Patient Information

Bimeox 0.3 mg/ml Eye Drops in Single-Dose Container

bimatoprost

Read the Entire Patient Information 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.
• Ask Your Doctor or Pharmacist if You Have Any Questions.
• This Medicine Has Been Prescribed for You Alone, 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 Side Effects, Ask Your Doctor or Pharmacist, Even If They Are Not Listed in This Leaflet. See Section 4.

Contents of the Patient Information Leaflet:

1. What Bimeox Is and for What It Is Used
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 Container and Additional Information

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

Bimeox is 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 medication acts 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.

Do not use this medication:

• 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 Bimeox.

Consult your doctor or pharmacist if:

During treatment, Bimeox may cause a loss of fat around the eye that can cause deepening of the eyelid crease, sunken 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 (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 Bimeox. Bimeox may also cause darkening and growth of eyelashes, as well as darkening of the skin around the eyelid. Over time, the iris color 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 patients under 18 years of age and should not be used in patients under 18 years of age.

Other medications and Bimeox:

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

Pregnancy, breastfeeding and fertility:

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

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

Driving and operating machinery:

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

Bimeox contains:

This medication contains 0.95 mg of phosphates in each ml of solution equivalent to 2.68 mg/ml of disodium phosphate heptahydrate..

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

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

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

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

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

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

1,2 3. Take a single-use vial from the bag and hold it in a vertical position (with the cap facing up) and turn the cap until it comes loose.

4. Gently pull the lower eyelid down to form a pocket. Invert the single-use vial and press until a drop falls into the affected eye or eyes.

5. Dispose of the single-use vial after use, even if there is solution left inside.

Wipe away any excess that runs down your cheek.

If you wear contact lenses, you must remove them before using this medication. Wait 15 minutes after using the drops to put in your contact lenses.

If you use more Bimeox than 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 immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Bimeox

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

If you interrupt treatment with Bimeox

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

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

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

Frequent side effects

These may affect more than 1 in 10 people

Affecting the eye

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

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
• Red eyelids

Rare side effects

These may affect up to 1 in 100 patients

Affecting the eye

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

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

Side effects of unknown frequency

Affecting the eye

• Sticky eyes
• Ocular discomfort

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

• 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 values in some blood tests indicating 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 calcium accumulation during treatment.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for 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.

This medication is for single use and does not contain preservatives. Do not conserve unused solution.

Do not use this medication after the expiration date that appears on the single-dose packaging and on the box after the expiration date (EXP). The expiration date is the last day of the month indicated.

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

Medications should not be thrown down the drain or in the trash. Dispose of the containers and medications you do not need atthe pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. By doing so, you will help protect the environment.

Composition of Bimeox

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

Appearance of the product and contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios Salvat, S.A.

C/ Gall, 30-36 – 08950

Esplugues de Llobregat

Barcelona - Spain

Last review date of this leaflet: May 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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