BIMATOPROST/TIMOLOL ZENTIVA 0.3 mg/mL + 5 mg/mL Eye Drops Solution

Introduction

Package Leaflet: Information for the Patient

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

bimatoprost/timolol

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

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

This medicine contains two different active substances (bimatoprost and timolol) that reduce high pressure in the eye. 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 inside of the eye. This liquid is continuously drained from the eye and new liquid is produced to replace it. If the liquid does not drain quickly enough, the pressure inside the eye increases and, over time, your vision could be damaged (a disease called glaucoma). This medicine works by reducing the production of liquid and also increasing the amount of liquid that is drained. This reduces the pressure inside the eye.

Bimatoprost/Timolol Zentiva eye drops solution is used to treat high pressure in the eye in adults, including the elderly. This high pressure can cause glaucoma. Your doctor will prescribe this medicine if other eye drops that contain beta-blockers or prostaglandin analogues have not had a sufficient effect on their own.

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

Do not useBimatoprost/Timolol Zentivaeye drops solution

• 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 a history of respiratory problems, such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that can 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, tell your doctor if you have or have had:

• coronary heart disease (symptoms may include chest pain or discomfort, difficulty breathing or feeling of suffocation), heart failure, low blood pressure;
• abnormal heart rhythms, such as slow heartbeat;
• respiratory problems, asthma or chronic obstructive pulmonary disease;
• poor blood circulation disorders (such as Raynaud's disease or Raynaud's syndrome);
• overactive thyroid gland, as timolol may mask the signs and symptoms of thyroid disease;
• diabetes, as timolol may mask the signs and symptoms of hypoglycaemia;
• severe allergic reactions;
• liver or kidney problems
• surface 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 vision to worsen), such as cataract surgery.

Tell your doctor before undergoing surgical anesthesia that you are using this medicine, as timolol may alter 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 when it comes into contact with the skin surface.

Children and adolescents

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

Other medicines and Bimatoprost/Timolol Zentiva

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, 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 using machines

This medicine may cause blurred vision in some patients. Do not drive or use machines until the symptoms have disappeared.

Bimatoprost/Timolol Zentiva contains benzalkonium chloride

This medicine contains 0.15 mg of benzalkonium chloride in every 3 ml of solution, equivalent to 0.05 mg/ml. Benzalkonium chloride can 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 putting them back in.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer of the front of the eye). Consult your doctor if you feel any unusual sensation, itching or pain in the eye after using this medicine.

Bimatoprost/Timolol Zentiva contains phosphates

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

Use in athletes:

This medicine contains timolol, and athletes should be aware that it may produce a positive result in doping tests.

3. How to use Bimatoprost/Timolol Zentiva

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one drop administered once a day, either in the morning or at night, in each eye that needs 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 using it for the first time.

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

If the drop falls outside the eye, try again.

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

If you use this medicine with another eye 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, talk to your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately, telephone 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 usual 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 other questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You can usually continue using the eye drops, unless the effects are severe. If you are concerned, talk to a doctor or pharmacist. Do not stop using Bimatoprost/Timolol Zentiva without talking to 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,
• irritation,
• conjunctival irritation (the transparent layer of the eye),
• sensitivity to light,
• eye pain,
• sticky eyes,
• dry eyes,
• feeling of having 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,
• hair growth around the eye,
• darkening of the eyelids,
• darker color around the eyes,
• longer eyelashes,
• eye irritation,
• tearful eyes,
• inflamed eyelids,
• reduced vision.

Affecting other parts of the body

• runny nose,
• headache.

Uncommon

(may affect up to 1 in 100 people)

Affecting the eye

• abnormal sensation in the eye,
• inflammation of the iris,
• conjunctivitis (inflammation of the transparent layer of the eye),
• painful eyelids,
• tired eyes,
• eyelashes growing inwards,
• darkening of the iris color,
• sunken eyes,
• drooping eyelid,
• retracted eyelid (moving away from the eye surface, causing incomplete closure of the eyelids),
• tightness of the eyelid skin,
• darkening of the eyelashes.

Affecting other parts of the body

• shortness of breath.

Frequency not known

(cannot be estimated from the available data)

Affecting the eye

• cystoid macular edema (inflammation of the retina that causes vision to worsen),
• eye inflammation,
• blurred vision,
• eye discomfort.

Affecting other parts of the body

• difficulty breathing/wheezing (production of sounds when breathing),
• symptoms of allergic reaction (swelling, redness of the eye and skin rash),
• changes in taste,
• dizziness,
• decreased heart rate,
• high blood pressure,
• sleep disorders,
• nightmares,
• asthma,
• hair loss,
• skin discoloration (around the eye),
• fatigue.

Other side effects reported with phosphate-containing eye drops

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side 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 which is stated on the label of the bottle and the carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Once opened, the solutions may become contaminated, which can cause eye infections. Therefore, you should discard the bottle 4 weeks after first opening, even if there is still some solution left. To remind you, write the date you opened the bottle in the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Bimatoprost/Timolol Zentiva

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

Appearance of the Product and Container Content

Bimatoprost/Timolol Zentiva is a colorless to slightly yellowish solution in a plastic bottle. Each container contains 1 or 3 plastic bottles, each provided with a screw cap. Each bottle contains 3 milliliters of solution, which fills approximately half of the bottle. The content is sufficient for 4 weeks of treatment. Only some package sizes may be marketed.

Marketing Authorization 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

You can request more information about this medication by contacting 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) under the following names:

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

Italy: Bimatoprost and Timolol Zentiva

Date of the Last Revision of this Leaflet:January 2023

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/