Skip to Content

EYDELTO 20 MG/ML EYE DROPS SOLUTION

Active substance(s): DORZOLAMIDE HYDROCHLORIDE / DORZOLAMIDE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

3. How to use Eydelto

Package leaflet:
Information for the user

20mg/ml Eye Drops, Solution
Dorzolamide (as hydrochloride)
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 pharmacist.
- 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.
- If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Eydelto is and what it is
used for
2. What you need to know before you
use Eydelto
3. How to use Eydelto
4. Possible side effects
5. How to store Eydelto
6. Contents of the pack and other
information

Always use this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure. The appropriate dosage
and duration of treatment will be
established by your doctor.
When this medicine is used alone,
the recommended dose is one
drop in the affected eye(s) in the
morning, in the afternoon and in
the evening.
If your doctor has recommended you
use this medicine with a beta-blocker
eye drop to lower eye pressure, then
the dose is one drop of Eydelto in the
affected eye(s) in the morning and in
the evening.
If you are using this medicine with
another eye drop, the drops should
be instilled at least 10 minutes apart.
Do not change the dose of the
medicine without consulting your
doctor.
If you have difficulty administering
your eye drops, seek the assistance
of a family member or carer.
Do not allow the tip of the multi-dose
container to touch the eye or areas
around the eye. It could cause injury
to your eye. The eye drops solution
may become contaminated with
bacteria that can cause eye infections
leading to serious damage of the eye,
even loss of vision.
To avoid possible contamination of
the multi-dose container, keep the tip
of the multi-dose container away
from contact with any surface.
Instructions for use

1. What Eydelto is and what
it is used for

Before instillation of the
eye drops:
Eydelto contains dorzolamide which
- Wash your hands before opening
belongs to a group of medicines
the bottle.
called ‘carbonic anhydrase inhibitors’.
- Do not use this medicine if you
This medicine is prescribed to lower
notice that the tamper-proof seal
raised pressure in the eye and to treat
on the bottle neck is broken before
glaucoma. This medicine can be used
you first use it.
alone or in addition to other
- When using for the first time,
medicines which lower the pressure in
before delivering a drop to the eye,
the eye (for example beta-blockers).
you should first of all practice using
Eydelto eye drops solution is a sterile
the dropper bottle by squeezing it
solution that does not contain a
slowly to deliver one drop, away
preservative.
from the eye.
- When you are confident that you
can deliver one drop at a time,
2. What you need to know
choose the position that you find
before you use Eydelto
most comfortable for the instillation
of the drops (you can sit down, lie
Do not use Eydelto:
on your back, or stand in front of
• if you are allergic to dorzolamide
a mirror).
hydrochloride or any of the other
Instillation:
ingredients of this medicine (listed
1. Hold the bottle directly below the
in section 6).
cap and turn the cap to open the
• if you have severe kidney
bottle. Do not touch anything with
impairment or problems, or a prior
the tip of the bottle to avoid
history of kidney stones.
contamination of the solution.
If you are not sure whether you
should use this medicine, contact
your doctor or pharmacist.
Warnings and precautions
Tell your doctor or pharmacist about
any medical problems you have now
or have had in the past, including eye
problems and eye surgeries, and about 2. Tilt your head backwards and hold
any allergies to any medications.
the bottle above your eye.
If you develop any eye irritation or any 3. Pull the lower eyelid down and look
new eye problems such as redness of
up. Squeeze the bottle gently in
the eye or swelling of the eyelids,
the middle and let a drop fall into
contact your doctor immediately.
your eye. Please note that there
If you suspect that this medicine is
might be a few seconds delay
causing an allergic reaction (for
between squeezing and the drop
example, skin rash, severe skin
coming out. Do not squeeze too
reaction or itching) stop its use and
hard.
contact your doctor immediately.
If you are not sure how to
If you have a history of contact
administer your medicine, ask your
hypersensitivity to silver, you should
doctor, pharmacist or nurse.
not use this product as dispensed
drops may contain traces of silver
from the container closure.
If you wear contact lenses, you
should consult your doctor before
using Eydelto.
Children and adolescents
Dorzolamide (preserved formulation)
has been studied in infants and
children less than 6 years of age
who have raised pressure in the
eye(s) or have been diagnosed with
glaucoma. For more information talk
to your doctor.

4. Blink a few times so that the
drop spreads over the eye.

Use in elderly
5. Repeat the instructions 2 – 4 to
In studies with Dorzolamide
deliver a drop into the other eye
(preserved formulation), the effects of
also, if your doctor has instructed
Dorzolamide (preserved formulation)
you to do this. Sometimes only one
were similar in both elderly and
eye needs to be treated and your
younger patients.
doctor will advise if this applies to
you and which eye needs
Use in patients with liver
treatment.
impairment
6.
After each use and prior to
Tell your doctor about any liver
recapping, the bottle should be
problems you now have or have
shaken once in a downwards
suffered from in the past.
direction, without touching the
Other medicines and Eydelto
dropper tip, in order to remove any
residual liquid on the tip. This is
Tell your doctor or pharmacist if you
necessary in order to ensure
are taking, have recently taken or
delivery of subsequent drops.
might take any other medicines.
Tell your doctor about all medicines
(including eye drops) that you are
using or plan to use, including those
obtained without a prescription,
particularly another carbonic
anhydrase inhibitor such as
acetazolamide, or a sulfa drug such
as sulfamethoxazole (medicines used
7. At the end of the 28-day in-use
to prevent the growth of bacteria).
shelf life of the medicine, there will
Pregnancy and breast-feeding
be some Eydelto left in the bottle.
Do not attempt to use the excess
If you are pregnant or breast-feeding,
medicine remaining in the bottle
think you may be pregnant or are
after you have completed the
planning to have a baby, ask your
course of treatment. Do not use
doctor or pharmacist for advice before
the eye drops for longer than 28
using this medicine.
days after first opening the bottle.
Pregnancy
If you use more Eydelto than
You should not use this medicine
you should
during pregnancy. Tell your doctor if
you are pregnant or intend to become If you put too many drops in your
pregnant.
eye or swallow any of the contents of
the container, you should contact
Breast-feeding
your doctor immediately.
You should not use this medicine

