Latanoprost Viatris 50 micrograms/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Latanoprost Viatris 50 micrograms/ml eye drops solution

latanoprost

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, or the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only and must 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 these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

The active substance of Latanoprost Viatris is 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 inside the eye into the bloodstream.

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

Latanoprost is also used to treat elevated pressure inside the eye and glaucoma in children and infants of all ages.

2. What you need to know before using Latanoprost Viatris

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

Do not use Latanoprost Viatris

• If you are allergic to latanoprost, benzalkonium chloride, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or your child’s doctor, or your pharmacist before starting to use Latanoprost Viatris or before using this medicine 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 closed-angle glaucoma’.
• If you or your child have glaucoma and either have no lens in the eye or have an artificial lens, or if your eye or your child’s eye is aphakic (missing the eye’s lens) or pseudoaphakic with rupture of the posterior lens capsule or with an anterior chamber lens.
• If you or your child have glaucoma caused by pigment dispersion 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 have known risk factors for swelling at the back of the eye (macular edema) or for inflammation of the iris (iritis/uveitis), for example, if you have a vascular disorder affecting the eyes or retinal abnormalities due to diabetes.
• If you have a condition in which the front part of the eye (cornea) may be affected.
• If you or your child are about to have or have recently had eye surgery (including cataract surgery).
• If you or your child have had or are currently experiencing a viral eye infection caused by the herpes simplex virus (HSV), especially if this was triggered by the use of prostaglandin analogues.
• If you or your child have eye problems (e.g., eye pain, irritation, inflammation, or blurred vision).
• If you or your child have dry eye, in which case your doctor will monitor carefully.
• If you or your child wear contact lenses. You can still use Latanoprost Viatris, but follow the instructions for contact lens wearers in section 3.

There is no experience with latanoprost treatment in acute attacks of closed-angle glaucoma.

Consult your doctor if any of the above conditions occur or have occurred in the past.

Using Latanoprost Viatris with other medicines

Tell your doctor, your child’s doctor, or your pharmacist if you or your child are using, have recently used, or might need to take any other medicines, including those obtained without a prescription. Latanoprost Viatris may interact with other medicines:

Latanoprost Viatris may affect the action of prostaglandins or prostaglandin derivatives (used to treat ocular hypertension). Their combination with Latanoprost Viatris is not recommended, as it may increase intraocular pressure.

Pregnancy and breastfeeding

Pregnancy

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

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

Breastfeeding

If you are breastfeeding, consult your doctor or pharmacist before using this medicine.

Latanoprost may pass into breast milk and therefore may affect the breastfed infant. Latanoprost Viatris must not be used during breastfeeding.

Driving and using machines

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

Latanoprost Viatris contains phosphates, benzalkonium chloride, and sodium

This medicine contains 6.34 milligrams of phosphate per millilitre and 0.2 milligrams of benzalkonium chloride per millilitre.

If you have severe damage to the transparent layer at the front of the eye (the cornea), phosphates may, in very rare cases, cause corneal calcification and clouding due to calcium accumulation during treatment.

Benzalkonium chloride may be absorbed by soft contact lenses and may also alter the colour of soft contact lenses. You must remove contact lenses before applying the drops and wait at least 15 minutes before reinserting them.

Benzalkonium chloride may also cause eye irritation, particularly if you have dry eyes or corneal disorders (the transparent layer at the front of the eye). If you experience an unusual sensation in the eyes, stinging, or eye pain after using this medicine, speak with your doctor.

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

3. How to use Latanoprost Viatris

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

The recommended dose for adults (including elderly patients) and children is one drop in the affected eye or eyes once daily, preferably administered in the evening. If you need to use other eye drops, these should be administered at an interval of at least five minutes.

Be careful when squeezing the bottle so that only one drop is instilled into the affected eye. Do not use latanoprost more than once a day, as administering it more frequently may reduce the treatment effect.

To properly administer latanoprost, 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.
4. Hold the tip of the bottle close to the eye, but without touching it.
5. Gently squeeze the bottle so that only one drop enters the eye. Release the lower eyelid.
6. Press your finger against the inner corner of the affected eye, near the nose. Apply pressure for one minute, keeping your eye closed.
7. Repeat the procedure in the other eye, if instructed by your doctor.
8. Replace the cap on the bottle.

