Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Mydriacyl 1% eye drops, solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tropicamide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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.
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BEFORE YOU USE MYDRIACYL 1 %
Do not use MYDRIACYL 1 %…
- 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…
- Not for injection. MYDRIACYL 1% eye drops should only be administered in the eye(s).
- 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.
Pregnancy and breast-feeding
If you are pregnant or might get pregnant, or if you
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are breast-feeding a baby, talk to your doctor before you use MYDRIACYL 1 %.
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 1 %.
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.
MYDRIACYL 1% contains Benzalkonium chloride
This medicine contains 0.0035 mg benzalkonium chloride in each drop which is equivalent to 0.1 mg/ ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
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.
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771721-0721 I MYDRCL 5mL GB Alex Nieschlag
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NEW SPECIAL INSTRUCTIONS GO HERE
By Alex Nieschlag 1:43 pm, Jul 30, 2021
30.07.2021
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HOW TO USE MYDRIACYLTM 1 % ( continued )
How to take it
- 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.
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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.
- 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
- 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. Marketing authorisation holder : Alcon Eye Care UK Limited Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL United Kingdom
07-2021
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.
Possible 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.
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- 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.
What MYDRIACYL 1 % looks like and contents of the pack MYDRIACYL 1 % is a clear, colourless solution supplied in a pack containing a 5 ml plastic bottle with a screw cap. Manufacturer : Alcon Laboratories Belgium Lichterveld 3 2870 Puurs-Sint-Amands, Belgium This leaflet was last revised in 12/2020
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How to store it
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 ).
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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
Frequently asked questions about Mydriacyl 1% eye drops, solution
How do I take Mydriacyl 1% eye drops, solution?
Mydriacyl 1% eye drops, solution comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Mydriacyl 1% eye drops, solution?
The active substance in Mydriacyl 1% eye drops, solution is tropicamide.
Are there equivalent medicines to Mydriacyl 1% eye drops, solution?
Medicines with the same active substance, strength and form include: Minims Tropicamide 0.5% w/v, Eye drops solution, Minims Tropicamide 1% w/v, Eye drops solution, Tropicamide 1% w/v eye drops, solution in single-dose container. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Mydriacyl 1% eye drops, solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Mydriacyl 1% eye drops, solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tropicamide
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Tropicamide is a short acting anticholinergic agent used as a mydriatic and cycloplegic. It is indicated for topical use for:
Diagnostic purposes for fundoscopy and cycloplegic refraction.
Use in pre- and post-operative states where a short acting mydriatic is required.
4.2. Posology and method of administration
Adults, Elderly and children:
Fundoscopy:
One or two drops of 0.5% solution instilled into the eyes 15 to 20 minutes prior to examination.
Cycloplegic Refraction:
One or two drops of 1% solution repeated after 5 minutes. If the patient is not seen within 20 to 30 minutes an additional drop may be instilled to prolong the effect.
Use in Children:
Tropicamide has been reported to be inadequate for cycloplegia in children. A more powerful cycloplegic agent such as atropine may be required. Do not use in concentrations greater than 0.5% in small infants (See section 4.4 Special warnings and precautions for use, section 4.8 Undesirable effects and section 4.9 Overdose)
Method of administration
• For topical ophthalmic use only.
• After cap is removed, if tamper evident nap collar is loose, remove before using product.
• Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
• If more than one topical ophthalmic product is being used, the products must be administered at least 5 minutes apart. Eye ointments should be administered last.
4.3. Contraindications
• Glaucoma or a tendency towards glaucoma (e.g. Narrow anterior chamber angle).
• Hypersensitivity to any component.
4.4. Special warnings and precautions for use
• Tropicamide may cause increased intraocular pressure. The possibility of undiagnosed glaucoma should be considered in some patients, such as elderly patients. Determine the intraocular pressure and an estimation of the depth of the angle of the anterior chamber prior to initiation of therapy.
• Tropicamide-induced psychotic reactions and behavioral disturbances may occur in patients with increased susceptibility to anticholinergic drugs (See Section 4.8 Undesirable effects).
• Extreme caution is advised for use in children and individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity.
• Use with caution in an inflamed eye as the hyperaemia greatly increases the rate of systemic absorption through the conjunctiva. To reduce systemic absorption the lacrimal sac should be compressed at the medial can thus by digital pressure for at least two minutes after instillation of the drops.
