LATANOPROST FARMALIDER 50 micrograms/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Latanoprost Farmalider 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 or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• Latanoprost Farmalider 50 micrograms/ml eye drops, solution will be referred to as Latanoprost Farmalider throughout this leaflet.

Contents of the pack

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

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

Latanoprost belongs to a group of medicines known as prostaglandin analogues.

It works by increasing the natural outflow of fluid from the eye into the bloodstream.

Latanoprost is used to treat diseases such as open-angle glaucoma and ocular hypertensionin adults. Both of these diseases cause increased pressure in the eye due to the build-up of fluid.

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

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

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

Do not use Latanoprost Farmalider:

• 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 plan to become pregnant.
• If you are breast-feeding.

Warnings and precautionsConsult your doctor or your child's doctor or pharmacist before starting to use Latanoprost Farmalider or before giving it to 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 wear contact lenses. You can continue to use Latanoprost, but you must follow the instructions in section 3 for contact lens wearers.
• If you have had or are having a viral infection of the eye caused by the herpes simplex virus (HSV).

Using Latanoprost Farmalider with other medicines

Latanoprost may interact with other medicines. Tell your doctor, your child's doctor or pharmacist if you or your child are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

Do not use Latanoprost during pregnancy or while breast-feeding.

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

Driving and using machines

When using Latanoprost, blurred vision may occur for a short time. If this happens, do not drive or use tools or machines until your vision is clear again.

Latanoprost contains benzalkonium chloride.

Latanoprost contains a preservative called benzalkonium chloride.

Benzalkonium chloride can be absorbed by soft contact lenses and may change the color of the contact lenses. You should remove your contact lenses before using this medicine and wait 15 minutes before putting them back in. Follow the instructions in section 3 for contact lens wearers.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal problems (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, itching or pain in the eye after using this medicine.

3. How to use Latanoprost Farmalider

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

If you are unsure, consult your doctor or your child's doctor or pharmacist again.

The recommended dose for adults (including the elderly) and children is one drop in the affected eye(s) once daily. It is best to administer it in the evening.

Do not use Latanoprost Farmalider more than once daily; the effectiveness of the treatment may decrease if it is administered more frequently.

Use Latanoprost Farmalider as your doctor or your child's doctor has told you until they tell you to stop.

Contact lens wearers

If you or your child wear contact lenses, you must remove them before using this medicine.

After applying this medicine, wait 15 minutes before putting your contact lenses back in.

Instructions for use

• First, wash your hands.
• Avoid touching the eye (or any other surface) with the tip of the bottle.
• If you use soft contact lenses, they must be removed before using the eye drops and wait at least 15 minutes before putting them back in.
• These drops come in a plastic bottle with a cap, and a dust cap with a security seal. When using the bottle for the first time, remove the dust cap by twisting it to the right to break the seal.
• Remove the inner cap.
• Tilt your head back and look up.
• Gently pull down the lower eyelid.
• Hold the bottle upside down over the eye and press it gently to release one drop into the eye.

• Keep the affected eye closed and press the inner corner of the closed eye with your finger for 1 minute. This is important to reduce the amount of medicine that passes to the rest of the body.

• Repeat in the other eye, if necessary.
• Replace the cap on the bottle after each use, and tighten the cap on the dropper.

If you use this medicine with other eye drops

Wait at least 5 minutes between using Latanoprost Farmalider and applying (or using) other eye drops.

If you use more Latanoprost Farmalider 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 become red and watery; this should go away, but if you are concerned, consult your doctor or your child's doctor.

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 taken.

If you forget to use Latanoprost Farmalider

Continue with the administration of the next dose as usual. Do not apply an extra drop in the eye to make up for the missed dose. If you are unsure, consult your doctor or pharmacist.

If you stop using Latanoprost Farmalider

If you want to stop using Latanoprost Farmalider, consult your doctor or your child's doctor.

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

4. Possible side effects

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

The following are side effects of using Latanoprost Farmalider eye drops:

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

• Gradual change in eye color due to an increase in the amount of brown pigment in the iris. If you have mixed-color eyes (blue-brown, gray-brown, yellow-brown or green-brown) you are more likely to experience this change than if your eyes are a single color (blue, gray, green or brown). The change in eye color may take years to develop, although it usually appears within 8 months of treatment. The change in eye color may be permanent and may be more noticeable if Latanoprost is used in only one eye. The change in eye color does not seem to be associated with any problems. The change in eye color does not progress once treatment with Latanoprost has been stopped.
• Redness of the eye.
• Ocular irritation (feeling of stinging, feeling of grit in the eye, itching, pain and feeling of a foreign body in the eye).
• Gradual change in the eyelashes of the treated eye and the fine hair around the eye

treated, observed in most patients of Japanese origin. These changes include an increase in color (darkening), length, thickness and number of eyelashes.

• Irritation or erosion of the surface of the eye, inflammation of the eyelids (blepharitis) and eye pain.

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

• Irritation or erosion of the surface of the eye (punctate keratitis), inflammation of the eyelids (blepharitis), eye pain and sensitivity to light (photophobia), conjunctivitis.

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

Swelling of the eyelids, dry eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), inflammation of the retina (macular edema)

• Skin rash.
• Chest pain (angina), awareness of heartbeat (palpitations)
• Asthma, difficulty breathing (dyspnea)
• Headache, dizziness
• Muscle pain, joint pain
• Nausea
• Vomiting

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

• Inflammation of the iris (iritis), symptoms of swelling or injury/damage to the surface of the eye, swelling around the eye (periorbital edema), misdirected eyelashes or extra row of eyelashes, scarring on the surface of the eye, accumulation of fluid in the colored part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the skin of the eyelids.
• Worsening of asthma
• Severe itching of the skin
• Appearance of viral eye infection caused by the herpes simplex virus (HSV).

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

Worsening of angina in patients who also have heart problems, sunken appearance of the eyes (deepening of the orbital sulcus)

Other side effects in children

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

In very rare cases, some patients with severe damage to the transparent layer on the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium deposits during treatment.

If you experience side effects, consult your doctor, your child's doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

Reporting of side effects

If you experience any side effects, consult your doctor or nurse, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Latanoprost Farmalider

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.

The expiry date is the last day of the month stated.

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

Once the bottle is opened, it is not necessary to store it in the refrigerator, but do not store it above 25°C. It must be used within 4 weeks of opening. When not using Latanoprost, keep the bottle in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Latanoprost Farmalider

The active substance is latanoprost.

1 ml of solution contains 50 micrograms of latanoprost.

The other ingredients (excipients) are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, water for injections.

Appearance of the product and pack contents

Latanoprost eye drops, solution is a clear, colorless liquid.

Latanoprost is available in pack sizes of 1, 3 and 6 units.

Not all pack sizes may be marketed.

Each unit contains one bottle of Latanoprost. Each bottle contains 2.5 ml of Latanoprost eye drops, solution.

Marketing authorisation holder and manufacturer:

Marketing authorisation holder:

Farmalider, S.A.

C/ La Granja, 1

28108 Alcobendas (Madrid)

Spain

Manufacturer:

FDC International Ltd.,

Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE, UK

Date of last revision of this leaflet:March 2022.

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