0.5% eye drops, solution
tropicamide
What Mydriacyl is and what it is used for
Mydriacyl 0.5% eye drops, the solution contains the active substance tropicamide.
Mydriacyl dilates pupil one and temporarily paralyzes the muscles in pupil one.
Mydriacyl is used in eye examinations. When the pupil is dilated, it is easier for the doctor to examine the eye.
Tropicamide contained in Mydriacyl may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Mydriacyl
Do not use Mydriacyl
- if you are allergic to tropicamide or any of the other ingredients of this medicine (listed in section 6).
- if you have a shallow anterior chamber or a narrow anterior chamber angle due to the risk of an acute increase in pressure in the eye ( acute glaucoma ).
Warnings and cautions
Talk to your doctor or pharmacist before using Mydriacyl.
Talk to your doctor as the use of Mydriacyl may cause:
- elevated pressure in the eye. You should have your eye pressure checked before starting treatment.
If you are taking other medicines: Also read the section “Other medicines and Mydriacyl”.
Children
- Do not use in concentrations higher than 0.5% in infants as there is a risk of serious side effects (see section “Possible side effects”).
- if Mydriacyl is given to infants, young children or premature babies, children with Down syndrome, spastic paralysis or brain damage. Talk to your doctor as serious side effects may occur while using this medicine.
- if Mydriacyl misses the eye, wash it off immediately.
Other medicines and Mydriacyl
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if you are taking:
- antihistamine is
- antidepressants
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Mydriacyl should not be used during pregnancy unless necessary.
Mydriacyl should not be used during breastfeeding.
Driving and using machines
This type of medicine can cause drowsiness, blurred vision, and photosensitivity. If you get any of these side effects, do not drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Mydriacyl contains benzalkonium chloride
If you wear contact lenses:
Remove the contact lenses (hard or soft) before using Mydriacyl and wait at least 15 minutes before reinserting the lenses.
Mydriacyl contains a preservative (benzalkonium chloride) that can irritate the eyes and has been found to discolor soft contact lenses. Avoid contact with soft contact lenses.
How to use Mydriacyl
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
Adults, including the elderly
2 drops in the eye (s) 20 to 25 minutes before the eye examination.
Children
Dose one is determined by the doctor who adjusts it individually for your child.
Use for children
Do not use in concentrations higher than 0.5% in infants as there is a risk of serious side effects. Also read the sections “Warnings and Precautions”, “If you have used too much Mydriacyl” and “Possible side effects”.
Use Mydriacyl only to drip into the eyes. Do not inject.
How to use Mydriacyl correctly
If the safety collar is loose when the cover has been removed, it must be removed before using the product.
- Take out the bottle of Mydriacyl.
- Wash your hands and sit in front of a mirror.
- Turn off the bottle cap.
- Hold the bottle with the tip down between your thumb and forefinger (picture 1).
- Tilt your head back. Pull down the lower eyelid with a clean finger until a “pocket” is formed between the lower eyelid and the eye. This is where the drop should be placed .
- Bring the tip of the bottle towards the eye. Use a mirror if it makes it easier.
- Avoid touching the eye or eyelid, surrounding areas or other surfaces with the drip tip. It may contaminate the eye drops in the bottle.
- Do not squeeze the bottle: it is designed so that a light pressure on the bottom is all that is needed (Fig. 2).
- Gently press on the bottom of the bottle to release one drop of Mydriacyl at a time (Figure 3).
- After using Mydriacyl, close the eyelid and gently press with a finger into the inner corner of the eye for 2 minutes (Fig. 4). It prevents Mydriacyl from reaching other parts of the body.
- If you are using Mydriacyl in both eyes, repeat steps 4 through 10 for the other eye.
- Tighten the bottle cap carefully immediately after use.
If a drop misses the eye, wipe it off immediately and try again.
If you use other eye drops or ointments, wait at least 5 minutes between using the medicines. Eye ointments should be used last.
If you use more Mydriacyl than you should
If you have used too much Mydriacyl, rinse everything out with lukewarm water. Do not drip in a few more drops until it is time for your next regular dose.
Symptoms of eye overdose may include redness and dry skin (children may get a rash), blurred vision, rapid and irregular heartbeat, fever, swollen abdomen in infants, seizures, hallucinations, or loss of coordination.
If you forget to use Mydriacyl
Continue with the next dose as planned. However, if it is almost time for your next dose, you can skip the missed dose and return to your regular dosing schedule.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been seen with Mydriacyl:
Common (affects 1 to 10 users in 100):
Effects on the eye: Temporary burning in the eye when the drops are given (eye pain), decreased nearsightedness, photosensitivity.
Common side effects: reddening of the skin, rapid heartbeat, fever, constipation, confusion, upset, hallucinations.
Uncommon (affects 1 to 10 users in 1,000):
General side effects: Allergic reactions, difficulty throwing water.
Rare (affects 1 to 10 users in 10,000):
Effects on the eye: Acute increase in pressure in the eye ( acute glaucoma ).
No known frequency (can not be calculated from the available data):
Eye effects: Blurred vision, increased pupil size (prolonged drug effect), eye irritation, reddening of the eyes, decreased production of tear fluid.
General side effects: Dizziness, headache, fainting, decreased blood pressure, nausea, rash, dry mouth, decreased intestinal motility, inability to vomit water, dry mucous membranes decreased sweating, dryness of the trachea and nasal passages.
How to store Mydriacyl
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
The bottle is discarded 4 weeks after opening.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is tropicamide. One ml of solution contains 5 mg of tropicamide.
- The other ingredients are benzalkonium chloride ( preservative ), sodium chloride, disodium edetate, hydrochloric acid and / or sodium hydroxide for pH adjustment and purified water.
What the medicine looks like and contents of the pack
Mydriacyl is colorless to a pale yellow solution supplied in a 15 ml low-density polyethylene plastic bottle (DROPTAINER) and a polypropylene screw cap.
Marketing Authorisation Holder
Alcon Nordic A / S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
Manufacturer
SA Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium