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MYDRIACYL 0.5% W/V EYE DROPS SOLUTION

Active substance(s): TROPICAMIDE / TROPICAMIDE / TROPICAMIDE

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B. PACKAGE LEAFLET

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Package leaflet: Information for the User
MYDRIACYL® 0.5 % 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.
2.
3.
4.
5.
6.

What MYDRIACYL 0.5 % is and what it is used for
Before you use MYDRIACYL 0.5 %
How to use MYDRIACYL 0.5 %
Possible side effects
How to store MYDRIACYL 0.5 %
Further information

1.
WHAT MYDRIACYL® 0.5% IS AND WHAT IT IS USED FOR
MYDRIACYL 0.5 % belongs to a group of medicines known as anticholinergics.
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.
MYDRIACYL 0.5 % may also be used before or after you have surgery on your eye.
2.

BEFORE YOU USE MYDRIACYL® 0.5 %

Do not use MYDRIACYL 0.5 %...
 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.
Ask your doctor for advice.
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 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.

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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.

Pregnancy and breast-feeding
If you are pregnant or might get pregnant or are breast feeding a baby, talk to your doctor before you
use MYDRIACYL 0.5 %.
Driving and using machines
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 0.5 %.
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.
HOW TO USE MYDRIACYL® 0.5 %

3.

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 examination.
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 )

3.

How to use
 Wash your hands before you start.
 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).





Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
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).
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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.

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 immediately.
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.

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.
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 pharmacist.
4.
POSSIBLE SIDE EFFECTS
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.
• 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

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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® 0.5 %

5.










6.

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).
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 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.
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.
Marketing authorisation holder :
Novartis Pharmaceuticals UK Limited
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom
Manufacturer :
Manufacturer :
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
This leaflet was last revised in 04/2017

Alcon®
a Novartis company
© 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.

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