Bimican

Package Leaflet: Information for the Patient

Bimican, 0.3 mg/ml, eye drops, solution
Bimatoprost

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Bimican and what is it used for

Bimican is a medicine used to treat glaucoma. It belongs to a group of medicines called prostamides.
Bimican is used to lower high pressure in the eye. It can be used alone or with other eye drops called beta-adrenergic blockers, which also lower the pressure inside the eye.
The eye contains a clear, watery fluid that nourishes the inside of the eye. This fluid is constantly drained from the eye and replaced with new fluid. If it is not drained quickly enough, the pressure in the eye increases. The action of this medicine is to increase the amount of fluid drained, which in turn lowers the pressure inside the eye. If left untreated, high pressure can lead to a disease called glaucoma and eventually damage vision.

2. Important information before using Bimican

When not to use Bimican:

• if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).
• if you have previously had to stop using eye drops due to an adverse reaction to the preservative benzalkonium chloride.

Warnings and precautions

Before starting to use Bimican, discuss it with your doctor or pharmacist.
Tell your doctor if:

• you have breathing difficulties
• you have kidney or liver problems
• you have had cataract surgery
• you have dry eye syndrome
• you have or have had problems with the cornea (the transparent layer on the front of the eye)
• you wear contact lenses (see "Bimican contains benzalkonium chloride")
• you have or have had a slow heart rate or low blood pressure
• you have or have had a viral infection or inflammation in the eye.

During treatment with Bimican, you may experience loss of fat tissue around the eye, which can cause deepening of the eyelid fold, sunken eyes, drooping eyelids (ptosis), skin tightening around the eye (dermatochalasis), and increased visibility of the white part of the eye (visibility of the lower part of the sclera). These changes are usually mild but can affect vision if they are pronounced. The changes may disappear after stopping treatment with Bimican. Bimican may also cause darkening and excessive growth of eyelashes and may also cause darkening of the skin around the eyelid. It may also darken the color of the iris. These changes may be permanent. The changes may be more noticeable if only one eye is treated.

Children and adolescents

Bimican should not be used in children under 18 years of age due to a lack of studies in this age group.

Bimican and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Bimatoprost may pass into breast milk, so you should not breastfeed during treatment with Bimican.

Driving and using machines

After using Bimican, vision may be blurred for a short time. Do not drive or use machines until your vision is clear.

Bimican contains benzalkonium chloride, phosphates

The medicine contains 0.05 mg of benzalkonium chloride per milliliter.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. You should remove contact lenses before using Bimican and wait at least 15 minutes before putting them back.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer on the front of the eye). If you experience any abnormal sensations in the eye, stinging, or pain in the eye after using Bimican, you should contact your doctor.
The medicine contains 0.96 mg of phosphates per milliliter. In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposits during treatment.

3. How to use Bimican

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Bimican should only be used in the eyes. The recommended dose is one drop of Bimican in the evening, once a day, in each eye that needs treatment.
If you are using Bimican with another eye medicine, wait at least 5 minutes between using Bimican and the other medicine.
Do not use this medicine more often than once a day, as this may reduce the effectiveness of the treatment.

Method of administration:

Do not use the bottle if the seal on the bottle neck is broken before first use.

• 1. Wash your hands. Tilt your head back and look up at the ceiling.
• 2. Gently pull down the lower eyelid to form a small pocket.
• 3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.
• 4. Release the lower eyelid and close your eye for 30 seconds.

Wipe away any excess medicine that runs onto your cheek.
If a drop misses your eye, try again.
To prevent infections and avoid eye injury, do not touch the tip of the bottle to your eye or anything else. Immediately after use, replace the cap and tighten the bottle.

Using more Bimican than you should

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

Forgetting to use Bimican

If you forget to use a dose of Bimican, use a single 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.

Stopping treatment with Bimican

To be effective, Bimican must be used every day. If you stop using Bimican, it may cause an increase in pressure inside the eye (intraocular pressure). Therefore, before planning to stop treatment, talk to your doctor.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Very common side effects

(occurring in more than 1 in 10 patients)
Eyelid changes

• longer eyelashes (up to 45% of patients)
• mild redness (up to 44% of patients)
• itching (up to 14% of patients).

Changes around the eyes

• loss of fat tissue around the eye, which can lead to deepening of the eyelid fold, sunken eyes, drooping eyelids (ptosis), skin tightening around the eye (dermatochalasis), and increased visibility of the white part of the eye (visibility of the lower part of the sclera).

Common side effects

(occurring in less than 1 in 10 patients)
Eyelid changes

• allergic reaction in the eye
• eye fatigue
• sensitivity to light
• darkening of the skin around the eye
• darkening of the eyelashes
• pain
• feeling of a foreign body in the eye
• stickiness of the eyes
• darkening of the iris
• difficulty seeing clearly
• irritation
• burning sensation
• inflammation, redness, and itching of the eyelids
• excessive tearing
• dryness
• worsening of vision
• blurred vision
• clouding of the transparent layer covering the eye surface
• small injuries on the eye surface, with or without inflammation.

General changes

• headaches
• increased liver function test results
• increased blood pressure.

Uncommon side effects

(occurring in less than 1 in 100 patients)
Eyelid changes

• cystic macular edema (swelling of the retina in the eye leading to impaired vision)
• eye inflammation
• bleeding into the retina
• swelling of the eyelids
• twitching of the eyelids
• contraction of the eyelids and their separation from the eye surface
• redness of the skin around the eye.

General changes

• nausea
• dizziness
• weakness
• hair growth around the eye.

Side effects with unknown frequency

(frequency cannot be estimated from available data)
Eyelid changes

• eye discomfort.

General changes:

• asthma
• worsening of asthma
• worsening of chronic obstructive pulmonary disease (COPD)
• shortness of breath
• symptoms of an allergic reaction (swelling, redness of the eye, and skin rash)
• skin discoloration (around the eye).

Other side effects reported with the use of phosphate-containing eye drops
In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposits during treatment.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bimican

There are no special storage instructions for this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
The bottle should be discarded no later than 4 weeks after first opening, even if there are still drops left. This will help prevent infection. To remember the date you opened the bottle, note it on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bimican contains

• The active substance is bimatoprost. Each milliliter of solution contains 0.3 mg of bimatoprost.
• The other ingredients are disodium phosphate dodecahydrate, citric acid monohydrate, sodium chloride, benzalkonium chloride, and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain the appropriate acidity (pH value).

What Bimican looks like and contents of the pack

Bimican is a colorless, clear solution for use as eye drops. It is available in cardboard boxes containing 1, 3, or 6 plastic bottles with LDPE dropper and HDPE cap with a tamper-evident seal. Each bottle contains 3 milliliters of solution, sufficient for 4 weeks of treatment.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Rompharm Company SRL
Eroilor Street, no. 1A
Otopeni, 075100, Ilfov
Romania
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19
83-200 Starogard Gdański
Date of last revision of the leaflet:October 2024