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MYDRIACYL 1% W/V EYE DROPS SOLUTION

Active substance(s): TROPICAMIDE

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44286-6

Package Leaflet - Information for the User

MYDRIACYL

®

1% w/v eye drops, solution

Tropicamide
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.

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

1

4. Possible side effects
5. How to store MYDRIACYL 1 %
6. Further information

WHAT MYDRIACYL 1 % IS AND WHAT IT IS USED FOR

MYDRIACYL 1 % belongs to a group of
medicines known as anticholinergics.

MYDRIACYL 1 % 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.

2

BEFORE YOU USE MYDRIACYL 1 %

Do not use MYDRIACYL 1 %...

Pregnancy and breast-feeding

• If you have or think that you may get
glaucoma.
• 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 1 %.

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
MYDRIACYL 1 %.

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
elderly.
- Changes in behavior (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 1 %, but discuss it with
your doctor first.

Use in children
• Do not use MYDRIACYL 1.0 % in small infants
because of the risk of serious adverse
reactions.
• Take special care if MYDRIACYL 1.0 % 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.

3

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 1 %
(benzalkonium chloride) that can discolour soft
contact lenses.

HOW TO USE MYDRIACYL 1 %

The usual dose
The usual dose for cycloplegia is 1 or 2 drops
in your eye(s), repeated after 5 minutes. If the
eye is not examined within 20 to 30 minutes
another drop may be added to prolong the
effect.

Remove the loose collar from the cap when
the bottle is first opened.
Always use MYDRIACYL 1 % exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

Continued over

3

HOW TO USE MYDRIACYL 1% ( continued )

How to use
• Wash your hands before you start.
• Twist off the bottle cap.
• Hold the bottle pointing down,
1
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
2
go in here (picture 1).
• Bring the bottle tip close to the eye.
Do this in front of a mirror if it helps.

• Do not get MYDRIACYL 1 % in your child’s
mouth ; wash your hands and your child’s
hands immediately after administration.
• MYDRIACYL 1 % 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 immediately.
• If a drop misses your eye, try again.
• If you use more MYDRIACYL 1 % than
you should rinse it all out with lukewarm
water see your doctor as soon as possible.

4

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 1 %, ask your doctor or
pharmacist.

• 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 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 : www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

HOW TO STORE MYDRIACYL 1 %

• 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
month.
• Do not use eye drops which have changed
colour or contain a precipitate (visible solids).

6

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.

POSSIBLE SIDE EFFECTS

Like all medicines, MYDRIACYL 1 % 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.

5

• 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.

FURTHER INFORMATION

What MYDRIACYL 1 % contains

What MYDRIACYL 1 % looks like
and contents of the pack

• The active substance is tropicamide 10 mg/ml
• The other ingredients are sodium chloride,
disodium edetate, benzalkonium chloride,
hydrochloric acid and/or sodium hydroxide
(to adjust pH) and purified water.

MYDRIACYL 1 % is a clear, colourless solution
supplied in a pack containing a 5 ml plastic
bottle with a screw cap.

Marketing authorisation holder :
Alcon Laboratories (UK) Ltd.
Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, United Kingdom.

Manufacturer :
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
This leaflet was last revised in March 2015.
®

© 2006, 2010, 2012, 2013, 2014 Novartis
10-2014

44286-6

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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.

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