Vizilatan Duo 50 micrograms/ml + 5 mg/ml solution for eye drops

Spain
Brand name Vizilatan Duo 50 micrograms/ml + 5 mg/ml solution for eye drops
Form solution, ophthalmic
Active substance / Dosage
LATANOPROST · 0,05 mg/ml
TIMOLOL MALEATE · 6,83 mg/ml
Prescription type Prescription Only Medicine
ATC code
S01E S01ED S01ED51
Registration number 85139
Manufacturer Bausch + Lomb Ireland Limited
Vizilatan Duo 50 micrograms/ml + 5 mg/ml solution for eye drops solution, ophthalmic

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vizilatan Duo 50 micrograms/ml + 5 mg/ml, eye drops solution

latanoprost/timolol

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

  • Keep this leaflet as 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 give it to others, even if they have the same symptoms as you, because it could harm them.
  • If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Vizilatan Duo is and what it is used for

It contains two active substances: latanoprost and timolol. Latanoprost belongs to a group of medicines called prostaglandin analogues. Timolol belongs to a group of medicines called beta-blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol reduces the production of fluid in the eye.

This medicine is used to reduce pressure inside the eye in patients with open-angle glaucoma or ocular hypertension. These conditions are associated with increased intraocular pressure, which may eventually affect vision. Your doctor will usually prescribe this medicine when other treatments have not been sufficiently effective.

This medicine can be used in adult men and women (including elderly patients), but it is not recommended for use in children and adolescents under 18 years of age.

Vizilatan Duo eye drops solution is a sterile solution without preservatives.

2. What you need to know before using Vizilatan Duo

Do not use Vizilatan Duo

  • If you are allergic to latanoprost or timolol, beta-blockers, or any of the other components of this medicine (listed in section 6).
  • If you have or have previously had respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-lasting cough).
  • If you have serious heart problems or cardiac rhythm disorders.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use this medicine 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 disturbances such as reduced heartbeat
  • Respiratory problems, asthma, or chronic obstructive pulmonary disease
  • Circulatory problems (such as Raynaud's disease and Raynaud's syndrome)
  • Diabetes, as timolol may mask the signs and symptoms of low blood sugar levels
  • Overactive thyroid gland (hyperthyroidism), as timolol may mask its signs and symptoms
  • If you are undergoing or have previously undergone any type of eye surgery (including cataract surgery)
  • Eye problems (such as eye pain, irritation, or inflammation, or blurred vision)
  • If you know you have dry eye
  • If you wear contact lenses. You may continue using this medicine, but you must follow the instructions provided in section 3 for contact lens wearers.
  • If you know you suffer from angina (especially a type known as Prinzmetal's angina)
  • If you know you experience severe allergic reactions that would normally require hospital treatment
  • If you have had or are currently experiencing a viral eye infection caused by the herpes simplex virus (HSV).

Inform your doctor before any surgical procedure that you are using this medicine, as timolol may alter the effects of certain medications used during anesthesia.

Children and adolescents

This medicine is not recommended for use in individuals under 18 years of age.

Other medicines and Vizilatan Duo

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including eye drops or medicines obtained without a prescription.

The effect of this medicine may be affected by, or may affect, other medicines you are taking, including other eye drops for glaucoma treatment. Inform your doctor if you are taking or plan to take medicines to lower blood pressure, heart medications, or treatments for diabetes.

In particular, inform your doctor or pharmacist if you are taking any of the following types of medicines:

  • Prostaglandins, prostaglandin analogs or derivatives (used for contraction and relaxation of smooth muscle, dilation and constriction of blood vessels, blood pressure control, and modulation of inflammation)
  • Beta-blockers (used to treat high blood pressure, angina, certain abnormal heart rhythms, heart attack, anxiety, migraines, glaucoma, and symptoms of hyperthyroidism)
  • Adrenaline (used to treat potentially life-threatening allergic reactions caused by insect bites or stings, food, medicines, latex, and other causes)
  • Medicines used to treat high blood pressure such as calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides, or parasympathomimetics
  • Quinidine (used to treat heart conditions and certain types of malaria)
  • Antidepressants known as fluoxetine and paroxetine.

Use of Vizilatan Duo with food and drink

Normal meals, food, or drinks do not affect when or how you should use this medicine.

Pregnancy, breast-feeding, and fertility

Pregnancy

Do not use this medicine if you are pregnant unless your doctor considers it necessary. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Breast-feeding

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

Fertility

Animal studies have not shown that latanoprost or timolol have any effect on male or female fertility.

Driving and using machines

You may experience blurred vision for a short period of time after using this medicine. If this occurs, do not drive or operate tools or machinery until your vision clears.

Vizilatan Duo contains macrogolglycerol hydroxystearate 40

This medicine contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.

Vizilatan Duo contains phosphate buffer

This medicine contains 0.18 mg of phosphates per drop, equivalent to 6.43 mg/ml.

If you have severe corneal damage (the transparent layer at the front of the eye), treatment with phosphates may, in very rare cases, lead to blurred vision due to calcium accumulation.

Use in athletes

This medicine contains timolol, which may result in a positive test in doping controls.

