Vizilatan duo

Package leaflet: Information for the patient

Vizilatan Duo, 50 micrograms/mL + 5 mg/mL,
eye drops, solution
Latanoprost + Timolol
Please read the entire leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. This includes any adverse reactions not mentioned in this leaflet. See section 4.

Leaflet contents

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

Vizilatan Duo 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 outflow of fluid from the eyeball into the bloodstream. Timolol works by reducing the amount of fluid produced in the eye.
Vizilatan Duo is used to lower intraocular pressure in patients with open-angle glaucoma or those with ocular hypertension. Both conditions are associated with elevated intraocular pressure and may affect vision. Your doctor will usually recommend using Vizilatan Duo if other treatments have not been sufficiently effective.
Vizilatan Duo eye drops can be used in adult women and men (including elderly patients), but should not be used in children and adolescents under 18 years of age.
Vizilatan Duo eye drops is a sterile solution that does not contain preservatives.

2. Important information before using Vizilatan Duo

When not to use Vizilatan Duo

• if the patient is allergic (hypersensitive) to the active substances (latanoprost or timolol), beta-adrenergic blocking agents, or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has or has previously had breathing problems such as asthma or severe chronic obstructive pulmonary disease (a serious lung condition which may cause wheezing, difficulty in breathing and/or long-term cough).
• if the patient has severe heart disease or heart rhythm disorders.

Warnings and precautions
Before starting treatment with Vizilatan Duo, inform your doctor or pharmacist if the patient:

has or has previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure
• heart rate disorders such as slow heartbeat
• breathing difficulties, asthma or chronic obstructive pulmonary disease (COPD)
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome)
• diabetes, because timolol may mask the subjective and objective symptoms of low blood sugar
• hyperthyroidism, because timolol may mask the subjective and objective symptoms
• has planned eye surgery (including cataract surgery), or if any eye surgery has previously been performed
• has eye problems (such as eye pain, eye surface irritation, eye inflammation or blurred vision)
• has dry eye syndrome
• wears contact lenses. Vizilatan Duo may still be used, but follow the instructions for contact lens use provided in section 3
• has angina (especially a type called Prinzmetal's angina)
• has severe allergic reactions requiring hospital treatment
• has had or currently has a viral eye infection caused by the Herpes Simplex virus (HSV).

Before surgery, inform your doctor that you are using Vizilatan Duo, because
timolol may affect the action of certain drugs used during anesthesia.

Children and adolescents
Vizilatan Duo should not be used in patients under 18 years of age.

Vizilatan Duo and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including eye drops, as well as any medicines you plan to take, even those available without a prescription.
Vizilatan Duo may interact with and be affected by other medicines, including eye drops used in the treatment of glaucoma. Inform your doctor if you are taking or plan to take medicines that lower blood pressure, heart medications, or medicines used in the treatment of diabetes.
In particular, inform your doctor or pharmacist if you are taking a medicine belonging to any of the following groups:

• Prostaglandins, prostaglandin analogues or prostaglandin derivatives (used to stimulate and inhibit smooth muscle contractions, vasodilation and vasoconstriction, blood pressure control, and modulation of inflammatory states)
• Beta-blockers (used in the treatment of high blood pressure, angina pectoris, certain heart rhythm disorders, myocardial infarction, anxiety, migraine, glaucoma, and hyperthyroidism)
• Epinephrine (used in the treatment of life-threatening allergic reactions caused by insect stings or bites, food, drugs, latex, and other factors)
• Medicines that lower blood pressure such as oral calcium channel blockers, guanethidine, antiarrhythmics, cardiac glycosides, or parasympathomimetics
• Quinidine (used in the treatment of heart disorders and certain types of malaria)
• Antidepressants such as fluoxetine, paroxetine.

Vizilatan Duo with food and drink
Normal meals, food or drinks do not affect when or how to use Vizilatan Duo.

Pregnancy, breastfeeding and fertility

Pregnancy
Vizilatan Duo should not be used during pregnancy unless your doctor decides it is necessary. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.

Breastfeeding
Vizilatan Duo should not be used during breastfeeding. Vizilatan Duo may pass into human milk. Consult your doctor before using any medicine during breastfeeding.

Effect on fertility
Animal studies have shown no effect of latanoprost and timolol on fertility in males or females.

Driving and using machines
Blurred vision may occur for a short time after using Vizilatan Duo. If the patient experiences such symptoms, they should not drive or operate machinery until these symptoms have resolved.

Vizilatan Duo contains macrogol glycerol hydroxystearate 40
This medicine contains macrogol glycerol 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.
In patients with severe corneal epithelial damage (the transparent front part of the eye), phosphates may, in very rare cases, during treatment, cause corneal clouding due to calcium deposits.

