Leaflet: information for the user

MAXIDEX 1 mg/ml eye drops in suspension

Dexamethasone

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as 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.

It is an eye drop suspension that contains dexamethasone as its active ingredient, a potent corticosteroid with anti-inflammatory and antiallergic properties, mainly, which reduces the inflammatory response caused by allergic, mechanical, or chemical agents.

Maxidex is indicated for the treatment of non-infectious eye inflammations that respond to corticosteroids, such as: anterior uveitis (inflammation of the uvea or middle layer of the eye), iris inflammation (iritis), ciliary body inflammation (ciclitis), or conjunctival inflammation (iridociclitis). Corneal inflammations (keratitis): keratitis caused by the Herpes Zoster virus and superficial keratitis punctata (with small points of damage on the cornea). Supplement in the treatment of flictenular keratoconjunctivitis (inflammation of the cornea and conjunctiva characterized by the presence of small nodules). Spring and allergic conjunctivitis. Corneal lesions caused by a foreign body. Thermal burns of the eyes.

Do not use Maxidex eye drops:

• If you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).
• If you have or think you have:
• • Untreated bacterial infection of the eye.
  • Corneal inflammation (keratitis) caused by herpes simplex or any other eye infection caused by a virus, such as smallpox or chickenpox.
  • Tuberculosis that affects the eye.
  • Fungal eye infections or untreated eye infections caused by parasites.

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Maxidex.

• Only use this medicine in your eye(s).
• This medicine may increase eye pressure, especially if you already have glaucoma or high eye pressure, or a family history, so you should use it under medical supervision.
• If you use this medicine for a long time, you may:
• • Develop high eye pressure and/or glaucoma (with optic nerve damage and decreased visual acuity). You should regularly check your eye pressure while using this medicine. Consult your doctor if you have any doubts. The risk of increased intraocular pressure and/or corticosteroid-induced cataract is higher in susceptible patients (e.g. diabetes).
  • Develop cataracts. You should visit your doctor regularly.
  • Develop Cushing's syndrome and/or adrenal gland suppression because the medicine reaches the blood. Consult your doctor if you experience 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 Maxidex. Consult 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.
• If your symptoms worsen or return suddenly, please contact your doctor. You may become more sensitive to eye infections with the use of this medicine. Corticosteroids can also mask the signs of an infection or intensify it, especially with prolonged use in pus-producing eye infections.
• If you already have a bacterial infection in your eyes, you should consult your doctor about your treatment.
• The prolonged use of corticosteroids in the eye may cause fungal infections of the cornea. In the event of such, treatment should be suppressed. The use of corticosteroids in the eye in excessive doses may delay the healing of eye wounds. It is also known that ocular NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) delay or slow down healing (see "Other medicines and Maxidex eye drops"). If you suffer from a condition causing thinning of the ocular tissue (the outer layers of the eye), the use of this medicine may cause corneal perforation.
• Contact your doctor if you experience blurred vision or other visual disturbances.

If you wear contact lenses:

• Wearing contact lenses (hard or soft) is not recommended during treatment of an eye inflammation.

Children:

The safety and efficacy of this medicine have not been established in children. Therefore, its use is not recommended in children.

The possible increase in intraocular pressure associated with the prolonged use of this medicine is especially important in pediatric patients; the risk of corticosteroid-induced glaucoma may be higher in children and occur before it does in adults.

Other medicines and Maxidex eye drops:

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

Inform your doctor if you are using ocular NSAIDs. The concomitant use of steroids and ocular NSAIDs may increase the problems of corneal healing.

Inform your doctor if you are using ritonavir or cobicistat, as it may cause an increase in the amount of dexamethasone in the blood.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The use of Maxidex during pregnancy is not recommended.

If you are breastfeeding, you should decide whether to stop breastfeeding or stop treatment with this medicine, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machinery:

You may notice that your vision becomes blurred for a while after applying the eye drops. Do not drive or operate machinery until this effect has disappeared.

