Package Leaflet: Information for the User

Monoprost 50 micrograms/mL eye drops in single-dose solution

Latanoprost

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

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. Storage of Monoprost

6. Contents of the pack and additional information

Monoprostbelongs to a group of medications known as prostaglandins. It works by increasingthe natural flow of fluid from the inside of the eye to the bloodstream.

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

Do not use Monoprost

• If you are allergic (hypersensitive) to latanoprost or to any of the other components of this medication (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 affect you:

• If you have had or are going 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 use contact lenses. You may continue to use Monoprost, but you must follow the instructions included in section 3 for contact lens users.
• If you have had or are having a viral eye infection caused by the herpes simplex virus (HSV).

Children

Monoprost has not been investigated in children (under 18 years).

Use of Monoprost with other medications

Monoprost may interact with other medications.Inform your doctor or pharmacist that you are using, have used recently or may need to use any other medication.

Pregnancy and breastfeeding

Do not use Monoprostif you are pregnantorbreastfeeding.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

When using Monoprost, 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.

Important information about one of the components of Monoprost.

Monoprost containshydroxyestearate of macrogolglycerol (derived from ricin oil) , which may cause allergic reactions.

Usual Dose

Users of Contact Lenses

If you use contact lenses, you must remove them before using Monoprost. After applying Monoprost, wait 15 minutes before putting your contact lenses back.

Usage Instructions

The eye drop is supplied in single-dose containers. The solution of a single-dose container of Monoprost must be used immediately after its first opening to treat the affected eye(s). Since the sterility cannot be guaranteed after the opening of each single-dose container, a new container must be opened before each use, which must be discarded immediately after administration.

To use the eye drop, please follow these instructions:

1. Wash your hands and sit or stand comfortably.

2. Open the package containing the single-dose containers. Note the date of the first opening on the package.

3. Separate a single-dose container from the strip.

4.Turn the tip of the single-dose container as shown. Do not touch the tip after opening the container.

5. Using your finger, gently separate the lower eyelid of the affected eye.

6.Place the tip of the single-dose container near the eye, but without touching it.

7. Press gently the single-dose container so that only one drop falls into the eye and thenremove your finger from the lower eyelid.

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

9.Repeat the procedure in the other eye, if your doctor has indicated. Each single-dose container contains sufficient quantity for both eyes.

10. After using it, discard the single-dose container. Do not store it for reuse. Since the sterility of the single-dose container cannot be guaranteed after its opening, a new container must be opened before each use.

Using Monoprost with Other Eye Drops

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

Using More Monoprost than Prescribed

If more drops have been applied to the eye than prescribed, you may feel a slight irritation in the eye and also the eyes may become red and tear; this situation should disappear, but if you are concerned, contact your doctor.

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

Missing a Dose

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 Monoprost

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

If you have any other doubts about the use of thismedication, ask your doctor,pharmacistor nurse.

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

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

Very common: mayaffect 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) it is more likely that you will see 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 can usually be seen at 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 the development of any problems.
  • The change in eye color does not progress once treatment with Monoprost has been suspended.

• Redness of the eye.
• Ocular irritation (sensation of burning, sensation of sand in the eye, itching, pain, and sensation of a foreign body in the eye).

• Gradual change in the eyelashes of the treated eye and the fine hair around the treated eye, observed in the majority of patients of Japanese origin. These changes include an increase in color (darkening), lengthening, thickening, and an increase in the number of eyelashes.

Common: mayaffect up to 1 in 10 patients

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

Uncommon: mayaffect up to 1 in 100 patients

• 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), 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: mayaffect up to 1 in 1,000 patients

• Inflammation of the iris (iritis), symptoms of swelling or damage to the surface of the eye, swelling around the eye (periorbital edema), eyelashes deviated or additional row of eyelashes, 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: mayaffect up to 1 in 10,000 patients

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 for the Pharmacovigilance of Medicines for Human Use: https//: notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, overwrap, and on the single-dose container. The expiration date is the last day of the month indicated.

Store below25°C.

After the first opening of the overwrap: use the single-dose containers within the 10 days following.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at thePHARMACYTAKE-BACKpoint. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofMonoprost

The active ingredient islatanoprost.

1 ml of eye drops contains 50 micrograms of latanoprost.

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

Appearance of the product and contents of the package

This medication is presented as an eye drop solution, in single-dose containers. The solution is slightly yellow and opalescent, without preservatives, contained in single-dose containers, presented in the interior of a package with 5 or 10 units. Each single-dose container contains 0.2 ml of eye drop solution.

The boxes contain 5 (1 x 5), 10 (2 x 5), 10 (1X10), 30 (6 x 5), 30 (3X10), 90 (18 x 5) or 90 (9X10) single-dose containers.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratoires Thea

12 RUE LOUIS BLERIOT

63017 CLERMONT-FERRAND CEDEX 2

FRANCE

Responsible for manufacturing

Excellvision

27, rue de la Lombardière

ZI la Lombardière

07100 ANNONAY

FRANCE

O

Laboratoires Thea

12 RUE LOUIS BLERIOT

63017 CLERMONT-FERRAND CEDEX 2

FRANCE

O

Lab Unithe

1 rue de l’Arquerie50200 Coutances

FRANCE

Local representative

Laboratorios Thea, S.A.

C/ Enric Granados, nº 86-88, 2nd floor

08008 – Barcelona

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

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

Monoprost

IrelandMonopost Unidose

Austria, Slovenia, Lithuania, Czech Republic, Slovak Republic, United Kingdom, Romania

Monopost

Estonia…………………………………………………………………………………Monopro

Date of the last review of this leaflet: February 2024