XALATAN 0.005% W/V EYE DROPS

Active substance: LATANOPROST

View full screen / Print PDF » Download PDF ⇩

Transcript
0.005% Eye Drops, Solution
RECTO

Latanoprost

8R3247
125

PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
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 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 eyes.

Instructions for use
1. Wash your hands and sit or stand comfortably.
2. Twist off the outer cap (which can be thrown
away).

Process Black

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.

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

Very common effects (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 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 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 effects (likely to affect less than 1 in 10 people):
• Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis)
and eye pain.

Uncommon effects (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 effects (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, light sensitivity (photophobia).
• Skin reactions on the eyelids, darkening of the skin of the eyelids.
• Asthma, worsening of asthma and shortness of breath (dyspnoea).
Very rare effects (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, 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.
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.
If any of the side effects become serious, or if you notice any side effects not listed in
this leaflet, please contact your doctor or pharmacist.

5. How to store Xalatan
Keep out of the reach and sight 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.
Store the unopened bottle at room temperature (below 25°C), protected from light.
After opening the bottle store it at room temperature (below 25°C) and use within
4 weeks of opening. When you are not using Xalatan, keep the bottle in the outer
carton, in order to protect it 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

The active substance is 0.005% (50 micrograms/ml) latanoprost.
The other ingredients are: benzalkonium chloride, sodium chloride, sodium
dihydrogen phosphate monohydrate (E339a) and anhydrous disodium phosphate
(E339b) dissolved in water for injections.

What Xalatan looks like and contents of the pack
Xalatan Eye Drops, Solution is a clear, colourless liquid.

Xalatan is available in pack sizes of 1, 3 and 6 cartons. Not all pack sizes may be
marketed.
Each carton contains one bottle of Xalatan. Each bottle contains 2.5ml of Xalatan Eye
Drops, Solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Pfizer Limited, Ramsgate Road, Sandwich,
Kent, CT13 9NJ, United Kingdom.

Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs,
Belgium.
This leaflet was last updated in: 06/2013

Ref: XN 23_0 UK

8R3247

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)