Maxidex contains benzalkonium chloride and phosphates:

This medicine contains 0.5 mg of benzalkonium chloride in each 5 ml bottle, equivalent to 0.1 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove your contact lenses before using this medicine and wait 15 minutes before putting them back.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medicine.

This medicine contains 6.5 mg of phosphates in each 5 ml bottle, equivalent to 1.3 mg/ml.

If you have severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

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

Ophthalmic route (in the eye/s).

The recommended dose is:

Adults:

Generally instill 1 or 2 drops in the affected eye, 5 or 6 times a day.

When a satisfactory response is observed after 3-4 days, the administration frequency can be gradually reduced to less times a day.

The maximum recommended treatment duration is 14 days unless your doctor has given you different instructions.

Usage recommendations:

• Wash your hands.
• Take the bottle (dropper) and shake it well before using.
• After opening the bottle for the first time, remove the plastic ring from the cap if it is loose.
• Hold the bottle, upside down, between your fingers (figure 1).
• Incline your head backward. Gently separate your eyelid from your eye with a finger until a pouch forms between your eyelid and eye, where the drop should fall (figure 2).
• Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
• Do not touch your eye or eyelid, nearby areas or other surfaces with the dropper. The drops could become contaminated.
• Press gently on the base of the bottle to allow one drop to fall at a time (figure 3).
• After using this eye drop, press the edge of your eye near your nose with your finger. This helps prevent the medication from passing into the rest of your body (figure 4).
• If drops are applied to both eyes, repeat all previous steps for the other eye.
• Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

If you are using other eye medications,wait at least 5 minutes between administering this eye drop and the other eye medications. Eye creams should be administered last.

If you use more Maxidex than you should

An overdose in the eyes can be eliminated by rinsing the eyes with warm water. Do not apply more drops until the next dose.

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 used.

If you forgot to use Maxidex

Do not apply a double dose to compensate for the missed doses.

Apply a single dose as soon as you remember and continue with the next dose that was scheduled. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects are classified by frequencies, which are defined as: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data).

The following side effects have been reported with this medicine:

Common side effects :

• Eye effects: eye discomfort.

Uncommon side effects :

• Eye effects: corneal inflammation (keratitis), conjunctivitis, dry eye, corneal spot, light sensitivity (photophobia), blurred vision, abnormal sensation in the eye, tearing, crusts on the eyelid, itching, eye irritation or redness.

• General effects: altered sense of taste (bad taste).

Frequency not known :

• Eye effects: glaucoma (increased intraocular pressure with decreased visual acuity), corneal ulcer, increased intraocular pressure, reduced vision, corneal damage, eyelid drooping, eye pain, enlarged pupil.

• General effects: hypersensitivity (allergy), dizziness, headache.

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

The prolonged use of eye corticosteroids may also cause:

• Increased intraocular pressure with optic nerve damage and decreased visual acuity.
• Cataract formation.
• Delayed corneal healing.
• In diseases that cause corneal thinning, there is a higher risk of perforation.

Corticosteroids may reduce resistance to eye infections, favoring their appearance.

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 through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://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 store at a temperature above 30°C.

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

To prevent infections, discard the bottle 4 weeks after first opening it.

Note the date of opening the bottle in the reserved box on the box.

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

Composition of MAXIDEX eye drops

• The active ingredient is dexamethasone. 1 ml of suspension contains 1 mg of dexamethasone (0.1%).
• The other components are: benzalkonium chloride, anhydrous disodium hydrogen phosphate, polysorbate 80, disodium edetate, sodium chloride, hypromellose, citric acid monohydrate and/or sodium hydroxide and purified water.

Appearance of the product and contents of the packaging

Maxidex is a white or slightly yellowish suspension eye drop. It is presented in a dropper bottle (plastic bottle with a screw cap).

Each package contains 5 ml of eye drops.

Holder of the marketing authorization

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona -Spain

Responsible for manufacturing

Siegfried El Masnou, S.A.

C/Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

or

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg, Germany

Last review date of this leaflet:January 2021

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