3. How to use Vizilatan Duo

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 for adults (including elderly patients) is one drop in the affected eye or eyes once daily.

Do not use this medicine more than once a day; the effectiveness of treatment may decrease if administered more frequently.

Use this medicine exactly as your doctor has instructed you, until he or she tells you to stop.

Your doctor may wish to carry out additional checks of your heart and circulation if you are using this medicine.

Contact lens wearers

If you wear contact lenses, you must remove them before using this medicine. After applying this medicine, you must wait 15 minutes before reinserting your contact lenses.

Instructions for use

Black and white technical drawing of a cylindrical medical device composed of an upper conical tip and a segmented central body

1a

A hand turns a capsule-shaped cap to the left to unscrew or open a cylindrical container held by the

1b

  • Remove the bottle (image 1a) from the carton and write the date of opening on both the carton and the bottle, in the space provided for this purpose.
  • Take the medicine bottle and a mirror.
  • Wash your hands.
  • Remove the cap (image 1b).

A hand holds a medicine bottle with a spout pointing downward while a black arrow points toward the

2

  • Hold the bottle upside down, placing your thumb on the wide part below the neck of the bottle and the other fingers on the bottom of the bottle. Before first use, pump the bottle repeatedly 15 times (image 2). A possible whitish appearance of the drops should not be a cause for concern.

Stylized drawing of a hand gently holding the skin below the

3

  • Tilt your head backward. With a clean finger, gently pull down the lower eyelid of the eye until a "pocket" forms between the eyelid and the eye. This is where you should place the drop (image 3).
  • Bring the tip of the bottle close to the eye. Use the mirror if it helps.

Black and white drawing showing a hand holding a dropper bottle to apply medication into the

4

5Line drawing of an eye with a hand holding a finger gently placed on the upper eyelid to keep it open

  • Do not let the dropper touch the eye, eyelid, surrounding areas, or any other surfaces. The drops could become contaminated.
  • Gently press the bottom of the bottle to release one drop of medication at a time (image 4).
  • If the drop does not fall into the eye, apply another drop.
  • After applying the medication, press with one finger on the corner of the treated eye near the nose for 2 minutes (image 5). This will prevent the medication from passing into the rest of the body.
  • If you need to use the drops in both eyes, repeat the same steps for the other eye.
  • Closely replace the cap on the bottle immediately after use.
  • Use only one medicine bottle at a time. Do not open the cap until you need to use the bottle.
  • To prevent infection, discard the bottle four weeks after first opening and use a new bottle.

If you are using Vizilatan Duo and another eye drop

Wait at least 5 minutes between applying this medicine and administering the other eye drop.

If you use more Vizilatan Duo than you should

If too many drops are applied, you may experience mild eye irritation, which could cause redness or tearing. This condition should resolve on its own, but if you are concerned, contact your doctor for advice.

If you swallow Vizilatan Duo

In case of accidental ingestion of this medicine, consult your doctor or call the Toxicology Information Service at telephone number: 91 562 04 20. If you ingest a large amount of this medicine, you may feel unwell, have stomach pain, feel tired, hot, dizzy, and begin to sweat.

If you forget to use Vizilatan Duo

Continue with the next dose as usual. Do not use a double dose to make up for the missed dose. If you are unsure about any aspect, consult your doctor or pharmacist.

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 cause adverse effects, although not everyone will experience them.

You may generally continue using the drops unless the effects are severe. If you have any concerns, consult a doctor or pharmacist. Do not stop using this medicine without speaking to your doctor.

Below is a list of known adverse effects associated with the use of eye drops containing the active substances latanoprost and timolol. The most important adverse effect is the possibility of a gradual, permanent change in eye colour. Eye drops containing the active substances latanoprost and timolol may also cause serious changes in heart function. Contact a doctor if you notice changes in your heart rate or heart function, and inform them that you are using this medicine.

The following are known adverse effects associated with the use of eye drops containing the active substances latanoprost and timolol:

Very common adverse effects (may affect more than 1 in 10 patients):

  • Gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to experience this change than if your eyes are of a single colour (blue, grey, green or brown). This change in eye colour may take years to occur. The colour change may be permanent and may be more noticeable if you use this medicine in only one eye. The change in eye colour does not appear to be associated with any eye problems. The change in eye colour does not progress once treatment with this medicine is stopped.

Common adverse effects (may affect less than 1 in 10 patients):

  • Eye irritation (burning sensation, gritty feeling, stinging, itching or sensation of a foreign body) and eye pain.

Uncommon adverse effects (may affect less than 1 in 100 patients):

  • Headache
  • Eye redness, eye infection (conjunctivitis), blurred vision, watery eyes, eye swelling, eye irritation or changes to the surface of the eye.
  • Skin redness or itching (pruritus)

Other adverse effects

Like other medicines applied to the eyes, latanoprost and timolol are absorbed into the bloodstream. The incidence of these adverse effects with eye drops is lower than when medicines are taken orally or injected.

Although not observed with eye drops containing the active substances latanoprost and timolol, the following adverse effects have occurred with each of the active substances in this medicine and could therefore occur when using this medicine. The listed adverse effects include reactions observed within the class of beta-blockers (e.g., timolol) when used to treat ocular conditions:

  • Development of viral eye infection caused by the herpes simplex virus (HSV)
  • Generalised allergic reactions including swelling under the skin in areas such as the face and limbs, which may obstruct the airways causing difficulty in swallowing or breathing, hives or itchy rash, localised and generalised rash, itching, or sudden severe allergic reaction potentially leading to death
  • Low blood glucose (sugar) levels
  • Dizziness
  • Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations
  • Fainting, stroke, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), unusual sensations such as tingling and headache
  • Swelling at the back of the eye (macular edema), cyst with fluid accumulation in the coloured part of the eye (iris cyst), light sensitivity (photophobia), appearance of sunken eyes (deepening of the eyelid sulcus)
  • Signs and symptoms of eye irritation (e.g., burning, stinging, itching, tearing, redness), eyelid swelling, corneal inflammation, blurred vision, and detachment of the layer beneath the retina containing blood vessels after filtration surgery, which may cause visual disturbances, reduced corneal sensitivity, dry eye, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (causing the eye to remain partially closed), double vision
  • Darkening of the skin around the eye, changes in eyelashes and hair around the eye (increased number, length, thickness, and darkening), changes in the direction of eyelash growth, swelling around the eyes, swelling of the coloured part of the eye (iritis/uveitis), scarring of the eye surface
  • Ringing or buzzing in the ears (tinnitus)
  • Angina, worsening of angina in patients who already have heart disease
  • Slow heart rate, chest pain, palpitations (awareness of heartbeat), edema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease causing difficulty breathing and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure
  • Low blood pressure, poor blood circulation causing numbness and paleness of fingers and toes as well as cold hands and feet
  • Dyspnea, narrowing of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma
  • Taste disturbances, nausea (uncommon), indigestion, diarrhea, dry mouth, abdominal pain, vomiting (uncommon)
  • Alopecia, skin rash with silvery appearance (psoriasiform rash) or worsening of psoriasis, skin rash
  • Joint pain, muscle pain not caused by exercise, muscle weakness, fatigue
  • Sexual dysfunction, decreased libido

In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (cornea) have developed opaque spots in the cornea due to calcium deposits during treatment.

Reporting of adverse effects

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

5. Storage of Vizilatan Duo

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

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

This medicine does not require any special storage conditions.

To prevent infection, discard the bottle four weeks after first opening. Write the date of first opening in the space provided for this purpose on the carton and on the label of the bottle.

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

6. Contents of the pack and other information

Composition of Vizilatan Duo

  • The active substances are latanoprost and timolol.

Each ml of solution contains 50 micrograms of latanoprost and 5 mg of timolol (as 6.8 mg timolol maleate).

  • The other components are macrogol glycerol hydroxystearate 40, sodium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate, hydrochloric acid and/or sodium hydroxide (to adjust pH), water for injections.

Appearance of Vizilatan Duo and contents of the pack

Vizilatan Duo is presented as 2.5 ml of aqueous solution, transparent and colourless, free from visible particles, in a cardboard box containing a white multidose bottle (HDPE) of 5 ml with pump (PP, HDPE, LDPE) and orange pressure cap and cylinder (HDPE).

Pack sizes:

Cardboard boxes contain 1, 3 or 4 bottles with 2.5 ml of solution.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

Lomapharm GmbH
Langes Feld 5
31860 Emmerthal
Germany

OR

Pharmathen S.A.
Dervenakion Str. 6
15351 Pallini
Attiki
Greece

OR

Bausch Health Poland Sp. z o.o.
ul. Przemyslowa 2
35/959 Rzeszów
Poland

OR

BAUSCH HEALTH POLAND SP. Z O.O.
Ul. Kosztowska 21
41-409 Myslowice
Poland

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

Local Representative

Bausch & Lomb S.A.
Avda. Valdelaparra, nº 4
28108 Alcobendas
Madrid
Spain

This medicine is authorised in the European Economic Area (EEA) Member States under the following names:

DK: Vizilatan Duo
FR: FIXALATIM 50 microgrammes/ml + 5 mg/ml, eye drops, solution
BE: Vizilaticom 50 microgram/ml + 5 mg/ml oogdruppels, oplossing
NL: Vizilaticom 50 microgram/ml + 5 mg/ml eye drops, solution
DE: Vizilatan Duo 0.05 mg/ml + 5 mg/ml Augentropfen, Lösung
AT: Vizilatan Duo 0.05 mg/ml + 5 mg/ml Augentropfen, Lösung
PT: Vizilatan Duo 0.05 mg/ml + 5 mg/ml colírio, solução
CZ: VIZILATAN DUO
RO: Vizilatan Duo 0.05 mg/ml + 5 mg/ml picaturi oftalmice, solutie
LU: Vizilatimo
HU: Vizilatan Duo 0.05 mg/ml + 5 mg/ml oldatos szemcsepp
EE: Vizilatan Duo
PL: Vizilatan Duo
IT: VIZILATAN

This leaflet was last revised in: June 2022.