MONOPROST 50 MICROGRAMMI/ML Eye drops, solution

Зміст інструкції

1. MONOPROST 50 micrograms/ml eye drops, solution in single dose container
   1. WHAT IS MONOPROST 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. PACKAGE CONTENTS AND OTHER INFORMATION
2. MONOPROST 50 micrograms/ml eye drops, solution
   1. WHAT IS MONOPROST 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. PACKAGE CONTENTS AND OTHER INFORMATION

MONOPROST 50 micrograms/ml eye drops, solution in single dose container

Latanoprost

Read this leaflet carefully before you start using this medicine as 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet:
• 1. What MONOPROST is and what it is used for
• 2. What you need to know before you use 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 IT IS USED FOR

MONOPROST belongs to a group of medicines known as prostaglandins. It lowers the pressure
inside your eye by increasing the natural outflow of fluid from the eye into the bloodstream.
MONOPROST is used to treat conditions known as open-angle glaucomaand ocular hypertension
. Both of these conditions are related to an increase in pressure inside your eye, which
could damage your 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 you think that any of the
following conditions apply to you:

• If you are about to have or have had eye surgery (including cataract surgery).
• If you suffer from eye problems (such as eye pain, irritation or inflammation, blurred vision).
• If you know you suffer from dry eyes.
• If you suffer from severe asthma or your asthma is not well controlled.
• If you wear contact lenses. You can use MONOPROST, but follow the instructions for contact lens wearers in section 3.
• If you have suffered or are suffering from a viral eye infection caused by the herpes simplex virus (HSV).

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

Other medicines and MONOPROST
MONOPROST can interact with other medicines. Tell your doctor or pharmacist if you are using, have
recently used or might use any other medicine.

Pregnancy, breastfeeding and fertility
Do not use MONOPROSTif you are pregnant or if you are breastfeeding.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Blurred vision may occur for a
short period of time after administering MONOPROST. If this happens to you, wait until your vision has returned to normal
before driving vehicles or using tools and machinery.

Important information about the excipients of MONOPROST
MONOPROST contains macrogolglycerol hydroxystearate (derived from castor oil) which may cause
skin reactions.

3. HOW TO USE MONOPROST

Usual dosage

• Use MONOPROST always following exactly the doctor's instructions. If you have doubts, consult your doctor or pharmacist.
• The usual dosage for adults (including the elderly) is one drop, once a day in the affected eye(s). Preferably in the evening.
• Do not use MONOPROST more than once a day, because the effectiveness of the treatment may be reduced if it is administered more frequently.

doctor's instructions, until the doctor tells you to stop. If you have doubts
consult your doctor, pharmacist or nurse.

Contact lens wearers
If you use contact lenses, you must remove them before using MONOPROST. After using MONOPROST you must
wait 15 minutes before putting the lenses back in.

Instructions for use
The eye drops are presented in single-dose containers. The solution of each single-dose container of
MONOPROST must be used immediately after opening and administered to the affected eye(s).
Because sterility cannot be maintained after opening the single-dose container, it is necessary to open a
new container before each administration and it must be discarded immediately afterwards.
Follow these instructions to use the drops:

• 1. Wash your hands and sit or lie down comfortably.
• 2. Gently lower the lower eyelid of the affected eye using a finger.
• 3. Bring the opening of the single-dose container to the eye, but without touching it.
• 4. Gently compress the single-dose container so that only one drop falls into the eye, then release the lower eyelid.

• 5. Press a finger on the corner of the affected eye, near the nose, for 1 minute keeping the eye closed.

• 6. Repeat the operation in the other eye if your doctor has told you to do so.
• 7. Dispose of the single-dose container after use. Do not keep the container for further use.

If you use MONOPROST together with other eye drops
Wait at least 5 minutes between the administration of MONOPROST and that of another eye drop.

If you use more MONOPROST than you should
If you have put too many drops in your eye, mild irritation in your eye may occur and your eyes
may water or become red. This should resolve, but if you are worried ask for advice from your
doctor.
Contact your doctor immediately if you have accidentally ingested MONOPROST.

If you forget to use MONOPROST
Continue with the usual dose at the usual time. Do not use a double dose to make up for forgetting a
dose. If you are unsure about anything, ask your doctor or pharmacist.

If you stop using MONOPROST
You must talk to your doctor if you want to stop using MONOPROST.
If you have any doubts about the use of MONOPROST, ask your doctor or pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are listed the known side effects for the use of MONOPROST:

Very common: may affect more than 1 in 10 people

• A gradual change in the color of your eye due to an increase in the amount of brown pigment in the colored part of the eye, known as the iris.
• If your eyes have a mixed coloration (blue-brown, grey-brown, yellow-brown or green-brown) you will more easily notice these changes compared to those with eyes of a single color (blue, grey, green or brown eyes).
• Any changes in eye color may take years to develop although they usually occur within 8 months of treatment.
• The change in coloration may be permanent and may be more noticeable if you use MONOPROST in only one eye.
• There appear to be no problems associated with the color change.
• The change in eye color does not continue after stopping treatment with MONOPROST.
• Redness of the eye.
• Eye irritation (burning sensation, gritty feeling, itching, stinging pain and foreign body sensation).
• A gradual change in the eyelashes of the treated eye and the hairs around it, observed mainly in subjects of Japanese origin. These changes include an increase in color (darkening), length, thickness and number of eyelashes.

Common: may affect up to 1 in 10 people

• Irritation or damage to the surface of the eye, inflammation of the eyelids (blepharitis), eye pain, sensitivity to light (photophobia), conjunctivitis.

Uncommon: may affect up to 1 in 100 people

• 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), awareness of heartbeat (palpitations).
• Asthma, shortness of breath (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.

Rare: may affect up to 1 in 1000 people

• Inflammation of the iris, (iritissymptoms of swelling or erosion/damage to the surface of the eye, swelling in the area around the eye (periorbital edema), eyelashes with abnormal direction or an extra row of eyelashes fluid-filled area inside the colored part of the eye (iris cyst).
• Skin reaction on the eyelids, darkening of the skin of the eyelids.
• Worsening of asthma.
• Severe skin itching
• development of viral infections in the eye caused by the herpes simplex virus (HSV).

Very rare: may affect up to 1 in 10000 people

• Worsening of angina in patients who also have heart disease.
• Appearance of a sunken eye (hollowing of the eye socket).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE MONOPROST

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, on the sachet and on the single-dose container.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
After first opening of the sachet: use the single-dose containers within 7 days.
After first opening of the single-dose container: use the single-dose container immediately and dispose of it
after use.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

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

Description of the appearance of MONOPROST and package contents
This medicine is an eye drop, solution in single-dose containers. The solution is slightly
yellow and opalescent without preservatives, presented in single-dose containers packaged in a bag of 5
units, each single-dose container containing 0.2 ml of product.
One pack contains 5 (1 x 5), 10 (2 x 5), 30 (6 x 5) or 90 (18 x 5) single-dose containers.
Not all 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 LOMBARDIERE
ZI LA LOMBARDI É RE
07100 ANNONAY
FRANCE
Or
LABORATOIRES THEA
12, RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
FRANCE

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Italy, Latvia,
Luxembourg, Netherlands, Norway, Poland, Portugal, Spain, Sweden: ........................................Monoprost
Ireland: ........................................................................................................................Monopost Unidose
Austria, Czech Republic, Lithuania, Great Britain, Romania, Slovak Republic, Slovenia: ...... Monopost
This leaflet was last approved on:
Detailed information on this medicine is available on the website of the [MA/Agency]

MONOPROST 50 micrograms/ml eye drops, solution

Latanoprost
Only for the 1 bottle of 2.5 ml pack: Generic medicine

Read this leaflet carefully before you start using this medicine as 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 be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What MONOPROST is and what it is used for
• 2. What you need to know before you use 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 IT IS USED FOR

MONOPROST belongs to a group of medicines known as prostaglandins. It lowers the pressure
inside your eye by increasing the natural outflow of fluids from inside the eye to the bloodstream.
MONOPROST is used to treat conditions known as open-angle glaucomaand ocular hypertension
in adults. Both of these conditions are related to an increase in pressure inside your
eye, which could damage your vision.
MONOPROST is an eye drop, solution, without preservative.

