Bimatoprost + timolol genetic

Package leaflet: Information for the user

Bimatoprost + Timolol Genetic, 0.3 mg/ml + 5 mg/ml, eye drops, solution
Bimatoprostum + Timololum
Please read this leaflet carefully before using the medicine because it contains
important information for you.

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

Leaflet contents:

1. What Bimatoprost + Timolol Genetic is and what it is used for
2. What you need to know before using Bimatoprost + Timolol Genetic
3. How to use Bimatoprost + Timolol Genetic
4. Possible side effects
5. How to store Bimatoprost + Timolol Genetic
6. Contents of the pack and other information

1. What Bimatoprost + Timolol Genetic is and what it is used for

Bimatoprost + Timolol Genetic contains two active substances (bimatoprost and timolol) that 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 from the eye and replaced by newly produced fluid. If the fluid cannot drain sufficiently quickly, pressure builds up inside the eye, which may eventually lead to damage to vision (causing a condition called glaucoma). Bimatoprost + Timolol Genetic works by reducing the production of fluid and increasing the outflow of fluid, thereby lowering the pressure inside the eye.
Bimatoprost + Timolol Genetic eye drops are used to treat high pressure in the eye in adults, including elderly people. High pressure may lead to glaucoma. Your doctor will prescribe Bimatoprost + Timolol Genetic when other eye drops containing beta-blockers or prostaglandin analogues alone have not been effective enough.

2. Information before using Bimatoprost + Timolol Genetic

When not to use Bimatoprost + Timolol Genetic eye drops, solution

• if the patient is allergic to bimatoprost, timolol, beta-adrenergic blocking agents (beta-blockers), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had or currently has a respiratory disease, such as asthma, or severe chronic obstructive pulmonary disease (severe lung disease which may cause wheezing, difficulty breathing, and long-lasting cough);
• if the patient has heart conditions such as bradycardia, heart block, or heart failure.

Warnings and precautions
Before starting treatment with this medicine, discuss with your doctor if the patient currently has or has previously had any of the following conditions:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or breathlessness), heart failure, hypotension,
• heart rhythm disorders, e.g. bradycardia,
• breathing disorders, asthma, or chronic obstructive pulmonary disease,
• circulatory disorders, e.g. Raynaud's disease or Raynaud's syndrome,
• overactive thyroid gland, as timolol may mask both subjective and objective symptoms of hyperthyroidism,
• diabetes, as timolow may mask both subjective and objective symptoms of low blood glucose,
• severe allergic reactions,
• liver or kidney disease,
• eye surface disorders,
• detachment of one of the layers of the eyeball following a procedure intended to reduce intraocular pressure,
• known risk factors for macular edema (swelling of the retina in the eye leading to worsening vision), such as cataract surgery.

Before undergoing anesthesia for surgery, inform your doctor that you are using Bimatoprost + Timolol Genetic, as timolol may alter the effects of certain drugs used during anesthesia.
Bimatoprost + Timolol Genetic may cause darkening and excessive growth of eyelashes, as well as darkening of the skin around the eye. Over time, it may also darken the color of the iris. These changes may be permanent. Changes may be more noticeable when only one eye is treated. In case of contact with the skin surface, Bimatoprost + Timolol Genetic may cause hair growth.

Children and adolescents
Bimatoprost + Timolol Genetic must not be used in children and adolescents under 18 years of age.

Bimatoprost + Timolol Genetic and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Other medicines may affect the action of Bimatoprost + Timolol Genetic, and Bimatoprost + Timolol Genetic may affect the action of other medicines, including other eye drops used in the treatment of glaucoma. Inform your doctor if you are taking or plan to take medicines for lowering blood pressure, medicines used in heart conditions, diabetes, quinidine (a medicine used in heart conditions or certain forms of malaria), or antidepressants known as fluoxetine and paroxetine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. Do not use Bimatoprost + Timolol Genetic during pregnancy unless advised otherwise by a doctor.
Do not use Bimatoprost + Timolol Genetic during breastfeeding. Timolol may pass into breast milk.
Before taking any medicine during breastfeeding, consult your doctor.

Driving and operating machinery
Bimatoprost + Timolol Genetic may cause blurred vision in some patients. Do not drive or operate machinery until symptoms resolve.

Bimatoprost + Timolol Genetic contains benzalkonium chloride
Bimatoprost + Timolol Genetic contains a preservative called benzalkonium chloride. This medicine contains 0.15 mg of benzalkonium chloride in each 3 ml of solution, equivalent to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Remove contact lenses before instilling this medicine and wait 15 minutes 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 discomfort, stinging, or pain in the eye occurs after using this medicine, contact your doctor.

Bimatoprost + Timolol Genetic contains phosphates
This medicine contains 2.88 mg of phosphates in every 3 ml of solution, equivalent to 0.96 mg/ml.
(See section 4. Other adverse effects reported during use of eye drops containing phosphates).

3. How to use Bimatoprost + Timolol Genetic

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
The recommended dose is one drop in each affected eye once daily, in the morning or evening.
This medicine should be used every day at the same time.
Instructions for administering the medicine
Do not use the bottle if the tamper-evident seal on the neck of the bottle is broken before first use.

1. Wash your hands. Tilt your head backwards and look upwards (Fig.1).
2. Gently pull down the lower eyelid to form a small pocket (Fig.2).
3. Turn the bottle upside down and gently squeeze it to instil one drop into each affected eye (Fig.3).
4. Release the lower eyelid and close the eye (Fig.4).
5. Without opening the eye, press with your finger on the inner corner of the closed eye (near the nose) and hold for 2 minutes. This helps prevent Bimatoprost + Timolol Genetic from being absorbed into the body (Fig.5).

