Bimifree

Package leaflet: Information for the patient

Bimifree, 0.3 mg/ml, eye drops, solution
Bimatoprost
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Bimifree is and what it is used for

Bimifree is a medicine used in glaucoma. It belongs to a group of medicines called prostamides.
Bimifree eye drops are used to reduce elevated intraocular pressure. This medicine may be used alone or in combination with other eye drops known as beta-blockers, which also reduce pressure inside the eye.
The eye contains a clear, watery fluid that nourishes the inside of the eye. This fluid is continuously drained from the eye and replaced by newly produced fluid. If the fluid is not drained quickly enough, pressure inside the eye increases. Bimifree works by increasing the outflow of fluid, thereby reducing intraocular pressure. Untreated high pressure may lead to a disease called glaucoma and ultimately to vision damage.
This medicine does not contain preservatives.

2. Important information before using Bimifree

When not to use Bimifree

• if the patient is allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Bimifree, consult a doctor or pharmacist if:

• the patient has breathing difficulties
• the patient has liver or kidney problems
• the patient has previously undergone cataract surgery
• the patient currently has or has had low blood pressure or slow heart rate
• the patient has had or currently has a viral infection or inflammation in the eye.

During treatment, Bimifree may cause loss of periorbital fat tissue, which may lead to deepening of the eyelid sulcus, sunken eyes, drooping of the upper eyelids (ptosis), skin tension around the eye (dermatochalasis-related 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. The changes may resolve after discontinuation of treatment with Bimifree.
Bimifree may also cause darkening and excessive growth of eyelashes, and may cause darkening of the skin around the eyelid. It may also darken the colour of the iris. These changes may be permanent. Changes may be more noticeable when treating only one eye.

Children and adolescents
Bimifree has not been studied in children and adolescents under 18 years of age; therefore, this medicine should not be used in children and adolescents under 18 years of age.

Bimifree with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using any medicine.
Bimifree may pass into human milk; therefore, breastfeeding should be avoided during treatment with this medicine.

Driving and using machines
After instilling Bimifree, vision may become temporarily blurred. Do not drive or operate machinery until vision clears.

Bimifree contains phosphates
The medicine contains 0.95 mg of phosphates per millilitre. In patients with severe damage to the cornea (the transparent front part of the eye), phosphates may, very rarely, cause corneal clouding due to calcium deposits during treatment.

3. How to use Bimifree

This medicine should always be used exactly as directed by the doctor. If in doubt, consult the doctor or pharmacist.
Bimifree should be used for the eyes only. The recommended dose is one drop of Bimifree in the evening, once daily, in each eye requiring treatment.
If the patient is using Bimifree together with other eye drops, at least a 5-minute interval should be maintained between the administration of Bimifree and the other eye medication. Ointments should be applied last.
Do not use this medicine more than once daily, as this may reduce the effectiveness of treatment.
Bimifree is a sterile solution that does not contain preservatives. See section 6. What Bimifree looks like and contents of the pack.

Before instilling eye drops:

• At first use, before administering the drops into the eye, the patient should practice using the dropper bottle by slowly squeezing it until one drop is dispensed from the bottle. This should be done away from the eye.
• If the patient is confident about being able to instill a single drop, they should assume the most comfortable position for instillation (sitting, lying on the back, or standing in front of a mirror).

Instructions for use:

1. Wash hands thoroughly before instilling the medicine.
2. Do not use the medicine if the packaging or bottle is damaged.
3. Before first use, unscrew the cap after ensuring that the tamper-evident ring on the cap is intact. A slight resistance will be felt when unscrewing until the ring breaks ( Figure 1 ).
4. If the tamper-evident ring is loose, remove it before using the medicine, as it may fall into the eye and cause injury.
5. Tilt the head backward and gently pull down the lower eyelid with a finger to form a "pocket" between the eyeball and the eyelid ( Figure 2 ). Avoid contact between the dropper tip and the eye, eyelids, or fingers.
6. Instill one drop by slowly squeezing the bottle ( Figure 3 ). Gently squeeze the middle part of the bottle so that the drop enters the patient's eye. Note that there may be a delay of several seconds between squeezing the bottle and the release of the drop. Do not squeeze the bottle too hard. If there are any doubts about how to use the medicine, the patient should consult the doctor, pharmacist, or nurse.
7. After instillation, press the tear duct (inner corner of the eye near the nose) with a finger for at least 2 minutes and keep the eye(s) closed during this time. This ensures the medicine penetrates into the eye and reduces the amount of medicine passing through the tear duct into the rest of the body.
8. If the doctor has prescribed drops for the second eye, repeat steps 5, 6, and 7.
9. After use and before closing the bottle, shake the bottle downward without touching the tip to remove any residual liquid from the dropper tip. This is necessary to ensure the ability to dispense subsequent drops. Immediately after use, close the bottle tightly ( Figure 4 ).

