Latadrop

Package Leaflet: Information for the User

Latadrop

50 micrograms/ml, eye drops, solution

Latanoprost

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this package leaflet, you may need to read it again.
In case of any doubts, consult the doctor of the adult patient or child
or pharmacist.
This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may
harm another person, even if the symptoms of their illness are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Latadrop and what is it used for

Latadrop belongs to a group of medicines known as prostaglandin analogues. It works by increasing
the natural outflow of fluid from the eye into the bloodstream.
Latadrop is used in adults to treat conditions known as open-angle glaucoma and ocular hypertension. Both of these conditions are associated with increased pressure in the eye, which can affect vision.
Latadrop is also used to treat increased eye pressure and glaucoma in children of all ages, including infants.

2. Important information before using Latadrop

Latadrop can be used in adult men and women (including elderly patients) and in children from birth to 18 years. Latadrop has not been studied in premature infants (before the end of the 36th week of gestation).

When not to use Latadrop

• 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 patient or child, before using Latadrop or giving it to the child, they should discuss it with the doctor or pharmacist:

• if the adult patient or child is scheduled to have eye surgery or has had it (including cataract surgery)
• if the adult patient or child has eye problems (such as eye pain, irritation or inflammation, blurred vision)
• if the adult patient or child has dry eyes
• if the adult patient or child has severe asthma or uncontrolled asthma
• if the adult patient or child wears contact lenses; they can continue to use Latadrop, but should follow the recommendations for contact lenses in section 3
• if the adult patient or child has had or currently has a viral eye infection caused by the herpes simplex virus (HSV).

Latadrop and other medicines

Latadrop may interact with other medicines. The doctor or pharmacist should be told about all medicines the adult patient or child is taking, or has recently taken, and about any medicines the adult patient or child will take, including those that are available without a prescription.
In particular, the doctor or pharmacist should be consulted if the patient is taking prostaglandins, prostaglandin analogues or prostaglandin derivatives.

Pregnancy and breastfeeding

Do not use Latadropduring pregnancy or breastfeeding. If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor before using this medicine.

Driving and using machines

During the use of Latadrop, vision disturbances may occur for a short time. In this case, do not driveor operate tools or machines until normal vision returns.

Latadrop contains phosphates and benzalkonium chloride

This medicine contains 6.34 mg of phosphates and 0.2 mg of benzalkonium chloride per milliliter.
In patients with severe damage to the transparent front part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposition during treatment.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Contact lenses should be removed before instillation and not reinserted for at least 15 minutes (see instructions for patients wearing contact lenses in section 3).
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer on the front of the eye).
If abnormal sensations in the eye, stinging or eye pain occur after using the medicine, the doctor should be consulted.

3. How to use Latadrop

This medicine should always be used as directed by the doctor of the adult patient or child.
In case of doubts, the doctor of the adult patient or child or pharmacist should be consulted.
The recommended dose for adult patients (including elderly patients) and children is one drop once a day into each affected eye (eyes). It is best to use the medicine in the evening.
Latadrop should not be used more than once a day, as more frequent administration may reduce the effectiveness of the treatment.
Latadrop should be used for as long as the doctor recommends for the adult patient or child.

Patients wearing contact lenses

If the adult patient or child wears contact lenses, they should be removed before using Latadrop eye drops. After using Latadrop, wait 15 minutes before reinserting the contact lenses.

Instructions for use

• 1. Wash your hands and sit or stand in a comfortable position.
• 2. Unscrew the cap. If the protective ring is loosened when the cap is unscrewed, it should be removed before using the medicine.
• 3. Gently pull down the lower eyelid of the affected eye.
• 4. Bring the tip of the bottle close to the eye, but do not touch it.
• 5. Gently squeeze the bottle until only one drop falls into the eye, then release the lower eyelid.
• 6. Press the inner corner of the treated eye for 1 minute, keeping the eye closed.
• 7. Repeat the above steps for the second eye, if the doctor has recommended it.
• 8. Screw the cap back on.

Using Latadrop with other eye drops

Wait at least 5 minutes between using Latadrop and using other eye drops.

Using a higher dose of Latadrop than recommended

If too many drops are accidentally administered to the eye, minor eye irritation may occur and the eyes may water and become red. These symptoms should resolve on their own, but if the patient is concerned, they should consult their doctor or the doctor of the child for advice.
If the adult patient or child accidentally swallows Latadrop, they should immediately consult a doctor.

Missing a dose of Latadrop

The next dose should be used as usual. Do not use a double dose to make up for a missed dose. If there are any further doubts, consult the doctor or pharmacist.

Stopping the use of Latadrop

If the patient wants to stop using Latadrop, they should consult the doctor of the adult patient or child.
In case of any further doubts about the use of the medicine, consult the doctor of the adult patient, the doctor of the child or pharmacist.

4. Possible side effects

Like all medicines, Latadrop can cause side effects, although not everybody gets them.
The following side effects are known to occur with Latadrop:
Very common(may affect more than 1 in 10 people)

• gradual change in eye color due to an increase in the amount of brown pigment in the colored part of the eye, known as the iris. In patients with different eye colors (blue-brown, gray-brown, yellow-brown or green-brown), these changes are more

visible than in patients with uniform eye color (blue, gray, green or brown).
Any changes in eye color may occur within a few years, although they are usually observed within 8 months of treatment. The change in eye color may be permanent and may be more noticeable if Latadrop is used in only one eye. It does not appear that the change in eye color is associated with any problems. After stopping Latadrop, the change in eye color does not progress.

• eye redness
• eye irritation (feeling of burning, grittiness, itching, stinging or feeling of a foreign body in the eye). If eye irritation occurs that is severe enough to cause excessive tearing or a desire to stop using the medicine, the doctor, pharmacist or nurse should be consulted immediately (within a week) to verify the treatment and ensure the patient receives proper treatment.
• gradual change in the appearance of eyelashes and hair around the treated eye. These changes include darkening, lengthening, thickening and increased number of eyelashes.

Common(may affect up to 1 in 10 people)

• irritation or defects on the surface of the eye, inflammation of the eyelid margins, eye pain, sensitivity to light (photophobia), conjunctivitis

Uncommon(may affect up to 1 in 100 people)

• swelling of the eyelids, dry eye, infections or irritation of the eye surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the macula (macular edema)
• skin rash
• chest pain (angina), feeling of heartbeat (palpitations)
• asthma, shortness of breath (dyspnea)
• chest pain
• headache, dizziness
• muscle pain, joint pain

Rare(may affect up to 1 in 1,000 people)

• inflammation of the iris, symptomatic edema or defects and (or) damage to the surface of the eye, swelling around the eye (periorbital edema), changes in the direction of eyelash growth or the appearance of an additional row of eyelashes, scarring on the surface of the eye, formation of fluid-filled spaces in the colored part of the eye (iris cysts)
• local skin reactions on the eyelids, darkening of the eyelid skin
• worsening of asthma
• severe itching of the skin
• herpes simplex virus eye infections

Very rare(may affect up to 1 in 10,000 people)

• sunken appearance of the eyes (deepening of the eyelid fold)
• worsening of angina in patients with heart disease

Side effects that occur more frequently in children than in adults are runny nose and nasal itching, as well as fever.
In very rare cases, in some patients with severe damage to the transparent front part of the eye (cornea), cloudy spots on the cornea have occurred due to calcium deposition during treatment.

Reporting side effects

If any side effects occur, including any side effects not listed in the package leaflet, the doctor or pharmacist should be told.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the 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: http://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Latadrop

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle.
The expiry date refers to the last day of the month.
Store in a refrigerator (at a temperature of 2°C – 8°C).
Store the bottle in the outer packaging to protect it from light.
After opening the bottle: do not store above 25°C.
Four weeks after opening the bottle, the product should be discarded, even if it is not completely used.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Latadrop contains

The active substance of Latadrop is latanoprost 50 micrograms/ml.
The other ingredients are benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, sodium hydroxide and purified water.

What Latadrop looks like and contents of the pack

Latadrop, eye drops, solution is a clear, colorless liquid.
Latadrop is available in packs of 1, 3 and 6 bottles. Not all pack sizes may be marketed.
Each bottle contains 2.5 ml of eye drop solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

Jadran-Galenski Laboratorij d.d.
Svilno 20
51000 Rijeka
Croatia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Solusin 50 mcg/ml eye drops, solution
Poland
Latadrop
Slovakia
Solusin 50 micrograms/ml eye drop solution
Slovenia
Latanox 50 micrograms/ml eye drops, solution
Date of last revision of the package leaflet:October 2021