Prospecto: information for the patient

Latanoprost Viatris 50 micrograms/ml eye drops in solution

latanoprost

Read this prospect carefully before starting to use the medicine, as it contains important information for you.

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

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

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

3.How to use Latanoprost Viatris

4.Possible adverse effects

5.Storage of Latanoprost Viatris

6.Contents of the package and additional information

The active ingredient of Latanoprost Viatrisis latanoprost,which belongs to a group of medicines known as prostaglandins.Latanoprost Viatris is a medicine that reduces intraocular pressure by increasing the natural drainage of fluid from the interior of the eye into the circulatory system.

Latanoprost 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.

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

Latanoprost Viatriscan be used in adult men and women (including elderly patients) and in children from birth to 18 years old. LatanoprostViatrishas not been investigated in premature children (less than 36 weeks of gestation).

Do not use Latanoprost Viatris

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

Warnings and precautions

Consult your doctor or the doctor treating your child,or your pharmacist before starting to useLatanoprostViatrisor before using this medication in your child, if you think any of the following apply to you or your child

• If you or your child have severe asthma or asthma that is not well controlled.
• If you or your child have a type of glaucoma known as ‘chronic angle-closure glaucoma’.
• If you or your child have glaucoma and at the same time do not have a lens or have an artificial lens or if your eye or your child's eye is aphakic (lacks a lens in the eye) or pseudophakic with posterior capsule rupture or anterior chamber lens.
• If you or your child have glaucoma caused by the formation of pigments in the anterior chamber angle of the eye.
• If you or your child have glaucoma caused by ocular inflammation or by the formation of new blood vessels inside the eye.
• If you or your child have congenital glaucoma.
• If you present known risk factors for swelling in the back of the eye (macular edema) or inflammation of the iris (iritis/uveitis)for example, if you have a vascular disorder affecting the eyes or retinal anomalies, such as those caused by diabetes.
• If you have a disorder in which the front part of the eye (cornea) can be affected
• If you or your child are about to have or have had eye surgery (including cataract surgery).
• If you or your child have suffered or are suffering from a viral infection in the eyes caused by the herpes simplex virus (HSV), especially if this was caused by the use of prostaglandin analogs.
• If you or your child have eye problems (for example, eye pain, irritation, or inflammation or blurry vision).
• If you or your child have dry eye, in which case your doctor will closely monitor you.
• If you or your child wear contact lenses. You can still useLatanoprost Viatris, but follow the instructions for contact lens users in section 3.

There is no experience in the treatment of latanoprost in acute angle-closure glaucoma attacks.

Consult your doctor if you experience or have ever experienced any of the circumstances mentioned above.

Use of Latanoprost Viatris with other medications

Inform your doctor, the doctor treating your child, or your pharmacist if you or your child are using or have used recently or may need to take any other medication, including those purchased without a prescription.Latanoprost Viatrismay interact with other medications:

Latanoprost Viatrismay affect the effect of prostaglandins or prostaglandin derivatives (used to treat ocular hypertension). It is not recommended to combine them withLatanoprost Viatrisas it may increase intraocular pressure.

Pregnancy and breastfeeding

Pregnancy

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

It may affect the fetus.Latanoprost Viatrisshould not be used during pregnancy.

Breastfeeding

If you are breastfeeding, consultyour doctor or pharmacist before using this medication.

Latanoprost may pass into breast milk and may affect the infant.Latanoprost Viatrisshould not be used during breastfeeding.

Driving and operating machinery

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

Latanoprost Viatriscontains phosphates, benzalkonium chloride, and sodium

This medication contains 6.34 milligrams of phosphate per milliliter and 0.2 milligrams of benzalkonium chloride per milliliter.

If you suffer a severe injury to the transparent layer of the front part of the eye (the cornea), phosphates may cause, in rare cases, corneal opacification due to calcium accumulation during treatment.

Benzalkonium chloride may be absorbed by soft contact lenses, and it may also alter the color of soft contact lenses. Remove the contact lenses before application and wait at least 15 minutes before reinserting them.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent layer in the front part of the eye). If you feel an abnormal sensation in your eyes, burning, or eye pain after using this medication, talk to your doctor

This medication contains less than 23 mg (1 mmol) of sodium per ml; it is essentially "sodium-free".

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

The recommended dose for adults (including elderly patients) and children is one drop in the affected eye or eyes once a day, administered preferably at night.If you have to use other eye drops, these must be applied with an interval of at least five minutes.

Be careful when pressing the bottle, so that only one drop is introduced into the affected eye. Do not use latanoprost more than once a day, as if it is administered more frequently it may decrease the effect of the treatment.

To administer latanoprost in an appropriate manner, you must follow the following steps:

1.Wash your hands and sit or stand comfortably.

2.Remove the cap.

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

4.Place the tip of the bottle close to the eye, but without touching it.

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

6.Press with your finger the affected eye, near the nose. Maintain the pressure for 1 minute, keeping your eye closed.

7.Repeat the procedure in the other eye, if your doctor has indicated it.

8.Replace the cap on the bottle.

If you use more Latanoprost Viatris than you should

Be careful when pressing the bottle, so that only one drop is introduced into the affected eye.If too many drops are applied to the eye, you may feel a slight irritation in it and the eye may water and redden. This should disappear, but if you are concerned, contact your doctor or the doctor treating your child for advice.

