Prescription Information for the Patient

Bimi 0.3 mg/ml Eye Drops Solution

Bimatoprost

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

Bimiis a medication for glaucoma. It belongs to a group of medications called prostamides.

This medicationis used to reduce elevated eye pressure. This medication can be used alone or with other eye drops called beta-blockers that also reduce pressure.

The eye contains a clear, watery liquid that maintains the inner part of the eye. This liquid drains continuously out of the eye and new liquid is generated to replace it. If the liquid does not drain at a sufficient speed, the pressure inside the eye increases.This medicationacts by increasing the drainage of the liquid. 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 use Bimi

• 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 use this medication, 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 had a viral infection or inflammation of the eye
• You use contact lenses (see section 3)

During treatment, Bimi may cause a loss of fat around the eye that can cause deepening of the eyelid crease, sinking of the eyes (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 (inferior scleral exposure). The changes are usually mild, but if they worsen, they may affect your field of vision. The changes may disappear if you stop using Bimi.

Bimatoprost may also cause darkening and growth of 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 visible if only one eye is being treated.

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

Children and adolescents

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

Other medications and Bimi

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

If you are using other eye drops, leave at least 5 minutes between the application of Bimi and the other drops. Ophthalmic ointments should be administered last.

Pregnancy, breastfeeding and fertility

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

This medication may pass into breast milk, therefore, do not use it if you are breastfeeding.

Driving and operating machinery

After instillation of bimatoprost, you may experience blurred vision for a short period of time. Do not drive or operate machinery until your vision clears.

Bimi contains phosphates

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

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

This medication should only be applied to the eyes. The recommended dose is one drop of bimatoprost once a day, at night, in each eye that needs treatment.

Bimatoprost has not been studied in patients who use contact lenses. Contact lenses should be removed before installation and can be reinserted 15 minutes after administration.

Do not use more than once a day as the effectiveness of the treatment may be reduced.

Bimi is a sterile solution that does not contain preservatives. See section 6.Appearance of Bimi and contents of the package.

Before instilling eye drops:

• When using it for the first time, before administering a drop to the eye, first practice using the dropper bottle by slowly squeezing it to release a drop in the air, away from the eye.
• When you are sure you can administer one drop at a time, choose the position that feels most comfortable for you to instill the drops (you can sit, lie on your back, or stand in front of a mirror).

Usage instructions:

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 tamper-evident ring on the cap has not been broken. You should feel a slight resistance until this tamper-evident ring breaks (see image 1).
4. If the tamper-evident ring is loose, discard it because it could fall into the eye and cause injury.
5. Tilt your head back and gently pull down your lower eyelid to form a pouch between your eye and eyelid (see image 2). Avoid contact between the tip of the bottle and your eye, eyelids, or fingers.
6. Instill one drop into the pouch by slowly pressing on the bottle (see image 3). Squeeze the bottle gently in the middle and let one drop fall into your eye. There may be a delay of a few seconds between the pressure and the drop's release. Do not squeeze too hard. If you are unsure how to administer your medication, consult your doctor, pharmacist, or nurse.
7. Compress the tear duct for about 2 minutes (pressing a finger against the corner of your eye next to your nose), and close your eyes and keep them closed during this time. This ensures that the drop is absorbed by the eye and that the amount of medication that drains through the tear duct into your nose is likely to be reduced.
8. Repeat steps 5 and 6 in the other eye if your doctor has instructed you to do so.
9. After use and before re-capping, the bottle must be shaken once downwards, without touching the tip of the dropper, to eliminate any residual liquid in the tip. This is necessary to ensure the delivery of subsequent drops. After instillation, screw the cap back onto the bottle (see image 4).
10. Additional information for the bottle containing 9 ml of solution: At the end of the 90-day period of validity of the medication once opened, there will be a littleBimileft in the bottle. Do not attempt to use the remaining excess medication in the bottle. Do not use the eye drops for more than 90 days after the first opening of the bottle.

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

image 1image 2image 3image 4

If you use moreBimithan you should

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

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

If you forgot to useBimi

If you forgot to apply this medication, use 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 withBimi

This medicationshould be used every day for it to work well. If you stop using it, the pressure inside your eye may increase, so consult your doctor before interrupting 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 side effect, consult your doctor or pharmacist. This includes possible side effects not mentioned in this leaflet.

Very common side effects

These may affect more than 1 in 10 patients

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) and making the white lower part of the eye more visible (exposure of the inferior sclera).

Common side effects

These may affect up to 1 in 100 patients

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 side effects

These may affect between 1 and 9 in 1,000 patients

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

Side effects of unknown frequency

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 ofbimatoprost 0.3 mg/ml single-dose, the following side effects have been observed with the multidose formulation with preservatives forbimatoprost 0.3 mg/mland may occur in patients usingbimatoprost 0.3 mg/ml single-dose:

• Burning sensation in the eye
• Allergic reaction in the eye
• Swollen eyelid
• Difficulty seeing clearly
• Worsening of vision
• Darker eyelashes
• Retinal hemorrhage
• Inflammation inside 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
• The eyelid has contracted and separated from the surface of the eye
• Nausea
• Redness of the skin around the eye
• Weakness
• Increased levels of some blood tests that indicate how the liver is functioning

Other side effects reported with eye drops containing phosphates:

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

This medication does not require any special storage conditions.

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

Dispose of 90 days after the first opening of the bottle.

Medicines should not be thrown away through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE Pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Bimi Composition

• The active ingredient is bimatoprost.

Each milliliter of solution contains 0.3 mg of bimatoprost.

Each drop contains approximately 0.0087 mg of bimatoprost.

Each bottle contains 3 ml or 9 ml of solution.

• The other components are sodium dodecahydrate phosphate, citric acid monohydrate, sodium chloride, diluted hydrochloric acid (to adjust the pH), and water for injection preparations.

Product appearance and packaging contents

Bimiis a transparent and colorless solution.

This medication is available in a white LDPE bottle (5 ml or 11 ml) with a HDPE multidose dropper applicator, which prevents contamination of the content due to a silicone valve system, filtered air return to the bottle, and a HDPE tamper-evident cap, and a cardboard box.

Packaging sizes: boxes containing 1 or 3 bottles of 3 ml solution or 1 bottle of 9 ml solution.

Only some packaging sizes may be commercially marketed.

Marketing Authorization Holder

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Responsible for Manufacturing

Rafarm S.A.

Thesi Pousi Xatzi Agiou Louka

Paiania, 190 02

Greece

Last review date of this leaflet:July 2022

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