3. How to use Vizilatan Duo

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose for adult patients (including elderly patients) is 1 drop in the affected
eye(s) once daily.
Vizilatan Duo should not be used more frequently than once daily, as this may
reduce the effectiveness of treatment.
Vizilatan Duo should be used according to the doctor's instructions, who will decide when treatment
should be discontinued.
If a patient is using Vizilatan Duo, the doctor may recommend additional examinations of the heart and
circulatory system.
Use of contact lenses
If the patient wears contact lenses, they should be removed before applying Vizilatan Duo.
After applying Vizilatan Duo, wait 15 minutes before reinserting contact lenses.
Instructions for using Vizilatan Duo

1a 1b	Remove the bottle from the carton (Fig. 1a) and write the date of first opening in the designated space on the carton. Prepare the medicine bottle and a mirror. Wash your hands. Remove the cap (Fig. 1b).
2	Hold the inverted bottle with your thumb on the top and the remaining fingers supporting the bottom of the bottle. Before first use, press (pump) the bottle approximately 15 times (Fig. 2). A possible whitish appearance of the drops should not concern the patient.
3	Tilt your head backward. Using a clean finger, gently pull the lower eyelid downward to create a "pocket" between the eyeball and the eyelid, into which the drop should be instilled (Fig. 3). Bring the dropper tip close to the eye. A mirror may be used to assist.
4	Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. Touching the dropper may lead to contamination of the drops. Gently press the bottom of the bottle to release a single drop at the appropriate time (Fig. 4). If the drop misses the eye, try again.
5	After instilling the drop, press with a finger on the inner corner of the eye near the nose for 2 minutes (Fig. 5). This helps prevent the medicine from draining into the rest of the body.
	If treating both eyes, repeat the procedure described above. Close the bottle tightly immediately after use. Only one bottle should be used at a time. Do not unscrew the cap until the bottle is needed. Discard the bottle 4 weeks after first opening to prevent infection and begin using a new bottle.

Using Vizilatan Duo with other eye drops
After administering Vizilatan Duo, wait at least 5 minutes before using any other eye drops.

Use of a higher than recommended dose of Vizilatan Duo
If more drops than recommended are administered, moderate eye irritation may occur, accompanied by tearing and redness. These symptoms should resolve on their own, but if the patient is concerned, they should contact their physician.

Accidental ingestion of Vizilatan Duo
In case of accidental ingestion of Vizilatan Duo, contact a physician. If a large amount of Vizilatan Duo eye drops is swallowed, symptoms may include malaise, abdominal pain, feeling of fatigue, facial flushing, dizziness, and sweating.

Missed dose of Vizilatan Duo
If a dose is missed, take the next dose at the scheduled time. Do not use a double dose to make up for a missed dose. If in doubt, consult a physician or pharmacist.

If you have any further questions regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You can usually continue using the eye drops unless the adverse reactions are severe. If in doubt, consult your doctor or pharmacist. Do not stop treatment with Vizilatan Duo without consulting your doctor.

The following are known adverse reactions occurring after administration of a medicine containing latanoprost and timolol as active substances. The most important adverse reaction is the possibility of a gradual, permanent change in eye colour. Eye drops containing latanoprost and timolol may possibly cause serious cardiac effects. Inform your doctor if you notice any changes in heart rate or cardiac function, and inform him/her that you are using Vizilatan Duo.

Known adverse reactions occurring after administration of eye drops containing latanoprost and timolol:

Very common (may affect more than 1 in 10 people):

• Gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye called the iris. Changes are observed significantly more frequently in patients whose iris colour is a mixture of colours (such as blue-brown, grey-brown, yellow-brown or green-brown) than in those with uniformly coloured eyes (blue, grey, green or brown). Changes in eye colour may develop over several years. The change in eye colour may be permanent and significantly more noticeable if only one eye is treated with Vizilatan Duo. The change in eye colour appears to be harmless. After discontinuation of Vizilatan Duo, progression of the eye colour change stops.

Common (may affect up to 1 in 10 people):

• Eye irritation (including burning sensation, grittiness, itching, stinging or foreign body sensation in the eye), eye pain.

Uncommon (may affect up to 1 in 100 people):

• Headache,
• Eye redness, eye infection (conjunctivitis), blurred vision, excessive tearing, blepharitis, eye surface irritation or damage,
• Skin rash, pruritus (itching).

Other adverse reactions
Like other eye medicines, Vizilatan Duo (latanoprost with timolol) is absorbed into the bloodstream. The frequency of adverse reactions after administration of eye drops is lower than with orally or intravenously administered medicines.

The following adverse reactions have not been reported with the combination of latanoprost and timolol, but have occurred with individual components of Vizilatan Duo and therefore may also occur with Vizilatan Duo. Among the listed adverse reactions are also those observed during treatment with beta-adrenergic blocking agents (e.g. timolol) in ocular diseases.

