Bimatoprost/timolol Zentiva 0.3 mg/ml + 5 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bimatoprost/Timolol Zentiva 0.3 mg/ml + 5 mg/ml eye drops solution

bimatoprost/timolol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Bimatoprost/Timolol Zentiva is and what it is used for

This medicine contains two different active substances (bimatoprost and timolol) that reduce elevated eye pressure. Bimatoprost belongs to a group of medicines called prostamides, an analogue of prostaglandins. Timolol belongs to a group of medicines called beta-blockers.

The eye contains a clear, aqueous fluid that maintains the inside of the eye. This fluid is continuously drained from the eye, and new fluid is produced to replace it. If the fluid does not drain quickly enough, pressure inside the eye increases, and over time your vision may become damaged (a condition known as glaucoma). This medicine works by reducing the production of fluid and also increasing the amount of fluid that is drained. This lowers the pressure inside the eye.

Bimatoprost/Timolol Zentiva eye drops are used to treat elevated intraocular pressure in adults, including elderly people. This increased pressure may lead to glaucoma. Your doctor will prescribe this medicine if other eye drops containing beta-blockers or prostaglandin analogues have not been sufficiently effective on their own.

2. What you need to know before using Bimatoprost/Timolol Zentiva

Do not use Bimatoprost/Timolol Zentiva eye drops

• if you are allergic to bimatoprost, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6);
• if you currently have or have previously had breathing problems such as asthma, or severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or persistent cough);
• if you have heart problems such as slow heart rate, heart block, or heart failure.

Warnings and precautions

Before starting treatment with this medicine, inform your doctor if you have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or suffocation), heart failure, low blood pressure;
• heart rate disorders, such as slow heartbeat;
• breathing problems, asthma, or chronic obstructive pulmonary disease;
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome);
• overactivity of the thyroid gland, as timolol may mask signs and symptoms of thyroid disorders;
• diabetes, as timolol may mask signs and symptoms of hypoglycemia;
• severe allergic reactions;
• liver or kidney problems;
• eye surface problems;
• separation of one of the layers inside the eyeball after surgery to reduce eye pressure;
• known risk factors for macular edema (swelling of the retina causing worsening vision), for example, cataract surgery.

Inform your doctor before undergoing surgical anesthesia that you are using this medicine, as timolol may alter the effects of certain medications used during anesthesia. This medicine may cause darkening and growth of eyelashes, as well as darkening of the skin around the eyelid. Over time, the color of the iris may also darken. These changes may be permanent and more noticeable if only one eye is being treated. This medicine may cause increased hair growth on skin areas that come into contact with the solution.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Bimatoprost/Timolol Zentiva

This medicine may interact with or be affected by other medicines you are taking, including other eye drops for glaucoma treatment. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Inform your doctor if you are taking or plan to take medications to lower blood pressure, for heart conditions, for diabetes treatment, quinidine (used to treat heart conditions and some types of malaria), or antidepressants known as fluoxetine and paroxetine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Do not use this medicine during pregnancy unless recommended by your doctor.

Do not use this medicine while breastfeeding. Timolol may pass into breast milk. Consult your doctor before using any medicine during breastfeeding.

Driving and using machines

This medicine may cause blurred vision in some patients. Do not drive or operate machinery until these symptoms have resolved.

Bimatoprost/Timolol Zentiva contains 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 using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

Bimatoprost/Timolol Zentiva contains phosphates

This medicine contains 2.85 mg of phosphates in each 3 ml of solution, equivalent to 0.95 mg/ml.

Use in athletes:

This medicine contains timolol, and athletes should be advised that it may lead to a positive result in doping control tests.

3. How to use Bimatoprost/Timolol Zentiva

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one drop administered once daily, either in the morning or in the evening, in each eye requiring treatment. Use this medicine every day at the same time.

Instructions for use

Do not use the bottle if the protective seal on the neck of the bottle is broken before first use.

1. Wash your hands. Tilt your head backward and look up at the ceiling.
2. Gently pull down the lower eyelid until a small pocket is formed.
3. Invert the bottle and squeeze it to release one drop into each eye requiring treatment.
4. Release the lower eyelid and close the eye.
5. With the eye closed, press with your finger on the inner corner of the closed eye (the area where it meets the nose) and maintain pressure for 2 minutes. This helps prevent the medicine from reaching the rest of the body.

If the drop falls outside the eye, try again.

To prevent contamination, avoid letting the tip of the bottle touch the eye or any other surface. Replace the cap and close the bottle immediately after use.

If you are using this medicine with another ophthalmic medicine, wait at least 5 minutes between administering this medicine and the other medicine. Use any eye ointment or gel last.

If you use more Bimatoprost/Timolol Zentiva than you should

If you use more Bimatoprost/Timolol Zentiva than you should, it is unlikely to cause you any serious harm. Apply the next dose at the usual time. If you are concerned, speak to your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Bimatoprost/Timolol Zentiva

If you forget to use this medicine, apply one drop as soon as you remember, and then return to your regular routine. Do not use a double dose to make up for forgotten doses.

If you stop using Bimatoprost/Timolol Zentiva

This medicine should be used every day for it to work properly.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone gets them. Generally, you may continue using the eye drops unless the effects are severe. If you are concerned, speak to a doctor or pharmacist. You must not stop using Bimatoprost/Timolol Zentiva without talking to your doctor.

