Bimatoprost + timolol genetic

Package leaflet: Information for the user

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• 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 single-dose eye drops are and what they are used for
2. Important information before using Bimatoprost + Timolol Genetic single-dose eye drops
3. How to use Bimatoprost + Timolol Genetic single-dose eye drops
4. Possible side effects
5. How to store Bimatoprost + Timolol Genetic single-dose eye drops
6. Contents of the pack and other information

1. What Bimatoprost + Timolol Genetic single-dose eye drops are and what they are used for

Bimatoprost + Timolol Genetic single-dose eye drops contain two active substances (bimatoprost and timolol) that reduce intraocular pressure. Bimatoprost belongs to a group of medicines called prostamides, 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 quickly enough, pressure inside the eye increases, which may eventually damage vision (causing a condition called glaucoma). Bimatoprost + Timolol Genetic single-dose eye drops work by reducing the production of fluid and increasing the amount of fluid drained. This leads to a reduction in intraocular pressure.
Bimatoprost + Timolol Genetic eye drops in single-dose containers are used to treat high eye pressure in adults, including elderly people. High eye pressure may lead to glaucoma. Your doctor will prescribe Bimatoprost + Timolol Genetic single-dose eye drops when other eye drops containing beta-blockers or prostaglandin analogues alone have not been sufficiently effective.

2. Important information before using Bimatoprost + Timolol Genetic single-dose eye drops, solution

When not to use Bimatoprost + Timolol Genetic single-dose 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, severe chronic obstructive pulmonary disease (severe lung disease which may cause wheezing, difficulty breathing, and long-lasting cough), or other breathing problems;
• if the patient has heart diseases such as bradycardia, heart block, or heart failure.

Warnings and precautions

Before starting to use 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 phenomenon;
• overactive thyroid gland, as timolol may mask the signs and symptoms of hyperthyroidism;
• diabetes, as timolol may mask the signs and symptoms of low blood sugar;
• severe allergic reactions;
• liver or kidney diseases;
• eye surface disorders;
• detachment of one of the layers of the eyeball following a procedure aimed at reducing intraocular pressure;
• known risk factors for macular edema (swelling of the retina in the eye leading to worsening of vision), such as cataract surgery.

Before undergoing surgical anesthesia, inform your doctor that you are using Bimatoprost + Timolol Genetic single-dose eye drops, as timolol may alter the effects of certain drugs used during anesthesia.

Bimatoprost + Timolol Genetic single-dose eye drops may cause darkening and increased growth of eyelashes, and 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 if only one eye is treated. If Bimatoprost + Timolol Genetic single-dose eye drops come into contact with the skin surface, they may cause excessive hair growth.

Children and adolescents

Bimatoprost + Timolol Genetic single-dose eye drops must not be used in children and adolescents under 18 years of age.

Bimatoprost + Timolol Genetic single-dose eye drops and other medicines

Other medicines may affect the action of Bimatoprost + Timolol Genetic single-dose eye drops, and Bimatoprost + Timolol Genetic single-dose eye drops may affect the action of other medicines, including other eye drops used in the treatment of glaucoma. Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Inform your doctor if you are taking or plan to take medicines for lowering blood pressure, medicines used for heart diseases, diabetes, quinidine (a medicine used for heart conditions or certain forms of malaria), or medicines used to treat depression known as 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 her doctor or pharmacist before using this medicine. Do not use Bimatoprost + Timolol Genetic single-dose eye drops during pregnancy unless advised otherwise by a doctor.

Do not use Bimatoprost + Timolol Genetic single-dose eye drops during breastfeeding. Timolol may pass into breast milk.

Before taking any medicine during breastfeeding, consult your doctor.

Driving and operating machinery

Bimatoprost + Timolol Genetic single-dose eye drops may cause blurred vision in some patients. Do not drive or operate machinery until symptoms resolve.

Bimatoprost + Timolol Genetic single-dose eye drops contain phosphates

This medicine contains 0.96 mg of phosphates per ml of solution.

(See section 4. Other adverse reactions reported during use of eye drops containing phosphates).

3. How to use Bimatoprost + Timolol Genetic single-dose formulation

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is one drop into each affected eye once daily, in the morning or
evening. The medicine should be used every day at the same time of day.
Instructions for administering the medicine
Wash your hands before use. Before use, ensure that the single-dose container is intact.
The solution must be used immediately after opening the container. To avoid contamination, do not touch the eye or any other surface with the open end of the container.