If the drop misses the eye, repeat the procedure.
To avoid contamination, do not let the tip of the bottle touch the eye or any other surface. Immediately
after use, replace and tighten the cap.
Using Bimatoprost + Timolol Genetic with other eye medicines
Wait at least 5 minutes between instilling Bimatoprost + Timolol Genetic and any other eye medicine.
Ocular ointments or gels should be applied last.
If more Bimatoprost + Timolol Genetic has been used than recommended
It is unlikely that using more than the recommended dose of Bimatoprost + Timolol Genetic will cause any serious harm. Take the next dose at the usual time. If in doubt, consult your doctor or pharmacist.
If you forget to use Bimatoprost + Timolol Genetic
Do not use a double dose to make up for a forgotten dose.
If you forget to use a dose of Bimatoprost + Timolol Genetic, instil one drop as soon as you remember, then continue using the medicine as scheduled.
Stopping treatment with Bimatoprost + Timolol Genetic
To ensure Bimatoprost + Timolol Genetic works properly, it must be used daily.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Generally, you can continue using the eye drops if the adverse reactions are not severe. If in doubt,
consult your doctor or pharmacist. Do not stop using Bimatoprost + Timolol Genetic without first
discussing it with your doctor.

The following adverse reactions may occur during treatment with Bimatoprost + Timolol Genetic (in both multi-dose and single-dose forms):

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

Common adverse reactions (may affect up to 1 in 10 people)
Eye-related:
burning sensation, itching, stinging pain, conjunctival irritation (irritation of the transparent membrane covering 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, eyelash growth, darkening of the eyelids, darker skin pigmentation around the eyes, eyelash lengthening, eye irritation, excessive tearing, eyelid swelling, limited vision.

Other parts of the body:
nasopharyngitis (common cold), headache.

Uncommon adverse reactions (may affect 1 in 100 people)
Eye-related:
abnormal eye sensations, iritis (inflammation of the iris), conjunctival oedema (swelling of the transparent eye layer), eyelid pain, eye fatigue, ingrown eyelashes, darkening of the iris, sunken eye appearance, eyelid retraction (eyelid pulled away from the eye surface), darkening of eyelashes.

Other parts of the body:
dyspnoea (shortness of breath).

Adverse reactions with unknown frequency:

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:
difficulty breathing / wheezing, allergic reaction symptoms (swelling, eye redness and skin rash), taste disturbances, dizziness, bradycardia (slow heart rate), high blood pressure, sleep disturbances, nightmares, asthma, hair loss, skin colour change (around the eyes), fatigue.

Other adverse reactions have been observed in patients using eye drops containing timolol or bimatoprost and may therefore also occur during treatment with Bimatoprost + Timolol Genetic. As with other topically applied ophthalmic medicines, timolol may enter the systemic circulation. This may lead to adverse reactions similar to those seen after oral and/or intravenous administration of beta-adrenergic receptor blocking agents. The frequency of systemic adverse reactions after eye drop administration is lower than after oral or injected administration. The listed adverse reactions 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 may be life-threatening
• Low blood glucose levels
• Depression, memory loss, hallucinations
• Fainting, stroke, reduced blood flow to the brain, worsening of myasthenia gravis (increased muscle weakness), tingling sensation
• Reduced corneal sensitivity, double vision, drooping of the eyelid, detachment of one of the layers of the eyeball following a procedure to lower intraocular pressure, inflammation of the eye surface, bleeding in the back of the eye (retinal haemorrhage), eye inflammation, increased blinking
• Heart failure, irregular heartbeat or cardiac arrest, slowing or speeding up of the heartbeat, fluid accumulation (mainly water) in the body, chest pain
• Low blood pressure, swollen or cold hands, feet and extremities due to blood vessel constriction
• Cough, worsening of asthma, exacerbation of a lung disease called chronic obstructive pulmonary disease (COPD)
• Diarrhoea, abdominal pain, nausea and vomiting, indigestion, dry mouth
• Red, scaly skin lesions, skin rash
• Muscle pain
• Decreased libido, sexual dysfunction
• Weakness
• Increased liver function test results in blood tests

Other adverse reactions reported with the use of eye drops containing phosphates

If a patient has severe damage to the transparent layer of the eyeball (cornea), phosphates may, very rarely during treatment, cause the appearance of cloudy spots on the cornea due to calcium deposits.

Reporting of adverse reactions

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 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 to provide more information on the safety of the medicine.

5. How to store Bimatoprost + Timolol Genetic

Keep this medicine out of the sight and reach of children.
Do not use Bimatoprost + Timolol Genetic after the expiry date stated on the bottle label and on the carton after EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
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 when the bottle was opened, write it down on the carton.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Bimatoprost + Timolol Genetic contains

• The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml (amount equivalent to 6.8 mg/ml timolol maleate).
• The other components are: benzalkonium chloride (preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, hydrochloric acid, concentrated (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

What Bimatoprost + Timolol Genetic looks like and contents of the pack
Bimatoprost + Timolol Genetic is a colourless, transparent solution supplied in a plastic bottle. Each pack contains 1 bottle made of LDPE, with a dropper made of LDPE, with a cap made of PP and a tamper-evident ring. Each bottle is filled approximately halfway and contains 3 millilitres of solution. This amount of solution is sufficient for 4 weeks of use.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Genetic S.p.A.
Via G. Della Monica 26
84083 Castel San Giorgio (SA)
Italy
Manufacturer
Genetic S.p.A.
Contrada Canfora 84084 Fisciano (SA)
Italy
For further information, please contact the representative of the Marketing Authorisation Holder: