Monoprost

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

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

Latanoprost
Please read this leaflet carefully before 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 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 prostaglandines. 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 glaucoma and ocular hypertension.
Both of these conditions are associated with increased pressure inside your eye, which may 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 any of the
following apply to you:

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

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

Other medicines and MONOPROST
MONOPROST may interact with other medicines. Consult your doctor or pharmacist if you are taking, have
recently taken, or might take any other medicines.

Pregnancy, breast-feeding and fertility
Do not use MONOPROST during pregnancy or while breast-feeding.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breast-feeding,
please consult your doctor or pharmacist before using this medicine.

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

Important information on excipients in MONOPROST
MONOPROST contains macrogol glycerol hydroxystearate (derived from castor oil), which may cause
skin reactions.

3. HOW TO USE MONOPROST

Recommended dose

• Always use MONOPROST exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
• The usual dose for adults (including elderly patients) is one drop once daily in the affected eye(s), preferably in the evening.
• Do not use MONOPROST more than once a day, as the effectiveness of treatment may be reduced if administered more frequently.
• Use MONOPROST as described in this leaflet or strictly follow your doctor’s instructions, until your doctor tells you to stop. If you have any doubts, consult your doctor, pharmacist, or nurse.

Contact lens wearers
If you wear contact lenses, you must remove them before using MONOPROST. After administering MONOPROST, wait 15 minutes before reinserting your contact lenses.

Instructions for use
The eye drops come in single-dose containers. The solution from each single-dose container of MONOPROST must be used immediately after opening and instilled into the affected eye(s).
Since sterility cannot be maintained after opening the single-dose container, a new container must be opened before each administration and must be discarded immediately after use.

Follow these instructions to apply the drops:

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

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

6. Repeat the procedure in the other eye if your doctor has instructed you to do so.
7. Discard the single-dose container after use. Do not save it for later use.

If you use MONOPROST with other eye drops
Wait at least 5 minutes between administering MONOPROST and any other eye drop.

If you use more MONOPROST than you should
If you have instilled too many drops into your eye, mild eye irritation may occur, and your eyes may water or become red. This should resolve on its own. However, if you are concerned, seek advice from your doctor.
Contact your doctor immediately if you have accidentally swallowed MONOPROST.

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

If you stop using MONOPROST
You should speak with your doctor before stopping treatment with MONOPROST.

If you have any doubts about how to use MONOPROST, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Below are the known adverse reactions associated with the use of MONOPROST:

Very common: may affect more than 1 in 10 people

• Gradual change in eye colour due to increased brown pigment in the coloured part of the eye (iris).

• If your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown), these changes may be more noticeable than in people with uniformly coloured eyes (blue, grey, green or brown).

• All changes in eye pigmentation may take years to develop, although they usually occur within 8 months of treatment.

• The change in eye colour may be permanent and may become more apparent if you use MONOPROST in only one eye.

• There appear to be no health problems associated with the colour change.

• The change in eye pigmentation does not continue after stopping treatment with MONOPROST.

• Eye redness.

• Eye irritation (burning sensation, gritty feeling, itching, stinging pain, foreign body sensation).

• Gradual changes in the eyelashes of the treated eye and surrounding hair, observed mainly in Japanese subjects. These changes include increased pigmentation (darkening), length, thickness and number of eyelashes.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• Eyelid swelling, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), retinal swelling (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 eye surface, swelling around the eye area (periorbital edema), abnormally directed eyelashes or an extra row of eyelashes, fluid-filled cyst in the coloured part of the eye (iris cyst).
• Skin reaction on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Severe skin itching.
• Development of viral eye infections caused by herpes simplex virus (HSV).

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

• Worsening of angina in patients with underlying heart disease.
• Sunken appearance of the eye (enophthalmos).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse reactions, 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 stated on the carton, sachet, and single-dose container.
The expiry date refers to the last day of that month.
Store 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 container immediately and discard it after use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What MONOPROST contains
The active substance is latanoprost.
1 ml of eye drops solution contains 50 micrograms of latanoprost.
The other components are: macrogol glycerol hydroxystearate 40, sorbitol, carbomer 974P, macrogol 4000,
disodium edetate, sodium hydroxide (to adjust pH), water for injections.

Description of the appearance of MONOPROST and pack contents
This medicine is an eye drop solution in single-dose containers. The solution is slightly yellow and opalescent, without preservatives, supplied in single-dose containers packed in foil sachets of 5 units. Each single-dose container contains 0.2 ml of product.
A 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 medicine is authorised in the European Economic Area countries 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, United Kingdom, 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]

PACKAGE LEAFLET: INFORMATION FOR THE USER

MONOPROST 50 micrograms/ml eye drops, solution

Latanoprost
For the pack containing 1 bottle of 2.5 ml only: Equivalent medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 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 prostaglandines. It lowers the pressure inside your 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 of these conditions are associated with increased pressure inside your eye, which may damage your vision.
MONOPROST is a preservative-free eye drop solution.

2. WHAT YOU SHOULD 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 any of the following
conditions apply to you:

• If you are about to undergo or have previously undergone eye surgery (including cataract surgery).
• If you have eye problems (such as eye pain, irritation or inflammation, blurred vision).
• If you know you suffer from dry eye.
• If you have severe asthma or your asthma is not well controlled.
• If you wear contact lenses. You may use MONOPROST, but follow the instructions for contact lens wearers provided in section 3.
• If you have previously or are currently suffering from a viral eye infection caused by 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 may interact with other medicines. Inform your doctor or pharmacist if you are taking, have
recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Do not use MONOPROST during pregnancy or while breastfeeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and use of machinery
After administration of MONOPROST, blurred vision may occur for a short period of time. If this happens to you, do not drive or operate tools and machines until your vision has returned to normal.
Important information about some of the excipients in MONOPROST
MONOPROST contains macrogol glycerol hydroxystearate (derived from castor oil) which may cause
skin reactions.

3. HOW TO USE MONOPROST

Recommended dosage

• Always use MONOPROST exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
• The usual dosage for adults (including elderly patients) is one drop once daily in the affected eye(s). The best time to administer the dose is in the evening.
• Do not use MONOPROST more than once a day, as the effectiveness of treatment may be reduced if administered more frequently.
• Always use MONOPROST exactly as described in this leaflet or as directed by your doctor, until your doctor tells you otherwise. If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine is an eye drop solution, preservative-free. Do not let the tip of the container touch the eye or surrounding areas. The tip of the container may become contaminated with bacteria that could cause serious eye infections, potentially leading to vision loss. To avoid possible contamination of the bottle, keep the bottle tip away from contact with any surface.

Contact lens wearers
If you wear contact lenses, you must remove them before using MONOPROST. After using MONOPROST, you must wait 15 minutes before reinserting your lenses.
Instructions for use
It is very important to follow the instructions below when using this product:

	Before using the medicine for the first time: -Check that the tamper-evident seal is intact. Then unscrew the tamper-evident seal firmly to open the bottle. -Wash your hands thoroughly and remove the cap from the tip of the bottle. Press several times with the bottle inverted to prime the pump mechanism until the first drop appears. This procedure is only required for the first use 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 any contact between the tip of the bottle and your fingers.
	2. Place your thumb on the tab at the top of the bottle and your index finger at the base of the bottle. Then place your middle finger on the second tab at the base of the bottle. Hold the bottle inverted.
	3. To use, tilt your head slightly backward and hold the dropper bottle vertically above the 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 tip of the bottle and your fingers or eyes. To administer one drop into the lower conjunctival sac of the affected eye(s), press the bottle briefly and firmly. The automatic dispenser releases exactly one drop with each press.
If the drop does not come out, gently tap the bottle to dislodge any drop remaining at the tip. In this case, repeat step 3.
	4. Close your eyelids and press with one finger at the inner corner of the eye, near the nose, for 1 minute. This helps prevent the eye drops from spreading into the rest of the body.
	5. Immediately after use, replace the cap securely on the tip of the bottle.

If you use MONOPROST together with other eye drops
Wait at least 5 minutes between the administration of MONOPROST and other eye drops.
If you use more MONOPROST than you should
If you have instilled too many drops into the eye, mild eye irritation may occur, and your eyes may water or become red. This should resolve on its own, but if you are concerned, consult your doctor.
Contact your doctor immediately if you have accidentally swallowed MONOPROST.
If you forget to use MONOPROST
Continue with your usual dose at the regular 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 using MONOPROST
You should speak with your doctor if you wish to discontinue the use of MONOPROST.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
The following are the adverse reactions known to occur 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 brown pigment in the coloured part of the eye, known as the iris.
• If your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to notice these changes compared to people with uniformly coloured eyes (blue, grey, green or brown eyes).
• All changes in eye colour may take years to develop, although they usually occur within 8 months of treatment.
• The change in eye colour 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 change in eye colour.
• The change in eye colour does not continue after stopping treatment with MONOPROST.
• Eye redness.
• Eye irritation (burning sensation, gritty feeling, itching, stinging pain, foreign body sensation in the eye).
• A gradual change in the eyelashes of the treated eye and surrounding hair, mainly observed in Japanese subjects. These changes include increased pigmentation (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, light sensitivity (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 around the eye area (periorbital edema), abnormally directed eyelashes or an additional row of eyelashes, fluid-filled area within the coloured part of the eye (iris cysts).
• Skin reaction on the eyelids, darkening of the skin of the eyelids.
• Worsening of asthma.
• Severe itching of the skin.
• 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 adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, 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 stated on the carton and on the bottle. The expiry date refers to the last day of that month.
Before opening: do not store above 25°C.
After first opening: MONOPROST may be used for 1 month for the 2.5 ml bottle and for 3 months for the 6 ml bottle, without any special storage conditions.
Write the date of first opening on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

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

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

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

Not all pack sizes may be marketed.

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Italy, Luxembourg, the 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 (Agenzia Italiana del Farmaco)