Maxidex 1 mg/ml eye drops in suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MAXIDEX 1 mg/ml eye drops, suspension

Dexamethasone

Please read this entire leaflet carefully before you start using this medicine, as 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 others, even if they have the same symptoms as you, because it could 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.

Contents of this leaflet

1. What MAXIDEX eye drops are and what they are used for
2. What you need to know before using MAXIDEX eye drops
3. How to use MAXIDEX eye drops
4. Possible adverse effects
5. How to store MAXIDEX eye drops
6. Contents of the pack and other information

1. What Maxidex eye drops are and what they are used for

It is an ophthalmic suspension containing dexamethasone as the active substance, a potent corticosteroid with mainly anti-inflammatory and antiallergic properties, which reduces the inflammatory response caused by allergenic, mechanical or chemical agents.

Maxidex is indicated for the treatment of non-infectious ocular inflammations that respond to corticosteroids, such as: anterior uveitis (inflammation of the uvea or the eye's middle layer), inflammations of the iris (iritis), of the ciliary body (cyclitis), or combined inflammations (iridocyclitis). Corneal inflammations (keratitis): keratitis caused by the Herpes Zoster virus and superficial punctate keratitis (with small lesion spots on the cornea). Adjunctive treatment of phlyctenular keratoconjunctivitis (inflammation of the cornea and conjunctiva characterized by the presence of small nodules). Vernal and allergic conjunctivitis. Corneal injuries due to foreign bodies. Thermal burns of the eye.

2. What you need to know before using Maxidex eye drops

Do not use Maxidex eye drops:

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

Warnings and precautions

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

• Use this medicine only in your eye(s).
• This medicine may increase intraocular pressure, especially if you already have glaucoma or elevated intraocular pressure, or a family history of these conditions; therefore, it should be used under medical supervision.
• If you use this medicine for a long time, you may:
  • Develop ocular hypertension and/or glaucoma (with optic nerve damage and reduced visual acuity). You should have your eye pressure monitored regularly while using this medicine. Consult your doctor if you have any doubts. The risk of elevated intraocular pressure and/or corticosteroid-induced cataract formation is higher in predisposed patients (e.g., diabetes).
  • Develop cataracts. You should visit your doctor frequently.
  • Develop Cushing's syndrome and/or suppression of adrenal gland function due to the medicine reaching the bloodstream. 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. Suppression of adrenal gland function may occur after stopping intensive or long-term treatment with Maxidex. 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.
• If your symptoms worsen or return suddenly, please contact your doctor. You may become more susceptible to eye infections while using this medicine. Corticosteroids may also mask signs of infection or worsen it, especially with prolonged use in purulent eye infections.
• If you already have a bacterial eye infection, consult your doctor about appropriate treatment.
• Prolonged use of corticosteroids in the eye may lead to fungal infections of the cornea. If this occurs, treatment should be discontinued. Excessive use of corticosteroids in the eye may delay healing of eye wounds. Ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are also known to slow or delay healing (see section "Other medicines and Maxidex eye drops"). If you have a condition causing thinning of ocular tissue (the outer layers of the eye), using this medicine could lead to corneal perforation.
• Contact your doctor if you experience blurred vision or other visual disturbances.

If you wear contact lenses:

• Wearing contact lenses (rigid or soft) is not recommended during treatment for eye inflammation.

Children

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

The potential increase in intraocular pressure associated with prolonged use of this medicine is particularly important in pediatric patients; the risk of corticosteroid-induced ocular hypertension may be higher in children and may occur earlier than in adults.

Other medicines and Maxidex eye drops

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are using ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Concomitant use of steroids and ophthalmic NSAIDs may increase problems with corneal healing.

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

Pregnancy, breastfeeding, and fertility

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.

Use of Maxidex during pregnancy is not recommended.

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

Driving and using machines

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

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 may be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

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 foreign body sensation, stinging, 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 corneal damage (the transparent layer at the front of the eye), treatment with phosphates, in very rare cases, may cause blurred vision due to calcium accumulation.

3. How to use Maxidex eye drops

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

Ophthalmic use (in the eye[s]).

Recommended dose:

Adults:

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

When a satisfactory response is observed after 3-4 days, the frequency of administration may be gradually reduced to fewer times per day.

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

Instructions for use:

• Wash your hands.
• Take the bottle (dropper container) and shake it well before use.
• After opening the bottle for the first time, remove the loose plastic seal ring if present.
• Hold the bottle upside down between your fingers (figure 1).
• Tilt your head backwards. Gently pull down the eyelid to form a pocket between the eyelid and your eye, where the drop should fall (figure 2).
• Bring the tip of the bottle close to your eye. A mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip. The drops could become contaminated.
• Gently squeeze the base of the bottle so that one drop falls at a time (figure 3).
• After using these eye drops, press your finger against the inner corner of the eye next to the nose. This helps prevent the medicine from passing into the rest of the body (figure 4).
• If applying drops to both eyes, repeat all the previous steps for the other eye.
• Close the bottle tightly immediately after use.

If a drop misses the eye, try again.

If you are using other ophthalmic medicines, wait at least 5 minutes between administration of this eye drop and other ophthalmic medicines. Ophthalmic ointments should be administered last.

If you use more Maxidex than you should

An overdose in the eyes can be removed by rinsing the eyes with lukewarm water. Do not apply further drops until the next scheduled dose.

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 used.

If you forget to use Maxidex

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

Use a single dose as soon as you remember, and then continue with your next scheduled dose. However, if it is almost time for your next dose, do not take the missed dose and continue with your next dose as per your usual schedule.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects are classified by frequency, defined as follows: 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 adverse effects have been reported with this medicine:

Common adverse effects:

• Eye-related effects: eye discomfort.

Uncommon adverse effects:

• Eye-related effects: inflammation of the surface of the eye (keratitis), inflammation of the conjunctiva (conjunctivitis), dry eye, corneal spot, light sensitivity (photophobia), blurred vision, abnormal sensation in the eye, tearing, eyelid crusting, itching, eye irritation or redness.

• General effects: disturbance of taste sensation (bad taste).

Frequency not known:

• Eye-related effects: glaucoma (increased intraocular pressure with reduced visual acuity), corneal ulcer, increased pressure in the eye(s), reduced vision, corneal damage, drooping of the eyelid, eye pain, enlargement of the pupil.

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

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

Prolonged use of corticosteroids in the eyes may also cause:

• Increased intraocular pressure with damage to the optic nerve and reduced visual acuity.
• Cataract formation.
• Delayed healing of the cornea.
• In diseases causing corneal thinning, there is an increased risk of perforation.

Corticosteroids may reduce resistance to ocular infections, thereby increasing the risk of their occurrence.

Reporting of adverse effects

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

5. Storage of Maxidex eye drops

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

Do not store above 30°C.

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

To avoid infection, discard the bottle 4 weeks after first opening.

Record the date you opened the bottle in the space provided for this purpose on the carton.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines no longer needed. This helps protect the environment.

6. Contents of the container and other information

Composition of MAXIDEX eye drops

• The active substance 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, monohydrate citric acid and/or sodium hydroxide, and purified water.

Appearance of the product and contents of the pack

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

Each container holds 5 ml of eye drops.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona - Spain

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

Date of the most recent revision of this leaflet: January 2021

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/