Skip to Content

LATANOPROST 50 MICROGRAMS/ML EYE DROPS SOLUTION IN SINGLE DOSE CONTAINER

Active substance(s): LATANOPROST / LATANOPROST

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PATIENT INFORMATION LEAFLET

2910
15.10.16[3]

Monopost 50 micrograms/ml eye drops,
solution in single dose container
(latanoprost)
This medicine is available using the above name but will be referred to as
Monopost throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, or 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 signs of illness are the same as
yours.
 If you get any side effects, talk to your doctor, or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
Section 4.
What is in this leaflet:
1. What Monopost is and what it is used for
2. What you need to know before you use Monopost
3. How to use Monopost
4. Possible side effects
5. How to store Monopost
6. Contents of the pack and other information
1. What Monopost is and what it is used for
Monopost belongs to a group of medicines known as prostaglandins. It
lowers the pressure within your eye by increasing the natural outflow of
fluid from inside the eye into the bloodstream.
Monopost is used to treat conditions known as open angle glaucoma and
ocular hypertension. Both of these conditions are linked with an increase
in the pressure within your eye, eventually affecting your eye sight.
2. What you need to know before you use Monopost
Do not use Monopost
 If you are allergic (hypersensitive) to latanoprost or any of the other
ingredients of this medicine (listed in section 6).
 If you are pregnant or trying to become pregnant.
 If you are breast feeding.
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before using Monopost if you
think any of the following 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 that you suffer from dry eyes.
 If you have severe asthma or your asthma is not well controlled.
 If you wear contact lenses. You can still use Monopost, but follow the
instruction for contact lens wearers in Section 3.
 If you have suffered or are currently suffering from a viral infection of
the eye caused by the herpes simplex virus (HSV).

Children
Monopost has not been investigated in children (below 18 years).
Other medicines and Monopost
Monopost may interact with other medicines. Tell your doctor or
pharmacist if you are using, have recently used or might use any other
medicines.
Pregnancy and breast-feeding
Do not use Monopost when you are pregnant or breast-feeding.
If you are pregnant or breast-feeding, 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
When you use Monopost you might have blurred vision, for a short time. If
this happens to you, do not drive or use any tools or machines until your
vision becomes clear again.
Important information about some of the ingredients of Monopost
Monopost contains macrogolglycerol hydroxystearate (derived from
castor oil) which may cause skin reactions.
3. How to use Monopost
Usual dose
 Always use Monopost exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
 The usual dose 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 Monopost more than once a day, because the effectiveness
of the treatment can be reduced if you administer it more often.
 Always use Monopost exactly as this leaflet tells you or as your doctor
has told you, until your doctor tells you to stop. Check with your doctor,
or pharmacist or nurse if you are not sure.

5. Press a finger against the corner of the affected eye by the nose. Hold
for 1 minute whilst keeping the eye closed.

Contact lens wearers
If you wear contact lenses, you should remove them before using
Monopost. After using Monopost you should wait 15 minutes before
putting your contact lenses back in.
Instructions for use
The drops are supplied in single-dose units. Use the solution from one
single dose unit for administration to the affected eye(s) immediately after
opening the container. Since sterility cannot be maintained after opening,
throw away the container immediately after using the solution. Open a
new single-dose unit each time you use Monopost.
These instructions tell you how to use the drops:
1. Wash your hands and sit or stand comfortably.
2. Use your finger to gently pull down the lower eyelid of your affected
eye.
3. Place the tip of the single-dose container close to, but not touching your
eye.
4. Squeeze the single-dose container gently so that only one drop goes
into your eye, then release the lower eyelid.

6. Repeat in your other eye if your doctor has told you to do this.
7. Throw away the single-dose container after use. Do not keep it to use it
again.
If you use Monopost with other eye drops
Wait at least 5 minutes between using Monopost and using other eye
drops.

If you use more Monopost than you should
If you put too many drops into your eye, you may have some minor
irritation in your eye and your eyes may water and turn red. This should
pass, but if you are worried talk to your doctor.
Contact your doctor as soon as possible if you swallow Monopost
accidentally.
If you forget to use Monopost
Carry on with the usual dosage at the usual time. Do not take a double
dose to make up for a forgotten dose. If you are unsure about anything
talk to your doctor or pharmacist.
If you stop using Monopost
Talk to your doctor if you want to stop using Monopost.

Rare: may affect up to 1 in 1,000 people
 Inflammation of the iris, the coloured part of the eye (iritis/uveitis),
swelling of the retina (macular oedema), symptoms of swelling or
scratching /damage to the surface of the eye, swelling around the eye
(periorbital oedema) misdirected eyelashes or an extra row of
eyelashes, sensitivity to light (photophobia).
 Skin reactions on the eyelids, darkening of the skin of the eyelids.
 Asthma, worsening of asthma and shortness of breath (dyspnoea).
Very rare: may affect up to 1 in 10,000 people
 Worsening of angina in patients who also have heart disease.
 Chest pain.
 Sunken eye appearance (eye sulcus deepening).

If you have any further questions on the use of this medicine, ask your
doctor, or pharmacist or nurse.

Patients have also reported the following side-effects: fluid filled area
within the coloured part of the eye (iris cyst), headache, dizziness,
palpitations, muscle pain, joint pain and developing a viral infection of the
eye caused by the herpes simplex virus (HSV).

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Reporting of side effects
If you get any side effects, talk to your doctor, or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.

Very common: may affect more than 1 in 10 people
 A gradual change in your eye colour by increasing the amount of brown
pigment in the coloured part of the eye known as the iris.
 If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown
or green-brown) you are more likely to see this change than if you
have eyes of one colour (blue, grey, green or brown eyes).
 Any changes in your eye colour may take years to develop although it
is normally seen within 8 months of treatment.
 The colour change may be permanent and may be more noticeable if
you use Monopost in only one eye.
 There appears to be no problems associated with the change in eye
colour.
 The eye colour change does not continue after Monopost treatment is
stopped.
 Redness of the eye.
 Eye irritation (a feeling of burning, grittiness, itching, stinging or the
sensation of a foreign body in the eye).
 A gradual change to eyelashes of the treated eye and the fine hairs
around the treated eye, seen mostly in people of Japanese origin.
These changes involve an increase of the colour (darkening), length,
thickness and number of your eye lashes.

You can also report side effects directly via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard

Common: may affect up to 1 in 10 people
 Irritation or disruption to the surface of the eye, eyelid inflammation
(blepharitis) and eye pain.
Uncommon: may affect up to 1 in 100 people
 Eyelid swelling, dryness of the eye, inflammation or irritation of the
surface of the eye (keratitis), blurred vision and conjunctivitis.
 Skin rash.

By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Monopost
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
carton, sachet and single-dose container. The expiry date refers to the
last day of that month.
Do not store above 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 immediately and
throw away the single-dose container after use.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.

6. Contents of the pack and other information
What Monopost contains
The active substance is Latanoprost.
One ml eye drops solution contains 50 micrograms of latanoprost.
Also contains:
macrogolglycerol hydroxystearate 40 (derived from castor oil), sorbitol,
carbomer 974P, macrogol 4000, disodium edetate, sodium hydroxide (for
pH-adjustment), water for injections.
What Monopost looks like and contents of the pack
This medicine is an eye drops, solution in single-dose container.
The solution looks slightly yellow and opalescent. It contains no
preservative.
The single-dose containers are packed in a sachet of 5 units, each singledose container holding 0.2 ml of solution.
A pack size contains 30 (6 sachets of 5) or 90 (18 sachets of 5) singledose containers.
Manufacturer and Product Licence holder
Manufactured by Excelvision, 27 Rue de la Lombardiere, Zi la
Lombardiere, 07100 Annonay, France.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2910

Leaflet revision and issue date (Ref) 15.10.16[3]
Monopost is a trademark of Laboratoires Théa.

PATIENT INFORMATION LEAFLET

2910
15.10.16[3]

Latanoprost 50 micrograms/ml eye drops,
solution in single dose container
This medicine is available using the above name but will be referred to as
Latanoprost throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, or 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 signs of illness are the same as
yours.
 If you get any side effects, talk to your doctor, or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
Section 4.
What is in this leaflet:
1. What Latanoprost is and what it is used for
2. What you need to know before you use Latanoprost
3. How to use Latanoprost
4. Possible side effects
5. How to store Latanoprost
6. Contents of the pack and other information
1. What Latanoprost is and what it is used for
Latanoprost belongs to a group of medicines known as prostaglandins. It
lowers the pressure within your eye by increasing the natural outflow of
fluid from inside the eye into the bloodstream.
Latanoprost is used to treat conditions known as open angle glaucoma
and ocular hypertension. Both of these conditions are linked with an
increase in the pressure within your eye, eventually affecting your eye
sight.
2. What you need to know before you use Latanoprost
Do not use Latanoprost
 If you are allergic (hypersensitive) to latanoprost or any of the other
ingredients of this medicine (listed in section 6).
 If you are pregnant or trying to become pregnant.
 If you are breast feeding.
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before using Latanoprost if
you think any of the following 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 that you suffer from dry eyes.
 If you have severe asthma or your asthma is not well controlled.
 If you wear contact lenses. You can still use Latanoprost, but follow the
instruction for contact lens wearers in Section 3.
 If you have suffered or are currently suffering from a viral infection of
the eye caused by the herpes simplex virus (HSV).

Children
Latanoprost has not been investigated in children (below 18 years).
Other medicines and Latanoprost
Latanoprost may interact with other medicines. Tell your doctor or
pharmacist if you are using, have recently used or might use any other
medicines.
Pregnancy and breast-feeding
Do not use Latanoprost when you are pregnant or breast-feeding.
If you are pregnant or breast-feeding, 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
When you use Latanoprost you might have blurred vision, for a short
time. If this happens to you, do not drive or use any tools or machines
until your vision becomes clear again.
Important information about some of the ingredients of Latanoprost
Latanoprost contains macrogolglycerol hydroxystearate (derived from
castor oil) which may cause skin reactions.
3. How to use Latanoprost
Usual dose
 Always use Latanoprost exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
 The usual dose 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 Latanoprost more than once a day, because the
effectiveness of the treatment can be reduced if you administer it more
often.
 Always use Latanoprost exactly as this leaflet tells you or as your
doctor has told you, until your doctor tells you to stop. Check with your
doctor, or pharmacist or nurse if you are not sure.

5. Press a finger against the corner of the affected eye by the nose. Hold
for 1 minute whilst keeping the eye closed.

Contact lens wearers
If you wear contact lenses, you should remove them before using
Latanoprost. After using Latanoprost you should wait 15 minutes before
putting your contact lenses back in.
Instructions for use
The drops are supplied in single-dose units. Use the solution from one
single dose unit for administration to the affected eye(s) immediately after
opening the container. Since sterility cannot be maintained after opening,
throw away the container immediately after using the solution. Open a
new single-dose unit each time you use Latanoprost.
These instructions tell you how to use the drops:
1. Wash your hands and sit or stand comfortably.
2. Use your finger to gently pull down the lower eyelid of your affected
eye.
3. Place the tip of the single-dose container close to, but not touching your
eye.
4. Squeeze the single-dose container gently so that only one drop goes
into your eye, then release the lower eyelid.

6. Repeat in your other eye if your doctor has told you to do this.
7. Throw away the single-dose container after use. Do not keep it to use it
again.
If you use Latanoprost with other eye drops
Wait at least 5 minutes between using Latanoprost and using other eye
drops.

If you use more Latanoprost than you should
If you put too many drops into your eye, you may have some minor
irritation in your eye and your eyes may water and turn red. This should
pass, but if you are worried talk to your doctor.
Contact your doctor as soon as possible if you swallow Latanoprost
accidentally.
If you forget to use Latanoprost
Carry on with the usual dosage at the usual time. Do not take a double
dose to make up for a forgotten dose. If you are unsure about anything
talk to your doctor or pharmacist.
If you stop using Latanoprost
Talk to your doctor if you want to stop using Latanoprost.

Rare: may affect up to 1 in 1,000 people
 Inflammation of the iris, the coloured part of the eye (iritis/uveitis),
swelling of the retina (macular oedema), symptoms of swelling or
scratching /damage to the surface of the eye, swelling around the eye
(periorbital oedema) misdirected eyelashes or an extra row of
eyelashes, sensitivity to light (photophobia).
 Skin reactions on the eyelids, darkening of the skin of the eyelids.
 Asthma, worsening of asthma and shortness of breath (dyspnoea).
Very rare: may affect up to 1 in 10,000 people
 Worsening of angina in patients who also have heart disease.
 Chest pain.
 Sunken eye appearance (eye sulcus deepening).

If you have any further questions on the use of this medicine, ask your
doctor, or pharmacist or nurse.

Patients have also reported the following side-effects: fluid filled area
within the coloured part of the eye (iris cyst), headache, dizziness,
palpitations, muscle pain, joint pain and developing a viral infection of the
eye caused by the herpes simplex virus (HSV).

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Reporting of side effects
If you get any side effects, talk to your doctor, or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.

Very common: may affect more than 1 in 10 people
 A gradual change in your eye colour by increasing the amount of brown
pigment in the coloured part of the eye known as the iris.
 If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown
or green-brown) you are more likely to see this change than if you
have eyes of one colour (blue, grey, green or brown eyes).
 Any changes in your eye colour may take years to develop although it
is normally seen within 8 months of treatment.
 The colour change may be permanent and may be more noticeable if
you use Latanoprost in only one eye.
 There appears to be no problems associated with the change in eye
colour.
 The eye colour change does not continue after Latanoprost treatment
is stopped.
 Redness of the eye.
 Eye irritation (a feeling of burning, grittiness, itching, stinging or the
sensation of a foreign body in the eye).
 A gradual change to eyelashes of the treated eye and the fine hairs
around the treated eye, seen mostly in people of Japanese origin.
These changes involve an increase of the colour (darkening), length,
thickness and number of your eye lashes.

You can also report side effects directly via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard

Common: may affect up to 1 in 10 people
 Irritation or disruption to the surface of the eye, eyelid inflammation
(blepharitis) and eye pain.
Uncommon: may affect up to 1 in 100 people
 Eyelid swelling, dryness of the eye, inflammation or irritation of the
surface of the eye (keratitis), blurred vision and conjunctivitis.
 Skin rash.

By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Latanoprost
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
carton, sachet and single-dose container. The expiry date refers to the
last day of that month.
Do not store above 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 immediately and
throw away the single-dose container after use.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.

6. Contents of the pack and other information
What Latanoprost contains
The active substance is latanoprost.
One ml eye drops solution contains 50 micrograms of latanoprost.
Also contains:
macrogolglycerol hydroxystearate 40 (derived from castor oil), sorbitol,
carbomer 974P, macrogol 4000, disodium edetate, sodium hydroxide (for
pH-adjustment), water for injections.
What Latanoprost looks like and contents of the pack
This medicine is an eye drops, solution in single-dose container.
The solution looks slightly yellow and opalescent. It contains no
preservative.
The single-dose containers are packed in a sachet of 5 units, each singledose container holding 0.2 ml of solution.
A pack size contains 30 (6 sachets of 5) or 90 (18 sachets of 5) singledose containers.
Manufacturer and Product Licence holder
Manufactured by Excelvision, 27 Rue de la Lombardiere, Zi la
Lombardiere, 07100 Annonay, France.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2910

Leaflet revision and issue date (Ref) 15.10.16[3]

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide