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LATACRIS 50 MICROGRAM/ML EYE DROPS SOLUTION

Active substance(s): LATANOPROST

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Latanoprost 0.005% eye drops, solution

1.3.1 UK

Package leaflet: Information for the user
Latacris 50 microgram/ml Eye Drops, solution
(latanoprost)
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 the doctor treating your child or your
pharmacist.
- This medicine has been prescribed for you or for your child. 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 the doctor treating your child or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Latacris Eye Drops is and what it is used for
2. What you need to know before you use Latacris Eye Drops
3. How to use Latacris Eye Drops
4. Possible side effects
5. How to store Latacris Eye Drops
6. Content of the pack and other information

1.

What Latacris Eye Drops is and what it is used for

Latacris Eye Drops belongs to a group of medicines known as prostaglandins-analogues.It works by
increasing the natural outflow of fluid from inside the eye into the bloodstream.
Latacris Eye Drops is used to treat conditions known as open angle glaucome and ocular hypertension.
Both of these conditions are linked with an increase in the pressure within your eye, eventually
affecting your eye sight.
Latacris is also used to treat increased eye pressure and glaucoma in all ages of children and
babies.

2.

What do you need to know before you use Latacris Eye Drops

Latacris Eye Drops can be used in adult men and women (including the elderly) and in children from
birth to 18 years of age. Latacris has not been investigated in prematurely born infants (less than 36
weeks gestation).
Do not use Latacris Eye Drops:
if you are allergic (hypersensitive) to latanoprost or to 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.

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Warnings and precautions
Talk to your doctor or the doctor treating your child or your pharmacist before you take Latacris
or before you give this to your child if you think any of the following apply to you or your child:
-

if you or your child are about to have or have had eye surgery (including cataract surgery);
if you or your child suffer form eye problems (such eye pain, irritation or inflammation, blurred
vision)
if you or your child suffer from dry eyes
if you or your child have severe asthama or your asthma is not well controlled
if you or your child wear contact lenses.You can still use Latacris Eye Drops , but follow the
instruction for contact lenses 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).

Other medicines and Latacris Eye Drops
Latacris Eye Drops may interact with other medicines. Please tell your doctor, the doctor treating your
child or pharmacist if you or your child are using or have used any other medicines including those
medicines (or eye drops) obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your
doctor or pharmist for advice before taking this medicine.
Pregnancy
Latacris Eye Drops should not be used during pregnancy.
Breast-feeding
Do not use Latacris Eye Drops when you are breast-feeding.
Driving and using machines
When you use Latacris Eye Drops 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.
Latacris Eye Drops contains preservative called Benzalkonium chloride.
This preservative may cause eye irritation or disruption to the surface of the 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 before using Latacris Eye Drops. After using Latacris Eye Drops you should wait 15 minutes
before putting the contact lenses back in. See the instructions for contact lens wearers in Section 3.

3.

How to use Latacris Eye Drops

Always use this medicine exactly as your doctor or the doctor treating your child or pharmacist has
told you. Check with your doctor or the doctor treating your child or pharmacist if you are not sure.
The recommended dose for adults (including the elderly) and children is 1 drop once a day in the
affected eye(s). The best time to do this is in the evening.
Do not use Latacris Eye Drops more than once a day, because the effectiveness of the treatment can be
reduced if you administer it more often.
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Use Latacris Eye Drops as instructed by your doctor or by the doctor treating your child until they tell
you to stop.
Contact lens wearers
If you or your child wear contact lenses, you should remove them before using Latacris Eye Drops.
After using Latacris Eye Drops you should wait 15 minutes before putting your contact lenses back in.

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 to 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 Latacris Eye Drops with other eye drops
Wait at least 5 minutes between using Latacris Eye Drops and using other eye drops
If you use more Latacris Eye Drops than you should
If you put too many drops into your eye, you may experience some minor irritation in your eye and
your eye may water and turn red. This shoud 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 swallow Latacris Eye Drops accidentally.
If you forget to use Latacris Eye Drops
Do not take a double dose to make up for a forgotten dose. Carry on with the usual dosage at the usual
time.

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If you stop using Latacris Eye Drops
You should speak to your doctor or the doctor treating your child if you want to stop using Latacris
Eye Drops.
If you have further questions on the use of this medicine, ask your doctor or the docter treating your
child or pharmist.

4.

Possible Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 to 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, (i.e. blue-brown, grey-brown, yellowbrown and 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 Latacris Eye Drops 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 Latacris Eye
Drops 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 of 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):
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 (karetitis),
blurred vision and conjunctivitis, skin rash.
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; 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.

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the
cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
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 and joint pain and developing a viral
infection of the eye caused by the herpes simplex virus (HSV).

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Additional side effects in children
Side effects seen more often in children compared to adults are runny itchy nose and fever.
Reporting of side effects
If you get any side effects, talk to your doctor, the doctor treating your child or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also report any side effects directly
to the national reporting system via the internet at {insert link to the relevant national
reporting system website’}; or you can report via {insert alternative ways of reporting - details will be
defined at national level}.
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Latacris eye Drops

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 and on the bottle. The
expiry date (EXP) refers to the last day of that month.
Keep the bottle in the outer carton, in order to protect from light.
Store the unopened bottle in a refrigerator (between 2°C and 8°C).
After opening the bottle it is not necessary to store the bottle in a refrigerator, but do not store it above
25°C. Use within 4 weeks of opening.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away any medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Latacris Eye Drops contains
-

The active substance is latanoprost.
1 ml of solution contains 50 micrograms of latanoprost.

-

The other ingredients are: sodium chloride, monobasic sodium phosphate,
disodium phosphate, anydrous (E339b), benzalkonium chloride, dissolved in purified water.

What Latacris Eye Drops looks like and contents of the pack
Latacris Eye Drops, Solution is a clear colourless liquid. Each bottle contains 2.5 ml of solution.
Latacris Eye Drops is available in pack sizes of 1, 3 and 6 bottles.
Not all pack sizes may be marketed.

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1.3.1 UK

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
NTC Srl.
Via Luigi Razza, 3 – 20124 Milan (Italy)
tel: +39 02 4385041
fax: +39 02 48195301
e-mail: info@ntc.pharma.com
Manufacturer:
BRUSCHETTINI S.r.l.
Via Isonzo, 6
16147 Genova
ITALY

This medicinal product is authorised in the Member States of the EEA under the following
names:
Ireland
United Kingdom
Germany
Greece
Poland

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Latacris

This leaflet was last revised in
05/2016.

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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.

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