during breast-feeding. Tell your doctor If you forget to use Eydelto
if you are breast-feeding or intend to
It is important to use this medicine
breast-feed.
as prescribed by your doctor.
If you miss a dose, use it as soon as
Driving and using machines
possible. However, if it is almost time
No studies on the effects on the
for the next dose, skip the missed
ability to drive or use machines have
dose and go back to your regular
been performed. There are side
effects associated with this medicine, dosing schedule.
Do not use a double dose to make up
such as dizziness and blurred vision,
for a forgotten dose.
which may affect your ability to drive
and/or operate machinery. Do not
If you stop using Eydelto
drive or operate machinery until you
If you want to stop using this
feel well or your vision is clear.
medicine talk to your doctor first.
If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.

23346100

4. Possible side effects

5. How to store Eydelto

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
If you develop allergic reactions
including hives, swelling of the face,
lips, tongue, and/or throat which may
cause difficulty in breathing or
swallowing, you should stop using this
medicine and seek immediate medical
advice.
The following side effects have been
reported with Dorzolamide either
during clinical trials or during postmarketing experience:
Very Common (may affect more
than 1 in 10 people)
• Burning and stinging of the eyes.
Common (may affect up to
1 in 10 people)
• Disease of the cornea with sore eye
and blurred vision (superficial
punctuate keratitis)
• Discharge with itching of the eyes
(conjunctivitis)
• Irritation/inflammation of the eyelid
• Blurred vision
• Headache, nausea
• Bitter taste
• Fatigue.
Uncommon (may affect up to
1 in 100 people)
• Inflammation of the iris.
Rare (may affect up to
1 in 1,000 people)
• Tingling or numbness of the hands
or feet
• Temporary short-sightedness which
may resolve when treatment is
stopped
• Development of fluid under the
retina (choroidal detachment,
following filtration surgery)
• Eye pain
• Eyelid crusting
• Low pressure in the eye
• Swelling of the cornea (with
symptoms of visual disturbances)
• Eye irritation including redness
• Kidney stones
• Dizziness
• Nose bleed
• Throat irritation
• Dry mouth
• Localised skin rash (contact
dermatitis)
• Severe skin reactions
• Allergic type reactions such as rash,
hives, itching, in rare cases possible
swelling of the lips, eyes and
mouth, shortness of breath, and
more rarely wheezing.
Not known (frequency cannot be
estimated from the available data)
• Shortness of breath
• Foreign body sensation in eye
(feeling that there is something in
your eye).

Keep this medicine out of the sight
and reach of children.
This medicinal product does not
require any special storage
conditions.
After first opening, the product may
be stored for a maximum of 28 days.
No special storage conditions are
required.
Do not use this medicine after the
expiry date which is stated on the
carton and the bottle after EXP. The
expiry date refers to the last day of
that month. Make sure the container
is properly closed.
Do not use this medicine if you notice
that the seal is broken the first time
you use the container.
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 protect the
environment.

Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible 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.

6. Contents of the pack and
other information
What Eydelto contains
• The active substance is
dorzolamide.
• Each ml contains 20mg of
dorzolamide (as dorzolamide
hydrochloride).
• The other ingredients are
hydroxyethyl cellulose, mannitol,
sodium citrate dihydrate, sodium
hydroxide, and water for injections.
What Eydelto looks like and
contents of the pack
Eydelto eye drops solution is
presented as a 5ml clear, colorless
aqueous, slightly viscous solution, in
white opaque 11ml LDPE bottle and
white Novelia nozzle (HDPE and
silicone) with a white HDPE cap.
Pack sizes: 1 or 3 bottles in a
cardboard box
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Aspire Pharma Ltd
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire, GU32 3QG
UK
Manufacturer
Pharmathen S.A.,
6 Dervenakion
15351 Pallini Attiki
Greece
and
EXCELVISION
27 st. La Lombardière, Zl La
Lombardière,
ANNONAY 07100
France
This leaflet was last revised in
04/2017

1010367-P2.6
23346100

Artwork for:
Product name:
Size:
PL/PA no:
Type:
Artwork dimensions:
Profile supplied:
Date of first artwork:
Reason for request:
Version no:
Date of revision:
Colours:
Font(s):
Artwork software:
BAC ref:

Aspire Pharma Limited
Eydelto 20mg/ml
PL 35533/0085
Leaflet
630mm x 120mm
Yes
28 October 2016
Text edits
2.6
26 April 2017
As swatch(es)
9pt Tahoma
InDesign CC
U145 (formerly U107)

Black

Expand Transcript

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