Vizilatan

Package leaflet: Information for the user

Vizilatan, 50 micrograms/ml, eye drops, solution
Latanoprost
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, the doctor treating your child, or pharmacist.
• This medicine has been prescribed for a specific person or their child. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you or your child experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Vizilatan is and what it is used for

Vizilatan belongs to a group of medicines known as prostaglandin analogues. Vizilatan works
by increasing the natural outflow of fluid from the eye into the bloodstream.
Vizilatan is used to treat open-angle glaucoma and ocular hypertension in adults. Both
conditions are associated with elevated intraocular pressure and may affect vision.
Vizilatan may also be used in children of any age and in infants to treat increased eye pressure
and glaucoma.
Vizilatan can be used in adult women and men (including elderly patients) and in children from
birth up to 18 years of age. The use of Vizilatan has not been studied in preterm newborns
(born before completing 36 weeks of gestation).
Vizilatan eye drops is a sterile solution that does not contain preservatives.

2. Important information before using Vizilatan

When not to use Vizilatan

• if the patient is allergic (hypersensitive) to latanoprost or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
If any of the following apply to the adult or child, discuss this with the adult's or child's treating physician or pharmacist before starting treatment with Vizilatan:

• if the adult or child has undergone eye surgery (including cataract surgery), or such surgery is planned,
• if the adult or child has eye disorders (such as eye pain, irritation or eye inflammation, blurred vision),
• if the adult or child has dry eyes,
• if the adult or child has severe or uncontrolled asthma,
• if the adult or child wears contact lenses. Vizilatan may still be used, but follow the instructions for contact lens wearers (see section 3),
• if the adult or child has had or currently has a viral eye infection caused by herpes simplex virus (HSV).

Vizilatan and other medicines
Vizilatan may interact with other medicines. Inform the adult's or child's doctor or pharmacist about all medicines (including eye drops) currently used or recently used by the adult or child, including those obtained without a prescription, as well as any medicines the patient plans to take. In particular, speak with a doctor or pharmacist if the patient is using prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

Pregnancy and breastfeeding
Vizilatan should not be used during pregnancy or breastfeeding unless considered necessary by a physician. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Driving and operating machinery
Blurred vision, a transient symptom, may occur after using Vizilatan. In such cases, do not drive or operate machinery until vision is restored to normal.

Vizilatan contains macrogol glycerol hydroxystearate 40
This medicine contains macrogol glycerol hydroxystearate 40, which may cause skin reactions.

Vizilatan contains phosphate buffer
This medicine contains 0.19 mg of phosphates per drop, equivalent to 6.79 mg/ml.

In very rare cases, in some patients with significant damage to the outer transparent layer of the eyeball (cornea), hazy spots caused by calcium deposits have appeared on the cornea during treatment.

3. How to use Vizilatan

This medicine should always be used exactly as directed by the physician in charge of the adult or
child. If in doubt, consult the physician in charge of the adult or child, or a pharmacist.
The recommended dose for adults (including elderly patients) and children is one drop once daily
into the affected eye(s). It is best to administer Vizilatan in the evening.
Using Vizilatan more frequently than once daily is not recommended, as this may reduce the
effectiveness of treatment.
Vizilatan should always be used for as long as directed by the physician in charge of the adult or child.
Contact lens wearers
Contact lenses should be removed before administering Vizilatan to the eye of an adult or child.
Contact lenses may be reinserted 15 minutes after application of Vizilatan.
Instructions for using Vizilatan

1a 1b	Remove the bottle from the carton (Fig. 1a) and enter the date of opening in the designated space on the carton and on the medicine bottle. 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). The appearance of a slightly cloudy drop should not concern the patient.
3	Tilt your own or the child's head backward. With a clean finger, gently pull the lower eyelid downward to form a "pocket" between the eyeball and the eyelid. The drop should be instilled into this pocket (Fig. 3). Bring the tip of the bottle 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 result in contamination of the solution. Gently press the bottom of the bottle to release a single drop of the medicine at the appropriate time (Fig. 4). If the drop misses the eye, repeat the attempt.
5	After instilling the drop, press with a finger on the inner corner of the eye near the nose for one minute (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 with other eye drops
After administering Vizilatan, wait at least 5 minutes before using any other eye drops.

Using more than the recommended dose of Vizilatan
If more drops than recommended are administered, moderate eye irritation with tearing and redness may occur. These symptoms should resolve on their own, but if the patient is concerned, they should contact the physician responsible for the adult or child to obtain advice.
In case of accidental ingestion of Vizilatan by an adult or child, contact a physician immediately.

Missing a dose of Vizilatan
If a dose is missed, take the next dose at the scheduled time. Do not use a double dose to make up for the missed dose. If you have any further doubts, consult your doctor or pharmacist.

