Bimifocal 0.3 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bimi 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, because it could 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.

Leaflet contents

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

1. What Bimi is and what it is used for

Bimi is a medicine for glaucoma. It belongs to a group of medicines called prostamides.

This medicine is used to reduce elevated eye pressure. This medicine may be used alone or in combination with other eye drops called beta-blockers, which also reduce pressure.

The eye contains a clear, aqueous fluid that maintains the inner structure of the eye. This fluid is continuously drained out of the eye, and new fluid is produced to replace it. If the fluid does not drain quickly enough, pressure inside the eye increases. This medicine works by increasing the drainage of fluid, thereby reducing the pressure inside the eye. If this pressure is not reduced, it may lead to a condition called glaucoma and cause damage to your vision.

This medicine does not contain preservatives.

2. What you need to know before using Bimi

Do not use Bimi

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine if:

• you have any respiratory problems
• you have liver or kidney problems
• you have previously undergone cataract surgery
• you currently have or have had low blood pressure or a slow heart rate
• you have had a viral infection or inflammation of the eye
• you wear contact lenses (see section 3)

During treatment, Bimi 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 (dermatocalasis involution), 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 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 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

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

Other medicines and Bimi

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, 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, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine may pass into breast milk; therefore, it should not be used during breastfeeding.

Driving and using machines

After instillation of bimatoprost, blurred vision may occur for a short period of time. Do not drive or operate machinery until you see clearly.

Bimi contains phosphates

This medicine contains 0.95 mg of phosphates per milliliter. If you have severe damage to the transparent layer at the front of the eye (the cornea), treatment with phosphates may, in very rare cases, lead to cloudy patches in the cornea due to calcium deposition.

3. How to use Bimi

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

This medicine is for ophthalmic use only. The recommended dose is one drop of bimatoprost once daily in the evening in each eye requiring treatment.

Bimatoprost has not been studied in patients wearing contact lenses. Contact lenses must be removed before instillation and may be reinserted 15 minutes after administration.

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

Bimi is a sterile solution without preservatives. See section 6. Appearance of Bimi and contents of the pack.

Before instilling eye drops:

• When using it for the first time, before administering a drop into the eye, you should first practice using the dropper bottle by slowly squeezing it to release one drop 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 (you may sit, lie down on your back, or stand 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 is damaged.
3. When using the medicine for the first time, unscrew the cap after ensuring that the tamper-evident seal on the cap has not been broken. You should feel slight resistance until this tamper-evident ring breaks (see image 1).
4. If the tamper-evident ring is loose, discard it, as it could fall into the eye and cause injury.
5. Tilt your head backwards and gently pull down the lower eyelid to form a pouch between the eye and the 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 gently squeezing the bottle (see image 3). Squeeze the bottle gently in the middle to release one drop into your eye. There may be a delay of a few seconds between squeezing 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. Press on the tear duct for about 2 minutes (by pressing a finger against the inner corner of the eye next to the nose) and keep your eyes closed during this time. This ensures that the drop is absorbed by the eye and likely reduces the amount of medicine draining through the tear duct into the nose.
8. Repeat steps 5 and 6 in the other eye if your doctor has instructed you to do so.
9. After use and before recapping, shake the bottle once downwards without touching the dropper tip to remove any residual liquid from the tip. This is necessary to ensure proper 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 shelf life of the medicine after first opening, a small amount of Bimi will remain in the bottle. Do not attempt to use the remaining excess medicine in the bottle. Do not use the eye drops for more than 90 days after first opening the bottle.

If a drop misses your eye, try again.

image 1 image 2 image 3 image 4

If you use more Bimi than you should

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

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

If you forget to use Bimi

If you forget to apply this medicine, use one drop as soon as you remember, and then continue with your usual routine. Do not use a double dose to make up for a forgotten dose.

If you stop using Bimi

This medicine must be used every day for it to work properly. If you stop using it, 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 side effect, consult your doctor or pharmacist. This includes possible side effects not mentioned in this leaflet.

Very common adverse effects

These may affect more than 1 in 10 patients

Affecting the eye

• Mild redness (up to 24% of people)
• Loss of fat around the eye area, which may lead to deepening of the eyelid groove, sunken eyes (enophthalmos), drooping 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 adverse effects

These may affect up to 1 to 9 in every 100 patients

Affecting the eye

• 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 around the eye
• Red eyelids

Uncommon adverse effects

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

Affecting the eye

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

Affecting the body

• Headaches
• Growth of hair around the eye

Adverse effects of unknown frequency

Affecting the eye

• Sticky eyes
• Ocular discomfort

Affecting the body

• 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, and skin rash)
• Dizziness
• High blood pressure
• Skin discoloration (periocular)

In addition to the adverse effects of bimatoprost 0.3 mg/ml single-dose, the following adverse effects have been observed with the multi-dose formulation containing preservatives for bimatoprost 0.3 mg/ml and may occur in patients using bimatoprost 0.3 mg/ml single-dose:

• Burning sensation in the eye
• Allergic reaction in the eye
• Eyelid inflammation
• Difficulty seeing clearly
• Worsening of vision
• Darker eyelashes
• Retinal hemorrhage
• Inflammation inside the eye
• Cystoid macular edema (retinal swelling within the eye leading to worsening of vision)
• Inflammation of the iris
• Eyelid twitching
• Eyelid contraction and separation from the eye surface
• Nausea
• Redness of the skin around the eye
• Weakness
• Increase in certain blood test values indicating liver function

Other adverse effects reported with eye drops containing phosphates:

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

Reporting of adverse effects

If you experience any adverse effect, talk to 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 Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bimi

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

Do not use this medicine after the expiry date stated on the carton and on the bottle following “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After first opening the bottle, store for up to 90 days at a temperature not exceeding 25 °C.

Discard 90 days after first opening the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bimi

• The active substance is bimatoprost.

Each ml 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 hydrogen phosphate dodecahydrate, citric acid monohydrate, sodium chloride, diluted hydrochloric acid (to adjust pH), water for injections.

Appearance of the product and contents of the container

Bimi is a clear, colourless solution.

This medicine is available in a white LDPE bottle (5 ml or 11 ml) with a multidose HDPE dropper dispenser, which prevents contamination of the contents through a silicone valve system, filtered air return to the bottle, and a tamper-evident HDPE screw cap, together with a cardboard box.

Pack sizes: cartons containing 1 or 3 bottles of 3 ml solution or 1 bottle of 9 ml solution.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Manufacturer

Rafarm S.A.

Thesi Pousi Xatzi Agiou Louka

Paiania, 190 02

Greece

Date of the most recent revision of this leaflet: July 2022

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