• Mydriacyl contain benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to the application of Mydriacyl and wait at least 15 minutes before reinsertion.
• Not for intravenous injection, life threatening adverse reactions have been reported to occur if this preparation is administered intravenously.
Pediatric Population
• Tropicamide may cause central nervous system disturbances, which may be dangerous in infants and children.
• Excessive use in children may produce systemic toxic symptoms. Use with extreme caution in infants, small or premature children, or children with Down syndrome, spastic paralysis or brain damage.
• Parents should be warned of the oral toxicity of this preparation for children and advised to wash their own hands and the child's hands after use.
4.5. Interaction with other medicinal products and other forms of interaction
The effect of anti-muscarinic agents may be enhanced by the concomitant administration of other drugs with anti-muscarinic properties such as amantadine, some anti-histamines, antipsychotics, phenothiazines and tricyclic anti-depressants.
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.
4.6. Fertility, pregnancy and lactation
Fertility
There is no adequate information on whether this drug may affect fertility in human males or females.
Pregnancy
There is insufficient evidence as to drug safety in pregnancy and lactation. This product should be used during pregnancy only when it is considered essential by a physician.
Lactation
It is unknown whether tropicamide/metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Mydriacyl therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
4.7. Effects on ability to drive and use machines
Tropicamide eye drops have a moderate influence on the ability to drive and use machines.
Tropicamide may cause drowsiness, blurred vision and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities unless vision is clear. Complete recovery from the effects of tropicamide eyedrops may take up to six hours.
4.8. Undesirable effects
The following adverse reactions have been reported following use of tropicamide topical ophthalmic preparations. Frequencies cannot be estimated from the available data. Within each System Organ Class adverse reactions are presented in order of decreasing seriousness.
System Organ Classification
MedDRA Preferred Term (v. 12.1)
Nervous system disorders
Not known (cannot be estimated from the available data): dizziness, headache
Eye disorders
Not known (cannot be estimated from the available data): vision blurred, photophobia, eye pain, eye irritation, ocular hyperaemia
Vascular disorders
Not known (cannot be estimated from the available data): syncope, hypotension
Gastrointestinal disorders
Not known (cannot be estimated from the available data): nausea
Skin and subcutaneous issue disorders
Not known (cannot be estimated from the available data): rash
General disorders and administration site conditions
Not known (cannot be estimated from the available data): drug effect prolonged (mydriasis)
Cycloplegic drugs may increase intraocular pressure and can precipitate angle-closure glaucoma in predisposed patients (See section 4.3 Contraindications and section 4.4 Special warnings and precautions for use).
Psychotic reactions, behavioural disturbances and cardio respiratory collapse have been reported with this class of drug, especially in children (See section 4.4 Special warnings and precautions for use).
Other toxic manifestations of anticholinergic drugs include flushing of the skin, dryness of the mouth, dryness of mucous membranes, dryness of the skin, bradycardia followed by tachycardia with palpitations and arrhythmias, decrease secretion in sweat glands and dryness of the mouth, diminished gastrointestinal motility and constipation, urinary urgency, difficulty and retention and decreased nasal, bronchial and lachrymal secretions.
Local: increased intraocular pressure, transient stinging and sensitivity to light secondary to pupillary dilation. Prolonged administration may lead to local irritation, hyperaemia, oedema and conjunctivitis.
Vomiting, giddiness and staggering may occur, a rash may be present in children and abdominal distention in infants.
Paediatric Population
Tropicamide may cause central nervous system disturbances, which may be dangerous in infants and children (See Section 4.4 Special warnings and precautions for use).
An increased risk for systemic toxicity has been observed in infants, small or premature children, or children with Down syndrome, spastic paralysis or brain damage with cycloplegic drugs (See Section 4.4 Special warnings and precautions for use).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
An ocular overdose of Tropicamide Eye Drops can be flushed from the eye(s) with lukewarm water.
Systemic toxicity may occur following topical use, particularly in children, it is manifested by flushing and dryness of the skin, (a rash may be present in children), blurred vision, a rapid and irregular pulse, fever abdominal distention in infants, convulsions and hallucinations and the loss of neuro-muscular co-ordination.
Treatment is symptomatic and supportive, (there is no evidence that physostigmine is superior to supportive management). In infants and small children the body surface must be kept moist. If accidentally ingested, induce emesis or perform gastric lavage.
💬 Ask about this leaflet
Ask anything about Mydriacyl 1% eye drops, solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.