Latanoprost Vir 50 micrograms/ml eye drops solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Latanoprost Vir 50 micrograms/ml eye drops solution

Latanoprost

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or the doctor treating your child or your pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or the doctor treating your child or your pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Latanoprost Vir is and what it is used for
2. What you need to know before using Latanoprost Vir
3. How to use Latanoprost Vir
4. Possible side effects
5. How to store 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 medicine used in patients suffering from a condition known as open-angle glaucoma, which causes increased pressure inside the eye.

The active substance in 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 inside the eye into the bloodstream.

Latanoprost Vir is also used to treat elevated intraocular pressure and glaucoma in children and infants of all ages.

2. What you need to know before using Latanoprost Vir

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

Do not use Latanoprost Vir

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

Warnings and precautions

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

• If you or your child have had or are about 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 asthma that is not well controlled.
• If you or your child wear contact lenses. You may continue using Latanoprost Vir, but you must follow the instructions provided in section 3 for contact lens wearers.
• If you have had or are currently experiencing a viral eye infection caused by the herpes simplex virus (HSV).

Use of Latanoprost Vir with other medicines

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

Latanoprost Vir may affect the action of prostaglandins or prostaglandin derivatives (used for ocular hypertension). Combining them with Latanoprost Vir is not recommended, as it may increase intraocular pressure.

Pregnancy and breastfeeding

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

This medicine may affect the fetus. Latanoprost Vir must not be used if you are pregnant or breastfeeding.

Driving and use of machines

As with other eye drops, if you experience blurred vision after instillation, wait until your vision clears before driving or operating machinery.

Important information about some of the ingredients of Latanoprost Vir

This medicine may cause ocular irritation because it contains benzalkonium chloride. Avoid contact with soft contact lenses. If you or your child wear contact lenses, remove them before applying the drops and wait at least 15 minutes before reinserting them. Benzalkonium chloride may discolour soft contact lenses.

3. How to use Latanoprost Vir

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

Dosage

The usual dose for adults (including elderly patients) and children is one drop in the affected eye or eyes once daily.

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

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

Method of administration

To properly administer Latanoprost Vir, follow these steps:

1. Wash your hands and sit or stand comfortably.
2. Unscrew the cap.
3. Using your finger, gently pull down the lower eyelid of the eye to be treated.

1. Place the tip of the bottle near the eye, but without touching it.
2. Gently squeeze the bottle so that only one drop enters the eye. Release the lower eyelid.
3. Press with your finger on the corner of the treated eye near the nose. Apply pressure for 1 minute, keeping your eye closed.
4. Repeat the procedure in the other eye, if instructed by your doctor.
5. Replace the cap on the bottle.

If you use more Latanoprost Vir than you should

If you have applied more drops in the eye than recommended, you may experience mild eye irritation, redness, and tearing; this should resolve on its own. However, if you are concerned, 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 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 a missed dose. If you forget to apply the eye drops at the usual time, wait until the next scheduled dose.

Do not administer an additional drop in the eye to compensate for the missed dose.

If you stop using Latanoprost Vir

Do not stop treatment unless instructed by your doctor or the doctor treating your child.

If you wear contact lenses

Latanoprost Vir contains benzalkonium chloride as a preservative, which may discolor soft contact lenses.

If you or your child wear contact lenses, remove them before applying Latanoprost Vir. Do not reinsert them until 15 minutes after applying Latanoprost Vir.

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

4. Possible adverse effects

Like all medicines, Latanoprost Vir may cause adverse effects, although not everyone experiences them.

The frequency of occurrence is classified as follows:

The following adverse reactions have been reported:

Very common adverse reactions:

• Change in eye color (eyes darken and become more brown).
• Red, watery eyes, stinging sensation, itching, pruritus, and eye pain; may feel as if there is a foreign body in the eye or eyes.
• Darkening, thickening, lengthening, or increased number of eyelashes and eyelid vellus hair.

Common adverse reactions:

• Inflammation of the eyelid margins.
• Eye pain.

Uncommon adverse reactions:

• Swelling of the eyelids.
• Dry eyes.
• Corneal inflammation.
• Blurred vision.
• Conjunctivitis.
• Skin rash.
• Nausea.
• Vomiting.

Rare adverse reactions:

• Certain forms of ocular inflammation (iritis, uveitis).
• Swelling and damage to the cornea (corneal edema).
• Swelling of the retina (macular edema).
• Swelling around the eye socket (periorbital edema), inward turning of eyelashes, which may occasionally cause eye irritation (uncommon).
• Sudden chest tightness caused by muscle spasms and inflammation of the respiratory mucosa, often accompanied by cough and mucus production (asthma); worsening of asthma and difficulty breathing (dyspnea).
• Skin rash on the eyelids.
• Darkening of the skin of the eyelids.

Very rare adverse reactions:

• Chest pain.
• Worsening of chest tightness (angina pectoris), if previously present.

Additional adverse reactions reported since latanoprost has been marketed (frequency not known):

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

Adverse reactions observed in children at a higher frequency than in adults are runny nose, nasal itching, and fever.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, 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 stated on the packaging and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

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

After first opening the bottle:

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 drops solution contains 50 micrograms of latanoprost.

One drop contains approximately 1.5 micrograms of latanoprost.

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

Appearance of the medicinal product and contents of the container

Latanoprost Vir is presented as an eye drop solution, transparent and colourless, in a low-density polyethylene (LDPE) bottle with a low-density polyethylene (LDPE) dropper and a high-density polyethylene (HDPE) screw cap with tamper-evident seal.

Each bottle contains 2.5 ml of ophthalmic solution, corresponding to approximately 80 drops of solution.

Latanoprost Vir is available in packs containing 1 bottle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent revision of this leaflet: May 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/