BIMEOX 0.3 mg/ml EYE DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS

Introduction

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Bimeox 0.3 mg/ml eye drops solution in single-dose container

bimatoprost

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• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. What is Bimeox and what is it used for

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

Bimeox is used to reduce high pressure in the eye. This medicine can be used alone or with other eye drops called beta-blockers that also reduce pressure.

The eye contains a clear, watery liquid that keeps the inside of the eye healthy. This liquid is constantly drained out of the eye and new liquid is produced to replace it. If the liquid does not drain quickly enough, the pressure inside the eye increases. This medicine works by increasing the drainage of the liquid. This reduces the pressure inside the eye. If this pressure is not reduced, it could lead to a disease called glaucoma and damage your vision.

This medicine does not contain preservatives.

2. What you need to know before starting to use Bimeox

Do not use this medicine:

• If you are allergic to bimatoprost or 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 Bimeox.

Talk to 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 had low blood pressure or a slow heart rate,
• you have had a viral infection or inflammation of the eye.

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

Children and adolescents

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

Other medicines and Bimeox

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor or pharmacist before using this medicine.

Bimeox may pass into breast milk, so you should not use it if you are breastfeeding.

Driving and using machines

After instilling Bimeox, you may experience blurred vision for a short time. Do not drive or use machines until you can see clearly.

Bimeox contains:

This medicine contains 0.95 mg of phosphates per ml of solution, equivalent to 2.68 mg/ml of disodium phosphate heptahydrate.

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

3. How to use Bimeox

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

The recommended dose is one drop in each eye that needs treatment, once a day, in the evening. This medicine should only be used in the eye.

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

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

Wash your hands before using it. Make sure the single-dose container is intact before using this medicine. The solution should be used immediately after opening the container. To avoid contamination, do not let the tip of the single-dose container touch the eye or any other surface.

1, 2, 3. Take a single-dose container from the bag and hold it upright (with the cap facing up) and twist the cap until it comes off.

4. Gently pull the lower eyelid down to form a pouch. Turn the single-dose container upside down and squeeze until one drop falls into the eye or affected eyes.

5. Discard the single-dose container after use, even if there is still solution inside.

Wipe away any excess that runs down your cheek.

If you wear contact lenses, you should remove them before using this medicine. Wait 15 minutes after using the drops before putting your contact lenses back in.

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If you use more of this medicine than you should, it is unlikely to cause you 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, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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

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Bimeox should be used every day for it to work well. If you stop using Bimeox, the pressure in the eye may increase, so talk to your doctor before stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects

These may affect more than 1 in 10 people

Affecting the eye

• Mild redness (up to 24% of people)
• Fat loss in the eye area that can cause deepening of the eyelid sulcus, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (involution of dermatocalasis), and increased visibility of the white part of the eye (inferior scleral exposure).

Common side effects

These 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
• Reddened eyelids

Uncommon side effects

These may affect up to 1 in 100 people

Affecting the eye

• Tired eyes
• Sensitivity to light
• Darker iris
• Inflamed and itchy eyelids
• Watery eyes
• Inflammation of the clear layer that covers the surface of the eye
• Blurred vision

• Affecting other parts of the body
• Headaches
• Excessive hair growth around the eye

Rare side effects

Affecting the eye

• Sticky eyes
• Eye discomfort

Affecting other parts of the body

• Asthma
• Worsening of asthma
• Worsening of chronic obstructive pulmonary disease (COPD)
• Breathing difficulties
• Symptoms of an allergic reaction (inflammation, redness of the eye, and skin rash)
• Dizziness
• High blood pressure
• Discoloration of the skin (periocular)

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

• Burning sensation in the eye
• Allergic reaction in the eye
• Eye lid inflammation
• Difficulty seeing clearly
• Worsening of vision
• Darker eyelashes
• Retinal hemorrhage
• Inflammation inside the eye
• Cystoid macular edema (inflammation of the retina inside the eye that leads to worsening of vision)
• Iris inflammation
• Eye lid twitching
• The eye lid has contracted and separated from the surface of the eye
• Nausea
• Redness of the skin around the eye
• Weakness
• Increased levels of certain blood tests that indicate how the liver is working

Other side effects reported with phosphate eye drops:

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

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaram.es.

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

5. Storage of Bimeox

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This medicine is for single use and does not contain preservatives. Do not store the unused solution.

Do not use this medicine after the expiry date stated on the single-dose container and on the carton after the expiry date (EXP). The expiry date is the last day of the month shown.

This medicine does not require any special storage temperature. However, once the bag is opened, you should use it within 30 days.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to your pharmacist. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Bimeox

• The active ingredient is bimatoprost. One ml of solution contains 0.3 mg of bimatoprost.
• The other ingredients are sodium chloride, disodium phosphate heptahydrate (E339), citric acid monohydrate (E330), and water for injection. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain the normal level of acidity (pH levels).

Appearance and pack contents

Bimeox is a clear and transparent solution supplied in single-dose plastic containers, each containing 0.4 ml of solution.

The carton contains 3 aluminum bags, each with 10 single-dose containers, with a total of 30 single-dose containers in the carton respectively.

Marketing authorization holder and manufacturer:

Laboratorios Salvat, S.A.

C/ Gall, 30-36 – 08950

Esplugues de Llobregat

Barcelona - Spain

Date of last revision of this leaflet: May 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS)

http://www.aemps.gob.es/