Latonest 50 micrograms/ml eye drops solution

Spain
Brand name Latonest 50 micrograms/ml eye drops solution
Form solution, ophthalmic
Active substance / Dosage
LATANOPROST · 0,05 mg
Prescription type Prescription Only Medicine
ATC code
S01E S01EE S01EE01
Registration number 83327
Manufacturer Esteve Pharmaceuticals S.A.
Latonest 50 micrograms/ml eye drops solution solution, ophthalmic

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Latanest 50 micrograms/ml eye drops solution

Latanoprost

Read the entire 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, the doctor treating your child, or your pharmacist.
  • This medicine has been prescribed for you or your child. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
  • If you or your child experience any side effects, consult your doctor, the doctor treating your child, or your pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Latanest is and what it is used for

Latanest belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream.

Latanest is used to treat conditions known as open-angle glaucoma and ocular hypertension in adults. Both conditions are associated with increased pressure inside the eye, which may eventually affect vision.

Latanest is also used to treat elevated intraocular pressure and glaucoma in infants and children of all ages.

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

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

2. What you need to know before using Latanest

Do not use Latanest:

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

Warnings and precautions

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

  • If you or your child have had 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 wear contact lenses. You may continue using Latanest, but you must follow the instructions provided in section 3 for contact lens wearers.
  • If you have had or are currently experiencing a viral eye infection caused by the herpes simplex virus (HSV).

Other medicines and Latanest

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

Pregnancy and breastfeeding

Pregnancy

Do not use Latanest if you are pregnant. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Breastfeeding

Do not use Latanest if you are breastfeeding.

Driving and use of machines

Blurred vision may occur for a short period after using Latanest. If this happens, do not drive or operate tools or machinery until your vision is clear again.

Latanest contains macrogolglycerol hydroxystearate 40

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

Latanest contains phosphate buffer

This medicine contains 6.35 mg of phosphates per ml of solution.

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

3. How to use Latanest

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

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

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

Use Latanest exactly as directed by your doctor or the doctor treating your child, until they tell you to stop.

Contact lens users

If you or your child wear contact lenses, they must be removed before using Latanest. After applying Latanest, wait 15 minutes before reinserting the contact lenses.

Instructions for use

Black and white technical drawing of a cylindrical medical device composed of a conical upper part and a segmented main body

1a

A hand rotates a capsule toward a cylindrical container held by another hand

1b

  • Remove the bottle (Figure 1a) from the carton and write the date of opening on the carton and on the bottle in the space provided.
  • Take the medicine and a mirror.
  • Wash your hands.
  • Remove the cap (Figure 1b).

A hand holds an inverted bottle with a dropper releasing a single drop of liquid downward, indicated by a downward-pointing arrow2

  • Hold the bottle upside down with your thumb on the top of the bottle and the other fingers at the base of the bottle. Before first use, pump the bottle repeatedly about 10 times until the first drop appears (Figure 2).

Line drawing of a hand gently pressing the area between the lower eyelid and the eyeball

3

  • Tilt the head or your child's head backward. Pull down the eyelid with a clean finger until a "pocket" forms between the eyelid and the eye. The drop will go here (Figure 3).
  • Bring the tip of the bottle close to the eye. Use a mirror if it helps.

A hand holds a dropper bottle above the eye

4

  • Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper. This could contaminate the drops.
  • Gently press the base of the bottle to release one drop of medicine (Figure 4).
  • If a drop does not enter the eye, try again.

Line drawing of a closed eye with a finger gently pressing on the upper eyelid to administer medication

5

  • After using the medicine, press with your finger at the inner corner of the eye near the nose for 1 minute (Figure 5). This helps prevent the medicine from passing into the rest of the body.
  • If using the drops in both eyes, repeat these same steps for the other eye.
  • Closely replace the cap on the bottle immediately after use.
  • Use only one medicine bottle at a time. Do not open the cap until you need to use the bottle.

2.5 ml:

  • You must discard the bottle 4 weeks after first opening it to prevent infections, and use a new bottle.

5 ml:

  • You must discard the bottle 8 weeks after first opening it to prevent infections, and use a new bottle.

If you use Latanest with other eye drops

Wait at least 5 minutes between the application of Latanest and the administration of other eye drops.

If you use more Latanest than you should

If you have applied more drops into the eye than you should have, you may experience mild eye irritation, and your eyes may become red and watery. This should resolve on its own, but if you are concerned, contact your doctor or your child's doctor.

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

If you forget to use Latanest

Continue with the next dose as usual. Do not apply an extra drop into the eye to make up for the missed dose. If you have any doubts, consult your doctor or pharmacist.

If you stop using Latanest

If you wish to stop using Latanest, consult your doctor or your child's doctor.

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

4. Possible adverse effects

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

The following adverse effects have been observed with eye drops containing the active substance latanoprost:

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

  • Gradual change in eye color due to an increase in brown pigment in the colored part of the eye known as 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 of a single color (blue, gray, green or brown). The change in eye color develops gradually over years, although it is usually noticeable after 8 months of treatment. The change in eye color may be permanent and may be more pronounced if Latanest is used in only one eye. The change in eye color does not appear to be associated with any eye problems. The change in eye color does not progress once treatment with Latanest is discontinued.
  • Eye redness.
  • Eye irritation (burning sensation, gritty feeling in the eye, itching, stinging, and foreign body sensation in the eye). If you experience severe eye irritation causing excessive tearing or that makes you consider stopping treatment, consult your doctor, pharmacist, or nurse as soon as possible (within one week). You may need to have your treatment reviewed to ensure you are receiving the appropriate treatment for your condition.
  • Gradual changes in the eyelashes of the treated eye and in the fine hair around the treated eye, commonly observed in patients of Japanese origin. These changes include darkening (increased pigmentation), lengthening, thickening, and increased number of eyelashes.

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

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

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

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

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

  • Inflammation of the iris (iritis), symptoms of swelling or injury/damage to the eye surface, swelling around the eye (periorbital edema), misdirected eyelashes or an additional row of eyelashes, scarring on the eye surface, fluid accumulation in the colored part of the eye (iris cyst).

  • Skin reactions on the eyelids, darkening of the eyelid skin.

  • Worsening of asthma.

  • Intense skin itching.

  • Development of a viral eye infection caused by the herpes simplex virus (HSV).

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

  • Worsening of angina in patients with pre-existing heart problems, appearance of sunken eyes (increased depth of the eyelid groove).

Adverse effects observed in children at a higher frequency than in adults include runny nose, nasal itching, and fever.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may 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 Latanest

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

Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

After first opening, this medicine does not require any special storage conditions.

2.5 ml:

The vial must be discarded 4 weeks after first opening to prevent infection. Write the date of opening on the cardboard box and on the vial in the space provided.

5 ml:

The vial must be discarded 8 weeks after first opening to prevent infection. Write the date of opening on the cardboard box and on the vial in the space provided.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Latanest

  • The active substance is latanoprost tartrate. 1 ml of solution contains 50 micrograms of latanoprost.
  • The other components are: macrogol glycerol hydroxystearate 40, sodium chloride, edetate disodium, sodium dihydrogen phosphate dihydrate, anhydrous disodium phosphate, hydrochloric acid and/or sodium hydroxide (for pH adjustment), water for injection purposes.

Nature of the product and contents of the container

2.5 ml:

Latanest eye drops solution is presented as a clear, colourless aqueous solution of 2.5 ml, corresponding to approximately 80 drops of solution, free from visible particles.

It is marketed in cardboard boxes containing one multidose white bottle (HDPE) of 5 ml with a pump (PP, HDPE, LDPE) and a green pressure cylinder and cap (HDPE).

5 ml:

Latanest eye drops solution is presented as a clear, colourless aqueous solution of 5 ml, corresponding to approximately 160 drops of solution, free from visible particles.

It is marketed in cardboard boxes containing one multidose white bottle (HDPE) of 5 ml with a pump (PP, HDPE, LDPE) and a green pressure cylinder and cap (HDPE).

Pack sizes:

Carton box containing 1 or 3 bottles with 2.5 ml of solution or 1 or 3 bottles with 5 ml of solution.

Not all pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Manufacturer

Lomapharm GmbH

Langes Feld 5

31860 Emmerthal

Germany

Pharmathen S.A.

Dervenakion Str. 6

Pallini 15351

Attiki

Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Denmark Tanafra

Cyprus Tanafra

France LATAZED 50 microgrammes/mL, eye drops solution

Germany Tanafra 50 Mikrogramm/ml Augentropfen, Lösung

Greece Tanafra

Italy LASTAFRY

Spain Latanest 50 micrograms/ml eye drops solution

Date of the most recent review of this leaflet: September 2024

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