The following adverse effects may occur with Bimatoprost/Timolol Zentiva:

Very common
(can affect more than 1 in 10 people)

Eye-related:

• Redness.

Common
(can affect up to 1 in 10 people)

Eye-related:

• Burning,
• Itching,
• Stinging,
• Conjunctival irritation (irritation of the transparent layer of the eye),
• Light sensitivity,
• Eye pain,
• Sticky eyes,
• Dry eyes,
• Feeling of having something in the eye,
• Small erosions on the eye surface with or without inflammation,
• Difficulty seeing clearly,
• Redness and itching of the eyelids,
• Growth of eyelid hair,
• Darkening of the eyelids,
• Darker skin around the eyes,
• Longer eyelashes,
• Eye irritation,
• Watery eyes,
• Swollen eyelids,
• Reduced vision.

Affecting other parts of the body:

• Runny nose,
• Headache.

Uncommon
(can affect up to 1 in 100 people)

Eye-related:

• Abnormal sensation in the eye,
• Iris inflammation,
• Conjunctivitis (inflammation of the transparent layer of the eye),
• Painful eyelids,
• Tired eyes,
• Eyelashes growing inward,
• Darkening of the iris color,
• Sunken eyes,
• Drooping eyelid,
• Retracted eyelid (pulling away from the eye surface, causing incomplete eyelid closure),
• Tightness of the eyelid skin,
• Darkening of eyelashes.

Affecting other parts of the body:

• Shortness of breath.

Frequency not known
(cannot be estimated from available data)

Eye-related:

• Cystoid macular edema (retinal swelling causing worsening vision),
• Eye inflammation,
• Blurred vision,
• Eye discomfort.

Affecting other parts of the body:

• Difficulty breathing/wheezing (making sounds when breathing),
• Symptoms of allergic reaction (swelling, eye redness, skin rash),
• Taste disturbances,
• Dizziness,
• Decreased heart rate,
• High blood pressure,
• Sleep disturbances,
• Nightmares,
• Asthma,
• Alopecia,
• Skin discoloration (periocular),
• Fatigue.

As the following additional adverse effects have been observed in patients using eye drops containing timolol or bimatoprost, they may also occur with Bimatoprost/Timolol Zentiva. Like other eye medications, timolol can be absorbed into the bloodstream. This may cause adverse effects similar to those seen with intravenous and/or oral beta-blockers. The likelihood of experiencing adverse effects with eye drops is lower than when medicines are taken orally or by injection. The listed adverse effects include those observed with bimatoprost and timolol when used to treat eye conditions:

• Severe allergic reactions with swelling and breathing difficulty, which may be potentially life-threatening.
• Hypoglycemia.
• Depression; memory loss; hallucination.
• Fainting; stroke; reduced blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation.
• Decreased sensitivity on the eye surface; double vision; ptosis; separation of one of the layers of the eyeball after surgery to reduce intraocular pressure; eye surface inflammation, bleeding at the back of the eye (retinal hemorrhage), inflammation inside the eye, increased blinking.
• Heart failure; irregularities or interruption of heartbeat; bradycardia or tachycardia; fluid retention, mainly water, accumulating in the body; chest pain.
• Low blood pressure; swelling or coldness of hands, feet, and limbs, caused by constriction of blood vessels.
• Cough; worsening of asthma; worsening of lung disease known as chronic obstructive pulmonary disease (COPD).
• Diarrhea; stomach pain; nausea and vomiting; indigestion; dry mouth.
• Scaly red patches on the skin; skin rash.
• Muscle pain.
• Decreased sex drive, sexual dysfunction.
• Weakness.
• Increased levels in certain blood test results indicating liver function.

Other adverse effects reported with eye drops containing phosphate

If you have severe damage to the transparent front layer of the eye (cornea), treatment with phosphates, in very rare cases, may cause cloudy patches in the cornea due to calcium deposits.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bimatoprost/Timolol Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label of the bottle and the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Once opened, the solution may become contaminated, which could cause ocular infections. Therefore, discard the bottle 4 weeks after first opening, even if there is still some solution remaining. To help you remember, write down the date you opened the bottle in the space provided on the carton.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bimatoprost/Timolol Zentiva

• The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml, corresponding to timomolol maleate 6.8 mg/ml.
• The other components are benzalkonium chloride (preservative), sodium chloride, disodium phosphate heptahydrate, monohydrated citric acid, and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to adjust the solution to the correct pH (acidity).
• The product contains benzalkonium chloride and phosphates; see section 2.

Appearance of the medicine and contents of the pack

Bimatoprost/Timolol Zentiva is a solution ranging from colourless to slightly yellow in a plastic bottle. Each pack contains 1 or 3 plastic bottles, each fitted with a screw cap. Each bottle contains 3 millilitres of solution, which fills approximately half the bottle. The contents are sufficient for 4 weeks of treatment. Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer

Rompharm Company S.r.l.
1A Eroilor Street
075100 Ilfov, Otopeni
Romania

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Zentiva Spain S.L.U.
Avenida de Europa, 19, Edificio 3, Planta 1
28224 Pozuelo de Alarcón, Madrid
Spain

This medicine is authorised in the European Economic Area countries and the United Kingdom (Northern Ireland) under the following names:

Netherlands, Germany, France, Estonia, United Kingdom (Northern Ireland), Spain, Denmark, Sweden: Bimatoprost/Timolol Zentiva
Italy: Bimatoprost e Timololo Zentiva

Date of the most recent revision of this leaflet: January 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/