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LATANOPROST 0.05 MG/ ML EYE DROPS SOLUTION

Active substance(s): LATANOPROST

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Package leaflet: Information for the user
Latanoprost 50 micrograms/ml, eye drops, solution
Latanoprost
Read all of this leaflet carefully before you start using this medicine, because it contains important
information for you.
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Keep this leaflet. You may need to read it again.

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If you have any further questions, ask your doctor or pharmacist.

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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.

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If you get any of the side effects, talk to your doctor or pharmacist. 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 prostaglandin analogues. It works by increasing
of the natural outflow of fluid from inside the eye out into the bloodstream.
Latanoprost is used to treat conditions known as open angle glaucoma and ocular hypertension. Both of
these conditions can be linked with an increase in the pressure within your eye and eventually they may
affect your eyesight.
Latanoprost is also used to treat increased eye pressure and glaucoma in all ages of children and babies.

2.

Before you use Latanoprost

Latanoprost can be used in adult men and women (including the elderly) and in children from birth
to 18 years of age. Latanoprost has not been investigated in prematurely born infants (less than 36
weeks gestation).
Do not use Latanoprost:
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if you are allergic to latanoprost or any of the other ingredients of this medicine listed in section 6;

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if you are pregnant or trying to become pregnant;

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if you are breast feeding.
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Warnings and precautions
Talk to your doctor or doctor treating your child or your pharmacist before you take Latanoprost or before
you give this to your child:
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if you or your child are about to have had eye surgery (including cataract surgery);

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if you or your child suffer from the eye problems (such as eye pain, irritation or inflammation, blurred
vision);

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if you or your child suffers from dry eyes;

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if you or your child have severe asthma, or the asthma is not well controlled;

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if you or your child wear contact lenses. You can still use Latanoprost, but follow the instruction for
contact lenses wear in Section 3;

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if you have suffered or are currently suffering from a viral infection of the eye caused by the herpes
simplex virus (HSV).

Other medicines and Latanoprost
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
Interaction of Latanoprost with other medicines is possible.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, do not
use this medicine.
Driving and using machines
When you use Latanoprost you might have blurred vision, for a short time. If this happen to you, do not
drive or use any tools or machines until your vision becomes clear again.
Latanoprost contains benzalkonium chloride that may cause eye irritation or disruption to the surface
of eye. Benzalkonium chloride can be absorbed by contact lenses and is known to discolour soft contact
lenses. Therefore avoid contact with soft contact lenses.
If you or your child wears contact lenses, they should be removed contact lenses before using
Latanoprost. After using Latanoprost you should wait 15 minutes before putting the contact lenses back
in. See the instruction for contact lens wearer in Section 3.
3.

How to use Latanoprost

Always use this medicine exactly as your doctor or doctor treating your child has told you. Check with
your doctor or doctor treating your child or pharmacist if you are not sure.
The usual dose for adults (including elderly) and children is one drop once a day into the affected
eye(s).The best time to do this is in the evening.
Do not use Latanoprost more often than once daily, because the effect of the treatment can be reduced if
you administer it more often.
If you or your child are also using other eye drops you must wait at least 5 minutes before administering
those other eye drops.

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Contact lens wearers
Avoid contact with soft contact lenses. If you or your child wears contact lenses, they should be removed
before using Latanoprost. After using Latanoprost you should wait at least 15 minutes before putting the
contact lenses back into eyes.
Instruction for use
1. Wash your hands and sit or stand comfortably.
2. Twist off the cap.
3. Use your finger to gently pull down the lower eyelid of your affected eye.
4. Place the tip of the bottle close to, but not touching your eye.
5. Squeeze the bottle gently so that only one drop goes into your eye then release the lower eyelid.
6. Press a finger against the corner of the affected eye by the nose. Hold for 1 minute whilst keeping
the eye closed.
7. Repeat in your other eye if your doctor has told you to do this.
8. Put the cap back on the bottle.

If you use more Latanoprost than you should
Be careful when you are squeezing the bottle so that you only put one drop into the affected eye.
If you put too many drops in your eye, you may feel some slight irritation in the eye and the eyes may
water and turn red. This should pass, but if you are worried contact your doctor or the doctor treating
your child for advice.
Contact your doctor as soon as possible if you or your child swallows Latanoprost accidentally.
If you forget to use Latanoprost
If you forget to use your eye drops at the usual time, wait until it is time for your next dose.
Do not take double dose to make up for a forgotten dose.
If you stop using Latanoprost
You should speak to your doctor or the doctor treating your child if you want to stop using this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following are known side effects of using Latanoprost:
Very common (may affect more than 1 in 10 people)
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A gradual change in your eye colour by increasing the amount of brown pigmentation the coloured
part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellowbrown 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 colour change does not continue after Latanoprost treatment is
stopped.

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Redness of the eye

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Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in
the eye).

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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.

Common (may affect up to 1 in 10 people):
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Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis), eye pain and
light sensitivity (photophobia).

Uncommon (may affect up to 1 in 100 people)
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Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye
(keratitis), blurred vision, conjunctivitis;

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Skin rash.

Rare (may affect up to 1 in 1,000 people)
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Inflammation of the iris, the coloured part of the eye (iritis/uveitis), swelling of the retina
(macular oedema), symptoms or swelling or scratching/damage to the surface of the eye, swelling
around the eyes (periorbital oedema), misdirected eyelashes or extra row of eyelashes;

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Skin reaction on the eyelids, darkening of the skin of the eyelids;

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Asthma, worsening of asthma and shortness of breath (dyspnoea).

Very rare (may affect up to 1 in 10,000 people)
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Worsening of angina in patients who also have heart disease, chest pain, sunken eye appearance (eye
sulcus deepening).

Patients have also reported the following side-effects: fluid filled area within the coloured part of the eye
(iris cyst), headache, dizziness, awareness of heart rhythm (palpitations), muscle pain, joint pain and
developing a viral infection of the eye caused by herpes simplex virus (HSV).
Side effects seen more often in children compared to adults are runny itchy nose and fever.
In very rare cases, some patients with severe damage to the clear layer at the front of the eye (cornea) have
developed cloudy patches on the cornea due to calcium build-up during treatment.

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Reporting of side effects
If you or your child gets any side effects, talk to your doctor or the doctor treating your child or
pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Latanoprost

Keep out of the sight and reach of children.
Before Latanoprost is first opened, store and transport refrigerated (2°C – 8°C).
Keep the bottle in the outer carton in order to protect from light. After opening, do not store above 25°C.
Each bottle should be thrown away 4 weeks after first opening.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date
refers to the last day of that month.
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.

6.

Contents of the pack and other information

What Latanoprost contains
The active substance is latanoprost. Each ml contains 50 micrograms latanoprost.
2.5 ml of eye drops, solution (content of a bottle) contains 125 micrograms of latanoprost.
The other ingredients are:
- benzalkonium chloride 0.2 mg/ml
- sodium chloride
- sodium dihydrogen phosphate monohydrate
- disodium phosphate anhydrous
- water, purifed
What Latanoprost looks like and contents of the pack
The eye drops are a colourless or pale-yellow, clear solution. Each bottle contains 2.5 ml eye drops,
solution.
Latanoprost is available in the following pack sizes: one bottle of 2.5 ml, 3 bottles of 2.5 ml and 6 bottles
of 2.5 ml.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Germany
Telephone:+49 (0)30 33093-0
Fax:+49 (0)30 33093-350

Manufacturer
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Germany
Telephone:+49 (0)30 33093-0
Fax:+49 (0)30 33093-350

This medicinal product is authorized in the Member States of the EEA under the following names:

United Kingdom

Latanoprost

Germany

Lanotan

This leaflet was last revised in 11/2016

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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