Monoprost

Package Leaflet: Information for the Patient

MONOPROST, 50 micrograms/ml, eye drops, solution

Latanoprost

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Monoprost and what is it used for
• 2. Important information 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 IS MONOPROST AND WHAT IS IT USED FOR

Monoprost belongs to a group of medicines known as prostaglandins. The medicine lowers the pressure in the eye by increasing the natural outflow of aqueous fluid from the eye into the bloodstream. Monoprost is used to treat a condition called open-angle glaucomaand a condition called ocular hypertensionin adults. Both conditions are associated with increased pressure in the eye and can affect vision. Monoprost is an eye drop solution without preservatives.

2. IMPORTANT INFORMATION BEFORE USING MONOPROST

When not to use Monoprost

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

Warnings and precautions

Before starting to use Monoprost, tell your doctor, pharmacist, or nurse if you have any of the following:

• If you have had eye surgery (including cataract surgery) or if it is planned.
• If you have eye problems (such as eye pain, inflammation, or irritation, blurred vision).
• If you have severe or uncontrolled asthma.
• If you wear contact lenses. You can use Monoprost, but follow the instructions for contact lens wearers in section 3.
• If you have had a viral infection of the eye caused by the Herpes simplexvirus (HSV).

Children

Do not give this medicine to children and adolescents under 18 years old, as there is no experience with the use of Monoprost in this age group.

Monoprost and other medicines

Monoprost may interact with other medicines. Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

Do not use Monoprostduring pregnancy or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

While using Monoprost, you may experience temporary blurred vision. If this happens, do not driveor operate machinery until the vision returns to normal.

Important information about some ingredients of Monoprost

Monoprost contains macrogolglycerol hydroxystearate 40 (derived from castor oil), which may cause skin reactions.

3. HOW TO USE MONOPROST

Normally used dose

• Always use Monoprost exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
• The recommended dose for adults (including the elderly) is one drop into the affected eye(s) once daily. The best time to administer the dose is in the evening.
• Do not use Monoprost more than once a day, as this may reduce the effect of the treatment.
• Use Monoprost exactly as described in this leaflet or as your doctor has told you, for as long as your doctor recommends. If you are not sure, ask your doctor, pharmacist, or nurse.
• This medicine is a solution for eye drops without preservatives. Do not touch the tip of the bottle (dropper) to the eye or its surroundings. This may lead to contamination with bacteria, which can cause eye infection leading to serious damage to the eye, even loss of vision. To avoid possible contamination of the bottle, keep the tip away from any surface.

For people wearing contact lenses

If you wear contact lenses, remove them before using Monoprost. Wait 15 minutes after using Monoprost before putting your contact lenses back in.

Instructions for use

It is important to follow these instructions when administering the medicine:

	Before using the medicine for the first time: Check that the protective cap is intact. Then, screw off the protective cap to open the bottle. Wash your hands thoroughly and remove the cap from the tip of the bottle. Press the bottle with the dropper down several times to activate the pump mechanism until the first drop appears. This procedure only applies to the first use of the medicine and is not necessary for subsequent administrations.
	1. Before each use, wash your hands thoroughly and remove the cap from the tip of the bottle. Avoid touching the tip of the bottle with your fingers.
	2. Place your thumb on the tab on top of the bottle and your index finger on the base of the bottle. Then, place your middle finger on the second tab at the base of the bottle. Hold the bottle upright with the bottom facing up.
	3. To administer the drop, tilt your head slightly back and hold the bottle with the dropper facing down vertically over the eye. With the index finger of your other hand, gently pull the lower eyelid down. The space created is called the lower conjunctival sac. Avoid touching the tip of the bottle with your fingers or eyes. To release a drop into the lower conjunctival sac of the affected eye(s), squeeze the bottle briefly and firmly. Due to the automatic dosing, a drop is released precisely with each pumping.
If a drop does not fall, gently shake the bottle to remove the drop remaining on the tip. In this case, repeat step 3.
	4. Close your eyelids and press the inner corner of your eye near your nose for 1 minute. This helps prevent the medicine from entering the entire body.
	5. Immediately after use, put the cap back on the tip of the bottle.

Using Monoprost with other eye drops

If you are using other eye drops, wait at least 5 minutes between administering Monoprost and the other eye drops.

Using a higher dose of Monoprost than recommended

If you accidentally use more eye drops than recommended, you may experience moderate eye irritation with redness and tearing. These symptoms should resolve on their own, but if you are concerned, you should consult your doctor for advice. If you accidentally swallow Monoprost, contact your doctor immediately.

Missing a dose of Monoprost

Take the dose at the usual time. Do not take a double dose to make up for a missed dose. If you are unsure, ask your doctor or pharmacist.

Stopping the use of Monoprost

If you want to stop using Monoprost, consult your doctor. If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Monoprost can cause side effects, although not everybody gets them. The following side effects are known to occur with Monoprost:

Very common: may affect more than 1 in 10 people

• Gradual change in eye color due to increased brown pigment in the colored part of the eye called the iris.
• This effect is more frequently observed in patients with mixed-colored irises (blue-brown, gray-brown, yellow-brown, or green-brown) than in patients with uniformly colored eyes (blue, gray, green, or brown).
• The change in eye color may take years to develop, but it is usually visible within 8 months of treatment.
• The change in eye color may be permanent and may be more noticeable if Monoprost is administered to only one eye.
• No symptoms have been associated with the change in iris pigmentation.
• The change in iris pigmentation has not been found to progress after discontinuation of Monoprost treatment.
• Eye redness.
• Eye irritation (feeling of burning, grittiness, itching, stinging, or the sensation of something in the eye).
• Gradual change in the appearance of eyelashes and vellus hairs in the treated eye (especially in patients of Japanese descent). These changes include increased pigmentation (darkening), length, thickness, and number of eyelashes.

Common: may affect up to 1 in 10 people

• Eye irritation and surface disorders, blepharitis, eye pain, sensitivity to light (photophobia), conjunctivitis.

Uncommon: may affect up to 1 in 100 people

• Eyelid swelling, dry eye, inflammation or irritation of the eye surface (cornea), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the macula (macular edema).
• Skin rash.
• Chest pain (angina pectoris), awareness of heartbeat (palpitations).
• Asthma, shortness of breath (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

Rare: may affect up to 1 in 1,000 people

• Iritis, symptoms of swelling or sensation of scratching/damage to the eye surface, swelling around the eyes (periorbital edema), changes in the direction of eyelash growth or the appearance of a double row of eyelashes, accumulation of fluid within the colored part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Severe itching of the skin.
• Development of a viral infection of the eye caused by the Herpes simplexvirus (HSV).

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

• Worsening of angina pectoris in patients with a history of this condition.
• Appearance of sunken eyes (deepening of the eyelid sulcus).

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products – Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MONOPROST

Keep the 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 that month. Before the first opening of the bottle: do not store above 25°C. After the first opening of the bottle: Monoprost can be used for 1 month in a 2.5 ml bottle and for 3 months in a 6 ml bottle, without special storage recommendations. Write the date of the first opening on the carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Monoprost contains

The active substance is latanoprost. 1 ml of eye drops contains 50 micrograms of latanoprost. The other ingredients are: macrogolglycerol hydroxystearate 40, sorbitol, carbomer 974P, macrogol 4000, disodium edetate, sodium hydroxide (for pH adjustment), water for injections.

What Monoprost looks like and contents of the pack

Monoprost is a light yellow, opalescent solution without preservatives. Monoprost is available in the following pack sizes:

• bottle of 2.5 ml (at least 70 drops without preservatives), for 1 month of treatment, with a pump and cap made of HDPE with a tamper-evident closure, placed in an Easygrip system, in a cardboard box.
• bottle of 6 ml (at least 190 drops without preservatives), for 3 months of treatment, with a pump and cap made of HDPE with a tamper-evident closure, placed in an Easygrip system, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

Manufacturer:

DELPHARM TOURS
Rue Paul Langevin
37170 Chambray Les Tours
France
Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

For further information, please contact the marketing authorization holder:

Thea Polska Sp. z o.o.
ul. Cicha 7
00-353 Warsaw
Tel. +48 22 642 87 77

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

Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Spain, Netherlands, Iceland, Luxembourg, Germany, Norway, Poland, Portugal, Sweden, Italy ................................ Monoprost
Austria, Czech Republic, Romania, Slovakia, Slovenia ....................................................................... Monopost

Date of last revision of the leaflet: 09-02-2024

Detailed information on this medicinal product is available on the website of the Agency for Medicinal Products, Medical Devices, and Biocidal Products.