• Development of viral infection of the eye caused by herpes simplex virus (HSV)

• Generalized allergic reactions including subcutaneous swelling which may occur on the face, limbs, and may obstruct airflow through the airways, causing difficulty in swallowing and breathing, urticaria or itchy rash, localised and generalized rash, pruritus, severe cases of life-threatening anaphylactic reactions

• Low blood sugar levels

• Dizziness

• Difficulty falling asleep (insomnia), depression, nightmares, memory loss, hallucinations

• Fainting, stroke, reduced blood flow to the brain, worsening of myasthenia symptoms (muscle weakness), tingling or numbness, headache

• Swelling of the posterior part of the eye (macular oedema), formation of fluid-filled spaces in the coloured part of the eye (iris cysts), light sensitivity (photophobia), sensation of sunken eyes (deepening of the eyelid sulcus)

• Eye irritation symptoms (burning, stinging, itching, tearing, redness), blepharitis, keratitis, blurred vision, and choroidal detachment following filtration surgery which may lead to visual disturbances, reduced corneal sensitivity, dry eyes, corneal erosion (defects of the outer surface of the eyeball), upper eyelid drooping (causing eyes to be half-closed), double vision

• Darkening of the skin around the eyes, changes in eyelashes and vellus hair around the eyes (increased number, length, thickness and darkening), misdirected eyelashes, periorbital oedema, iris swelling - the coloured part of the eye (iritis and/or uveitis), cicatrizing conjunctivitis

• Ringing in the ears (tinnitus)

• Angina pectoris, worsening of angina in patients with pre-existing heart disease, chest pain

• Slowing of heart rate, chest pain, palpitations (awareness of heartbeat), oedema (fluid accumulation), arrhythmias and disturbances in heart rate and rhythm, congestive heart failure (a condition characterised by shortness of breath and swelling of feet and legs due to fluid accumulation), cardiac arrhythmias, cardiac arrest, heart failure

• Decreased arterial blood pressure, poor blood circulation manifesting as numbness and pallor of fingers and toes, sensation of cold hands and feet

• Shallow breathing, bronchospasm (mainly in patients with pre-existing respiratory conditions), difficulty breathing, cough, asthma, exacerbation of asthma

• Taste disturbances, nausea (uncommon), dyspepsia, diarrhoea, dry mouth sensation, abdominal pain, vomiting (uncommon)

• Hair loss, skin rash with white-silvery lesions (psoriasiform) or exacerbation of psoriasis symptoms, skin rash

• Joint pain, muscle pain not caused by physical exertion, muscle weakness, fatigue

• Sexual dysfunction, decreased libido

In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may very rarely cause corneal clouding during treatment due to calcium deposits.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 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 container after EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
This medicine should be discarded 4 weeks after first opening the bottle to prevent contamination.
Please record the date of first opening of the bottle in the designated space on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Vizilatan Duo contains

• The active substances in this medicine are latanoprost and timolol. Each ml of eye drops contains 50 micrograms of latanoprost and 5 mg of timolol (as 6.8 mg timolol maleate).
• Other components are: macrogolglycerol hydroxystearate 40, sodium chloride, disodium edetate, disodium dihydrogen phosphate dihydrate, sodium phosphate, hydrochloric acid and/or sodium hydroxide (for pH adjustment), water for injections.

What Vizilatan Duo looks like and contents of the pack
Vizilatan Duo is a clear, colourless aqueous solution with a volume of 2.5 ml, contained in a white multidose container (HDPE) with a capacity of 5 ml, equipped with a pump (PP, HDPE, LDPE), an orange pressure cylinder, and a cap (HDPE). The container is placed in a cardboard box.
Pack sizes: 1, 3 or 4 bottles of 2.5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Bausch+Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24 PPT3
Ireland

Manufacturers:
Pharmathen S.A.
Dervenakion 6
15351 Pallini Attiki
Greece
Lomapharm GmbH
Langes Feld 5
31860 Emmerthal
Germany

This medicinal product is authorised in the following names in the Member States of the European Economic Area:
Austria Vizilatan Duo 0.05 mg/ml + 5 mg/ml eye drops, solution
Belgium Vizilaticom 50 microgram/ml + 5 mg/ml oogdruppels, oplossing / Vizilaticom 50 microgrammes/ml + 5 mg/ml, collyre en solution / Vizilaticom 50 Mikrogramm/ml + 5 mg/ml Augentropfen, Lösung
Denmark Vizilatan Duo
Estonia Vizilatan Duo
Luxembourg Vizilaticom
Germany Vizilatan Duo 0.05 mg/ml + 5 mg/ml Augentropfen, Lösung
France KILATIM 50 microgrammes/ml + 5 mg/ml, collyre en solution
Spain Vizilatan Duo 0.05 mg/ml + 5 mg/ml colirio en solución
Netherlands Vizilaticom 50 microgram/ml + 5 mg/ml eye drops, solution
Poland Vizilatan Duo
Portugal Vizilatan Duo 0.05 mg/ml + 5 mg/ml colírio, solução
Czech Republic Vizilatan Duo
Romania Vizilatan Duo 0.05 mg/ml + 5 mg/ml picături oftalmice, soluţie
Hungary Vizilatan Duo 0.05 mg/ml + 5 mg/ml oldatos szemcsepp
Italy Vizilatan