In case of overdose or accidental ingestion, consult your doctor or the doctor treating your child, or your pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20. You may feel sick, dizzy, tired, short of breath, or experience stomach pain and sweating.

If you forgot to use Latanoprost Viatris

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

If you interrupt the treatment with Latanoprost Viatris

You must talk to your doctor or the doctor treating your child if you want to interrupt latanoprost.

If you wear contact lenses:

If you or your child wear contact lenses, you must remove them before applying latanoprost.Do not put them back on until 15 minutes have passed since the application of latanoprost.A preservative in latanoprost called benzalkonium chloride may cause eye irritation and alter the color of soft contact lenses.

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

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

If you experience any of the following side effects,stop using the medication and consult your doctor or go to the nearest hospital emergency department as soon as possible:

Rare(may affect up to 1 in 100 people):

• Uveitis, which may be noticed as eye pain, blurred vision, sensitivity to light, tearing, or redness of the eye, possibly with floating cells in your vision.
• Swelling in the back of the eye (macular edema) or fluid-filled cysts in the back of the eye.
• Chest pain, which may radiate to the arms, neck, or jaw, chest discomfort with a feeling of oppression or pressure, difficulty breathing, or a feeling of discomfort (nausea). These effects may be signs of angina, which means your heart is not receiving enough blood.

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

• Herpes simplex virus (HSV) eye infection, associated with inflammation/irritation of the eye surface (keratitis).

Other possible side effects:

Very common(may affect more than 1 in 10 people):

• Change in eye color (they darken and become a more brownish color).
• Red eyes.
• Ocular irritation: feeling of burning, sandpaper-like (pruritus), itching, and stinging in the eyes; you may feel like you have something in your eye. If you experience severe ocular irritation that causes excessive tearing, or if you consider stopping this medication, speak with your doctor, pharmacist, or nurse immediately (within a week). You may need to review your treatment to ensure you are receiving the appropriate treatment for your condition.
• Darkening, thickening, lengthening, or increased number of eyelashes and eyelid hair.

Common(may affect up to 1 in 10 people):

• Erosion or damage to the top layer (cornea) of the eye (keratitis punctata), which occurs mainly without noticeable symptoms. Your doctor or optician may notice this when looking at the surface of the eye.
• Inflammation of the eyelid edgeswith crusts that cause the eyelids to stick together.
• Eye pain.
• Increased sensitivity to light in the eyes.
• Itching, redness, or tearing of the eyes with a sticky film on the eyelashes (conjunctivitis).

Rare(may affect up to 1 in 100 people):

• Headache.
• Dizziness.
• Swelling of the eyelids.
• Dry eyes.
• Blurred vision.
• Rapid heartbeats perceived as stabbing in the chest (palpitations).
• Sudden onset of chest stiffness caused by muscle spasms and swelling of the respiratory tract linings, often with coughing or coughing with mucus (asthma).
• Difficulty breathing (dyspnea).
• Skin rash.
• Muscle pain and joint pain
• Chest pain.
• Nausea.
• Vomiting.

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

• Swelling and damage to the cornea (corneal edema).
• Swelling around the eye border (periorbital edema).
• Inverted eyelashes towards the inside, which occasionally may cause ocular irritation.
• A new layer of eyelashes that grow behind the existing eyelashes.
• A fluid-filled cyst within the colored part of the eye (iris cyst).
• Worsening of asthma.
• Skin rash on the eyelids.
• Darkening of the skin of the eyelids.
• Itching of the skin.

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

• Changes in the skin and tissues around the eye causing deep skin folds.
• In rare cases, some patients with severe damage to the transparent front layer of the eye (cornea) have developed cloudy patches in the cornea due to calcium accumulation during treatment.

Other side effects in children and adolescents

The side effects observed most frequently in children than in adults are runny nose and nasal itching and fever.

Reporting side effects:

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the label and packagingafter the CAD.The expiration date is the last day of the month indicated.

Store in 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.The product must be discarded four weeks after opening, even if it has not been completely consumed.

Medications should not be thrown away through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. In this way, you will help protect the environment.

Latanoprost Viatris 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 are benzalkonium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate, (see section 2, Latanoprost Viatris contains phosphates and benzalkonium chloride), sodium chloride, purified water.

Appearance of the product and contents of the container

Latanoprost Viatris is presented in the form of eye drop solution, transparent and colorless, in a translucent low-density polyethylene bottle with a white high-density polyethylene screw cap.

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

Latanoprost Viatris is available in the following presentations: 1 x 2.5 ml, 3 x 2.5 ml and 6 x 2.5 ml. Some package sizes may only be marketed.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible person for manufacturing:

Jadran Galenski Laboratorij d.d.

Svilno, 20

51000 Rijeka

Croatia

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

ItalyLatanoprost Mylan Pharmaceuticals 50 microgrammi/ml Eye Drop Solution

SpainLatanoprost Viatris 50 micrograms/ml eye drop solution

NetherlandsLatanoprost Mylan 0.05 mg/ml Eye Drops, solution

This leaflet was last revised in:March 2022.

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/