LATANOPROST YONSUNG 50 micrograms/ml eye drops in single dose containers

Introduction

Package Leaflet: Information for the Patient

Latanoprost Yonsung 50 micrograms/ml eye drops, solution in single-dose container

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Latanoprost Yonsung is and what it is used for
2. What you need to know before starting to use Latanoprost Yonsung
3. How to use Latanoprost Yonsung
4. Possible side effects
5. Storage of Latanoprost Yonsung
6. Contents of the pack and further information

1. What Latanoprost Yonsung is and what it is used for

Latanoprost Yonsung belongs to a group of medications known as prostaglandin analogs. It works by increasing the natural outflow of fluid from the inside of the eye into the bloodstream.

Latanoprost Yonsung is used to treat diseases known as open-angle glaucoma and ocular hypertension. Both diseases are related to an increase in pressure inside the eye, which can affect vision.

2. What you need to know before starting to use Latanoprost Yonsung

Do not use Latanoprost Yonsung

If you are allergic (hypersensitive) to latanoprost or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use latanoprost if you think any of the following situations apply to you:

• If you have undergone or are going to undergo eye surgery (including cataract surgery).
• If you have eye problems (such as eye pain, irritation, or inflammation, blurred vision).
• If you have dry eyes.
• If you have severe asthma or uncontrolled asthma.
• If you use contact lenses. You can continue to use latanoprost, but you must follow the instructions included in section 3 for contact lens users.
• If you have had or are having a viral eye infection caused by the herpes simplex virus (HSV).

Children

The use of this medication has not been studied in children (under 18 years of age).

Other medications and Latanoprost Yonsung

Latanoprost may interact with other medications. Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Pregnancy and breastfeeding

Do not use Latanoprost Yonsungif you are pregnant or breastfeeding, unless your doctor considers it necessary.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

When using latanoprost, blurred vision may occur for a short period. If this happens, do not driveor use tools or machines until your vision is clear again.

Latanoprost Yonsung contains phosphates

This medication contains 6.3 mg/ml of phosphates, which is equivalent to 0.24 mg/drop.

If you have severe damage to the clear layer on the front of the eye (the cornea), treatment with phosphates, in very rare cases, may cause cloudy patches on the cornea due to calcium deposits produced during treatment.

3. How to use Latanoprost Yonsung

• Follow your doctor's instructions for using latanoprost exactly. If you are unsure, consult your doctor or pharmacist again.
• The usual dose for adults (including elderly patients) is one drop in the affected eye(s) once a day. It is preferable to administer it at night.
• Do not use latanoprost more than once a day, as the effectiveness of the treatment may decrease if it is administered more frequently.
• Use latanoprost as your doctor has indicated until they tell you to stop.

Contact lens users

If you use contact lenses, you must remove them before using latanoprost. After applying latanoprost, wait 15 minutes before putting your contact lenses back in.

Instructions for use

Each carton contains 3 or 9 sachets. Open only one sachet at a time. Use all the single-dose containers before opening the next sachet.

Separate the single-dose container from the strip before use.

1. Wash your hands and sit or stand comfortably.
2. Gently separate the lower eyelid of the affected eye with your finger.
3. Place the tip of the single-dose container near the eye, without touching it.
4. Gently press the single-dose container so that only one drop falls into the eye, then release your finger from the lower eyelid.
5. Press the tip of the affected eye, near the nose, with your finger. Apply pressure for 1 minute, keeping your eye closed.

1. Repeat in the other eye, if your doctor has indicated it.
2. After use, discard the single-dose container. Do not save it for later use.

If you use Latanoprost Yonsung with other eye drops

Wait at least 5 minutes between applying latanoprost and administering other eye drops.

If you use more Latanoprost Yonsung than you should

If you have applied more drops in the eye than you should, you may feel mild irritation in the eye, and your eyes may become red and tearful. This situation should resolve on its own, but if you are concerned, contact your doctor.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to use Latanoprost Yonsung

Continue with the next scheduled dose as usual. Do not apply an extra drop in the eye to make up for the missed dose. If you have doubts, consult your doctor or pharmacist.

If you stop using Latanoprost Yonsung

If you want to stop using latanoprost, you must consult your doctor.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following adverse reactions are known with the use of latanoprost:

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

• 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.
• • If you have mixed-color eyes (blue-brown, gray-brown, yellow-brown, or green-brown), you are more likely to experience this change than if your eyes are a single color (blue, gray, green, or brown).
  • The change in eye color may take years to develop, although it can usually be noticed after 8 months of treatment.
  • The change in eye color may be permanent and may be more noticeable if this medication is used in only one eye.
  • The change in eye color does not seem to be associated with the development of any problems.
  • The change in eye color does not progress once treatment with this medication has been stopped.
• Redness of the eye.
• Ocular irritation (feeling of stinging, feeling of grit in the eye, itching, pain, and feeling of a foreign body in the eye). If you experience severe ocular irritation that makes your eyes water excessively or makes you consider stopping treatment, consult your doctor, pharmacist, or nurse as soon as possible (within a week). You may need to have your treatment reviewed to ensure you are receiving the appropriate treatment for your condition.
• Gradual change in the eyelashes of the treated eye and the fine hair around the treated eye, observed in most patients of Japanese origin. These changes include an increase in color (darkening), length, thickness, and number of eyelashes.

Common side effects(may affect up to 1 in 10 patients):

• Irritation or erosion of the eye surface, eyelid inflammation (blepharitis), and eye pain, and sensitivity to light (photophobia), conjunctivitis.

Uncommon side effects(may affect up to 1 in 100 patients):

• Swelling of the eyelids, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the retina (macular edema).
• Skin rash.
• Chest pain (angina), feeling the heartbeat (palpitations).
• Asthma, difficulty breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.

Rare side effects(may affect up to 1 in 1,000 patients):

• Inflammation of the iris (iritis), symptoms of swelling or injury/damage to the eye surface, swelling around the eye (periorbital edema), misdirected eyelashes or extra row of eyelashes, scarring of the eye surface, accumulation of fluid in the colored part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Severe itching of the skin.
• Development of a viral eye infection caused by the herpes simplex virus (HSV).

Very rare side effects(may affect up to 1 in 10,000 patients):

• Worsening of angina in patients who also have heart problems.

Very rare cases of corneal calcification associated with the use of eye drops containing phosphates have been reported in some patients with significantly damaged corneas.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Toxicology Surveillance System: https//:notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Latanoprost Yonsung

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

Do not use this medication after the expiration date shown on the packaging, carton, and single-dose container. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Keep the sachet in the carton once opened to protect it from light.

After opening the sachet: use the single-dose containers within 20 days.

After opening the single-dose container: use immediately and discard the single-dose container after use.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If you have doubts, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Latanoprost Yonsung

• The active ingredient is latanoprost 50 micrograms/ml.
• The other ingredients (excipients) are sodium carmellose, D-mannitol, tiloxapol, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, hydrochloric acid (for pH adjustment), water for injectable preparations.

Appearance of the product and pack contents

Latanoprost Yonsung eye drops are a colorless or slightly yellowish solution in single-dose containers.

The single-dose containers are packaged in a sachet with 10 units (two strips of 5 single-dose containers), each single-dose container contains 0.2 ml of eye drops in solution.

The cartons contain 30 single-dose containers (3 sachets with 10 single-dose containers).

The cartons contain 90 single-dose containers (9 sachets with 10 single-dose containers).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

YONSUNG GmbH

Zeppelinstrasse 14

78244 Gottmadingen

Germany

Local representative

XENTENEL PHARMA EUROPE, S.L.

Vallsolana Garden Business Park

Camí de Can Camps, 17-19 – Kibo Building

08174 Sant Cugat del Vallès

Spain

93 836 4600

[email protected]

Date of the last revision of this package leaflet: May 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)