sign in sign up
<<
Home , Cycloplegia, Mydriasis

771721

Package Leaflet - Information for the User ™ MYDRIACYL 1 % w / v eye drops, solution

Read all of this leaflet carefully before you start using this . • 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 4. Possible side effects is used for 5. How to store MYDRIACYL 1 % 2. Before you use MYDRIACYL 1 % 3. How to use MYDRIACYL 1 % 6. Further information 1 WHAT MYDRIACYL 1 % IS AND WHAT IT IS USED FOR

MYDRIACYL 1 % belongs to a group of MYDRIACYL 1 % may also be used before or known as . after you have surgery on your eye. It is used to enlarge the of your eye ( ) to allow for easier examination of the inside of the eyeball and to relax the muscles in your eye ( ) when your vision is being tested. 2 BEFORE YOU USE MYDRIACYL 1 % Do not use MYDRIACYL 1 %... are breast-feeding a baby, talk to your doctor • If you have or think that you may get before you use MYDRIACYL 1 %. . • If you are allergic to tropicamide or any of Driving and using machines the other ingredients listed in section 6. You may experience temporary drowsiness, and sensitivity to when using Ask your doctor for advice. this medicine. Do not drive or use any machines unless your vision is clear. This Take special care... may take up to 6 hours after you have used • Not for . MYDRIACYL 1% eye drops MYDRIACYL 1 %. should only be administered in the eye(s). • Consult your doctor for advice; use of this product Using other medicines may cause: Tell your doctor or pharmacist if you are - Increase in the pressure in your eye. You should taking or have recently taken any other have your eye pressure checked before initiation medicines, including medicines obtained of therapy, especially in elderly. without a prescription. This is particularly - Changes in behavior (especially in infants and important if you are taking medicines for the children). treatment of allergies, depression, anxiety, heart , asthma or other breathing • If your eyes are red. problems, motion sickness, Parkinson’s • If you are not able to use medicines called disease, bladder or gastrointestinal problems. belladonna alkoloids, (you may be more likely to experience side effects). MYDRIACYL 1% contains If any of these apply, you may still be able to use Benzalkonium chloride MYDRIACYL 1%, but discuss it with your doctor first. This medicine contains 0.0035 mg benzalkonium chloride in each drop which is equivalent to 0.1 mg/ Use in children ml. • Do not use MYDRIACYL 1.0 % in small infants because of the risk of serious adverse reactions. Benzalkonium chloride may be absorbed by soft • Take special care if MYDRIACYL 1.0 % is contact lenses and may change the colour of the being administered to infants, small or premature contact lenses. You should remove contact lenses children, children with : Down syndrome, spastic before using this medicine and put them back 15 paralysis, brain damage. Consult your doctor for minutes afterwards. Benzalkonium chloride may also advice as serious adverse reactions may occur cause eye irritation, especially if you have dry eyes or with the use of this product. disorders of the (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging Pregnancy and breast-feeding or pain in the eye after using this medicine, talk to If you are pregnant or might get pregnant, or if you your doctor. 3 HOW TO USE MYDRIACYL 1 % The usual dose Remove the loose collar from the cap when The usual dose for cycloplegia is 1 or 2 drops the bottle is first opened. in your eye( s ), repeated after 5 minutes. If the Always use MYDRIACYL 1 % exactly as your eye is not examined within 20 to 30 minutes doctor has told you. You should check with another drop may be added to prolong the your doctor or pharmacist if you are not sure. effect.

Continued over

771721-0721 I MYDRCL 5mL GB Process Black Alex Nieschlag NEW 30.07.2021

SPECIAL INSTRUCTIONS GO HERE By Alex Nieschlag

1:43 pm, Jul 30, 2021 3 HOW TO USE MYDRIACYL™ 1 % ( continued ) How to use • Do not touch your eye or , surrounding areas or other surfaces with the • Wash your hands before you start. dropper. It could infect the drops. • Twist off the bottle cap. • Gently press on the base of the bottle to • Hold the bottle pointing down, 1 release one drop at a time ( picture 2 ). between your thumb and fingers. • Do not squeeze the bottle, only a gentle • Tilt your head back. press on the bottom is needed. • Pull down your lower eyelid • Press the corner of your eye nearest to with a finger, until there is a your nose with a finger for 2 minutes ‘pocket’ between the eyelid immediately after use. This will reduce the and your eye. The drop will 2 amount of the medicine getting to the rest of go in here ( picture 1 ). your body. Keep the eyelid closed for 2 minutes. • Bring the bottle tip close to the eye. • If you use drops in both eyes, repeat the Do this in front of a mirror if it helps. steps for your other eye. Put the bottle cap firmly back on immediately after use.