1. Tear off one single-dose container from the strip (Fig.1).
2. Hold the single-dose container vertically (with the cap pointing upwards) and unscrew the cap (Fig.2).
3. Gently pull down the lower eyelid to form a small pocket. Turn the single-dose container upside down and squeeze it gently to instill one drop into the treated eye(s) (Fig.3).
4. With the eye closed, press a finger against the inner corner of the eye (where the eye meets the nose) and hold for 2 minutes. This helps prevent Bimatoprost + Timolol Genetic from being absorbed into the rest of the body.
5. Dispose of the single-dose container after use, even if some solution remains.

If the drop misses the eye, repeat the procedure. Wipe away any excess medicine running onto the cheek.
Patients wearing contact lenses
If the patient wears contact lenses, they should be removed before using this medicine. Wait 15 minutes after using the medicine before reinserting the lenses.
Using Bimatoprost + Timolol Genetic single-dose formulation with other eye medicines
Wait at least 5 minutes between instilling Bimatoprost + Timolol Genetic single-dose formulation and any other eye medicine. Ointments or gels should be applied last.
Accidental overdose of Bimatoprost + Timolol Genetic single-dose formulation
If more than the recommended dose of Bimatoprost + Timolol Genetic single-dose formulation is used, it is unlikely to cause serious harm. The next dose should be taken at the usual time. If in doubt, consult a doctor or pharmacist.
Missed dose of Bimatoprost + Timolol Genetic single-dose formulation
If a dose of Bimatoprost + Timolol Genetic single-dose formulation 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 Bimatoprost + Timolol Genetic single-dose formulation
For Bimatoprost + Timolol Genetic single-dose formulation to work 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 single-dose eye drops without first discussing it with your doctor.

The following adverse reactions may occur during treatment with Bimatoprost + Timol0l Genetic (both in multi-dose and single-dose forms):

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

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), sensitivity to light, eye pain, sticky eyes, dry eyes, sensation 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, eyelash growth, darkening of the eyelids, darker skin pigmentation around the eyes, eyelash elongation, eye irritation, excessive tearing, eyelid swelling, limited vision.

Other parts of the body:
nasal inflammation (catarrrh), 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 (swelling of the transparent layer of the eye), eyelid pain, eye fatigue, ingrown eyelashes, darkening of the iris, sensation of sunken eyes, eyelid retraction (separation of the eyelid from the eye surface), darkening of eyelashes.

Other parts of the body:
shortness of breath.

Adverse reactions with unknown frequency of occurrence:
Eye-related:
cystoid macular oedema (swelling in the retina inside the eye leading to worsening of vision), eye swelling, blurred vision, eye discomfort.

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

Other adverse reactions observed in patients using eye drops containing timolol or bimatoprost may also occur during treatment with Bimatoprost + Timolol Genetic. As with other topically applied ophthalmic medicines, timolol may pass into the systemic circulation. This may lead to adverse reactions similar to those seen with oral and/or intravenous administration of beta-adrenergic receptor blocking agents. The frequency of systemic adverse reactions after administration of eye drops is lower than with 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 eyelid, detachment of one of the layers of the eyeball after a procedure to reduce intraocular pressure, corneal inflammation, bleeding in the back of the eye (retinal haemorrhage), eye inflammation, increased frequency of blinking
• Heart failure, irregular heartbeat or cardiac arrest, slowed or accelerated heart rate, fluid retention (mainly water) in the body, chest pain
• Low blood pressure, swollen or cold hands, feet and limbs due to narrowing of blood vessels
• 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 a serious 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 effects occur, including any possible adverse effects not listed in this leaflet, please consult your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 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 Bimatoprost + Timolol Genetic single-dose units

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the single-dose container, sachet, and carton after "Exp". The expiry date refers to the last day of the stated month.
This medicine is intended for single use only and does not contain preservatives. Do not store unused solution.
There are no special storage temperature requirements for this medicine. Store the single-dose containers in their sachet and carton to protect from light. The shelf life after first opening of the sachet is 7 days.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Bimatoprost + Timolol Genetic in single-dose form 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 ingredients are: 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 in single-dose form looks like and contents of the pack
Bimatoprost + Timolol Genetic in single-dose form is a colourless, transparent solution supplied in single-dose containers containing 0.4 ml of solution.
The packs contain 6 foil sachets, each containing 5 single-dose containers – a total of 30 single-dose containers.

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 more detailed information, please contact the representative of the marketing authorisation holder: