Monoprost 50 micrograms/ml eye drops solution in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Monoprost 50 micrograms/ml eye drops solution in single-dose container

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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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
5. How to store Monoprost
6. 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 works by increasing the natural outflow of fluid from inside 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 can eventually affect vision.

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 ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Monoprost if any of the following apply to you:

• If you have had or are about to have 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 currently have a viral eye infection caused by the herpes simplex virus (HSV).

Children

Monoprost has not been studied in children (under 18 years of age).

Using 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 and breastfeeding

Do not use Monoprost if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding, 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 after 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 ingredients of Monoprost.

Monoprost contains macrogolglycerol hydroxystearate (derived from castor oil), which may cause 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 into the affected eye(s) once daily. It is preferable to administer it in the evening.
• Do not use Monoprost more than once a day, as treatment efficacy may decrease if administered more frequently.
• Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor. If in doubt, ask your doctor, pharmacist, or nurse.

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

The eye drops are supplied in single-dose containers. The solution from a single-dose container of Monoprost must be used immediately after first opening to treat the affected eye(s). Since sterility cannot be maintained after opening each single-dose container, a new container must be opened before each use and must be discarded immediately after administration.

To use the eye drops, please follow these instructions:

1. Wash your hands and sit or stand comfortably.
2. Open the pouch containing the single-dose containers. Note the date of first opening on the pouch.
3. Separate one single-dose container from the strip.

1. Twist the tip of the single-dose container as shown. Do not touch the tip after opening the container.

1. Gently pull down the lower eyelid of the affected eye using your finger.
2. Place the tip of the single-dose container close to the eye, but without touching it.
3. Gently squeeze the single-dose container so that only one drop falls into the eye, then release the lower eyelid.

1. Press with your finger at the corner of the affected eye near the nose. Apply pressure for 1 minute, keeping your eye closed.

1. Repeat the procedure in the other eye, if instructed by your doctor. Each single-dose container contains enough solution for both eyes.
2. After use, discard the single-dose container. Do not save it for later use. Since sterility of the single-dose container cannot be guaranteed after opening, a new container must be opened before each use.

If you use Monoprost with other eye drops

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

If you use more Monoprost than you should

If you have applied more drops than recommended, you may experience mild eye irritation, redness, and tearing. 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.

If you forget to use Monoprost

Continue with your next dose as usual. Do not apply an extra drop 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 discontinue 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 will experience 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 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 may take years to develop, although it is usually noticeable after 8 months of treatment.
  • The color change may be permanent and may be more noticeable if Monoprost is used in only one eye.
  • The change in eye color does not appear to be associated with any eye problems.
  • The eye color change does not progress once treatment with Monoprost is discontinued.

• Eye redness.

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

Common: may affect up to 1 in 10 patients

• Eye surface irritation or erosion, eyelid inflammation (blepharitis), eye pain, and light sensitivity (photophobia), conjunctivitis.

Uncommon: 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: 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, 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: 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 sulcus).

Reporting of adverse effects

If you experience any adverse effect, talk to 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://www.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 outer packaging, sachet, and on the single-dose container. The expiry date refers to the last day of the month indicated.

Store below 25°C.

After first opening the sachet: use the single-dose containers within 10 days.

After first opening the single-dose container: use immediately and discard the single-dose container after use.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 glyceryl hydroxystearate 40, sorbitol, carbomer 974P, macrogol 4000, disodium edetate, sodium hydroxide (for pH adjustment), water for injections.

Appearance of the medicine and contents of the pack

This medicine is presented as eye drops in solution, in single-dose containers. The solution is slightly yellowish and opalescent, preservative-free, contained in single-dose units packed inside a pouch containing 5 or 10 units. Each single-dose container contains 0.2 ml of eye drop solution.

Cartons contain 5 (1 x 5), 10 (2 x 5), 10 (1 x 10), 30 (6 x 5), 30 (3 x 10), 90 (18 x 5) or 90 (9 x 10) single-dose containers.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer

EXCELVISION
27, rue de la Lombardière
ZI la Lombardière
07100 ANNONAY
FRANCE

OR

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

OR

LABORATOIRE UNITHER
1 rue de l’Arquerie 50200 Coutances
FRANCE

OR

FAREVA Mirabel
Route de Marsat
Riom
63693 Clermont-Ferrand Cedex 9
FRANCE

Local representative

LABORATORIOS THEA, S.A.
C/ Enric Granados, nº 86-88, 2ª planta
08008 – Barcelona
SPAIN

This medicine is authorised 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, Latvia, Luxembourg, Norway, Poland, Portugal, Sweden:
Monoprost

Ireland:
Monopost Unidose

Austria, Slovenia, Lithuania, Czech Republic, Slovakia, United Kingdom, Romania:
Monopost

Estonia:
Monopro

Date of the most recent review of this leaflet: May 2025