• Do not get MYDRIACYL 1 % in your child’s Symptoms of overdose may include : flushing and mouth ; wash your hands and your child’s dryness of the skin ( a rash may be present in hands immediately after administration. children ), blurred vision, rapid and irregular pulse, • MYDRIACYL 1 % may be harmful, fever, abdominal swelling in infants, convulsions, especially in children, if too much is used hallucinations, or loss of coordination. or if it is accidentally swallowed. If this In case of severe overdose or accidental happens, the body surface of infants and ingestion, immediately seek advice from your children should be kept moist. doctor, pharmacist as serious reactions may Contact your doctor or hospital emergency occur ( especially in children ). department immediately. • If you are using other or eye • If a drop misses your eye, try again. ointment medicines, leave at least 5 minutes • If you use more MYDRIACYL 1% than you between each medicine. Eye ointments should should rinse it all out with lukewarm water see be administered last. your doctor as soon as possible. If you have any further questions on the use of MYDRIACYL 1 %, ask your doctor or pharmacist. 4 POSSIBLE SIDE EFFECTS

Like all medicines, MYDRIACYL 1 % can cause • In children, other effects that may occur side effects, although not everybody gets them. include : • You may experience some or all of the Skin rash, changes in behaviour, enlarged or following effects in your eye( s ) : abnormal abdomen ( in infants ). More extreme Temporary blurred vision, sensitivity to light, reactions such as confusion, excitement, pain, irritation, redness, increase in pupil size, hallucinations, increasing drowsiness, rapid increased pressure in the eye ( which may breathing and changes in pulse rate require cause headache ). urgent medical advice and attention. • You may also experience effects in other areas of your body including : Reporting of side effects If you get any side effects, talk to your doctor, Dizziness, headache, fainting, decreased blood pharmacist or nurse. This includes any possible pressure, nausea and rash. Psychotic reactions side effects not listed in this leaflet. You can also and behavioural disturbances have been report side effects directly via the Yellow Card reported with this class of , especially in Scheme at : www.mhra.gov.uk / yellowcard. By children, flushing of the skin, dryness of reporting side effects you can help provide more mucous membranes, dryness of skin, irregular information on the safety of this medicine. heartbeat, decrease in sweating and dryness of the mouth, constipation, inability to ( completely ) empty the bladder. 5 HOW TO STORE MYDRIACYL 1 %

• Keep out of the reach and sight of children. • Stop using the bottle 4 weeks after first • Do not store in a refrigerator or freezer or opening, to prevent infections. above 25 °C. • Medicines should not be disposed of via • Keep the container in the outer carton. waste water or household waste. Ask your pharmacist how to dispose of medicines no • Keep the container tightly closed. longer required. These measures will help to • Do not use the drops after the expiry date protect the environment. ( marked ‘Exp’ ) on the bottle and the carton. • Do not pass this medicine on to others. The expiry date refers to the last day of that It may harm them, even if their symptoms are month. the same as yours. • Do not use eye drops which have changed colour or contain a precipitate ( visible solids ). 6 FURTHER INFORMATION What MYDRIACYL 1 % contains What MYDRIACYL 1 % looks like • The active substance is tropicamide 10 mg / ml and contents of the pack • The other ingredients are sodium chloride, MYDRIACYL 1 % is a clear, colourless solution disodium edetate, benzalkonium chloride, supplied in a pack containing a 5 ml plastic hydrochloric acid and / or sodium hydroxide bottle with a screw cap. ( to adjust pH ) and purified water.

Marketing authorisation holder : Manufacturer : Alcon Eye Care UK Limited Alcon Laboratories Belgium Park View, Riverside Way, Watchmoor Park, Lichterveld 3 Camberley, Surrey, GU15 3YL 2870 Puurs-Sint-Amands, Belgium United Kingdom This leaflet was last revised in 12/2020

07-2021 771721