Wipe away any excess medicine running down the cheek.
If the drop misses the eye, repeat the instillation.

Figure 1. Figure 2. Figure 3. Figure 4.
If the patient wears contact lenses, they should be removed before using the medicine, and the patient should wait at least 15 minutes before reinserting them.

Use of more than the recommended dose of Bimifree
If more than the recommended dose of Bimifree is used, it is unlikely to cause any serious harm. The next dose should be taken at the usual time.
If in doubt, consult the doctor or pharmacist.

Missed dose of Bimifree
If a dose of Bimifree is missed, instill one drop as soon as remembered, then continue with the regular dosing schedule. Do not use a double dose to make up for the missed dose.

Stopping treatment with Bimifree
Bimifree should be used daily to be effective. If the patient stops using Bimifree, this may lead to an increase in intraocular pressure. Therefore, talk to the doctor before planning to stop treatment.
If there are any further doubts about using this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Very common adverse effects
May affect at least 1 in 10 people
Eye-related symptoms

• mild redness of the eye (up to 24% of patients)

Symptoms related to the area around the eye

• loss of fat 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 part of the sclera)

Common adverse effects
May affect 1 to 9 in 100 people
Eye-related symptoms

• minor surface defects of the eye, with or without inflammation
• irritation
• eye itching
• pain
• dryness
• sensation of a foreign body in the eye
• eyelash elongation
• darkening of the skin around the eyes
• eyelid redness

Uncommon adverse effects
May affect 1 to 9 in 1,000 people
Eye-related symptoms

• eye fatigue
• light sensitivity
• darkening of the iris
• itching and swelling of the eyelids
• tearing
• swelling of the transparent layer lining the surface of the eye
• blurred vision

General body symptoms

• headache
• increased hair growth around the eyes

Adverse effects of unknown frequency
Eye-related symptoms

• sticky eyes
• eye discomfort

General body symptoms

• asthma
• worsening of asthma
• exacerbation of a lung disease called chronic obstructive pulmonary disease (COPD)
• shortness of breath
• symptoms of allergic reaction (swelling, eye redness, and skin rash)
• dizziness
• increased blood pressure
• skin pigmentation (around the eye)

In addition to the adverse effects observed after administration of bimatoprost 0.3 mg/ml
in single-dose formulation (without preservative), the following adverse effects
have been observed after administration of bimatoprost 0.3 mg/ml in multi-dose formulation (with preservative);
these effects may also occur in patients using Bimifree 0.3 mg/ml (multi-dose packaging, without preservative):

• burning sensation in the eye
• allergic reaction in the eye
• blepharitis (inflammation of the eyelids)
• difficulty seeing clearly
• eye stickiness
• worsening of vision
• darkening of eyelashes
• retinal haemorrhage
• ocular inflammatory condition
• cystoid macular oedema (retinal swelling in the eye leading to worsening of vision)
• iritis (inflammation of the iris)
• eyelid twitching
• eyelid contraction and retraction from the eye surface
• nausea
• redness of the skin around the eye
• weakness
• increased liver function test results

Other adverse effects reported with ophthalmic solutions containing
phosphates
In patients with severe damage to the transparent front part of the eye (cornea), phosphates
may very rarely cause corneal clouding due to calcium deposits during treatment.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, please inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Bimifree

No special storage instructions are required for this medicine.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the stated month.
The marking on the packaging: EXP indicates the expiry date, and Lot indicates the batch number.
After first opening the bottle – store for 90 days at a temperature below 25°C.
Dispose of the bottle 90 days after first opening.
Medicines must 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. Package contents and other information

What Bimifree contains

• The active substance is bimatoprost. Each ml of solution contains 0.3 mg of bimatoprost. Each bottle contains 3 ml of solution – not less than 80 drops. One drop (approximately 29.4 microliters) of solution contains approximately 8.82 micrograms of bimatoprost.
• Other ingredients are: citric acid monohydrate, disodium phosphate dodecahydrate, sodium chloride, hydrochloric acid (diluted, for pH adjustment), water for injections.

What Bimifree looks like and contents of the pack
Bimifree is a clear, colourless solution.
The medicine is available in white 5 ml bottles (LDPE) containing 3 ml of solution,
with a multi-dose dropper (HDPE) preventing bacterial contamination of the solution
thanks to a system consisting of a silicone membrane and filtration of air drawn into
the bottle, with a closure cap made of HDPE with a tamper-evident ring, packed in a cardboard box.
Pack sizes:
1 bottle of 5 ml containing 3 ml of solution.
3 bottles of 5 ml each containing 3 ml of solution.
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
Rafarm S.A.
Thesi Pousi Xatzi Agiou Louka
Paiania, 190 02
Greece