LATANOPROST VIR 50 micrograms/ml EYE DROPS SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Latanoprost Vir 50 micrograms/ml eye drops, solution

Latanoprost

Read all of this leaflet carefully before you start 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Latanoprost Vir is an eye drop solution that is administered to patients suffering from a disease known as open-angle glaucoma that causes increased pressure inside the eye.

The active substance of Latanoprost Vir belongs to a group of medicines known as prostaglandins.

Latanoprost Vir is a medicine that reduces intraocular pressure by increasing the natural drainage of fluid from the inside of the eye to the circulatory system.

Latanoprost Vir is also used to treat increased pressure inside the eye and glaucoma in children and babies of all ages.

2. What you need to know before you use Latanoprost Vir

Latanoprost Vir can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Latanoprost Vir has not been investigated in preterm infants (less than 36 weeks of gestation)

Do not use Latanoprost Vir

• If you are allergic (hypersensitive) to latanoprost or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or trying to become pregnant
• If you are breast-feeding

Warnings and precautions

Consult your doctor or the doctor treating your child or pharmacist before starting to use Latanoprost Vir or before administering it to your child, if you consider that any of the following situations affect you or your child:

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

Using Latanoprost Vir with other medicines

Latanoprost Vir may interact with other medicines. Inform your doctor, the doctor treating your child, or pharmacist if you or your child are using or have recently used other medicines (or eye drops), even those obtained without a prescription.

Latanoprost Vir may affect the effect of prostaglandins or prostaglandin derivatives (used for ocular hypertension). It is not recommended to combine them with Latanoprost Vir as it may increase intraocular pressure.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

It may affect the fetus. Latanoprost Vir should not be used if you are pregnant or breast-feeding.

Driving and using machines

As with other eye drops, if you experience blurred vision when applying the drops, wait until it clears before driving or using machines.

Important information about some of the ingredients of Latanoprost Vir

This medicine may cause eye irritation because it contains benzalkonium chloride. Avoid contact with soft contact lenses. If you or your child use contact lenses, you must remove them before application and wait at least 15 minutes before putting them back. Benzalkonium chloride alters the color of soft contact lenses.

3. How to use Latanoprost Vir

Follow exactly the instructions of administration of this medicine indicated by your doctor or the doctor treating your child. Consult your doctor, the doctor treating your child, or pharmacist if you have any doubts.

Dose

The usual dose for adults (including the elderly) and children is one drop in the affected eye(s) once a day.

It is preferable to administer it at night. Do not use Latanoprost Vir more than once a day; the effectiveness of the treatment may decrease if it is administered more frequently

Use Latanoprost Vir as your doctor or the doctor treating your child has indicated until they tell you to stop.

Method of administration

To administer Latanoprost Vir properly, you must follow these steps:

1. Wash your hands and sit or stand comfortably.
2. Remove the cap.
3. Gently separate the lower eyelid of the eye to be treated with your finger.

1. Place the tip of the bottle close to the eye, but without touching it.
2. Gently squeeze the bottle so that only one drop is introduced into the eye. Remove your finger from the lower eyelid.
3. Press the affected eye near the nose with your finger for 1 minute, keeping your eye closed.
4. Repeat the operation in the other eye, if your doctor has indicated it.
5. Put the cap back on the bottle.

If you use more Latanoprost Vir than you should

If you have applied more drops in the eye than you should, you may feel a slight irritation in the eye and your eyes may also become red and tear; this situation should disappear, but if it worries you, contact your doctor or the doctor treating your child.

Contact your doctor immediately if you or your child accidentally ingest Latanoprost Vir.

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

If you forget to use Latanoprost Vir

Do not use a double dose to make up for forgotten doses. If you forget to apply the eye drops at the usual time, wait until the time indicated for the next dose.

Do not administer an additional drop in the eye to make up for the forgotten dose.

If you stop using Latanoprost Vir

Do not stop treatment unless your doctor or the doctor treating your child has indicated it.

If you wear contact lenses

Latanoprost Vir contains benzalkonium chloride as a preservative that can alter the color of soft contact lenses.

If you or your child wear contact lenses, remove them before applying Latanoprost Vir. Do not put them back until 15 minutes have passed since the application of Latanoprost Vir.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Latanoprost Vir can cause side effects, although not everybody gets them.

The frequency at which they appear is classified as follows:

The following side effects have been reported:

Very common side effects:

• Change in eye color (they become darker and more brown).
• Red and tearful eyes, feeling of irritation, itching, pruritus, and pain in the eyes; it may seem like there is a foreign body in the eye or eyes.
• Darkening, thickening, lengthening, or increase in the number of eyelashes and eyelid hair.

Common side effects:

• Inflammation of the eyelid margins.
• Eye pain.

Uncommon side effects:

• Swelling of the eyelids.
• Dry eye.
• Inflammation of the cornea.
• Blurred vision.
• Conjunctivitis.
• Rash.
• Nausea
• Vomiting

Rare side effects:

• Certain forms of eye inflammation (iritis, uveitis).
• Swelling and damage to the cornea (corneal edema).
• Swelling of the retina (macular edema).
• Swelling around the eye socket (periorbital edema), eyelashes inverted inward, which can occasionally cause eye irritation (uncommon).
• Sudden chest tightness caused by muscle spasms and inflammation of the mucous membranes of the airways, often with coughing and expectoration of mucus (asthma); worsening of asthma and difficulty breathing (dyspnea).
• Rash on the eyelids.
• Darkening of the eyelid skin.

Very rare side effects:

• Chest pain.
• Worsening of chest tightness (angina pectoris) if you already had it previously.

Since the marketing of latanoprost, other side effects have been reported (frequency not known):

• Headache.
• Dizziness.
• Palpitations.
• Muscle pain and joint pain.
• Accumulation of fluid in the colored part of the eye (iris cyst)
• Development of a viral eye infection caused by the herpes simplex virus (HSV)

The side effects observed in children at a higher frequency than in adults are runny nose and itchy nose and fever.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Latanoprost Vir

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

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date is the last day of the month stated.

Store the unopened Latanoprost Vir bottle in a refrigerator (between 2°C and 8°C). Keep the bottle in the outer carton to protect it from light.

After first opening the bottle:

Do not store above 25°C and use within four weeks.

Medicines should not be disposed of via wastewater 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

Composition of Latanoprost Vir

• The active substance is latanoprost

1 ml of eye drop solution contains 50 micrograms of latanoprost.

One drop contains approximately 1.5 micrograms of latanoprost.

• The other ingredients (excipients) are benzalkonium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, sodium chloride, purified water.

Appearance of the product and contents of the pack

Latanoprost Vir is presented as a clear and colorless eye drop solution in a low-density polyethylene (LDPE) bottle with a low-density polyethylene (LDPE) dropper and a high-density polyethylene (HDPE) screw cap with a breakable opening tab.

Each bottle contains 2.5 ml of eye drop solution, which corresponds to approximately 80 drops of solution.

Latanoprost Vir is available in packs of 1 bottle.

Marketing authorization holder and manufacturer

Marketing authorization holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid) Spain

Manufacturer

HBM Pharma s.r.o.

Slabinská 30

03086 Martin

Slovak Republic

or

Pharma Stulln GmbH Werkstrasse 3

92551 Stulln

Germany

or

Jadran Galenski Laboratorij D.D.

Svilno, 20

51000 (Rijeka)

Croatia

Date of last revision of this leaflet: May 2022

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