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Active substance(s): TROPICAMIDE

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Package Leaflet - Information for the User


0.5 % w/v eye drops, solution

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 your 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 get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

1. What MYDRIACYL 0.5 % is and
what it is used for
2. Before you use MYDRIACYL 0.5 %
3. How to use MYDRIACYL 0.5 %


4. Possible side effects
5. How to store MYDRIACYL 0.5 %
6. Further information



MYDRIACYL 0.5 % belongs to a group of
medicines known as anticholinergics.

MYDRIACYL 0.5 % may also be used before or
after you have surgery on your eye.

It is used to enlarge the pupil of your eye
(mydriasis) to allow for easier examination of
the inside of the eyeball and to relax the
muscles in your eye (cycloplegia) when your
vision is being tested.




Do not use MYDRIACYL 0.5 %...

Pregnancy and breast-feeding

• If you have or think that you may get
• If you are allergic to tropicamide or any of
the other ingredients listed in section 6.

If you are pregnant or might get pregnant or
are breast feeding a baby, talk to your doctor
before you use MYDRIACYL 0.5 %.

Ask your doctor for advice.

You may experience temporary drowsiness,
blurred vision and sensitivity to light when using
this medicine. Do not drive or use any
machines unless your vision is clear. This
may take up to 6 hours after you have used

Take special care...
• Consult your doctor for advice; use of this
product may cause:
- Increase in the pressure in your eye. You
should have your eye pressure checked
before initiation of therapy, especially in
- Changes in behaviour (especially in infants
and children).
• If your eyes are red.
• If you are not able to use medicines called
belladonna alkoloids, (you may be more
likely to experience side effects).
If any of these apply, you may still be able to
use MYDRIACYL 0.5 %, but discuss it with
your doctor first.

Use in children
• Do not use in concentrations greater than
0.5 % in small infants because of the risk of
serious adverse reactions.
• Take special care if MYDRIACYL 0.5 % is being
administered to infants, small or premature
children, children with : Down syndrome,
spastic paralysis, brain damage. Consult your
doctor for advice as serious adverse reactions
may occur with the use of this product.


Driving and using machines

Using other medicines
Tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription. This is particularly
important if you are taking medicines for the
treatment of allergies, depression, anxiety,
heart disease, asthma or other breathing
problems, motion sickness, Parkinson’s
disease, bladder or gastrointestinal problems.

Important information if you wear
Contact Lenses
Do not use the drops while wearing contact
lenses. Wait at least 15 minutes after use
before putting your lenses back in. There is a
preservative in MYDRIACYL 0.5 %
(benzalkonium chloride) that can discolour soft
contact lenses.



The usual dose
The usual dose to enlarge the pupil before
examination of the inside of your eye is 1 or 2 
drops in your eye(s) 15 to 20 minutes before

Remove the loose collar from the cap when
the bottle is first opened.
Always use MYDRIACYL 0.5 % exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

Continued over


HOW TO USE MYDRIACYL 0.5 % ( continued )
How to use
• Wash your hands before you
• Twist off the bottle cap.
• Hold the bottle pointing down,
between your thumb and fingers.
• Tilt your head back.
• Pull down your lower eyelid with
a finger, until there is a ‘pocket’
between the eyelid and your eye.
The drop will go in here (picture 1). 2
• Bring the bottle tip close to the
eye. Do this in front of a mirror if
it helps.
• Do not get MYDRIACYL 0.5 % in your child’s
mouth ; wash your hands and your child’s
hands immediately after administration.
• MYDRIACYL 0.5 % may be harmful,
especially in children, if too much is used or
if it is accidentally swallowed. If this
happens, the body surface of infants and
children should be kept moist. Contact your
doctor or hospital emergency department
• If a drop misses your eye, try again.
• If you use more MYDRIACYL 0.5 % than
you should rinse it all out with lukewarm water
see your doctor as soon as possible.


In case of severe overdose or accidental
ingestion, immediately seek advice from your
doctor, pharmacist as serious reactions may
occur (especially in children).
• If you are using other eye drop or eye
ointment medicines, leave at least 5 minutes
between each medicine. Eye ointments should
be administered last.
If you have any further questions on the use
of MYDRIACYL 0.5 %, ask your doctor or

• In children, other effects that may occur
include :
Skin rash, changes in behaviour, enlarged or
abnormal abdomen (in infants). More extreme
reactions such as confusion, excitement,
hallucinations, increasing drowsiness, rapid
breathing and changes in the pulse rate require
urgent medical advice and attention.
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:
By reporting side effects you can help provide
more information on the safety of this medicine.



• Keep out of the reach and sight of children.
• Do not store in a refrigerator or freezer or
above 25 °C.
• Keep the container in the outer carton.
• Keep the container tightly closed.
• Do not use the drops after the expiry date
(marked ‘Exp’) on the bottle and the carton.
The expiry date refers to the last day of that
• Do not use eye drops which have changed
colour or contain a precipitate (visible solids).


Symptoms of overdose may include : flushing and
dryness of the skin (a rash may be present in
children), blurred vision, rapid and irregular pulse,
fever, abdominal swelling in infants, convulsions,
hallucinations, or loss of coordination.


Like all medicines, MYDRIACYL 0.5 % can cause
side effects, although not everybody gets them.
• You may experience some or all of the
following effects in your eye(s) :
Temporary blurred vision, sensitivity to light,
pain, irritation, redness, increase in pupil size,
increased pressure in the eye (which may
cause headache).
• You may also experience effects in other
areas of your body including :
Dizziness, headache, fainting, decreased blood
pressure, nausea and rash. Psychotic reactions
and behavioural disturbances have been
reported with this class of drug, especially in
children, flushing of the skin, dryness of
mucous membranes, dryness of skin, irregular
heartbeat, decrease in sweating and dryness of
the mouth, constipation, inability to (completely)
empty the bladder.


• Do not touch your eye or eyelid,
surrounding areas or other surfaces with the
dropper. It could infect the drops.
• Gently press on the base of the bottle to
release one drop at a time (picture 2).
• Do not squeeze the bottle, only a gentle
press on the bottom is needed.
• Press the corner of your eye nearest to your
nose with a finger for 2 minutes immediately
after use. This will reduce the amount of the
medicine getting to the rest of your body. Keep
the eyelid closed for 2 minutes.
• If you use drops in both eyes, repeat the steps
for your other eye. Put the bottle cap firmly
back on immediately after use.

• Stop using the bottle 4 weeks after first
opening, to prevent infections.
• Medicines should not be disposed of via
waste water or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
• Do not pass this medicine on to others.
It may harm them, even if their symptoms are
the same as yours.


What MYDRIACYL 0.5 % contains
• The active substance is tropicamide 5 mg/ml
• The other ingredients are sodium chloride,
disodium edetate, benzalkonium chloride,
hydrochloric acid and/or sodium hydroxide
(to adjust pH) and purified water.
Marketing authorisation holder :
Alcon Laboratories (UK) Ltd.
Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, United Kingdom.

What MYDRIACYL 0.5 % looks like
and contents of the pack
MYDRIACYL 0.5 % is a clear, colourless solution
supplied in a pack containing a 5 ml plastic bottle
with a screw cap.

Manufacturer :
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
This leaflet was last revised in December 2014.

© 2006, 2010, 2012, 2013, 2014 Novartis


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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.