Prospecto: information for the patient

Bimatoprost/Timolol Zentiva0.3mg/ml + 5mg/ml eye drops in solution

bimatoprost/timolol

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isBimatoprost/Timolol Zentivaand for what it is used

2. What you need to know before starting to useBimatoprost/Timolol Zentiva

3. How to useBimatoprost/Timolol Zentiva

4. Possible adverse effects

5. Storage ofBimatoprost/Timolol Zentiva

6. Contents of the package and additional information

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

The eye contains a clear, watery liquid that maintains the interior of the eye. This liquid drains continuously from the eye and new liquid is generated to replace it. If the liquid does not drain at a sufficient speed, the pressure inside the eye increases and, in the long term, your vision could be damaged (a disease called glaucoma). This medicine acts by reducing the production of liquid and also increasing the amount that drains. This reduces the pressure inside the eye.

Bimatoprost/Timolol Zentiva eye drops are used for the treatment of high eye pressure in adults, including elderly people. This high pressure can cause glaucoma. Your doctor will prescribe this medicine if other eye drops containing beta-blockers or prostaglandin analogues have not had a sufficient effect on their own.

No useBimatoprost/Timolol Zentivaeye drops

- if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients of this medicine (listed in section6);

- if you have or have had respiratory problems, such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing and/or persistent coughing);

- if you have heart problems such as low heart rate, heart block or heart failure.

Warnings and precautions

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

- coronary heart disease (symptoms may include chest pain or pressure, difficulty breathing or feeling of suffocation), heart failure, low blood pressure;

- irregular heart rhythms, such as slow heart rate;

- respiratory problems, asthma or chronic obstructive pulmonary disease;

- circulatory disorders (such as Raynaud's disease or Raynaud's syndrome);

- hyperactivity of the thyroid gland, as timolol may mask the signs and symptoms of thyroid diseases;

- diabetes, as timolol may mask the signs and symptoms of hypoglycemia;

- severe allergic reactions;

- liver or kidney problems

- eye problems

- separation of one of the layers of the inside of the eyeball after surgery to reduce eye pressure;

- known risk factors for macular edema (inflammation of the retina that causes a worsening of vision), for example, cataract surgery.

Inform your doctor before undergoing surgery that you are using this medicine, as timolol may modify the effects of some medicines used during anesthesia. This medicine may cause darkening and growth of eyelashes, as well as darkening of the skin around the eyelid. Over time, it may also darken the color of the iris. These changes may be permanent and more noticeable if only one eye is being treated. This medicine may cause hair growth in contact with the skin surface.

Children and adolescents

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

Other medicines andBimatoprost/Timolol Zentiva

This medicine may affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.Inform your doctor if you are using or plan to use medicines to lower blood pressure, for the heart, for the treatment of diabetes, quinidine (used to treat heart conditions and some types of malaria) or for the treatment of depression, known as fluoxetine and paroxetine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine. Do not use this medicine if you are pregnant unless your doctor recommends it.

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

Driving and operating machinery

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

Bimatoprost/Timolol Zentivacontains 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 alter the color of contact lenses. 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 (transparent layer of the front of the eye). Consult your doctor if you feel a strange sensation, burning or pain in the eye after using this medicine.

Bimatoprost/Timolol Zentivacontains 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 warned that it may produce a positive result in doping control tests.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one drop administered once a day, either in the morning or in the evening, in each eye that requires treatment. Use this medication 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 using it for the first time.

1.Wash your hands. Tilt your head back and look up towards the ceiling.

2.Gently pull down your lower eyelid until a small space is created.

3.Invert the bottle and press it to release one drop into each eye that requires treatment.

4.Release your lower eyelid and close your eye.

5.With your eye closed, press the corner of your closed eye (the area where it meets the nose) with your finger and maintain the pressure for 2 minutes. This helps prevent the medication from entering 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 use this medication with another eye medication, wait at least 5 minutes between administering this medication and the other medication. Use any eye ointment or gel last.

If you use moreBimatoprost/Timolol Zentivathan you should

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to useBimatoprost/Timolol Zentiva

If you forgot to use this medication, apply one drop as soon as you remember and return to your usual routine. Do not use a double dose to compensate for the missed doses.

If you interrupt treatment withBimatoprost/Timolol Zentiva

This medication should be used daily for it to work properly.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Generally, you can continue using the eye drops unless the side effects are severe. If you are concerned, speak with a doctor or pharmacist. Do not stop using Bimatoprost/Timolol Zentiva without speaking with your doctor.

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

Very common

(may affect more than 1 in 10 people)

Affecting the eye

• Redness.

Common

(may affect up to 1 in 10 people)

Affecting the eye

• Burning.
• Itching.
• Stinging.
• Conjunctival irritation (the transparent layer of the eye).
• Light sensitivity.
• Eyelid pain.
• Eye stickiness.
• Dry eyes.
• Sensation of something in the eye.
• Small erosions on the surface of the eye with or without inflammation.
• Difficulty seeing clearly.
• Redness and itching of the eyelids.
• Excessive hair growth around the eye.
• Darkening of the eyelids.
• Darker color around the eyes.
• Longer eyelashes.
• Ocular irritation.
• Watery eyes.
• Inflamed eyelids.
• Reduced vision.

Affecting other parts of the body

• Runny nose.
• Headache.

Rare

(may affect up to 1 in 100 people)

Affecting the eye

• 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 (moving away from the surface of the eye, causing incomplete eyelid closure).
• Tightness of the eyelid skin.
• Darkening of the eyelashes.

Affecting other parts of the body

• Shortness of breath.

Unknown frequency

(cannot be estimated from available data)

Affecting the eye

• Macular edema cystoid (inflammation of the retina causing vision impairment).
• Eye inflammation.
• Blurred vision.
• Ocular discomfort.

Affecting other parts of the body

• Difficulty breathing/ wheezing (production of sounds while breathing).
• Allergic reaction symptoms (swelling, redness of the eye, and skin rash).
• Changes in taste.
• Dizziness.
• Decreased heart rate.
• High blood pressure.
• Sleep disturbances.
• Nightmares.
• Asthma.
• Hair loss.
• Decoloration of the skin (periocular).
• Fatigue.

As the following additional side effects have been seen in patients using timolol or bimatoprost eye drops, it is possible that they may occur with Bimatoprost/Timolol Zentiva. As other medications applied to the eyes, timolol is absorbed into the bloodstream. This may cause side effects similar to those observed with intravenous or oral beta-blockers. The likelihood of experiencing side effects with the use of eye drops is lower than when medications are taken, for example, orally or injected. Among the listed side effects are the reactions observed with bimatoprost and timolol when used to treat eye conditions:

Other side effects reported with eye drops containing phosphate

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label of the bottle and the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Once opened, the solutions may become contaminated, which can cause eye infections. Therefore, you must discard the bottle 4 weeks after having opened it for the first time, even if there is still some solution left. To remember, write the date you opened the bottle in the space provided on the box.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Bimatoprost/Timolol Zentiva

Appearance of the product and contents of the package

Bimatoprost/Timolol Zentivais a colorless to slightly yellow solution in a plastic bottle. Each package contains 1 or 3plastic bottles, each with a screw cap. Each bottle contains 3milliliters of solution, which fills the bottle to approximately half. The contents are sufficient for 4weeks of treatment. Some package sizes may be marketed.

Holder of the marketing authorization

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Responsible for manufacturing

Rompharm Company S.r.l.

1A Eroilor Street

075100 Ilfov, Otopeni

Romania

For more information about this medication, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

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

Italy: Bimatoprost e Timololo Zentiva

Last review date of this leaflet:January 2023

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/