Introduction

Package Insert: Information for the User

Latanest 50 micrograms/mL Eye Drops Solution

Latanoprost

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

Keep this package insert, as you may need to refer to it again.
If you have any questions, consult your doctor, your child's doctor, or pharmacist.
This medication has been prescribed to you or your child, and should not be given to others, even if they have the same symptoms as you, as it may harm them.
If you or your child experience any adverse effects, consult your doctor, your child's doctor, or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Latanest and for what it is used

2. What you need to know before starting to use Latanest

3. How to use Latanest

4. Possible adverse effects

5. Storage of Latanest

6. Contents of the package and additional information

1. What is Latanest and what is it used for

Latanest belongs to a group of medications known as prostaglandin analogs. It acts by increasing the natural drainage of fluid from the interior of the eye to the bloodstream.

Latanest is used to treat diseases known asopen-angle glaucoma and ocular hypertensionin adults. Both diseases are related to an increase in pressure within the eye, which can affect vision.

Latanest is also used to treat increased pressure within the eye and glaucoma ininfants and childrenof all ages.

Latanest can be used in adult men and women (includingolder adultsand in children from birth to 18 years of age. Latanest has not been investigated in premature children (less than 36 weeks of gestation).

Latanest eye drops in solution, is a sterile solution that does not contain preservatives.

2. What you need to know before starting to use Latanest

Do not use Latanest:

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

Warnings and precautions

If you consider that any of the following situations affect you or your child, consult your doctor, or the doctor treating your child, or the pharmacist before using Latanest or before administering it to your child:

If you or your child have undergone or are about to undergo 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 use contact lenses. You may continue to use Latanest, but you 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).

Other medications and Latanest

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

Pregnancy and breastfeeding

Pregnancy

Do not use Latanestif you are pregnant.If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Breastfeeding

Do not use Latanestif you are breastfeeding.

Driving and operating machinery

When using Latanest, blurred vision may appear for a short period of time. If this happens,do not driveor use tools or machinery until your vision returns to normal.

Latanest containsmacrogolglycerol hydroxystearate 40

This medication contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.

Latanest containsphosphate buffer

This medication contains 6.35 mg of phosphates in each ml of solution.

If you suffer from severe damage to the transparent layer at the front of the eye (cornea), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

3. How to use Latanest

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

The recommended dose for adults (including elderly patients) and children is one drop once a day in the affected eye(s). The best time to instill the product is at night.

Do not use Latanest more than once a day, because the effectiveness of the treatment may decrease if administered more frequently.

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

Users of contact lenses

If you or your child use contact lenses, you must remove them before using Latanest. After applying Latanest, wait 15 minutes before putting the contact lenses back in.

Instructions for use

1a 1b	Take the bottle(figure 1a)out of the cardboard box and write the date of opening on the cardboard box and on the bottle in the provided space. Take the medication and a mirror. Wash your hands. Remove the cap(figure 1b).
2	Hold the bottle upside down with your thumb on the top of the bottle and your other fingers on the base of the bottle. Before the first use, pump the bottle repeatedly, approximately 10 times, until the first drop appears(figure 2).
3	Tilt your head or your child's head back. Pull down on the eyelid with a clean finger, until there is a "pocket" between the eyelid and the eye. The drop will enter here(figure 3). Bring the tip of the bottle close to the eye. Use a mirror if it helps.
4	Do not touch the eye or eyelid, the surrounding areas or other surfaces with the dropper.It could infect the drops. Gently press the base of the bottle to release one drop of medication(figure 4). If a drop does not enter the eye, try again.
5	After using the medication, press with your finger the corner of the eye, near the nose, for 1 minute(figure 5). This helps to prevent the medication from passing into the rest of the body.
	If you use the drops in both eyes, repeat these same steps for the other eye. Close the bottle cap tightly immediately after use. Use a single bottle of medication at a time. Do not open the cap until you need to use the bottle. 2.5 ml: You must discard the bottle once 4 weeks have passed since it was first opened, to prevent infections, and use a new bottle. 5 ml: You must discard the bottle once 8 weeks have passed since it was first opened, to prevent infections, and use a new bottle.

Using Latanest with other eye drops

Wait at least 5 minutes between applying Latanest and administering other eye drops.

Using more Latanest than you should

If more drops than you should have been applied to the eye, you may feel a slight irritation in the eye and also the eyes may become red and tearful. This situation should resolve, but if you are concerned, contact your doctor or the doctor treating your child.

In case of accidental ingestion by you or your child of Latanest, consult your doctor or pharmacist as soon as possible, or call the Toxicological Information Service, phone: 91 562 04 20.

Missing a dose of Latanest

Continue with the administration of the next dose in the usual manner. Do not apply an additional drop to the eye to compensate for the missed dose. If you have doubts, consult your doctor or pharmacist.

Stopping treatment with Latanest

If you want to stop using Latanest, consult your doctor or the doctor treating your child.

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

4. Possible Adverse Effects

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been observed with the use of eye drops containing the active substance latanoprost:

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

Gradual change in eye color due to an increase in the amount of brown pigment in the colored part of the eye known as the iris. If you have mixed-colored 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 takes years to develop, although it may be noticeable within 8 months of treatment. The change in eye color may be permanent and may be more noticeable if Latanest is used in only one eye. The change in eye color does not appear to be associated with any problems. The change in eye color does not progress once treatment with Latanest has been discontinued.
Redness of the eye.
Ocular irritation (sensation of burning, sensation of sand in the eye, itching, stinging, and sensation of a foreign body in the eye). If you experience severe ocular irritation that causes excessive tearing or makes you consider stopping treatment, consult your doctor, pharmacist, or nurse as soon as possible (within a week). You may need to have your treatment reviewed to ensure you are receiving the appropriate treatment for your condition.
Gradual change in the eyelashes of the treated eye and the fine hair around the treated eye, commonly observed in patients of Japanese origin. These changes include an increase in color (darkening), lengthening, thickening, and an increase in the number of eyelashes.

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

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

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

Swelling of the eyelids, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the retina (macular edema).
Skin rash.
Chest pain (angina), feeling the heart rhythm (palpitations).
Asthma, difficulty breathing (dyspnea).
Chest pain.
Headache, dizziness.
Muscle pain, joint pain.
Nausea.
Vomiting.

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

Inflammation of the iris (iritis), symptoms of swelling or damage to the eye surface, swelling around the eye (periorbital edema), eyelashes deviated or additional row of eyelashes, scars on the eye surface, accumulation of fluid in the colored part of the eye (iris cyst).
Reactions on the skin of the eyelids, darkening of the skin of the eyelids.
Worsening of asthma.
Intense itching of the skin.
Development of a viral eye infection caused by the herpes simplex virus (HSV).

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

Worsening of angina in patients with underlying heart problems, appearance of sunken eyes (greater depth of the eyelid crease).

The side effects observed in children at a frequency greater than in adults are runny nose, itching of the nose, and fever.

If you experience severe damage to the transparent layer of the front part of the eye (cornea), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, 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 of 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 medicine.

5. Latanest Storage

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

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

Store below 25°C.

After the first opening, this medication does not require special storage conditions.

2.5 ml:

Discard the bottle once 4 weeks have passed after opening it for the first time, to prevent infections. Write the date of opening the bottle on the carton box and on the bottle in the provided space.

5 ml:

Discard the bottle once 8 weeks have passed after opening it for the first time, to prevent infections. Write the date of opening the bottle on the carton box and on the bottle in the provided space.

Medicines should not be thrown away through the drains or in the trash. Deposit the containers and medicines that you do not need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help to protect the environment.

6. Contents of the packaging and additional information

Composition of Latanest

-The active ingredient is latanoprost tartrate. 1 ml of solution contains 50 micrograms of latanoprost.

-The other components are: macrogolglycerol hydroxystearate 40, sodium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, anhydrous disodium phosphate, hydrochloric acid or/and sodium hydroxide (for pH adjustment), water for injection

Appearance of the product and contents of the package

2.5 ml:

Latanest eye drops in solution are presented as a transparent and colorless aqueous solution of 2.5 ml, corresponding to approximately 80 drops of solution, free of visible particles.

It is marketed in carton boxes, which contain a white multidose vial (HDPE) of 5 mlwith a pump (PP, HDPE, LDPE) and a green pressure cylinder and cap (HDPE).

5 ml:

Latanest eye drops in solution are presented as a transparent and colorless aqueous solution of 5 ml, corresponding to approximately 160 drops of solution, free of visible particles.

It is marketed in carton boxes, which contain a white multidose vial (HDPE) of 5 mlwith a pump (PP, HDPE, LDPE) and a green pressure cylinder and cap (HDPE).

Package sizes:

Box with 1 or 3 vials with2.5 ml of solutionor 1 or 3 vials with5 ml of solution.

All package sizes may not be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Responsible for manufacturing

Lomapharm GmbH

Langes Feld 5

31860 Emmerthal

Germany

Pharmathen S.A.

Dervenakion Str. 6

Pallini 15351

Attiki

Greece

This medicine is authorized in the member states of the European Economic Area with the following names:

DenmarkTanafra

CyprusTanafra

FranceLATAZED 50 microgrammes/mL, collyre en solution

GermanyTanafra 50 Mikrogramm/ml Augentropfen, Lösung

GreeceTanafra

ItalyLASTAFRY

SpainLatanest 50 microgramos/ml colirio en solución

Last review date of this leaflet: September 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

Latanest 50 microgramos/ml colirio en solucion

Introduction

1. What is Latanest and what is it used for

2. What you need to know before starting to use Latanest

3. How to use Latanest

4. Possible Adverse Effects

5. Latanest Storage

6. Contents of the packaging and additional information

Talk to a doctor online

Анна Морет

Алина Цуркан

Андрей Попов

Евгений Яковенко

Latanest 50 microgramos/ml colirio en solucion

Introduction

1. What is Latanest and what is it used for

2. What you need to know before starting to use Latanest

3. How to use Latanest

4. Possible Adverse Effects

5. Latanest Storage

6. Contents of the packaging and additional information

Talk to a doctor online

Анна Морет

Алина Цуркан

Андрей Попов

Евгений Яковенко

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