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 you think that any of the following
conditions apply to you:

• If you are about to have or have had eye surgery (including cataract surgery).
• If you suffer from eye problems (such as eye pain, irritation or inflammation, blurred vision).
• If you know you suffer from dry eyes.
• If you suffer from severe asthma or your asthma is not well controlled.
• If you wear contact lenses. You can use MONOPROST, but follow the instructions for contact lens wearers in section 3.
• If you have suffered or are currently suffering from a viral eye infection caused by the herpes simplex virus (HSV).

Children
Do not give this medicine to children under 18 years of age. MONOPROST has not been studied in
this population.

Other medicines and MONOPROST
MONOPROST can interact with other medicines. Tell your doctor or pharmacist if you are using, have
recently used or might use any other medicine.

Pregnancy, breastfeeding and fertility
Do not use MONOPROSTif you are pregnant or if you are breastfeeding.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Blurred vision may occur for a
short period of time after administering MONOPROST. If this happens to you, do not drive vehiclesor use tools and machinery until
your vision returns to normal.

Important information about some of the excipients of MONOPROST
MONOPROST contains macrogolglycerol hydroxystearate (derived from castor oil) which may cause
skin reactions.

3. HOW TO USE MONOPROST

Usual dosage

• Use MONOPROST always following exactly the doctor's instructions. If you have doubts, consult your doctor or pharmacist.
• The usual dosage for adults (including the elderly) is one drop, once a day in the affected eye(s). The best time to do this is in the evening.
• Do not use MONOPROST more than once a day, because the effectiveness of the treatment may be reduced if it is administered more frequently.

exactly the doctor's instructions, until the doctor tells you to stop. If you have
doubts, consult your doctor, pharmacist or nurse.

• This medicine is an eye drop, solution, without preservative. Do not allow the tip of the container to touch the eye or the areas around the eye. The tip of the container could become contaminated with bacteria that can cause serious eye infections with severe damage, up to loss of vision. To avoid possible contamination of the bottle, keep the tip of the bottle away from contact with any surface.

Contact lens wearers
If you use contact lenses, you must remove them before using MONOPROST. After using MONOPROST you must
wait 15 minutes before putting the lenses back in.

Instructions for use
It is very important to follow the following instructions when using the product:

	o Before using the medicine for the first time: c Check that the guarantee seal is not broken. Then unscrew the guarantee seal firmly to open the bottle. m Wash your hands thoroughly and remove the cap from the tip of the bottle. Press several times with the bottle upside down, to activate the pump mechanism until the first drop appears. This procedure is only for the first use and is not necessary for subsequent administrations.
	a F 1. Before each use, wash your hands thoroughly and remove the cap from the tip of the bottle. Avoid any contact of the bottle tip with your fingers. l
	e d 2. 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.
	n 3. To use, tilt your head slightly backwards and hold the bottle with the dropper vertical above the eye. With the index finger of the other hand, lower the lower eyelid of the eye slightly. The space created is called the inferior conjunctival sac. Avoid contact of the bottle tip with your fingers and eyes. To administer a drop into the inferior conjunctival sac of the affected eye(s) (s), press the bottle briefly and firmly. The automatic dispenser releases exactly one drop with each press.
a t If the drop does not come down, gently shake the bottle to remove the drop remaining on the tip. In this case, repeat point 3.
	I a 4. Close your eyelids and press with a finger at the inner corner of the eye, near the nose, for 1 minute. This helps to prevent the spread of the eye drops throughout the body. z
	5. Close the tip of the bottle with the cap immediately after use.

