Bimaroz duo

Package leaflet: Information for the patient

Bimaroz Duo, 0,3 mg/ml + 5 mg/ml, eye drops, solution
Bimatoprost + Timolol
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Bimaroz Duo is and what it is used for

Bimaroz Duo contains two active substances (bimatoprost and timolol), which reduce intraocular pressure. Bimatoprost belongs to a group of medicines called prostamides – which are prostaglandin analogues. Timolol belongs to a group of medicines known as beta-blockers.
The eye contains a clear, watery fluid that nourishes the inside of the eye. This fluid is continuously drained and replaced by newly produced fluid. If the fluid cannot drain quickly enough, pressure inside the eye increases, which may eventually lead to damage to vision (a condition known as glaucoma). Bimaroz Duo works by reducing the production of fluid and increasing the outflow of fluid. This results in a reduction of intraocular pressure.

2. Important information before using Bimaroz Duo

When not to use Bimaroz Duo eye drops, solution:

• if the patient is allergic to bimatoprost, timolol, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has or has had breathing problems such as asthma or severe chronic obstructive pulmonary disease (severe lung disease which may cause wheezing, difficulty breathing, and/or long-lasting cough);
• if the patient has heart problems such as slow heartbeat, heart block, or heart failure.

Warnings and precautions
Before starting treatment with Bimaroz Duo, consult your doctor or pharmacist if the patient has or has had:

• coronary heart disease (symptoms may include chest pain or pressure, shortness of breath, or angina), heart failure, low blood pressure;
• heart rhythm disorders, such as slow heartbeat;
• breathing difficulties, asthma, or chronic obstructive pulmonary disease;
• circulatory disorders (e.g. Raynaud's disease or Raynaud's phenomenon);
• hyperthyroidism, because timolol may mask subjective and objective symptoms of thyroid disease;
• diabetes, because timolol may mask subjective and objective symptoms of low blood sugar;
• severe allergic reactions;
• liver or kidney disorders;
• disorders affecting the surface of the eye;
• detachment of one of the layers of the eyeball following intraocular pressure-lowering surgery;
• known risk factors for macular edema (swelling of the retina in the eye leading to worsening vision), such as cataract surgery.

Before undergoing surgical anesthesia, inform your doctor that you are using Bimaroz Duo, as timolol may alter the effects of certain drugs used during anesthesia.
During treatment with Bimaroz Duo, loss of fat tissue around the eye may occur, which may lead to deepening of the eyelid groove, sunken eyes, drooping of the upper eyelids (ptosis), skin tension 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 treatment with Bimaroz Duo. Bimaroz Duo may also cause darkening and excessive growth of eyelashes, as well as darkening of the skin around the eyelid. The color of the iris may also become darker. These changes may be permanent. Changes may be more noticeable when only one eye is treated.
Bimaroz Duo may cause excessive hair growth when in contact with the skin surface.

Children and adolescents
Bimaroz Duo must not be used in children and adolescents under 18 years of age.

Bimaroz Duo and other medicines
Bimaroz Duo may interact with other medicines the patient is taking, including other eye drops used in glaucoma treatment. Inform 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. Inform your doctor if the patient is taking or intends to take medicines that lower blood pressure, medicines used for heart conditions, medicines used in diabetes treatment, quinidine (used in treating heart conditions and certain types of malaria), or medicines used to treat depression: fluoxetine and paroxetine.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine. Bimaroz Duo must not be used during pregnancy unless specifically advised by a doctor.
Use of Bimaroz Duo during breastfeeding is not recommended. Timolol may pass into breast milk. Consult a doctor before using any medicine during breastfeeding.

Driving and operating machinery
Bimaroz Duo may cause blurred vision in some patients. Do not drive or operate machinery until symptoms resolve.

Bimaroz Duo contains a preservative - benzalkonium chloride
The medicine contains 0.05 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Contact lenses must be removed before instilling the drops and at least 15 minutes should elapse before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, contact your doctor.

3. How to use Bimaroz Duo

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
The usual dose is one drop per day, in the morning or evening, in each eye requiring treatment.
The medicine should be used every day at the same time.
Instructions for use
Do not use the bottle if the tamper-evident seal on the neck of the bottle is broken before first use.
1. 2. 3. 4. 5.

1. Wash your hands. Tilt your head back and look 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.
5. Press with your finger on the inner corner of the closed eye (the corner next to the nose) and hold for 2 minutes. This helps prevent Bimaroz Duo from being absorbed into the body.

If the drop misses the eye, repeat the instillation.
To avoid contamination, do not let the tip of the bottle touch the eye or any other surface.
Replace the cap and screw the bottle tightly immediately after use.
If using Bimaroz Duo together with other eye medicines, wait at least 5 minutes between applying Bimaroz Duo and the other medicine. Ointments or gels should be applied last.
Use of more Bimaroz Duo than recommended
If more Bimaroz Duo is used than recommended, it is unlikely to cause any serious problems.
Apply the next dose at the usual time.
If in doubt, consult your doctor or pharmacist.
Missed dose of Bimaroz Duo
If you miss a dose of Bimaroz Duo, apply one drop as soon as you remember, then continue using the medicine as scheduled.
Do not use a double dose to make up for a missed dose.
Stopping Bimaroz Duo
To ensure Bimaroz Duo works properly, it must be used every day.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
You can usually continue using the drops unless the adverse reactions are severe. If in doubt, consult a doctor or pharmacist.
Do not stop using Bimaroz Duo without speaking to your doctor.

The following adverse reactions may occur during treatment with Bimaroz Duo:

Very common adverse reactions (may affect more than 1 in 10 people)
Eye-related:

• redness;
• loss of fat tissue around the eye, which may lead to deepening of the eyelid groove, sunken eyes, drooping eyelids (ptosis), tightness of the skin 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 (may affect up to 1 in 10 people)
Eye-related:

• burning sensation;
• itching;
• stinging pain;
• conjunctival irritation (irritation of the transparent surface layers of the eye);
• light sensitivity;
• eye pain, sticky eyes, dry eyes, sensation of a foreign body in the eye;
• minor damage to the eye surface, with or without inflammation;
• blurred vision;
• redness and itching of the eyelids;
• increased hair growth around the eye;
• darkening of the eyelids;
• darker skin colour around the eyes;
• eyelash elongation;
• eye irritation;
• watery eyes;
• eyelid swelling;
• narrowing of the visual field.

Other parts of the body:

• cold;
• dizziness;
• headache.

Uncommon adverse reactions (may affect up to 1 in 100 people)
Eye-related:

• abnormal sensations in the eye;
• iritis (inflammation of the iris);
• conjunctival oedema;
• eyelid pain;
• eye fatigue;
• ingrown eyelashes;
• darkening of the iris colour;
• eyelid retraction (eyelid pulling away from the eye surface);
• darkening of eyelashes.

Other parts of the body:

• shortness of breath.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data)
Eye-related:

• cystoid macular oedema (swelling of the retina in the eye leading to worsening of vision);
• eye oedema;
• blurred vision;
• eye discomfort.

Other parts of the body:

• breathing difficulties/wheezing;
• symptoms of allergic reaction (swelling, redness of the eyes and skin rash);
• changes in taste sensation;
• decreased heart rate;
• difficulty sleeping;
• nightmares;
• asthma;
• hair loss;
• fatigue;
• hallucinations;
• skin discolouration (around the eye).

Additional adverse reactions have been observed in patients using eye drops containing timolol or bimatoprost, and therefore these may also occur during treatment with Bimaroz Duo. Like other ophthalmic medicines, timol0l is absorbed into the bloodstream. This may cause adverse reactions similar to those seen with intravenous and/or oral beta-adrenergic receptor blocking agents. The likelihood of adverse reactions after using eye drops is lower than with oral or injected medicines. The listed adverse reactions include those observed during treatment with bimatoprost and timolol for eye diseases:

• severe allergic reactions with swelling and breathing difficulties, which may be life-threatening;
• low blood sugar levels;
• depression, memory loss;
• fainting, stroke, reduced blood flow to the brain, worsening of myasthenia gravis symptoms (severe muscle weakness), tingling;
• reduced corneal sensitivity, double vision, drooping eyelid, detachment of one of the layers of the eyeball after intraocular pressure-lowering surgery, eye surface inflammation, bleeding in the back of the eye (retinal haemorrhage), eye inflammation, increased frequency of blinking;
• heart failure, irregular or stopped heartbeat, decreased or increased heart rate, fluid accumulation in the body – mainly water, chest pain;
• low blood pressure, high blood pressure, swelling or cooling of hands, feet and limbs due to blood vessel constriction;
• cough, worsening of asthma, worsening of a lung disease called chronic obstructive pulmonary disease (COPD);
• diarrhoea, abdominal pain, nausea or vomiting, indigestion, dry mouth;
• red, scaly patches on the skin, skin rash;
• decreased libido, sexual dysfunction;
• weakness;
• increased liver function test results indicating how the liver is functioning.

Other adverse reactions reported with phosphate-containing eye drops
In very rare cases, some patients with severe damage to the transparent front layer of the eye (cornea) developed corneal clouding due to calcium deposits during treatment.

Reporting of adverse reactions
If any adverse reactions occur, including those 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bimaroz Duo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and the cardboard box after EXP. The expiry date refers to the last day of the specified month.
There are no special storage instructions.
After opening, the solution may become contaminated, which could lead to eye infections. Therefore, the bottle should be discarded 4 weeks after first opening, even if there is still some solution remaining. To help remember the date of opening, write it down on the cardboard box.
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. Contents of the pack and other information

What Bimaroz Duo contains

• The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml in the form of timolol maleate 6.8 mg/ml.
• Other ingredients: monohydrate citric acid, disodium hydrogen phosphate heptahydrate, sodium chloride, benzalkonium chloride (preservative), and purified water. Small amounts of concentrated hydrochloric acid or sodium hydroxide may be added (to adjust pH) (acidity).

What Bimaroz Duo looks like and contents of the pack

Bimaroz Duo is a colourless or slightly yellow solution in a plastic bottle.
White LDPE bottles with dark blue HDPE caps and white LDPE dropper tips, packed in cardboard boxes.

Available pack sizes:

• Cardboard boxes containing 1 or 3 bottles with 3 ml of solution each.

Each bottle is approximately half-filled and contains 3 millilitres of solution.
This amount is sufficient for 4 weeks of treatment.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Rompharm Company S.R.L.
Eroilor Street, no. 1A
075100 Otopeni, Ilfov
Romania