PACKAGE INSERT

Package Insert: Information for the User

Amiriox 0.3 mg/ml Eye Drops Solution

bimatoprost

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others 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 not listed in this package insert. See section 4.

Amirioxcontains the active ingredient bimatoprost, which is a medication for glaucoma. It belongs to a group of medications called prostamidas.

Bimatoprostis used to reduce high eye pressure in adults. This medication can be used alone or with other eye drops called beta-blockers that also reduce pressure.

This medication works by increasing the amount of fluid that drains from the eye to prevent accumulation. This reduces the pressure inside the eye. If this pressure is not reduced, it could cause a disease called glaucoma and damage your vision.

This medication does not contain preservatives.

No useAmiriox

• If you are allergic to bimatoprost or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to usebimatoprost.

Consult your doctor or pharmacist if:

• You have any respiratory problems
• You have liver or kidney problems
• You have had cataract surgery in the past
• You have or have had low blood pressure or low heart rate
• You have suffered a viral infection or eye inflammation

During treatment, Amiriox may cause a loss of fat around the eye that can cause deepening of the eyelid crease, eye sinking (enophthalmos), drooping of the upper eyelids (ptosis), stretching of the skin around the eye (dermatochalasis involution) and that the white lower part of the eye becomes more visible (exposure of the inferior sclera). The changes are usually mild, but if they worsen, they may affect your field of vision. The changes may disappear if you stop using Amiriox. Amiriox may also cause darkening and growth of eyelashes, as well as darkening of the skin around the eyelid. The iris color may darken. These changes may be permanent and more visible if only one eye is being treated.

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

Children and adolescents

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

Other medications and Amiriox

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

If you are using other eye drops, wait at least 5 minutes between the administration ofbimatoprostand the other eye drops. Eye ointments should be administered last.

Pregnancy,breastfeeding and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Bimatoprost may pass into breast milk, so you should not breastfeed while using this medication.

Driving and operating machinery

You may experience blurred vision for a short period of time after using this medication. Do not drive or operate machinery until you can see clearly again.

Amiriox contains phosphates

This medication contains 0.95 mg of phosphates in each ml. If you suffer from severe damage to the transparent layer of the front part of the eye (cornea), treatment with phosphates, in very rare cases, may cause blurred vision due to calcium accumulation.

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

Bimatoprostmust be used only in the eye. The recommended dose is one drop ofbimatoprostin each eye that requires treatment, once a day, in the late afternoon.

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

If you usebimatoprostwith another eye medication, wait at least 5 minutes between the use ofbimatoprostand the other eye medication.

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

This medication is a sterile solution that does not contain preservatives. See section 6.Appearance ofAmirioxand contents of the container.

Before administering the eye drops:

• When using it for the first time, practice using the bottle with dropper by slowly pressing until a drop is released into the air, away from the eye.
• When you are sure you can administer one drop at a time, choose the position you find most comfortable for administering the drops (sitting, lying on your back, or standing in front of a mirror).

Instructions for use:

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

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

To help prevent infections and eye injuries, prevent the tip of the container

from touching the eye or any other surface. Replace the cap and close the container immediately

after use.

Diagram 1.Diagram 2.Diagram 3.Diagram 4.

If you use moreAmirioxthan you should

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

If you forgot to useAmiriox

If you forgot to applythis medication, apply one drop as soon as you remember and then return to your usual routine. Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment with Amiriox

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience any type of side effect, consult your doctor or pharmacist, even if it is about possible side effects that do not appear in this leaflet.

Very common: may affect more than 1 in 10 people

Affecting the eye

• Mild redness (up to 24% of people)
• Loss of fat in the eye area that can cause deepening of the eyelid groove, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (dermatochalasis involution) and making the white lower part of the eye more visible (exposure of the inferior sclera).

Common: may affect up to 1 in 10 people

Affecting the eye

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

Uncommon: may affect up to 1 in 100 people

Affecting the eye

• Tired eyes
• Sensitivity to light
• Darker iris
• Swollen and itchy eyelids
• Excessive tearing
• Inflammation of the transparent layer covering the surface of the eye
• Blurred vision

Affecting the body

• Headaches
• Excessive hair growth around the eye

Unknown frequency: cannot be estimated from available data

Affecting the eye

• Sticky eyes
• Ocular discomfort

Affecting the body

• Asthma
• Worsening of asthma
• Worsening of chronic obstructive pulmonary disease (COPD)
• Difficulty breathing
• Allergic reaction symptoms (inflammation, redness of the eye and skin rash)
• Dizziness
• High blood pressure
• Decoloration of the skin (periocular)

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

• Burning sensation in the eye
• Allergic reaction in the eye
• Swelling of the eyelids
• Difficulty seeing clearly
• Worsening of vision
• Darkening of eyelashes
• Retinal hemorrhage (bleeding in the back of the eye)
• Inflammation in the interior of the eye
• Macular edema (inflammation of the retina inside the eye that leads to worsening of vision)
• Inflammation of the iris
• Fasciculations of the eyelid
• Eyelid separation from the surface of the eye
• Nausea
• Redness of the skin around the eye
• Weakness
• Increased values in some blood tests that indicate how the liver is functioning

Other side effects reported with eye drops containing phosphate

In very rare cases, some patients with severe damage to the transparent layer on the front of the eye (the cornea) have developed cloudy spots in the cornea, due to the accumulation of calcium during treatment.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is about possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

This medication does not require special storage conditions.

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

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

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

Dispose of the bottle 90 days after it has been opened for the first time.

Medications should not be thrown away through drains or in the trash. Deposit the containers and medications that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications that you do not need. In this way, you will help protect the environment.

Composition of Amiriox:

• The active ingredient is bimatoprost. One milliliter of solution contains 0.3 mg of bimatoprost.
• The other ingredients are sodium dodecahydrogenephosphate, citric acid monohydrate, sodium chloride, diluted hydrochloric acid (for pH adjustment), and water for injection.

Appearance of Amiriox and contents of the packaging

Amiriox is a colorless and transparent solution.

This medication is available in white LDPE bottles of 5 ml, with 3 ml of solution each, with a HDPE multidose dropper and a HDPE screw cap with a safety seal.

The dropper has a silicone valve system that prevents the reflux of contaminated liquid into the bottle and allows filtered air to enter.

Packaging sizes:

Boxes containing 1 or 3 bottles of 3 ml solution each.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

SIFI S.p.A.

Via Ercole Patti 36

95025 Aci Sant'Antonio (CT)

Italy

Responsible 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

SIFI IBÉRICA S.L.

C/ Poeta Joan Maragall, 47

4th floor, door 402

28020 Madrid - Spain

Last review date of this leaflet:August 2024

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