Bimifree Combi

Leaflet attached to the packaging: patient information

Bimifree Combi, 0.3 mg/ml + 5 mg/ml, eye drops, solution
Bimatoprost + Timolol

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Bimifree Combi and what is it used for

Bimifree Combi contains two active substances (bimatoprost and timolol) that lower eye pressure. Bimatoprost belongs to a group of medicines called prostamides, prostaglandin analogs. Timolol belongs to a group of medicines called beta-blockers. The eye contains a clear, watery fluid that nourishes the inside of the eye. The fluid is constantly drained from the eye and replaced by new fluid. If the fluid cannot be drained quickly enough, the pressure in the eye increases, which can eventually lead to vision damage (causing a disease called glaucoma). The action of Bimifree Combi is to reduce the production of fluid and increase the amount of fluid drained. This leads to a decrease in pressure inside the eye. Bimifree Combi eye drops are used to treat high pressure in the eye in adults, including the elderly. High pressure can lead to glaucoma. The doctor will prescribe Bimifree Combi when the action of other eye drops containing beta-blockers or prostaglandin analogs is insufficient. The medicine does not contain preservatives.

2. Important information before using Bimifree Combi

When not to use Bimifree Combi

• if the patient is allergic to bimatoprost, timolol, beta-adrenergic blockers (beta blockers) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had or has a respiratory disease, such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and prolonged coughing);
• if the patient has heart diseases, such as too slow heart rate, heart block, or heart failure.

Warnings and precautions

Before starting treatment with Bimifree Combi, the patient should discuss with their doctor or pharmacist if they have or have had any of the following conditions:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or choking), heart failure, low blood pressure,
• heart rhythm disorders, such as too slow heart rate,
• breathing disorders, asthma, or chronic obstructive pulmonary disease,
• circulatory disorders, such as Raynaud's disease or Raynaud's syndrome,
• overactive thyroid gland, as timolol may mask the signs and symptoms of thyroid disease,
• diabetes, as timolol may mask the signs and symptoms of low blood sugar,
• severe allergic reactions,
• liver or kidney disease,
• eye surface diseases,
• separation of one of the layers of the eyeball after surgery to lower eye pressure,
• known risk factors for macular edema (swelling of the retina in the eye leading to vision impairment), such as cataract surgery.

Before anesthesia for surgery, the patient should tell their doctor about using Bimifree Combi, as timolol may affect the action of some anesthetics. During treatment with Bimifree Combi, the medicine may cause loss of fat tissue around the eye, which can lead to deepening of the eyelid fold, sunken eyes, drooping eyelids (ptosis), skin tension around the eye (dermatochalasis), and increased visibility of the lower white part of the eye (visibility of the lower part of the sclera). These changes are usually mild, but if they are pronounced, they can affect the field of vision. The changes may disappear after discontinuation of Bimifree Combi treatment. Bimifree Combi may also cause darkening and excessive growth of eyelashes, as well as 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 when treating only one eye. If Bimifree Combi comes into contact with the skin, it may cause hair growth.

Children and adolescents

Bimifree Combi should not be used in children and adolescents under 18 years of age.

Bimifree Combi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. Bimifree Combi may affect the action of other medicines or other medicines taken by the patient may affect the action of Bimifree Combi, including eye drops used to treat glaucoma. The patient should tell their doctor about taking or planning to take medicines that lower blood pressure, heart disease medicines, diabetes medicines, quinidine (a medicine used to treat heart disease or certain types of malaria), or depression (fluoxetine, paroxetine). If the patient is using other eye drops at the same time,they should leave at least a 5-minute interval between administrations of the next medicines. Eye ointments should be used last.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Bimifree Combi should not be used during pregnancy, unless the doctor recommends otherwise. Bimifree Combi should not be used during breastfeeding. Timolol may pass into breast milk. Before taking any medicine during breastfeeding, the patient should consult their doctor.

Driving and using machines

Bimifree Combi may cause loss of sharp vision in some patients. The patient should not drive or operate machines until the symptoms have resolved.

Bimifree Combi contains phosphates

The medicine contains 1.4 mg of phosphates per milliliter. In patients with severe damage to the clear, front part of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposition during treatment.

3. How to use Bimifree Combi

This medicine should always be used exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose is one drop into each eye that needs treatment once a day, in the morning or evening. The medicine should be used every day at the same time. Bimifree Combi has not been studied in patients wearing contact lenses. Before using the medicine, the patient should remove their contact lenses and wait at least 15 minutes before putting them back on. Bimifree Combi is a sterile solution that does not contain preservatives. See section 6. What Bimifree Combi looks like and what the packaging contains.

Before administering the eye drops:

• When using the bottle for the first time, before administering the eye drops, the patient should test the use of the bottle with the dropper by slowly squeezing it until one drop is released from the bottle. This should be done away from the eye.
• If the patient is sure they can administer a single drop of the medicine, they should take the most comfortable position for administration (they can sit, lie on their back, or stand in front of a mirror).

Instructions for use:

• 1. Before administering the medicine, the patient should wash their hands thoroughly.
• 2. If the packaging or bottle is damaged, the medicine should not be used.
• 3. Before using the eye drops for the first time, the patient should unscrew the cap after making sure the tamper-evident ring on the cap is intact. When unscrewing, a slight resistance will be felt until the ring breaks (Figure 1).
• 4. If the tamper-evident ring is loose, it should be removed before using the medicine, as it may fall into the eye and cause injury.
• 5. The patient should tilt their head back and gently pull the lower eyelid down with their finger to form a "pocket" between the eye and the eyelid (Figure 2). The patient should avoid touching the tip of the dropper with the eye, eyelids, or fingers.
• 6. The patient should administer one drop by slowly squeezing the bottle (Figure 3). The bottle should be gently squeezed in the middle, so the drop gets into the patient's eye. The patient should remember that there may be a few seconds' delay between squeezing the bottle and the drop being released. The patient should not squeeze the bottle too hard. If the patient has any doubts about using the medicine, they should consult their doctor, pharmacist, or nurse.

• 7. After administering the medicine, the patient should press the tear duct (the corner of the eye near the nose) with their finger for at least 2 minutes and keep their eye (eyes) closed during this time. This will ensure the medicine penetrates the inside of the eye and reduce the amount of medicine that enters the body through the tear duct.
• 8. If the doctor recommends using drops in the other eye, the patient should repeat the actions from points 5, 6, and 7.
• 9. After use and before closing the bottle, the patient should shake the bottle downwards without touching the tip of the dropper to remove any remaining liquid from the tip of the dropper. This is necessary to ensure the next drops can be administered. Immediately after use, the patient should tightly close the bottle (Figure 4).

If the drop does not get into the eye, the patient should repeat the attempt to administer the drop.

Figure 1.
Figure 2.
Figure 3.
Figure 4.

Using more than the recommended dose of Bimifree Combi

In case of using more than the recommended dose of Bimifree Combi, it is unlikely to cause serious harm. The next dose should be taken at the usual time. In case of doubt, the patient should consult their doctor or pharmacist.

Missing a dose of Bimifree Combi

In case of missing a dose of Bimifree Combi, the patient should use a single drop as soon as they remember and then continue with their usual dosing schedule. The patient should not use a double dose to make up for the missed dose.

Stopping treatment with Bimifree Combi

Bimifree Combi should be used every day to be effective. If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bimifree Combi can cause side effects, although not everybody gets them. In general, the patient can continue using the eye drops if the side effects are not severe. If the patient has any doubts, they should consult their doctor or pharmacist. The patient should not stop using Bimifree Combi without discussing it with their doctor. During treatment with Bimifree Combi, the following side effects may occur:

Very common side effects

May occur in at least 1 in 10 patients
Related to the eye
redness.
Related to the area around the eye:
loss of fat tissue around the eye, which can lead to deepening of the eyelid fold, sunken eyes, drooping eyelids (ptosis), skin tension around the eye (dermatochalasis), and increased visibility of the lower white part of the eye (visibility of the lower part of the sclera).

Common side effects

May occur in 1 to 9 in 100 patients
Related to the eye
burning sensation, itching, stinging, irritation of the conjunctiva (the transparent membrane covering the eye), sensitivity to light, eye pain, stickiness of the eye, dryness of the eye, feeling of a foreign body in the eye, minor damage to the surface of the eye (with or without inflammation), blurred vision, redness and itching of the eyelids, hair growth around the eye, darkening of the eyelids, darker skin tone around the eye, lengthening of eyelashes, eye irritation, excessive tearing, swelling of the eyelids, limited vision.
Related to other parts of the body
runny nose, dizziness, headache.

Uncommon side effects

May occur in 1 to 9 in 1000 patients
Related to the eye
abnormal sensations in the eye, inflammation of the iris, swelling of the conjunctiva (the transparent membrane covering the eye), eyelid pain, eye fatigue, ingrown eyelashes, darkening of the iris, separation of the eyelid from the eye surface, darkening of the eyelashes.
Related to other parts of the body
shortness of breath.

Side effects with unknown frequency

Related to the eye
cystoid macular edema (swelling of the retina in the eye leading to vision impairment), eye swelling, blurred vision.
Related to other parts of the body
breathing difficulties/wheezing, symptoms of allergic reactions (swelling, redness of the eye and skin rash), taste disturbances, slow heart rate, sleep disturbances, nightmares, asthma, hair loss, fatigue.
Additional side effects have been observed in patients using eye drops containing timolol or bimatoprost, so they may also occur during treatment with Bimifree Combi. Like other ophthalmic medicines used locally, timolol may penetrate the systemic circulation. This may lead to similar side effects as when beta-adrenergic blockers are taken orally and/or intravenously. The frequency of systemic side effects after using eye drops is lower than after oral or intravenous administration. These side effects include those observed with the use of bimatoprost and timolol in the treatment of eye diseases:

• Severe allergic reactions with swelling and breathing difficulties, which can be life-threatening
• Low blood sugar
• Depression, memory loss, dizziness, hallucinations
• Fainting, stroke, reduced blood flow to the brain, worsening of myasthenia (increased muscle weakness), tingling sensation
• Decreased sensitivity of the eye surface, double vision, drooping eyelid, separation of one of the layers of the eyeball after surgery to lower eye pressure, inflammation of the eye surface, bleeding in the back of the eye (bleeding into the retina), eye inflammation, more frequent blinking, stickiness of the eye, discomfort in the eyes
• Heart failure, irregular heartbeat or cardiac arrest, slowing or acceleration of heart rate, fluid accumulation (mainly water) in the body, chest pain
• Low blood pressure, high blood pressure, swollen or cold hands, feet, and limbs due to narrowing of blood vessels
• Cough, worsening of asthma, worsening of chronic obstructive pulmonary disease (COPD)
• Diarrhea, abdominal pain, nausea and vomiting, indigestion, dry mouth
• Red, scaly skin changes, skin rash, skin discoloration (around the eye)
• Muscle pain
• Decreased sex drive, sexual disorders
• Weakness
• Elevated liver function test results

Other side effects reported in relation to the use of eye drops containing phosphates In very rare cases, in some patients with significant damage to the outer, transparent layer of the eyeball (cornea), during treatment, dull spots appeared on the cornea due to calcium deposition.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Bimifree Combi

There are no special precautions for storage. The medicine should be kept out of 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 month. The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. After opening the bottle - store for 90 days at a temperature below 25°C. The bottle should be discarded after 90 days from its first opening. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Bimifree Combi contains

• The active substances of the medicine are bimatoprost and timolol.
• Each ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (in the form of 6.83 mg of timolol maleate). Each bottle contains 3 ml of solution.
• The other ingredients are disodium phosphate dodecahydrate, citric acid monohydrate, sodium chloride, sodium hydroxide or hydrochloric acid, diluted (to adjust pH), water for injections.

What Bimifree Combi looks like and what the packaging contains

Bimifree Combi is a clear, colorless solution. The medicine is available in white bottles with a capacity of 5 ml (LDPE) containing 3 ml of solution, with a multi-dose dropper (HDPE) that prevents contamination of the solution with bacteria thanks to a system consisting of a silicone membrane and air filtration entering the bottle, with a cap made of HDPE with a tamper-evident ring, in a cardboard box. Packaging: 1 bottle with a capacity of 5 ml containing 3 ml of solution. 3 bottles with a capacity of 5 ml containing 3 ml of solution each. Not all pack sizes may be marketed.

Marketing authorization holder

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

Date of last revision of the leaflet: