
• Eye infections
• High eye pressure (glaucoma)

• If used frequently, it is possible that the kidneys will not produce enough hormones (corticosteroid suppression). This could cause low blood sugar, dehydration, weight loss, and disorientation.

Very 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 (edema facial)
• Drooping eyelids (ptosis)
• Inflammation of the eye that causes pain and redness (uveitis)
• Calcium sediment on the surface of the eye (corneal calcification)
• Inflamed surface of the eye that provides blurry vision, dry eyes, light sensitivity, 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 of 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 available data.

Endocrine problems: excessive hair growth (particularly in women), muscle weakness and wasting, purple striae on the skin, increased blood pressure, irregular or absent menstruation, changes in body protein and calcium levels, delayed growth in children and adolescents, and facial and body swelling and weight gain (called "Cushing's Syndrome") (see section 2, "Warnings and precautions").

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not use the eye drops after 28 days following the first opening of the bottle.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fridex

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

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

Appearance of the product and contents of the packaging

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

Marketing Authorization Holder

NTC S.r.l.

Via Luigi Razza, 3

20124

Milan - Italy

Responsible for Manufacturing

Rafarm S.A.

Thesi Pousi-Xatzi Agiou Louka

Paiania Attiki 19002, P.O.Box37

Greece

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

NTC Ophthalmics Iberica, S.L.

Calle Pinar, 5

28006 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Italy: Fridex

Spain: Fridex

Last review date of this leaflet:June 2020

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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