AMEXXINE 1 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Amexxine 1 mg/ml, eye drops solution

dexamethasone phosphate

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Amexxine and what is it used for

Amexxine is a multidose eye drop solution that contains the active substance dexamethasone. This substance is a corticosteroid that inhibits inflammatory symptoms.

Amexxine is indicated for the treatment of eye inflammation. The eye should not be infected (red eye, discharge, tearing, etc.); otherwise, this medicine should be combined with specific treatment for the infection (see section 2).

2. What you need to know before you start using Amexxine

Do not use Amexxine

• If you have an eye infectionthat may be bacterial (acute purulent infection), fungal, viral (herpes virus, vaccinia virus, varicella-zoster virus) or amoebic.
• If you have corneal damage(perforation, ulcers or lesions associated with incomplete healing).
• If you have ocular hypertension(high intraocular pressure) caused by glucocorticosteroids (corticosteroid family).
• If you are allergic(hypersensitive) to dexamethasone phosphate sodiumor any of the other components of this medicine (listed in section 6).

Warnings and precautions

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

DO NOT INJECT, DO NOT INGEST

Avoid contact between the tip of the dispenser and the eye or eyelids.

• Strict control by your ophthalmologist is required during the use of this medicine in any case and in particular:
• • In children and the elderly. More frequent ophthalmological monitoring is recommended.
  • If you have an eye infection, you should only use this medicine if the infection is being treated with an anti-infective.
  • If you have a corneal ulcer, do not use local treatment with dexamethasone or Amexxine, unless inflammation is the primary cause of delayed healing.
  • If you have high intraocular pressure or have previously experienced an increase in intraocular pressure after local steroid treatment, you are at risk of increased intraocular pressure if treated with Amexxine.
  • If you have glaucoma.
• Children: Prolonged treatment should be avoided.
• Severe allergic conjunctivitis: If you have severe allergic conjunctivitis that does not respond to usual treatment, use this medicine only for a short period.
• Diabetes: If you are diabetic, inform your ophthalmologist.
• Red eye: Do not use this medicine in case of undiagnosed red eye.
• Contact lenses: You should avoid wearing contact lenses during treatment with this medicine.
• Patients with a history of hypersensitivity to silver should not use this medicine, as the drops may contain traces of silver.

Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first manifestations of a syndrome called Cushing's syndrome. Suppression of adrenal gland function may occur after intensive or prolonged treatment with dexamethasone. 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.

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

Other medicines and Amexxine

If you are using any other medicine that is applied to the eye, you should wait 15 minutes between each application.

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

Calcium phosphate deposits in the cornea have been described during concomitant use of corticosteroids and local beta-blockers.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breastfeeding

• There is not enough data on the use of this medicine in pregnant women to assess the possible adverse effects.

For this reason, it is not recommended to use this medicine during pregnancy.

• It is not known if this medicine is excreted in breast milk. However, the total dose of dexamethasone is low.

Therefore, this medicine can be used during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

As with all eye drops, temporary blurred vision or other visual disturbances may affect your ability to drive or use machines. Do not drive or use machines until your vision has returned to normal.

Amexxine contains phosphates

This medicine contains 2.177 mg of phosphates in each ml of solution.

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

3. How to use Amexxine

Dosage

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is 1 drop, 4 to 6 times a day in the affected eye. In severe cases, treatment may be started with 1 drop every hour and should be reduced to 1 drop every 4 hours when a favorable response is observed. Gradual reduction of dose is recommended to avoid relapse.

• In elderly patients: no dose adjustment is necessary.
• In children: prolonged use should be avoided.

Method of administration

Ophthalmic route: this medicine is for administration in the eye.

Administration method

? Wash your handscarefully before using the product.

??Introduce one dropinto the affected eye, while tilting your head back slightly with your gaze directed upwards and pulling the lower eyelid down with your finger.

??Immediately after application, gently pressthe inner corner of the treated eye with your finger for a few minutes (to reduce the risk of systemic reactions and increase the penetration of the active substance into the eye).

? After use and before closing it again,the multidose container should be shaken once downwards, without touching the tip of the dropper, to eliminate any remaining liquid on the tip. This procedure is necessary to ensure the administration of the following drops.

Frequency of administration

4 to 6 times a day.

Duration of treatment

The duration of treatment may vary from several days to a maximum of 14 days.

If you use more Amexxine than you should

If too much product has been applied to the eye and you notice persistent irritation, rinse the eye with sterile water.

Contact your doctor or pharmacist immediately.

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

If you forget to use Amexxine

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

If you stop treatment with Amexxine

Do not stop treatment abruptly. Always consult your doctor if you decide to stop treatment.

If you have any further questions on 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 everybody gets them:

Endocrine disorders:

Uncommon (may affect up to 1 in 100 people)

• If used frequently, it is possible that the kidneys do not produce enough hormones (suppression of adrenal gland function). This may manifest as a decrease in blood sugar levels, dehydration, weight loss, and confusion.

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

Eye disorders:

Very common: may affect more than 1 in 10 people

• Increased intraocular pressure after 2 weeks of treatment.

Common: may affect up to 1 in 10 people

• Discomfort, irritation, burning, itching, stinging, and blurred vision after application. These symptoms are usually transient and mild.

Uncommon: may affect up to 1 in 100 people

• Allergic reactions and hypersensitivity to any of the components of the eye drops,
• Delayed wound healing,
• Clouding of the lens (cataract),

Infections,

• Glaucoma.

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

• Inflammation of the eye membranes (conjunctivitis),
• Pupil dilation (mydriasis),
• Swelling (facial edema),
• Drooping eyelid (ptosis),
• Inflammation of the iris (uveitis),
• Corneal calcification,
• Inflammation of the cornea (crystalline keratopathy),
• Changes in corneal thickness,
• Corneal edema,
• Corneal ulceration,
• Corneal perforation.
• Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet.

You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amexxine

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

Do not use this medicine after the expiry date stated on the multidose container after EXP. The expiry date is the last day of the month shown.

After first opening of the pouch: use the multidose container within 28 days of opening.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Amexxine

• The active substance is dexamethasone phosphate. Each ml of solution contains 1 mg of dexamethasone phosphate (as dexamethasone phosphate sodium).
• The other ingredients are sodium hydrogen phosphate dodecahydrate (E 399), sodium chloride, disodium edetate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

Appearance of Amexxine and contents of the pack

Amexxine is a clear and transparent eye drop solution that comes in a multidose container. Each multidose container is a 11 ml white low-density polyethylene bottle (with dropper and screw cap) containing 6 ml of solution. The carton contains 1 or 3 multidose containers.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Pharmaselect International Beteiligungs GmbH

Ernst-Melchior-Gasse 20

1020 Wien, Austria.

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

Austria, Bulgaria, Denmark, Germany, Netherlands: Dexanova

Belgium: Darazon

Croatia, Hungary, Czech Republic: Darazur

Slovakia: Daraoc

Italy, Portugal: Amexzur

Date of last revision of this package leaflet:January 2023.

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.