AMIRIOX 0.3 MG/ML EYE DROPS SOLUTION

Package Leaflet: Information for the User

Introduction

PACKAGE LEAFLET

Package leaflet: information for the user

Amiriox 0.3 mg/ml eye drops solution

bimatoprost

Read the entire 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, and you should not give it to other people, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Amiriox is and what it is used for

Amiriox contains the active substance bimatoprost, which is a medicine for glaucoma. It belongs to a group of medicines called prostamides.

Bimatoprost is used to reduce elevated intraocular pressure in adults. This medicine can be used alone or in combination with other eye drops called beta-blockers that also reduce pressure.

This medicine works by increasing the amount of fluid drained from the eye, thereby preventing fluid buildup. This reduces the pressure inside the eye. If this pressure is not reduced, it could lead to a condition called glaucoma and damage your vision.

This medicine does not contain preservatives.

2. What you need to know before using Amiriox

Do not use Amiriox

• if you are allergic to bimatoprost or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

Talk to your doctor or pharmacist if:

• you have any breathing problems
• you have liver or kidney problems
• you have previously undergone cataract surgery
• you have or have had low blood pressure or a slow heart rate
• you have had a viral infection or ocular inflammation

During treatment, Amiriox may cause loss of fat around the eye, which can lead to deepening of the eyelid sulcus, sunken eyes (enophthalmos), drooping of the upper eyelids (ptosis), stretching of the skin around the eye (involution of dermatochalasis), and increased visibility of the lower white part of the eye (inferior scleral show). These changes are usually mild, but if they become more pronounced, they may affect your field of vision. These changes may resolve if you stop using Amiriox. Amiriox may also cause darkening and growth of the eyelashes, as well as darkening of the skin around the eyelid. It may darken the color of the iris. These changes may be permanent and more noticeable if only one eye is being treated.

If you have a history of contact hypersensitivity to silver, you should not use this medicine.

Children and adolescents

Bimatoprost has not been studied in individuals under 18 years of age and therefore should not be used in patients under 18 years of age.

Other medicines and Amiriox

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

If you are using other eye drops, wait at least 5 minutes between the administration of bimatoprost and the other eye drops. Ophthalmic ointments should be administered last.

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.

Bimatoprost may pass into breast milk; therefore, you should not breastfeed while using this medicine.

Driving and using machines

Blurred vision may occur for a short period of time after using this medicine. Do not drive or operate machinery until your vision clears.

Amiriox contains phosphates

This medicine contains 0.95 mg of phosphates per ml. If you have severe damage to the transparent outer layer at the front of the eye (cornea), treatment with phosphates may, in very rare cases, lead to blurred vision due to calcium accumulation.

3. How to use Amiriox

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

Bimatoprost should be used only in the eye. The recommended dose is one drop of bimatoprost in each eye requiring treatment, once daily, in the late afternoon.

Bimatoprost has not been studied in patients wearing contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them.

If you use bimatoprost with another eye medication, wait at least 5 minutes between using bimatoprost and the other eye medication.

Do not use the medicine more than once a day, as this may reduce the effectiveness of treatment.

This medicine is a sterile solution that contains no preservatives. See section 6. Appearance of Amiriox and contents of the container.

Before administering the eye drops:

• When using for the first time, practice using the dropper bottle by gently squeezing until one drop is dispensed into the air, away from the eye.
• Once you are confident that you can administer one drop at a time, choose the position that is most comfortable for instilling the drops (sitting, lying on your back, or standing in front of a mirror).

Instructions for use:

1. Wash your hands thoroughly before using this medicine.
2. Do not use the medicine if the container or bottle is damaged.
3. When using the medicine for the first time, unscrew the cap after ensuring that the security seal ring has not been broken. You should feel slight resistance until the security seal ring breaks (see drawing 1).
4. If the security seal ring becomes loose, discard it, as it could fall into the eye.
5. Tilt your head backward and gently pull down the lower eyelid to form a pouch between the eye and the eyelid (see drawing 2). Do not let the tip of the bottle touch the eye, eyelids, or fingers.
6. Gently squeeze the center of the bottle to release one drop into the eye (see drawing 3). There may be a delay of a few seconds between squeezing and the drop falling. Be sure not to squeeze too hard. If you are unsure how to use this medicine, consult your doctor, pharmacist, or nurse.
7. With the eye closed, press your finger against the corner of the closed eye (where the eye meets the nose) and hold for 2 minutes. This ensures the drop is absorbed by the eye and helps prevent the medicine from reaching the rest of the body.
8. Repeat steps 5, 6, and 7 in the other eye if your doctor has instructed you to do so.
9. After use, shake the bottle once in a downward direction, without touching the dropper tip, to remove any residual liquid from the tip. This will ensure proper administration of subsequent drops. Replace and tighten the cap on the bottle (see drawing 4).

