LATANOPROST 0.005% W/V EYE DROPS SOLUTION

Active substance: LATANOPROST

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231-30-50502-C LEA LATANOPROST 50mcg EYE DROPS 2.5ml TUK
Version:

2

16 January 2013

PL Number(s),
PL 00289/1668. TEVA UK Licence (Responsible Regulatory Officer = TEVA UK Ltd, Post Licence Team),
MA Holder & Packer: Packed at Ratiopharm/Merckle, Ulm.
Reason for revision: Version 1: Text Updates, TEVA UK Ltd Regulatory, 28/09/12 11:41. Trackwise: 159015.
V2: Code updates from (Sifi), Breath Ltd. 15/01/13 16:42.

Dimensions: 4-page leaflet
L: 220mm x 122mm p/p
Fonts: Varients of Univers
Base Font Size: 9pt

Pharma Code (top to bottom
on the front face when reading the
text design right way up):

Colours:

3rd Party Code: L1030A

Please refer to the
latest version of the
full base material
specification: 92655

412 (10011101)

IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN
BLACK

Original Artwork Scale = 1:1 (100%)
50mm

• Swelling of the skin around the
eyes
• Changes in the texture of the
fine hair on the eyelids and
direction of growth of the
eyelashes sometimes resulting
in eye irritation
• Localised skin reaction on the
eyelids
• Worsening of asthma
symptoms and sudden asthma
attacks with breathlessness
• Darkening of eye lids
• Growth of extra eyelashes
from the glands of the upper
or lower eyelid (distichiasis).
Very rare side effects (affects less
than 1 user in 10,000):
• Chest pain
• Worsening of chest pain
(angina) in patients suffering
with heart disease.
Unknown side effects (frequency
cannot be estimated from the
available data):
• Palpitations (irregular or rapid
heartbeats)
• Headache
• Dizziness
• Muscle ache and painful joints
• Fluid filled area within the
coloured part of the eye (iris
cyst)
• Inflammation of the cornea of
the eye caused by the herpes
simplex virus (herpetic keratitis).
Side effects seen more often in
children compared to adults are
runny itchy nose and fever.
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
pharmacist.

is stated on the carton and the
bottle after EXP The expiry date
.
refers to the last day of that
month.
Do not use Latanoprost eye drops
if you notice that the solution is
not clear and
colourless.
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 Latanoprost eye drops
contain:
The active substance is
latanoprost.
1 ml of eye drops contains
50 micrograms of latanoprost.
One drop contains approximately
1.56 micrograms of latanoprost.
2.5 ml bottle of eye drops contains
125 micrograms of latanoprost.
The other ingredients are
benzalkonium chloride, sodium
chloride, sodium dihydrogen
phosphate dihydrate, disodium
phosphate dodecahydrate,
purified water.
What Latanoprost eye drops look
like and contents of the pack
Eye drops, solution.
A clear colourless solution.
Pack sizes: 1 x 2.5 ml eye drops,
3 x 2.5 ml eye drops, 6 x 2.5 ml
eye drops.
Not all pack sizes may be
marketed.
5 HOW TO STOREEYE
LATANOPROST
Marketing Authorisation Holder
DROPS
and Manufacturers
Keep out of the reach and sight Marketing Authorisation Holder:
Teva UK Limited, Eastbourne,
of children.
Store in a refrigerator (2°C - 8°C). BN22 9AG.
Manufacturer:
Do not freeze.
Keep the bottle in the outer carton Merckle GmbH,
Ludwig-Merckle-Strasse 3,
in order to protect from light.
After first opening the bottle: do D-89143 Blaubeuren, Germany
This leaflet was last revised in
not store above 25°C and use
September 2012
within 4 weeks.
Do not use Latanoprost eye
50502-C
PL 00289/1668
drops after the expiry date which
L1030A

LATANOPROST
0.005% W/V EYE DROPS
SOLUTION
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Read all of this
leaflet carefully
before you start
using this
medicine.
• Keep this leaflet. You may need
to read it again.
• If you have any further questions,
ask your doctor or pharmacist.
• This medicine has been
prescribed for you. 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 pharmacist.
IN THIS LEAFLET:

1. What Latanoprost eye drops
are and what they are used for
2. Before you use Latanoprost
eye drops
3. How to use Latanoprost eye
drops
4. Possible side effects
5. How to store Latanoprost eye
drops
6. Further information

1

WHAT LATANOPROST EYE
DROPS ARE AND WHAT
THEY ARE USED FOR

Latanoprost eye drops is a solution
for use only in your eyes. It
contains a drug called latanoprost
which belongs to a group of
medicines called prostaglandins.
Latanoprost eye drops are used to
lower raised pressure in your eye
caused by a condition known as
glaucoma or ocular hypertension
(high pressure in the eye).
It works by increasing the natural
outflow of fluid from inside the
eye into the blood stream. If
raised pressure in the eye is not
treated it may affect your eyesight.
The effect (pressure lowering)
will start within 3 – 4 hours after

applying the drops, reaching
maximum effect after 8 – 12 hours.
The effect lasts for at least 24 hours.
Latanoprost eye drops is/are also
used to treat increased eye
pressure and glaucoma in all ages
of children and babies.

2

BEFORE YOU USE
LATANOPROST EYE
DROPS

Do not use Latanoprost eye drops:
• If you know you are allergic
(causing red, itchy, swollen and
watering eyes) to latanoprost
or any of the other ingredients
of Latanoprost eye drops,
listed at the end of this leaflet.
Take special care with
Latanoprost eye drops:
• If the colour of your eyes is
mixed, such as yellow-brown,
grey-brown, blue-brown or
green-brown using Latanoprost
eye drops may cause your eye
colour to become browner.
Change of colour is not seen in
clear blue eyes, and very seldom
in uniform grey, green or brown
eyes. The changes usually
happen gradually within the
first 8 months of treatment or
maybe later. You can continue
treatment even if these changes
occur as Latanoprost eye drops
will still work. Please discuss
with your doctor before starting
therapy as he will want to
follow your treatment.
Treatment of one single eye may
cause a difference in eye colours
• If your eye lid(s) or skin around
the eye(s) turns darker brown
• If you have recently had, or are
going to have a surgical
operation on your eyes
• If you have ever been treated
in the past for infections of the
eye known as iritis and uveitis
or a disease known as dry-eye
syndrome. Your doctor will be
able to tell you about these
• If you have asthma tell your
doctor
• If you have an eye from which the
lens is absent (aphakic) or you
have partial or complete opacity
of the lens of one or both eyes,
which might impair vision or
cause blindness (pseudoaphakic).

Ref:

231-30-50502-C LEA LATANOPROST 50mcg EYE DROPS 2.5ml TUK
Version:

2

16 January 2013

PL Number(s),
PL 00289/1668. TEVA UK Licence (Responsible Regulatory Officer = TEVA UK Ltd, Post Licence Team),
MA Holder & Packer: Packed at Ratiopharm/Merckle, Ulm.
Reason for revision: Version 1: Text Updates, TEVA UK Ltd Regulatory, 28/09/12 11:41. Trackwise: 159015.
V2: Code updates from (Sifi), Breath Ltd. 15/01/13 16:42.

Dimensions: 4-page leaflet
L: 220mm x 122mm p/p
Fonts: Varients of Univers
Base Font Size: 9pt

Pharma Code (top to bottom
on the front face when reading the
text design right way up):

Colours:

3rd Party Code: L1030A

Please refer to the
latest version of the
full base material
specification: 92655

(PANTONE® is a registered
trademark of Pantone, Inc.)

412 (10011101)

IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

Latanoprost eye drops should be
used with caution in patients
with a history of herpetic
keratitis, and should be avoided
in cases of active herpes simplex
keratitis and in patients with a
history of recurrent herpetic
keratitis specifically associated
with prostaglandin analogues.
Using other medicines
Please tell your doctor or
pharmacist if you are taking or
have recently taken any other
medicines, including medicines
obtained without a prescription
and herbal medicines.
Definitive drug interaction data
are not available.
If you are using other types of
eye drops together with
Latanoprost eye drops, these
should be put in 5 minutes before
or 5 minutes after the application
of Latanoprost eye drops.
Pregnancy and breast-feeding
Pregnancy
The unborn child might be
affected. Therefore Latanoprost
eye drops should not be used
during pregnancy.
If you are pregnant, think you
may be pregnant or are planning
to have a baby, please tell your
doctor.
Breast-feeding
The child might be affected.
Latanoprost eye drops should
not be used when breast-feeding.
Driving and using machines
As with other eye drops your
eyesight might be blurred or
slightly impaired particularly
when you first put the drops in.
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 eye drops
Latanoprost eye drops contains
benzalkonium chloride. This
preservative may cause eye
irritation. Benzalkonium chloride
may be absorbed by contact
lenses and it is known to
discolour soft contact lenses.
Therefore, avoid contact with

contact lenses. Remove contact
lenses prior to application of
Latanoprost eye drops and wait
at least 15 minutes before
putting them back in (see section
3 “HOW TO
USE
LATANOPROST
EYE DROPS”).

3

HOW TO
USE
LATANOPROST EYE
DROPS

Always use Latanoprost eye
drops exactly as your doctor has
told you. You should check with
your doctor or pharmacist if you
are not sure.
Adults (including the elderly)
and children (from birth to 18
years of age):
The usual dosage is 1 drop in the
affected eye(s) in the evening.
Do not use Latanoprost eye
drops more than once a day,
because the effectiveness of the
treatment can be reduced if you
administer it more often.
Instructions for use
1. Wash your hands before using
the drops.
2. Twist off the outer protective
cap with the “wings”
.

3. Twist off the inner protective
cap.

4. Lean your head backwards.
Pull down the lower eye-lid
carefully with your forefinger.

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5. Place the tip of the bottle close
to but not touching the eye and
press gently so that one drop
goes into the eye to be treated.
6. Apply pressure on the nasal
corner of the eye for 1 minute
after
application of
eye drop, in
order to
minimise
reabsorption
of the active ingredient into
the blood.
7. The protective cap should be
replaced after use.

If you wear contact lenses
These must be removed before
you put in the drops and should
not be put back in until 15 minutes
after you have applied the eye
drops.
Prematurely born infants
Latanoprost has not been
investigated in prematurely born
infants (less than 36 weeks
gestation).
If you use more Latanoprost eye
drops than you should
An overdose can cause irritation in
your eyes. Your eyes may become
itchy, red and may stick together.
Contact your doctor or nearest
hospital if you have used far too
much Latanoprost eye drops, or
if you or someone else drinks the
fluid by accident. Always take
the bottle or this leaflet with you.
If you forget to use Latanoprost
eye drops
If you miss a dose continue with
the next dose as normal. Do not
take a double dose to make up
for a forgotten dose.
If you stop using Latanoprost
eye drops
Do not stop the treatment unless
told to do so by your doctor.

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

4

POSSIBLE SIDE EFFECTS

Like all medicines, Latanoprost
eye drops can cause side effects,
although not everybody gets
them.
The following side effects have
been reported:
Very common side effects
(affects more than 1 user in 10):
• The iris might turn darker
brown, especially in people with
mixed eye colour i.e. yellowbrown, grey-brown, blue-brown
or green-brown eyes. See
Section 2 ”Take special care
with Latanoprost eye drops”
• Redness of the eye
• Eye irritation (burning,
grittiness, itching, stinging,
including feeling that there is a
foreign body in your eye)
• a gradual change to eyelashes
and to fine hairs around the
treated eye (darkening,
thickening, lengthening,
increased number) (mostly in
Japanese people).
Common side effects (affects 1
to 10 users in 100):
• Irritation or disruption to the
surface of the eye
• Inflammation of the eyelid
(blepharitis)
• Eye pain.
Uncommon side effects (affects
1 to 10 users in 1,000):
• Puffy, swollen and sore eyelids
(oedema)
• Dry eyes
• Infection of the cornea
(keratitis)
• Blurred vision
• Conjunctivitis
• Skin rash.
Rare side effects (affects 1 to 10
users in 10,000):
• Inflammation of the front of
the eye including the iris
(iritis/uveitis)
• Blurred vision from swelling at
the back of the eye
• Swelling and small scratches
to the front surface of the eye

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.

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