If you use MONOPROST together with other eye drops
Wait at least 5 minutes between the administration of MONOPROST and that of other eye drops.

If you use more MONOPROST than you should
If you have put too many drops in your eye, mild irritation may occur in your eye and your eyes
may water or become red. This should resolve, but if you are worried, ask for advice from your
doctor.
Contact your doctor immediately if you have accidentally swallowed MONOPROST.

If you forget to use MONOPROST
Continue with the usual dose at the usual time. Do not use a double dose to make up for the missed dose. If you are unsure about anything, consult your doctor or pharmacist.

If you stop the treatment with MONOPROST
You must talk to your doctor if you want to stop using MONOPROST.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are listed the known side effects associated with the use of MONOPROST:

Very common: may affect more than 1 in 10 people

• A gradual change in the colour of your eye due to an increase in the amount of brown pigment in the coloured part of the eye, known as the iris.
• If your eyes have a mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) you will more easily notice these changes compared to those with eyes of a single colour (blue, grey, green or brown eyes).
• Any changes in eye colour may take years to develop, although they usually occur within 8 months of treatment.
• The change in colour may be permanent and may be more noticeable if you use MONOPROST in only one eye.
• There do not appear to be any problems associated with the change in eye colour.
• The change in eye colour does not continue after stopping treatment with MONOPROST.
• Redness of the eye.
• Eye irritation (burning sensation, gritty sensation, itching, stinging pain and feeling of something in the eye).
• A gradual change in the eyelashes of the treated eye and the hairs around it, observed mainly in subjects of Japanese origin. These changes include an increase in colour (darkening), length, thickness and number of eyelashes.

Common: may affect up to 1 in 10 people

• Irritation or damage to the surface of the eye, inflammation of the eyelids (blepharitis), eye pain, sensitivity to light (photophobia), conjunctivitis.

Uncommon: may affect up to 1 in 100 people

• Swelling of the eyelids, dry eye, inflammation or irritation of the surface of the eye (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, shortness of breath (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.

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

• Inflammation of the iris (iritis, symptoms of swelling or erosion/damage to the surface of the eye, swelling in the area around the eye (periorbital edema), eyelashes with abnormal direction or an additional row of eyelashes, area filled with fluid inside the coloured part of the eye (iris cyst).
• Skin reaction on the eyelids, darkening of the skin of the eyelids.
• Worsening of asthma.
• Severe skin itching
• Development of viral infections in the eye caused by the herpes simplex virus (HSV).

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http:// www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE MONOPROST

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and the vial. The expiry date refers to the last day of that month.
Before opening: do not store at a temperature above 25°C.
After first opening: MONOPROST can be used for 1 month for the 2.5 ml vial and for 3 months
for the 6 ml vial, without any particular storage conditions.
Write the date of first opening on the package.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What MONOPROST contains
The active ingredient is latanoprost.
1 ml of eye drops solution 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.

Description of MONOPROST and package contents
MONOPROST is a slightly yellow and opalescent solution, without preservative.
MONOPROST is available in the following formats:

• Multidose bottle of 2.5 ml (at least 70 drops without preservative), for one month of treatment, with Easygrip pump and ergonomic supports.
• Multidose bottle of 6 ml (at least 190 drops without preservative), for 3 months of treatment, with Easygrip pump and ergonomic supports.

Not all 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
DELPHARM TOURS
RUE PAUL LANGEVIN
37170 CHAMBRAY LES TOURS
FRANCE
Or
LABORATOIRES THEA
12, RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
FRANCE

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Italy, Luxembourg, Netherlands,
Norway, Poland, Portugal, Spain, Sweden................................................................... Monoprost
Austria, Czech Republic, Romania, Slovak Republic, Slovenia ...............................................Monopost

This leaflet was last updated on:
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency