Monoprost 50 micrograms/ml eye drops solution

Spain
Brand name Monoprost 50 micrograms/ml eye drops solution
Form solution, ophthalmic
Active substance / Dosage
LATANOPROST · 0,125 mg
Prescription type Prescription Only Medicine
ATC code
S01E S01EE S01EE01
Registration number 82878
Manufacturer Laboratoires Thea
Monoprost 50 micrograms/ml eye drops solution solution, ophthalmic

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Monoprost 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. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if the adverse effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Monoprost is and what it is used for

Monoprost belongs to a group of medicines known as prostaglandins. It reduces the pressure inside the eye by increasing the natural outflow of fluid from within the eye into the bloodstream.

Monoprost 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.

Monoprost is a preservative-free eye drop solution.

2. What you need to know before using Monoprost

Do not use Monoprost

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Monoprost if you consider that any of the following situations apply to you:

  • If you have undergone or are about to undergo eye surgery (including cataract surgery).
  • If you have eye problems (such as eye pain, irritation or inflammation, blurred vision).
  • If you have severe asthma or asthma that is not well controlled.
  • If you wear contact lenses. You may continue using Monoprost, 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).

Children and adolescents

Do not administer this medicine to children and adolescents under 18 years of age. Monoprost has not been studied in this population.

Use of Monoprost with other medicines

Monoprost may interact with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breast-feeding and fertility

Do not use Monoprost if you are pregnant or breast-feeding.

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

Driving and using machines

Blurred vision may occur for a short period of time when using Monoprost. If this happens to you, do not drive and do not operate tools or machinery until your vision clears again.

Important information about some of the components of Monoprost

Monoprost contains macrogolglycerol hydroxystearate (a derivative of castor oil), which may cause skin allergic reactions.

3. How to use Monoprost

Usual dose

  • Follow exactly the administration instructions for Monoprost provided by your doctor. If in doubt, consult your doctor or pharmacist again.
  • The usual dose for adults (including elderly patients) is one drop in the affected eye or eyes once daily. It is preferable to administer it at night.
  • Do not use Monoprost more than once a day, as the treatment's efficacy may decrease if administered more frequently.
  • Follow exactly the administration instructions for the medicine contained in this leaflet or those provided by your doctor, until your doctor instructs you to stop treatment. If in doubt, ask your doctor, pharmacist, or nurse.
  • This medicine is a preservative-free ophthalmic solution. Do not let the tip of the bottle touch the eyes or surrounding areas. It may become contaminated with bacteria capable of causing eye infections, which could lead to serious eye damage or even vision loss. To avoid possible contamination of the bottle, avoid contact between the tip of the bottle and any surface.

Contact lens users

If you wear contact lenses, you must remove them before using Monoprost. After applying Monoprost, wait 15 minutes before reinserting your contact lenses.

Instructions for use

It is important to follow the instructions below when using this product:

Schematic drawing of a bottle with a dropper and an eye, indicating with an arrow the upper part of the container for the

Before using this medicine for the first time:

  • Check that the safety seal is intact. To open the bottle, unscrew the cap firmly.
  • Wash your hands thoroughly and remove the cap from the bottle. With the bottle upside down, press down several times to activate the pump mechanism until the first drop appears. This process is only necessary the first time the medicine is used and is not required for subsequent administrations.

A hand holding a small bottle and positioning it above the

  1. Before each use, wash your hands thoroughly and remove the cap from the bottle. Avoid any contact between the dropper tip and your fingers.

Black and white drawing of a hand holding a cylindrical container or syringe for a

  1. Place your thumb on the tab at the top of the bottle and your index finger at the base of the bottle. Then, also place your middle finger on the second tab at the base of the bottle. Hold the bottle upside down.

Technical drawing showing a hand holding a medical device above the skin and a

  1. To use, tilt your head slightly backward and hold the dropper bottle vertically over your eye. With the index finger of your other hand, gently pull down the lower eyelid. The space created is called the lower conjunctival sac. Avoid contact between the dropper tip and your fingers or eyes.

To instill one drop into the lower conjunctival sac of the affected eye(s), press briefly but firmly on the bottle. Thanks to the automatic dosing system, exactly one drop is released with each pump.

If the drop does not come out, gently shake the bottle to draw out the remaining drop from the tip of the dropper. In this case, repeat step 3.

Black and white drawing of a hand gently pressing the closed eyelid of a face with the 

  1. Close your eyelids and press with your finger for 1 minute on the inner corner of the eye closest to the nose. This helps prevent the eye drops from draining into the rest of your body.
  1. Immediately close the dropper bottle with the cap immediately after use.

If you use Monoprost with other eye drops

Wait at least 5 minutes between applying Monoprost and using other eye drops.

If you use more Monoprost than you should

If you have applied more drops into the eye than you should, 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.

In case of accidental ingestion of Monoprost, consult your doctor as soon as possible.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Monoprost

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

If you stop using Monoprost

If you wish to stop using Monoprost, you must consult your doctor.

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

4. Possible adverse effects

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

The following adverse reactions are known with the use of Monoprost:

Very common: may affect more than 1 in 10 patients.

  • Gradual change in eye colour due to increased amounts of brown pigment in the coloured part of the eye known as the iris.

    • If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to experience this change than if your eyes are of a single colour (blue, grey, green or brown).
    • The change in eye colour may take years to develop, although it is usually noticeable by 8 months of treatment.
    • The colour change may be permanent and may be more noticeable if Monoprost is used in only one eye.
    • The change in eye colour does not appear to be associated with the development of any problems.
    • The change in eye colour does not progress once treatment with Monoprost is discontinued.

  • Redness of the eye.

  • Eye irritation (burning sensation, gritty feeling in the eye, itching, pain, and foreign body sensation in the eye).

  • Gradual changes in the eyelashes of the treated eye and in the fine hair around the treated eye, observed in most Japanese patients. These changes include increased pigmentation (darkening), elongation, thickening, and increased number of eyelashes.

Common: may affect up to 1 in 10 patients

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

Uncommon: 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 coloured part of the eye (uveitis), swelling of the retina (macular edema).
  • Skin rash.
  • Chest pain (angina), awareness of heartbeat (palpitations).
  • Asthma, breathing difficulty (dyspnea).
  • Chest pain.
  • Headache, dizziness.
  • Muscle pain, joint pain.
  • Nausea, vomiting.

Rare: 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 extra row of eyelashes, accumulation of fluid in the coloured part of the eye (iris cyst).
  • Skin reactions on the eyelids, darkening of the eyelid skin.
  • Worsening of asthma.
  • Intense itching of the skin.
  • Development of a viral eye infection caused by the herpes simplex virus (HSV).

Very rare: may affect up to 1 in 10,000 patients

  • Worsening of angina in patients who also have heart problems.
  • Sunken appearance of the eye (deepening of the eye socket).

Reporting of adverse effects

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

5. Storage of Monoprost

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 bottle. The expiry date refers to the last day of the month indicated.

Before first opening the bottle: Do not store above 25°C.

After first opening the bottle: Monoprost may be used for up to 1 month for the 2.5 ml bottle and up to 3 months for the 6 ml bottle, without special storage conditions.

Record the date of first opening on the carton.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Monoprost

The active substance is latanoprost.

1 ml of eye drops contains 50 micrograms of latanoprost.

The other components (excipients) are: macrogol glycerol hydroxystearate 40, sorbitol, carbomer 974P, macrogol 4000, disodium edetate, sodium hydroxide (for pH adjustment), water for injections.

Appearance of the product and contents of the pack

Monoprost is a slightly yellowish, opalescent solution without preservatives.

Monoprost is available in the following pack sizes:

  • multidose bottle of 2.5 ml (at least 70 preservative-free drops) for 1 month of treatment, including a pump equipped with an Easygrip device with ergonomic grips.
  • multidose bottle of 6 ml (at least 190 preservative-free drops) for 3 months of treatment, including a pump equipped with an Easygrip device with ergonomic grips.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATOIRES THEA
12 RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
FRANCE

Manufacturer

DELPHARM TOURS
RUE PAUL LANGEVIN
37170 CHAMBRAY LES TOURS
FRANCE

OR

LABORATOIRES THEA
12 RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
FRANCE

Local Representative

Laboratorios Thea, S.A.
C/ Enric Granados nº 86-88, 2nd floor
08008 – BARCELONA

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

Germany, Belgium, Bulgaria, Cyprus, Denmark, Spain, Finland, France, Greece, Netherlands, Iceland, Italy, Luxembourg, Norway, Poland, Portugal, Sweden

Monoprost

Austria, Slovenia, Czech Republic, Slovakia, Romania

Monopost

Date of the most recent review of this leaflet: February 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/.