Amiriox

Patient Information Leaflet: Information for the User

Amiriox 0.3 mg/mL eye drops, solution

Bimatoprost
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this 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 an antiglaucoma medicine. It belongs to a
class of medicines called prostamides.
Amiriox is used to reduce elevated intraocular pressure in adults. This medicine can be used alone or in
combination with other eye drops known as beta-blockers, which also help reduce pressure in the eye.
This medicine works by increasing the amount of fluid drained from the eye, thereby preventing its
accumulation. In this way, it reduces pressure inside the eye. If left untreated, elevated intraocular
pressure can lead to a condition called glaucoma and may eventually cause vision loss.
This medicine does not contain any preservative.

2. What you need to know before using Amiriox

Do not use this medicine

• 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 using Amiriox.
Consult your doctor or pharmacist if:

• you have breathing problems
• you have liver or kidney problems
• you have previously undergone cataract surgery
• you have or have previously had low blood pressure or a slow heartbeat
• you have had a viral infection or inflammation of the eye

Amiriox may cause darkening and lengthening of the eyelashes, and may also darken the skin around the eyelids. Over time, the colour of the iris may also darken. These changes may be permanent and are more noticeable if only one eye is treated. If you have previously experienced contact hypersensitivity to silver, you must not use this medicine.

Children and adolescents
Amiriox has not been tested in patients under 18 years of age and therefore must not be used in patients under 18 years of age.

Other medicines and Amiriox
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using another eye medicine, wait at least 5 minutes between applying Amiriox and the other medicine. Ocular ointments should be used last.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Amiriox may pass into breast milk; therefore, breastfeeding is not recommended during treatment with this medicine.

Driving and using machines
After administration of Amiriox, you may experience transient blurred vision. In this case, do not drive or operate machinery until your vision has cleared.

Amiriox contains phosphates
This medicine contains 0.9 mg of phosphates per millilitre. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use Amiriox

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Amiriox must be applied only to the eyes. The recommended dose is one drop of Amiriox once daily, in the
evening, in each eye to be treated.
Amiriox has not been studied in patients wearing contact lenses. Contact lenses must be removed prior to
instillation and may be reinserted 15 minutes after administration.
If you are using another eye medicine, wait at least 5 minutes after using Amiriox before applying the second
eye medicine.
Do not use it more than once a day, as the effectiveness of treatment may be reduced.
Amiriox is a sterile solution that contains no preservatives. See section 6. Description of the appearance of
Amiriox and contents of the pack.
Before administering the eye drops:

• If you are using the medicine for the first time, before instilling a drop into the eye, practice using the dropper bottle by gently squeezing it to release a drop, away from the eye.
• Once you are confident you can dispense one drop at a time, choose the position you find most comfortable for administering the eye drops (sitting, lying down, 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 packaging or bottle shows signs of damage.
3. When using the medicine for the first time, unscrew the cap after ensuring that the sealed ring on the cap is not broken. You should feel slight resistance until this tamper-evident ring breaks (see figure 1).
4. If the tamper-evident ring is loose, remove it, as it could fall into the eye and cause injury.
5. Tilt your head backward and gently pull down the lower eyelid to form a small pocket between the eye and the eyelid (see figure 2). Avoid letting the tip of the bottle touch the eye, eyelids, or fingers.
6. Instil one drop of eye drops into the pocket between the eye and the eyelid (conjunctival sac) by gently squeezing the bottle (see figure 3). Gently press the center of the bottle to release one drop into the eye. There may be a delay of a few seconds between squeezing the bottle and the drop coming out. Do not squeeze too hard. If you are unsure how to administer the medicine, consult your doctor, pharmacist, or nurse.
7. With the eye closed, press a finger against the corner of the eye (where the eye meets the nose) and hold pressure for 2 minutes. This ensures the drop is absorbed by the eye and helps prevent the medicine from entering the rest of the body.
8. Repeat steps 5, 6, and 7 in the other eye if prescribed by your doctor.
9. After use and before recapping, shake the bottle once downward without touching the dropper tip, to remove any residual liquid from the tip. This ensures proper delivery of subsequent drops. After instillation, screw the cap back onto the bottle (see figure 4).

If a drop misses the eye, try again.
To avoid eye infections and injury, the tip of the bottle must not touch the eye or come into contact with any other surfaces. After using the bottle, replace the cap and close the bottle securely.

Figure 1. Figure 2. Figure 3. Figure 4.
If you use more Amiriox than you should
Using more of this medicine than recommended is unlikely to cause serious harm. Take the next dose at your usual time. If you are concerned, consult your doctor or pharmacist.
If you forget to use Amiriox
If you forget to use this medicine, as soon as you remember, instil one drop and then continue with your regular dosing schedule. Do not use a double dose to make up for the missed dose.
If you stop using Amiriox
For Amiriox to work properly, it must be used every day. If you stop using Amiriox, your eye pressure may increase; therefore, you should speak with your doctor before stopping this treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist.
Very common: may affect more than 1 in 10 people
Eye-related

• Mild eye redness (up to 24% of people)

Common: may affect up to 1 in 10 people
Eye-related

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Itching of the eye
• Pain
• Dryness
• Feeling of a foreign body in the eye
• Longer eyelashes
• Darkening of the skin around the eye
• Red eyelids

Uncommon: may affect up to 1 in 100 people
Eye-related

• Tired eyes
• Light sensitivity
• Darkening of the iris colour
• Itchy and swollen eyelids
• Tearing
• Swelling of the transparent layer covering the surface of the eye
• Blurred vision

Systemic (affecting the whole body)

• Headache
• Growth of hairs around the eye

Frequency not known: frequency cannot be estimated from the available data
Eye-related

• Sticky eyes
• Eye discomfort

Systemic (affecting the whole body)

• Asthma
• Worsening of asthma
• Worsening of the lung disease known as chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, eye redness, skin rash)
• Dizziness
• Increase in blood pressure values
• Skin discolouration (around the eye)

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

• Burning sensation inside the eye
• Allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Darkening of eyelashes
• Retinal bleeding
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye leading to worsening of vision)
• Inflammation of the iris
• Eyelid spasms
• Eyelid tightening, pulling away from the eye surface
• Sunken eyes
• Nausea
• Redness of the skin around the eyes
• Weakness
• Increased liver function test values in blood analyses

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent layer of the front part of the eye (the cornea) have developed opaque areas on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 bottle and on the
package. The expiry date refers to the last day of that month.
After first opening the bottle: store for 90 days at a temperature below 25°C.
Discard the bottle 90 days after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amiriox contains

• The active substance is bimatoprost. One mL of solution contains 0.3 mg of bimatoprost.
• The other components are disodium phosphate dodecahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid, diluted (for pH adjustment), purified water.

Description of the appearance of Amiriox and contents of the pack
Amiriox is a clear, colourless solution.
This medicinal product is available in white LDPE bottles of 5 mL, each containing 3 mL of solution, with a multidose dropper made of HDPE and a tamper-evident HDPE screw cap.
The dropper has a silicone valve system that prevents reflux of contaminated liquid into the bottle and allows filtered air inflow.
Pack sizes:
Carton packs containing 1 or 3 bottles, each containing 3 mL of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SIFI S.p.A.
Via Ercole Patti 36
95025 Aci Sant'Antonio (CT)
Italy
Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A. (Warsaw Pharmaceutical Works Polfa S.A.)
22/24 Ul. Karolkowa
01-207 Warsaw
Poland