Package leaflet: Information for the patient

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

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult the physician treating the adult or child, or a pharmacist.
This medicine has been prescribed for a specific adult or child. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the physician treating the adult or child, or the pharmacist. See section 4.

Leaflet contents

What Latalux is and what it is used for
What you need to know before using Latalux
How to use Latalux
Possible side effects
How to store Latalux
Contents of the pack and other information

1. What Latalux is and what it is used for

Latalux belongs to a group of medicines known as prostaglandin analogues. This medicine works by increasing the natural outflow of aqueous humour from the eye into the bloodstream.
Latalux is used in the treatment of a condition known as open-angle glaucoma and intraocular hypertension in adults. Both conditions are associated with elevated intraocular pressure and may eventually affect vision.
Latalux is also used in the treatment of elevated intraocular pressure and glaucoma in children of all ages, including full-term newborns and infants.

2. Important information before using Latalux

Latalux can be used in adult men and women (including elderly patients) and in children from birth up to 18 years of age. Latalux has not been studied in preterm newborns (born before completing 36 weeks of gestation).
When not to use Latalux:

if the patient is allergic 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 patient's physician or pharmacist before starting treatment with Latalux:

if the adult or child has undergone eye surgery (including cataract surgery), or such surgery is planned;
if the adult or child has eye problems (such as eye pain, eye inflammation, or eye irritation, 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. Latalux 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).

Latalux and other medicines
Latalux may interact with other medicines. Inform the patient's doctor or pharmacist about all medicines (including eye drops) the patient is currently taking or has recently taken, even those available without a prescription, as well as any medicines the patient plans to take. In particular, talk to the doctor or pharmacist if the patient is taking prostaglandins, prostaglandin analogues, or prostaglandin derivatives.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. Latalux should not be used during pregnancy or while breastfeeding.
Driving and operating machinery
Blurred vision may occur for a short period after using Latalux. In such cases, do not drive or use any tools or operate machinery until normal vision returns.
Latalux contains benzalkonium chloride and phosphate buffers
This medicine contains 0.006 mg of benzalkonium chloride per drop, equivalent to 0.2 mg/mL.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Remove contact lenses before instilling the drops and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal eye sensations, stinging, or eye pain occur after using the medicine, contact a doctor.
The medicine contains 6.85 mg of phosphates per drop, equivalent to 0.19 mg per drop. In patients with serious damage to the cornea (the transparent layer at the front of the eye), phosphates may very rarely cause corneal clouding due to calcium deposits during treatment.

3. How to use Latalux

This medicine should always be used exactly as prescribed by the physician treating the adult or
child. If in doubt, consult the physician treating the adult or child, or a pharmacist.
The usual dose for adults (including elderly patients) and children is 1 drop into the affected eye (eyes) once daily, preferably in the evening.
It is not recommended to use Latalux more frequently than once daily, as this may reduce the effectiveness of treatment.
Latalux should always be used for as long as prescribed by the treating physician.

Use of contact lenses
If the adult or child wears contact lenses, they should be removed before administering Latalux. Contact lenses may be reinserted 15 minutes after using Latalux.

Instructions for use

Wash your hands and stand or sit comfortably.
Remove the protective cap from the bottle.
Gently pull down the lower eyelid of the treated eye with the fingertip. Bring the dropper tip close to the eye without touching it.
Gently squeeze the bottle so that only one drop enters the eye, then release the lower eyelid.
Press with a finger on the inner corner of the treated eye, near the nose. Maintain pressure for 1 minute with the eye closed.
If instructed by the doctor, repeat the above steps for the other eye.
Replace the protective cap on the bottle.

Using Latalux with other eye drops
Wait at least 5 minutes between applying Latalux and any other eye drops.

Accidental overdose of Latalux
Squeeze the bottle gently so that only one drop enters the affected eye.
If more than one drop is administered, mild eye irritation with redness and tearing may occur. These symptoms should resolve, but if the patient is concerned, they should contact the treating physician for advice.
If Latalux is accidentally ingested by an adult or child, seek immediate medical advice from a doctor.

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

Stopping Latalux treatment
The patient should speak with their doctor or the child’s treating physician before stopping Latalux.

If you have any further questions about the use of this medicine, consult the physician treating the adult or child, or a pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Known adverse reactions occurring after administration of Latalux:
Very common (may affect more than 1 in 10 people):

Gradual change in eye colour due to increased amount of brown pigment in the part of the eye called the iris. This change is more likely in patients with mixed-coloured eyes (e.g. blue-brown, grey-brown, yellow-brown or green-brown) than in those with uniformly coloured eyes (blue, grey, green or brown). Any changes in eye colour may develop over years, although they are usually observed within 8 months of treatment. The colour change may be permanent and more noticeable if Latalux is used in only one eye. The change in eye colour appears not to be associated with any problems. The eye colour change does not progress after discontinuation of Latalux.
Eye redness
Eye irritation (burning, gritty sensation under the eyelids, itching, stinging or foreign body sensation in the eye). If a patient experiences severe eye irritation with excessive tearing or is considering discontinuing this medicine, they should contact their doctor, pharmacist or nurse immediately (within one week). Re-evaluation of treatment may be necessary to ensure appropriate management.
Gradual change in the appearance of eyelashes of the treated eye or fine hairs around the treated eye, usually observed in individuals of Japanese origin. These changes include darkening of colour, length, thickness and number of eyelashes.
Common (less than 1 in 10 people):
Eye surface irritation or damage, inflammation of the eyelid margins (blepharitis), eye pain and light sensitivity (photophobia), conjunctivitis

Uncommon (less than 1 in 100 people):

Eyelid swelling, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye, retinal swelling (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 (less than 1 in 1000 people):

Iritis, symptoms of swelling or scratch/injury to the eye surface, swelling around the eye (periorbital oedema), ingrown eyelashes or an extra row of eyelashes, scarring on the eye surface, formation of fluid-filled areas in the coloured part of the eye (iris cyst)
Skin reactions on the eyelids, darkening of eyelid skin
Worsening of bronchial asthma
Acute skin itching
Development of viral eye infection caused by herpes simplex virus (HSV)

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

Worsening of angina in patients with heart disease, appearance of sunken eyes (deepening of the eyelid sulcus)

Adverse reactions observed more frequently in children than in adults were rhinitis and fever.
In very rare cases, in some patients with severe damage to the transparent front layer of the eye (cornea), corneal clouding occurred due to calcium deposits during treatment.
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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Latalux
Keep the medicine out of the sight and reach of children.
Unopened bottles of Latalux should be stored in the refrigerator (2°C – 8°C).
Keep the medicine in the outer packaging to protect it from light. After first opening the bottle: do not store above 25°C.
Discard the bottle 4 weeks after opening.
Do not use this medicine after the expiry date stated on the bottle and carton after "EXP". The expiry date (EXP) refers to the last day of the specified month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Latalux contains
The active substance is latanoprost. 1 ml of eye drop solution contains 50 micrograms of latanoprost. 2.5 ml of eye drop solution (the content of the bottle) contains 125 micrograms of latanoprost.
The other ingredients are: disodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, benzalkonium chloride 0.2 mg/ml, purified water.

What Latalux looks like and contents of the pack
Latalux is a clear or slightly yellow, colourless liquid. Each bottle with dropper contains 2.5 ml of eye drops.
Latalux is available in the following pack sizes:
1 bottle with dropper containing 2.5 ml of eye drops.
3 bottles with dropper, each containing 2.5 ml of eye drops.
6 bottles with dropper, each containing 2.5 ml of eye drops.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
[email protected]

Manufacturer
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin
Germany
Telephone: +49 (0)30 33093-0
Fax: +49 (0)30 33093-350

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands LATALUX 50 microgram/ml, oogdruppels, oplossing
Bulgaria LATALUX 50 микрограма/ml Капки за очи, разтвор
Czech Republic LATALUX 50 mikrogramů/ml oční kapky, roztok
Lithuania LATALUX 50 mikrogramų/ml akių lašai, tirpalas
Latvia LATALUX 50 mikrogrami/ml acu pilieni, šķīdums
Poland Latalux

Date of latest revision: 06/2023