Stopping the use of Vizilatan
Talk to the physician responsible for the adult or child if the patient plans to discontinue using Vizilatan.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Known adverse reactions occurring after administration of Vizilatan:

Very common (may occur in 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 known as the iris. These changes are more noticeable in patients with mixed-coloured eyes (blue-brown, grey-brown, yellow-brown or green-brown) than in patients with uniformly coloured eyes (blue, grey, green or brown). Any changes in eye colour may occur over several years, although they are normally observed within 8 months of treatment. The change in eye colour may be permanent and may be more noticeable if Vizilatan is used in only one eye. The change in eye colour does not appear to be associated with any problems. After discontinuation of Vizilatan, the change in eye colour does not progress.
• Eye redness.
• Eye irritation (burning sensation, grittiness, itching, stinging or foreign body sensation in the eye). If eye irritation occurs to such an extent that it causes excessive tearing or a desire to discontinue the medicine, consult a doctor, pharmacist or nurse immediately (within one week). Re-evaluation of treatment may be necessary to ensure appropriate management for the patient.
• Gradual change in the appearance of eyelashes and surrounding hairs in the treated eye, particularly in individuals of Japanese origin. These changes include darkening, lengthening, thickening and increased number of eyelashes.

Common (may occur in less than 1 in 10 people):

• Inflammation of the eyelid margins (blepharitis).
• Eye pain, sensitivity to light (photophobia).
• Eye irritation (conjunctivitis).
• Inflammation or irritation of the eye surface (punctate keratitis), most often without symptoms.

Uncommon (may occur in less than 1 in 100 people):

• Eyelid swelling.
• Dry eye.
• Corneal inflammation (keratitis).
• Blurred vision.
• Inflammation of the coloured part of the eye (uveitis).
• Retinal swelling (macular oedema), including retinal swelling within the eye leading to visual deterioration (cystoid macular oedema).
• Skin rash.
• Chest pain (angina), sensation of heart pounding (palpitations).
• Asthma, shortness of breath (dyspnoea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea.
• Vomiting.

Rare (may occur in less than 1 in 1000 people):

• Inflammation of the iris (iritis).
• Symptoms of swelling (corneal oedema) or defects/damage (corneal defects) on the eye surface.
• Swelling around the eye (periorbital oedema).
• Abnormal direction of eyelash growth or an additional row of eyelashes.
• Scarring on the eye surface.
• Fluid-filled area in the coloured part of the eye (iris cyst).
• Local skin reactions on the eyelids, darkening of eyelid skin.
• Worsening of asthma.
• Severe skin itching.
• Viral eye infections caused by herpes simplex virus (HSV) (herpetic keratitis).
• Formation of fluid-filled blisters on the eye surface, which may cause redness, irritation and swelling of the eye and surrounding tissues (ocular pemphigoid or pseudemphysematous conjunctivitis).

Very rare (may occur in less than 1 in 10,000 people):

• Worsening of angina in patients with heart disease.
• Sunken eye appearance (deepening of the eyelid groove).

Unknown (frequency cannot be estimated from available data):

• Cough and inflammation of the nose or throat (nasopharyngitis).
• Upper respiratory tract infection.
• Eyelid redness (erythema of the eyelid).
• Eyelid irritation.
• Crusting at the eyelid margins.
• Lacrimation (increased tearing).

Cold, nasal itching and fever are adverse reactions occurring more frequently in children and adolescents than in adults.
In very rare cases, some patients with significantly damaged transparent membrane covering the front part of the eyeball (cornea) developed corneal opacities during treatment due to calcium deposition.

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 Drug Reactions, 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle after: EXP. The expiry date refers to the last day of the specified month.
Please pay attention to the following storage conditions:
Unopened bottles: Store below 25°C.
After first opening of the bottle: No special storage conditions required.
The medicine should be discarded 28 days after first opening of the bottle to prevent contamination.
Record the date of first opening of the bottle in the space provided on the bottle label and carton.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Vizilatan contains

• The active substance is: latanoprost.
• Each ml of solution contains 50 micrograms of latanoprost.
• The other ingredients are: macrogol glycerol hydroxystearate 40, sodium chloride, disodium edetate, disodium dihydrogen phosphate dihydrate, disodium phosphate anhydrous, hydrochloric acid and/or sodium hydroxide (to adjust pH), water for injections.

What Vizilatan looks like and contents of the pack
Vizilatan is a clear, colourless aqueous solution with a volume of 2.5 ml, equivalent to approximately 80 drops of solution, free from visible particles, contained in a white multidose container (HDPE) with a capacity of 5 ml, equipped with a pump (PP, HDPE, LDPE) and an orange pressure cylinder, as well as a cap (HDPE).
Pack sizes available: 1, 3 or 4 bottles containing 2.5 ml of solution each, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bausch+Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
Pharmathen S.A.
Dervenakion 6
15351 Pallini Attiki
Greece
Lomapharm GmbH
Langes Feld 5
31860 Emmerthal
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark Vizilatan
Bulgaria Визилат 0,05 mg/ml капки за очи, разтвор
Czech Republic Vizilatan
Greece Visiolatan
France Vizilatan 50 microgrammes/ml, collyre en solution
Croatia Vizilatan 50 mikrograma/ml l kapi za oko, otopina
Hungary Vizilatan 0,05 mg/ml oldatos szemcsepp
Netherlands Vizilatan
Poland Vizilatan
Slovakia Vizilatan 0,05 mg/ml
Austria Vizilatan 0,05 mg/ml Augentropfen, Lösung
Belgium Vizilatan 50 microgrammes/ml collyre en solution
Cyprus Visiolatan
Estonia Vizilatan
Germany Vizilatan 0,05 mg/ml Augentropfen, Lösung
Luxembourg Vizilatan 50 microgram/ml collyre en solution
Portugal Vizilatan
Romania VIZILATAN 50 micrograme/ml picaturi oftalmice, solutie
Spain Vizilatan 50 microgramos/ml colirio en solución