If you use more Latanoprost Viatris than you should

Be careful when squeezing the bottle so that only one drop is instilled into the affected eye. If too many drops are applied into the eye, you may experience mild eye irritation, tearing, and redness. This should resolve, but if you are concerned, contact your doctor or your child's doctor for advice.

In case of overdose or accidental ingestion, contact your doctor, your child's doctor, or your pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20. You may feel sick, dizzy, tired, short of breath, or experience stomach pain and sweating.

If you forget to use Latanoprost Viatris

Do not use a double dose to make up for missed doses. If you forget to instill the eye drops at the usual time, wait until the next scheduled dose. Do not administer an extra drop to make up for the missed dose.

If you stop using Latanoprost Viatris

You should speak with your doctor or your child's doctor if you wish to discontinue latanoprost.

If you wear contact lenses:

If you or your child wear contact lenses, they must be removed before instilling latanoprost. Do not reinsert them until 15 minutes after latanoprost has been administered. A preservative in latanoprost called benzalkonium chloride may cause eye irritation and may change the color of soft contact lenses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

• Inflammation of the outer or middle layer of the eye, which you may notice as eye pain, blurred vision, light sensitivity, tearing, or eye redness, possibly with floating spots in your vision.
• Swelling at the back of the eye (macular edema) or fluid-filled cysts at the back of the eye.
• Chest pain, which may spread to the arms, neck, or jaw, chest discomfort with a feeling of tightness or pressure, difficulty breathing, or feeling unwell (nausea). These effects may be signs of angina, meaning that your heart is not receiving enough blood.

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

• Viral eye infection caused by the herpes simplex virus (HSV), associated with inflammation/irritation of the eye surface (keratitis).

Other possible adverse effects:

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

• Change in eye color (eyes darken and become browner).
• Red eyes.
• Eye irritation: burning, gritty, itchy, or stinging sensation in the eyes; you may feel as if you have something in your eye. If you experience eye irritation severe enough to cause excessive tearing or that makes you consider stopping this medicine, speak to your doctor, pharmacist, or nurse immediately (within one week). Your treatment may need to be reviewed to ensure you continue receiving appropriate therapy 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 outer layer (cornea) of the eye (punctate keratitis), which mostly occurs without obvious symptoms. Your doctor or optometrist may detect this when examining the eye surface.
• Inflammation of the eyelid margins with crusting, causing eyelids to stick together.
• Eye pain.
• Increased sensitivity to light in the eyes.
• Itching, redness, or tearing of the eye with a sticky film on the eyelashes (conjunctivitis).

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

• Headache.
• Dizziness.
• Swelling of the eyelids.
• Dry eyes.
• Blurred vision.
• Rapid heartbeats felt as pounding in the chest (palpitations).
• Sudden onset of chest tightness caused by muscle spasms and swelling of the airway linings, often with cough or cough 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 area (periorbital edema).
• Eyelashes turning inward, which may occasionally cause eye irritation.
• A new row of eyelashes growing 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 very 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 deposits during treatment.

Other adverse effects in children and adolescents

Adverse effects observed more frequently in children than in adults are runny nose, nasal itching, and fever.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Latanoprost Viatris

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

Do not use this medicine after the expiry date stated on the label and packaging following "EXP". The expiry date refers to the last day of the month indicated.

Store in a 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. The product must be discarded four weeks after opening, even if not completely used.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Latanoprost Viatris

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 are benzalkonium chloride, monohydrate sodium dihydrogen phosphate, 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 as a transparent, colourless eye drop solution in a translucent low-density polyethylene dropper bottle with a white high-density polyethylene screw cap.

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

Latanoprost Viatris is available in the following pack sizes: 1 x 2.5 ml, 3 x 2.5 ml and 6 x 2.5 ml. Some pack sizes may not be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Jadran Galenski Laboratorij d.d.
Svilno, 20
51000 Rijeka
Croatia

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Italy Latanoprost Mylan Pharmaceuticals 50 microgrammi/ml Collirio, soluzione
Spain Latanoprost Viatris 50 micrograms/ml eye drops solution
Netherlands Latanoprost Mylan 0.05 mg/ml Oogdruppels, oplossing

This leaflet has been revised in: March 2022.

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