Bimican

Package leaflet: Information for the patient

Bimican, 0.3 mg/ml, eye drops, solution
Bimatoprostum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Bimican is and what it is 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 Bimican is and what it is used for

Bimican is a medicine used to treat glaucoma. It belongs to a group of medicines called prostamides.
Bimican is used to reduce elevated intraocular pressure. This medicine may be used alone or in combination with other eye drops called beta-blockers, which also reduce intraocular pressure.
The eye contains a clear, watery fluid that nourishes the inside of the eye. This fluid is continuously drained from the eye, and new fluid is produced to replace it. If the fluid is not drained sufficiently quickly, pressure inside the eye increases. This medicine works by increasing the outflow of fluid, thereby reducing intraocular pressure. Untreated elevated pressure may lead to a disease called glaucoma and ultimately to vision damage.

2. Important information before using Bimican

When not to use Bimican:

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

Warnings and precautions
Before starting treatment with Bimican, discuss this with your doctor or pharmacist.
Inform your doctor if:

• the patient has breathing difficulties
• the patient has kidney or liver function disorders
• the patient has undergone cataract surgery
• the patient has dry eye syndrome
• the patient has or has had corneal problems (the transparent layer at the front of the eye)
• the patient wears contact lenses (see section "Bimican contains benzalkonium chloride")
• the patient has or has had bradycardia or low blood pressure
• the patient has had or currently has a viral infection or inflammation in the eye.

During treatment with Bimican, loss of periorbital fat tissue may occur, which can lead to deepening of the eyelid sulcus, enophthalmos, upper eyelid ptosis, skin tightness around the eye (dermatochalasis-induced involution), and increased visibility of the lower white part of the eye (exposure of the lower sclera). These changes are usually mild, but if pronounced, they may affect the visual field. These changes may resolve after discontinuation of Bimican treatment. Bimican may also cause darkening and excessive growth of eyelashes, as well as darkening of the skin around the eyelid. It may also darken the iris color. These changes may be permanent. Changes may be more noticeable when only one eye is treated.

Children and adolescents
Bimican should not be used in children under 18 years of age due to lack of data in this age group.

Bimican with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Bimatoprost may pass into breast milk; therefore, breastfeeding should not be performed during treatment with Bimican.

Driving and operating machinery
After instilling Bimican, vision may become temporarily blurred. Do not drive or operate machinery until vision has improved.

Bimican contains benzalkonium chloride, phosphates
The medicine contains 0.05 mg of benzalkonium chloride per millilitre.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Contact lenses must be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or pain in the eye occur after using the medicine, consult a doctor.
The medicine contains 0.96 mg of phosphates per millilitre. In patients with severe damage to the transparent front part of the eye (cornea), phosphates may, very rarely, during treatment, cause corneal calcification and clouding due to calcium deposition.

3. How to use Bimican

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Bimican is for ocular use only. The recommended dose is one drop of Bimican in each eye requiring treatment,
administered once daily in the evening.
If Bimican is used together with another eye medication, at least 5 minutes should elapse between the application of Bimican and the other medicine.
Do not use this medicine more than once a day, as this may reduce the effectiveness of treatment.
Instructions for use:
Do not use the bottle if the tamper-evident seal on the neck of the bottle is damaged before first use.

1. Wash your hands. Tilt your head backward and look upward at the ceiling.
2. Gently pull down the lower eyelid to form a small pocket.
3. Turn the bottle upside down and squeeze it gently to instill one drop into each eye requiring treatment.
4. Release the lower eyelid and close the eye for 30 seconds.

Wipe away any excess medicine that flows onto the cheek.
If the drop misses the eye, try again.
To prevent infections and avoid eye injury, do not let the tip of the bottle touch the eye or any other surface. Immediately after use, replace and tighten the cap on the bottle.
Use of more than the recommended dose of Bimican
If more than the recommended dose of Bimican is used, it is unlikely to cause any serious harm. The next dose should be taken at the usual time.
If in doubt, consult a doctor or pharmacist.
Missed dose of Bimican
If a dose of Bimican is missed, apply a single drop as soon as remembered, then continue with the regular dosing schedule. Do not use a double dose to make up for a missed dose.
Discontinuation of Bimican
For Bimican to be effective, it must be used daily. Discontinuing treatment with Bimican may lead to an increase in intraocular pressure. Therefore, consult a doctor before planning to stop treatment.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Very common adverse reactions
(occur in more than 1 in 10 patients)

Eye-related symptoms

• Longer eyelashes (in up to 45% of patients)
• Mild eye redness (in up to 44% of patients)
• Itching (in up to 14% of patients)

Symptoms related to the eye area

• Loss of fatty tissue around the eye, which may lead to deepening of the eyelid groove, sunken eyes, drooping eyelids (ptosis), skin tightness around the eye (dermatological involution due to dermatochalasis), and increased visibility of the lower white part of the eye (exposure of the lower sclera).

Common adverse reactions
(occur in less than 1 in 10 patients)

Eye-related symptoms

• Allergic reaction in the eye
• Eye fatigue
• Light sensitivity
• Darkening of the skin around the eye
• Darkening of eyelashes
• Pain
• Foreign body sensation in the eye
• Eye stickiness
• Darkening of the iris
• Difficulty seeing clearly
• Irritation
• Burning sensation
• Inflammation, redness, and itching of the eyelids
• Watery eyes
• Dryness
• Worsening of vision
• Blurred vision
• Swelling of the transparent layer lining the eye surface
• Minor damage to the eye surface, with or without inflammation

General systemic symptoms

• Headache
• Increased liver function test results in blood tests
• Increased blood pressure

Uncommon adverse reactions
(occur in less than 1 in 100 patients)

Eye-related symptoms

• Cystoid macular edema (swelling of the retina in the eye leading to worsening vision)
• Eye inflammation
• Retinal hemorrhage
• Eyelid swelling
• Eyelid twitching
• Eyelid contraction and retraction from the eye surface
• Redness of the skin around the eye

Whole-body symptoms

• Nausea
• Dizziness
• Weakness
• Increased hair growth around the eye

Adverse reactions with unknown frequency
(frequency cannot be estimated from available data)

Eye-related symptoms

• Eye discomfort

Whole-body symptoms

• Asthma
• Worsening of asthma
• Worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, eye redness, and skin rash)
• Skin discoloration (around the eye)

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Bimican

No special storage instructions are required for this medicine.
The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the bottle
after EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
The bottle should be discarded no later than four weeks after first opening, even if there are still drops remaining. This precaution prevents contamination. To help remember the date of opening, write it down on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This practice helps protect the environment.

6. Contents of the pack and other information

What Bimican contains

• The active substance is bimatoprost. Each ml 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 adjust the pH to the appropriate level.

What Bimican looks like and contents of the pack
Bimican is a colourless, clear solution used as eye drops.
It is available in cardboard packs containing 1, 3 or 6 plastic bottles made of LDPE with a dropper made of LDPE and a cap made of HDPE with a tamper-evident seal. Each bottle contains 3 ml of solution. This is sufficient for 4 weeks of treatment.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Rompharm Company SRL
Str. Eroilor, nr 1A
Otopeni, 075100, Ilfov
Romania

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański