PATIENT INFORMATION LEAFLET

Latanoprost Vir 50 micrograms/mL eye drops in solution

Latanoprost

Read this leaflet carefully before you start using this medicine because 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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. Storage of Latanoprost Vir

6. Contents of the pack and additional information

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

The active ingredient of Latanoprost Vir belongs to a group of medications known as prostaglandins.

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

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

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

Do not use Latanoprost Vir

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

Warnings and precautions

Consult your doctor or the doctor treating your child or your 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 undergone or are going to undergo eye surgery (including cataract surgery)
• If you or your child have eye problems (such as eye pain, irritation, or inflammation, blurry 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 use contact lenses. They may continue to use Latanoprost Vir, but they 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)

Use of Latanoprost Vir with other medications

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

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

Pregnancy and lactation

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

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

Driving and operating machinery

Like other eye drops, if you experience blurry vision when applying the drops, wait until it disappears before driving or operating machinery.

Important information about some of the components of Latanoprost Vir

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

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

Dose

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

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

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

Administration Form

To administer Latanoprost Vir properly, you must follow the following steps:

1. Wash your hands and sit or stand comfortably.

2. Unscrew the cap.

3. Using your finger, gently separate the lower eyelid from the eye to be treated..

4. Place the tip of the bottle close to the eye, but not touching it.

5. Press the bottle carefully so that only one drop enters the eye. Remove your finger from the lower eyelid.

6. Press the affected eye's outer corner, near the nose, with your finger. Maintain eye closure for 1 minute.

7. Repeat the procedure in the other eye, if your doctor has instructed you to do so.

8. Replace the cap on the bottle.

If you use more Latanoprost Vir than you should

If more drops than prescribed have been applied to the eye, you may feel a slight irritation in the eye and it may become red and watery; this situation should resolve, but 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Latanoprost Vir

Do not use a double dose to compensate for missed doses. If you forget to apply the eye drop at the usual time, wait until the next scheduled dose.

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

If you interrupt treatment with Latanoprost Vir

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

If you wear contact lenses

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

Remove your contact lenses before applying Latanoprost Vir. Do not reinsert them until 15 minutes have passed since the application of Latanoprost Vir.

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

Like all medications, Latanoprost Vir may cause side effects, although not everyone will experience them.

The frequency at which they occur is classified as follows::

The following side effects have been reported:

Very frequent side effects:

• Eye color change (darkening and becoming more brown).

• Red, watery, itchy, burning, stinging, or painful eyes; may appear as if there is a foreign body in the eye or eyes.

• Darkening, thickening, lengthening, or increased number of eyelashes and eyelid hair.

Frequent side effects:

• Inflammation of the eyelid edges.

• Eye pain.

Infrequent side effects:

• Swelling of the eyelids.

• Dry eyes.

• Corneal inflammation.

• Blurred vision.

• Conjunctivitis.

• Skin rash.

• Nausea

• Vomiting

Rare side effects:

• Certain forms of eye inflammation (iritis, uveitis).

• Corneal edema (swelling and damage).

• Macular edema (retinal swelling).

• Periorbital edema (swelling around the eye), eyelid inversion inward, which occasionally may cause eye irritation (infrequent).

• Sudden chest tightness caused by muscle spasms and mucous membrane inflammation in the respiratory tract, often with cough and mucus expectoration (asthma); worsening of asthma and breathing difficulty (dyspnea).

• Skin 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 (unknown frequency):

• 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 (VHS)

in children, the following side effects have been observed at a higher frequency than in adults: runny nose, nasal itching, and fever.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging or in the bottle after CAD. The expiration date is the last day of the month indicated.

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

After the first opening of the bottle:

Do not store at a temperature above 25°C and use before four weeks have passed.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Latanoprost Vir Composition

• The active ingredient is latanoprost

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

One drop contains approximately 1.5 micrograms of latanoprost.

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

Product appearance and packaging contents

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

Each bottle contains 2.5 ml of eye drop solution corresponding to approximately 80 drops of solution.

Latanoprost Vir is available in packaging of 1 bottle.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid) Spain

Responsible 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

Last review date of this leaflet: May 2022

The detailed and updated information on this medication is available on the website ofthe Spanish Agency of Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/