LATANOPROST 0.005% W/V EYE DROPS SOLUTION

Active substance: LATANOPROST

View full screen / Print PDF » Download PDF ⇩

Transcript
PATIENT INFORMATION LEAFLET

2596
12.08.14[2]

Xalatan® 0.005% w/v Eye Drops, Solution
Latanoprost
This medicine is available using the above name but will be referred to as
Xalatan throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine.
Even if you have already used Xalatan or a similar medicine before,
we advise you to read this text carefully. The information may have
been changed.
 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 symptoms are the
same as yours.
 If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or the doctor treating
your child or your pharmacist. See section 4.
In this leaflet:
1. What Xalatan is and what it is used for
2. Before you use Xalatan
3. How to use Xalatan
4. Possible side effects
5. How to store Xalatan
6. Further information
1. What Xalatan is and what it is used for
Xalatan belongs to a group of medicines known as prostaglandin
analogues. It works by increasing the natural outflow of fluid from inside
the eye into the bloodstream.
Xalatan 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.
Xalatan is also used to treat increased eye pressure and glaucoma in all
ages of children and babies.
2. Before you use Xalatan
Xalatan can be used in adult men and women (including the elderly) and
in children from birth to 18 years of age. Xalatan has not been
investigated in prematurely born infants (less than 36 weeks gestation).
Do not use Xalatan if you are
 Allergic (hypersensitive) to latanoprost or any of the other ingredients of
Xalatan (see section 6 for the list of ingredients in your medicine)
 Pregnant or trying to become pregnant
 Breast feeding

Take special care with Xalatan

Talk to your doctor or the doctor treating your child or your
pharmacist before you take Xalatan 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 from eye problems (such as eye pain, irritation
or inflammation, blurred vision)
 If you or your child suffers from dry eyes
 If you or your child have severe asthma or the asthma is not well
controlled
 If you or your child wear contact lenses. You can still use Xalatan, 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).
Taking other medicines
Xalatan may interact with other medicines. Please tell your doctor, the
doctor treating your child or pharmacist if you or your child are taking or
have taken any other medicines including those medicines (or eye drops)
obtained without a prescription.
Pregnancy
Do not use Xalatan when you are pregnant. Tell your doctor immediately
if you are pregnant, think you are pregnant, or are planning to become
pregnant.
Breast-feeding
Do not use Xalatan when you are breast-feeding.
Driving and using machines
When you use Xalatan 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 Xalatan
Xalatan contains a 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 wear contact lenses, they should be removed before
using Xalatan. After using Xalatan 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 Xalatan
Always use Xalatan exactly as your doctor or the doctor treating your
child has told you. You should check with your doctor or the doctor
treating your child or pharmacist if you are not sure.
The usual dosage for adults (including the elderly) and children is one drop
once a day in the affected eye(s). The best time to do this is in the evening.
Do not use Xalatan more than once a day, because the effectiveness of
the treatment can be reduced if you administer it more often.
Use Xalatan 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, they should be removed before
using Xalatan. After using Xalatan you should wait 15 minutes before
putting the contact lenses back into the eye.
Instructions for use
1. Wash your hands and sit or stand comfortably.
2. Twist off the outer cap (which can be thrown
away).

3. Unscrew the protective inner cap. The
protective cap should be retained.

4. Use your finger to gently pull down
the lower eyelid of your affected eye.
5. Place the tip of the bottle close to,
but not touching your eye.
6. Squeeze the bottle gently so that
only one drop goes into your eye,
then release the lower eyelid.
7. Press a finger against the corner of
the affected eye by the nose. Hold
for 1 minute whilst keeping the eye
closed.
8. Repeat in your other eye if your
doctor has told you to do this.
9. Put the protective inner cap back on
the bottle.

If you use Xalatan with other eye drops
Wait at least 5 minutes between using Xalatan and taking other eye
drops.
If you use more Xalatan than you should
If you put too many drops into the eye, it may lead to some minor 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
Xalatan accidentally.
If you forget to use Xalatan
Carry on with the usual dosage at the usual time. Do not take a double
dose to make up for the dose you have forgotten. If you are unsure about
anything talk to your doctor or pharmacist.

If you stop using Xalatan
You should speak to your doctor or the doctor treating your child if you
want to stop taking Xalatan.

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.

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

The following are known side effects of using Xalatan:
Very common (likely to 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 greenbrown) 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 Xalatan 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 Xalatan 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.
Common (likely to affect less than 1 in 10 people):
 Irritation or disruption to the surface of the eye, eyelid inflammation
(blepharitis), eye pain and light sensitivity (photophobia).
Uncommon (likely to affect less than 1 in every 100 people):
 Eyelid swelling, dryness of the eye, inflammation or irritation of the
surface of the eye (keratitis), blurred vision and conjunctivitis.
 Skin rash.
Rare (likely to affect less than 1 in every 1000 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 (likely to affect less than 1 in 10,000 people):
 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 the herpes simplex virus
(HSV).
Side effects seen more often in children compared to adults are: runny
itchy nose and fever.

By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Xalatan
Keep out of the sight and reach of children.
Do not use Xalatan after the expiry date which is stated on the carton and
bottle. The expiry date refers to the last day of that month.
Do not store above 25oC.
Store in the original package in order to protect from light.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. Further information
What Xalatan contains
Each 1 ml of solution contains 50 micrograms of latanoprost as active
ingredient.
Other ingredients: benzalkoniumchloride, sodium chloride, sodium
dihydrogen phosphate monohydrate (E339a) and anhydrous disodium
phosphate (E339b) dissolved in water for injections.
What Xalatan looks and contents of the pack
Xalatan is a clear, colourless liquid.
Each carton contains one bottle of Xalatan. Each bottle contains 2.5ml of
solution.
Product Licence Holder and Manufacturer
Manufactured by: Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870
Puurs, Belgium and procured from within the EU by Product Licence
holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2596

Leaflet revision and issue date (Ref.) 12.08.14[2]
Xalatan is a trademark of Pfizer Health AB.

Expand view ⇕

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
(web4)