Package Leaflet: Information for the User

Fridex 1 mg/ml eye drops in single-dose solution

Dexamethasone phosphate

Read this 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This medication contains the active ingredient dexamethasone, which is a corticosteroid indicated to stop inflammatory symptoms (pain, heat, swelling, and redness).

This medication is indicated for the treatment of eye inflammation.

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

Do not useFridex

• if you are allergic to dexamethasone phosphate or any of the other components of this medication (listed in section 6);
• if you have an eye infection that may be caused by bacteria (acute purulent infection), fungi, or viruses (herpes virus, vaccinia virus, varicella virus) or caused by amoebas (a parasite);
• if you have damage to the surface of your eye (small holes, ulcers, or unhealed injuries);
• if you have high eye pressure that is known to be caused by glucocorticoids (a family of corticosteroid medications).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

Do not inject, do not ingest.

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

A strict eye control is needed during the use of Fridex and, in particular:

• for children and the elderly. A more frequent control is recommended.
• if you have an eye infection. Use this medication only if you are being treated with an anti-infective medication at the same time.
• if you have a corneal ulcer (an open wound on the surface of your eye with sometimes extreme pain, tears, squinting, and vision loss). Do not use this medication unless the inflammation is the main cause of the delayed healing.
• if you have high eye pressure. If you have already had high eye pressure after using an eye steroid medication, 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 your eyes) that another medication has not been able to treat. Use this medication only for a short period of time.
• if you have diabetes. Inform your ophthalmologist or optician about your disease before using this medication.
• if you have an undiagnosed red eye. Do not use this medication before talking to your doctor.
• diabetic: if you are diabetic, inform your ophthalmologist or optician.
• if you have an undiagnosed red eye, do not use this medication.
• for children and the elderly. A more frequent control is recommended.

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.

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

Children

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

Use of Fridex with other medications

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, as these medications may increase the amount of dexamethasone in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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.

Driving and operating machinery

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

Fridex contains phosphate

This medication contains 0.4461 mg of phosphates in 0.3 ml, which is equivalent to 1.487 mg/ml.

If you suffer a severe damage to the transparent layer on the front of your eye (the cornea), the phosphates may cause, in very rare cases, cloudy patches on the cornea due to the accumulation of calcium during treatment.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

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

If your condition is more severe, you may be instructed to start with 1 drop every hour and then change to 1 drop every 4 hours, after the medication has started to work. It is essential to reduce the dose gradually to avoid the condition worsening again.

Use in elderly people

No dosage adjustment is needed.

Use in children

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

Method of administration

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

1) Open the aluminum foil package containing 5 single-dose vials.

2) Wash your hands thoroughly before using these drops.

3) Separate a single-dose vial from the strip and open the top of the single-dose vial (Figure 1).

4) Tilt your head back and gently lower the lower eyelid with your finger (Figure 2). Place one drop in the eye to be treated. Avoid contact between the tip of the vial and the eye or eyelids (Figure 3).

5) Immediately after placing the drop in the eye, press gently with your finger on the inner corner of the eye closest to the nose for a few minutes (Figure 4). This helps prevent the eye drops from spreading to the rest of your body.

6) Dispose of the single-dose vial after use. Do not save it for reuse.

Treatment duration

Usually, 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 it hurts, rinse it 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 doses.

If you interrupt the treatment with Fridex

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

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

Like all medicines, this medicine 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)

• 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
• 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 be shown by low blood sugar levels, dehydration, weight loss, and feeling confused about where you are.

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

• inflamed surface of the eye that produces red eyes, tears, and irritation (conjunctivitis)
• enlarged pupil (mydriasis)
• swelling of the face (facial edema)
• 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, 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 of the surface of the eye (corneal edema)
• ulcer on the surface of the eye that causes pain, tears, closed eyes, and vision loss
• small holes in the surface of the eye (corneal perforation)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly tothe Spanish Medicinal Product Vigilance Systemvia www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

After opening the single-dose container: discard any residual solution remaining in the single-dose container after instillation.

Keep single-dose containers within the outer packaging to protect them from light and use within 60 days.

Store the single-dose container in the outer packaging to protect it from light.

Store below 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of containers and unused medications at the SIGRE point of the pharmacy or any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Fridex

• The active principle is dexamethasone sodium phosphate. Each milliliter of solution contains 1 mg of dexamethasone phosphate (as dexamethasone sodium phosphate), equivalent to 40 micrograms of dexamethasone phosphate (with a theoretical drop volume of approximately 40 microliters).

• The other components are: edetate disodium, dodecahydrate sodium phosphate, sodium chloride, hydrochloric acid (to adjust the pH), sodium hydroxide (to adjust the pH), and water for injectable preparations.

Appearance of the product and contents of the packaging

Fridex is a transparent and colorless solution that is supplied in single-dose containers.

Each single-dose container contains 0.3 mL of solution.

A box contains 20 or 30 single-dose containers packaged in sachets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

NTC S.r.l.

Via Luigi Razza, 3

20124 Milan (Italy)

Responsible manufacturer

Farmigea SpA

Via Giovan Battista Oliva, 6/8

56121 Pisa (PI)

Italy

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

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:

Portugal: Dexametasona NTC

United Kingdom: Dexamethasone phosphate 1 mg/mL (as sodium phosphate) Eye drops, Solution in a single-dose container

Spain: Fridex 1 mg/ml eye drops in solution in a single-dose container

Last review date of this leaflet: July 2019

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/