If a drop does not reach your eye, try again.

To help prevent infections and avoid eye injury, ensure the tip of the container does not touch the eye or any other surface. Replace the cap and close the container immediately after use.

Drawing 1. Drawing 2. Drawing 3. Drawing 4.

If you use more Amiriox than you should

If you use more Amiriox than prescribed, it is unlikely to cause you any serious harm. Apply the next dose at the usual time. If you are concerned, consult your doctor or pharmacist.

If you forget to use Amiriox

If you forget to apply this medicine, instill one drop as soon as you remember, and then return to your regular routine. Do not apply a double dose to make up for a missed dose.

If you stop using Amiriox

This medicine must be used every day for it to work properly. If you stop using this medicine, the pressure inside the eye may increase; therefore, consult your doctor before stopping treatment.

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 can cause adverse effects, although not everyone experiences them.

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.

Very common: may affect more than 1 in 10 people

Eye-related effects:

• Mild redness (up to 24% of people)
• Loss of fat around the eye area, which may lead to deepening of the eyelid crease, sunken eyes (enophthalmos), drooping of the eyelids (ptosis), stretching of the skin around the eye (dermatocalasis involution), and increased visibility of the lower white part of the eye (inferior scleral show).

Common: may affect up to 1 in 10 people

Eye-related effects:

• Small erosions on the surface of the eye, with or without inflammation
• Irritation
• Itching of the eyes
• Pain
• Dryness
• Sensation of having something in the eye
• Longer eyelashes
• Darker skin color around the eye
• Red eyelids

Uncommon: may affect up to 1 in 100 people

Eye-related effects:

• Tired eyes
• Light sensitivity
• Darker iris
• Swollen and itchy eyelids
• Watery eyes
• Inflammation of the transparent layer covering the surface of the eye
• Blurred vision

Body-related effects:

• Headaches
• Growth of hair around the eye

Frequency not known: cannot be estimated from available data

Eye-related effects:

• Sticky eyes
• Ocular discomfort

Body-related effects:

• Asthma
• Worsening of asthma
• Worsening of the lung disease known as chronic obstructive pulmonary disease (COPD)
• Difficulty breathing
• Symptoms of allergic reaction (swelling, eye redness, skin rash)
• Dizziness
• High blood pressure
• Skin discoloration (periocular)

In addition to the adverse effects of bimatoprost 0.3 mg/ml in preservative-free single-dose units, the following side effects have been observed with the multidose formulation of bimatoprost 0.3 mg/ml containing preservatives and could occur in patients using the preservative-free multidose formulation of bimatoprost 0.3 mg/ml:

• Burning sensation in the eye
• Allergic reaction in the eye
• Eyelid inflammation
• Difficulty seeing clearly
• Worsening of vision
• Darkening of eyelashes
• Bleeding at the back of the eye (retinal hemorrhage)
• Inflammation inside the eye
• Cystoid macular edema (retinal inflammation within the eye leading to worsening vision)
• Inflammation of the iris
• Eyelid twitching (fasciculations)
• Eyelid separating from the surface of the eye
• Nausea
• Redness of the skin around the eye
• Weakness
• Increased values in certain blood tests indicating liver function

Other adverse effects reported with eye drops containing phosphate

Very rarely, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed cloudy spots in the cornea due to calcium deposits during treatment.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amiriox

This medicine does not require any special storage conditions.

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

Do not use this medicine after the expiry date stated on the label of the container and on the carton after “EXP”. The expiry date is the last day of the month indicated.

After first opening the bottle – store for 90 days at a temperature below 25°C.

Discard the bottle 90 days after first opening.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amiriox:

• The active substance is bimatoprost. One ml of solution contains 0.3 mg of bimatoprost.
• The other ingredients are sodium hydrogen phosphate dodecahydrate, citric acid monohydrate, sodium chloride, diluted hydrochloric acid (for pH adjustment), and water for injections.

Appearance of Amiriox and contents of the pack

Amiriox is a colourless and transparent solution.

This medicine is available in white LDPE bottles of 5 ml, each containing 3 ml of solution, with a multidose HDPE dropper dispenser and a screw cap made of HDPE with a tamper-evident seal.

The dropper dispenser incorporates a silicone valve system that prevents reflux of contaminated liquid back into the bottle and allows entry of filtered air.

Pack sizes:

Cartons containing 1 or 3 bottles, each with 3 ml of solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

SIFI S.p.A.

Via Ercole Patti 36

95025 Aci Sant'Antonio (CT)

Italy

Manufacturer

RAFARM S.A.

Thesi Pousi Xatzi Agiou Louka

190 02 Paiania

Greece

or

SIFI S.p.A.

Via Ercole Patti 36

95025 Aci Sant'Antonio (CT)

Italy

Local representative

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Date of the most recent revision of this leaflet: August 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.