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.
Mydrilate 0.5% Eye Drops
⚠ 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 Cyclopentolate hydrochloride 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 Mydrilate eye drops are prescription eye drops containing the active ingredient cyclopentolate hydrochloride. They are available in two strengths, 0.5% and 1 %. They belong to a group of medicines known as mydriatic (used for pupil dilation) and cycloplegic (used to block the muscles of the eye that control the shape of the lens). Mydrilate eye drops are applied on the surface of the eyes for diagnostic purposes during eye examinations and refraction tests. They can also be used to treat some types of eye inflammation (iritis and uveitis). 2. BEFORE YOU USE MYDRILATE EYE DROPS Do not use Mydrilate eye drops • • • • • •
if you are allergic (hypersensitive) to cyclopentolate hydrochloride, benzalkonium chloride or any other ingredients listed in section 6 if you suffer from glaucoma (high pressure in the eyeball) or if you are at risk of having it (i.e. your close family suffered from glaucoma, you are over 60, you have increased pressure in the eye, you had an eye injury) if you wear soft contact lenses – wait at least 15 minutes after removal of contact lenses prior to application. Mydrilate eye drops may discolour the lenses. if you suffer from paralytic ileus (loss of movement in the gut resulting in intestinal blockage) in children with brain damage, particularly if they may have seizures or fits if you are pregnant or breastfeeding
Mydrilate eye drops should not be used for infants three months of age or younger.
Nov 2025
Take special care with Mydrilate eye drops if you: • • • • • •
suffer from, or are prone to increased eye pressure especially in elderly patients have an enlarged prostate (males only) suffer from heart problems especially angina, heart attacks or heart failure suffer from ataxia (condition causing unsteadiness and coordination problems) have an inflamed eye(s) – inflammation greatly increases the risk that more of the eye drops are absorbed into the bloodstream are sensitive to belladonna alkaloids (drugs such as atropine used mainly to: dilate the pupils, prevent motion sickness, reduce secretion and dry up a runny nose, relieve stomach cramps)
Taking other medicines Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines are known to interact with Mydrilate eye drops:
- antihistamines
- medications for mental illness such as butyrophenones and phenothiazines
- tricyclic antidepressants (e.g. amitriptyline, lofepramine, trimipramine)
- amantadine, an antiviral drug used in the treatment of influenza A and Parkinson's disease Pregnancy and Breast-feeding Mydrilate eye drops should not be used if you are pregnant, trying to become pregnant or are breast-feeding unless considered essential by your doctor. Ask your doctor or pharmacist for advice before taking any medications. Driving and using machines Using Mydrilate eye drops may cause blurred vision, difficulty in focusing and sensitivity to light. Driving, operating machinery or engaging in hazardous activities such as climbing ladders should be avoided. Complete recovery from these symptoms takes 24 hours. Important information about one of the ingredients of Mydrilate This medicine contains 0.1 mg benzalkonium chloride in each millilitre. 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 take it
MYDRILATE EYE DROPS Always use Mydrilate eye drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. When using this product for the first time, screw down the cap firmly on the bottle to pierce the seal at the tip of the plastic nozzle and then unscrew the cap for use. Be sure to replace the cap after use. To reduce absorption into the blood stream place one finger at the inner corner of the eye near the nose and apply gentle pressure immediately after dispensing the drops. This will prevent the medicine from draining from the eye. Ask your doctor how to do this correctly.
Nov 2025
Dosage For diagnostic eye examinations your doctor will generally give you Mydrilate eye drops as follows: Adults and the elderly:
- One drop of 0.5 % solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination.
- Deeply pigmented eyes may require the use of a 1 % solution. Children 6 – 16 years:
- One drop of 1 % solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination. Children under 6 years:
- One or two drops of 1 % solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination. For inflammatory conditions of the eye Mydrilate eye drops are generally used as follows: Adults and the elderly:
- One or two drops of 0.5 % solution instilled into the eye up to 4 times daily or as required.
- Deeply pigmented eyes may require the use of a 1 % solution. Children:
- At the discretion of the physician. Mydrilate eye drops should not be used for infants three months of age or younger. If you accidentally swallow Mydrilate eye drops You should wash your hands after use. If Mydrilate eye drops are accidentally swallowed, contact your doctor or pharmacist immediately describing the symptoms. If you use more Mydrilate eye drops than you should Contact your doctor, hospital, or pharmacy if you have used more Mydrilate eye drops than prescribed. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Mydrilate eye drops can cause side effects although not everybody gets them. If you experience the following side effects, you should stop using Mydrilate Eye Drops immediately and seek urgent medical advice:
- irregular heart rate
- urinary retention (difficulty passing urine) The following side effects have been observed in children or infants. If they occur, treatment should be stopped immediately and urgent medical advice should be sought:
- fits, a jerk or spasm of a part of the body (usually a leg or an arm), difficulty speaking or speaking in nonsensible ways (reported in a small number of patients)
- collapse, affecting breathing, heart rate and blood pressure Other side effects that have been observed are:
- increased pressure in the eyeball
- temporary stinging of the eye
- sensitivity to light due to pupil dilation
Nov 2025
• • • • • • • • • • •
dry mouth flushing dry skin heart palpitations slow or faster heartbeat urinary urgency (difficulty in holding your bladder) painful urination constipation vomiting dizziness and staggering following prolonged use: eye irritation, hyperaemia (excessive blood in the vessels of the eye), oedema (excessive fluid in the eye) and conjunctivitis (commonly called "redeye"- inflammation of the outermost layer of the eye and inner surface of the eyelids)
Children and infants Other side effects that have been observed in children are:
- rash
- psychiatric reactions
- behavioural disturbances
- bloating of the stomach in infants
- intestinal tissue death (called necrotising enterocolitis) may occur in premature babies The frequency of all the possible side effects listed above is classed as 'not known', which means that it cannot be estimated from the available data. 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 any side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
How to store it
MYDRILATE EYE DROPS Keep out of the sight and reach of children. Do not freeze. Store in the original package in order to protect from light. Before first opening Store in a refrigerator (between 2°C – 8°C). Prior to first opening: Remove from refrigerator and store at room temperature for 30 minutes. After first opening: Do not store above 25°C. Do not refrigerate. Discard 28 days after first opening. Do not use the eye drops after the expiry date which you will find printed on the packaging.
Nov 2025
6. FURTHER INFORMATION What Mydrilate eye drops contain: Mydrilate eye drops 5 ml dropper bottle contain either 0.5% or 1% of the active ingredient Cyclopentolate Hydrochloride. Each solution also contains the inactive ingredients: boric acid, potassium chloride, benzalkonium chloride solution and purified water. What Mydrilate eye drops look like: The eye drops are available in 5 ml dropper bottles. Marketing Authorisation Holder and Manufacturer for UK: Esteve Pharmaceuticals Ltd, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT, United Kingdom This leaflet was last revised in November 2025.
Nov 2025
Frequently asked questions about Mydrilate 0.5% Eye Drops
How do I take Mydrilate 0.5% Eye Drops?
Mydrilate 0.5% Eye Drops 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 Mydrilate 0.5% Eye Drops?
The active substance in Mydrilate 0.5% Eye Drops is cyclopentolate hydrochloride.
Are there equivalent medicines to Mydrilate 0.5% Eye Drops?
Medicines with the same active substance, strength and form include: Minims Cyclopentolate Hydrochloride 0.5%, Eye drops solution, Minims Cyclopentolate Hydrochloride 1%, Eye drops solution, Mydrilate 1.0% Eye Drops. 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 Mydrilate 0.5% Eye Drops, 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 Mydrilate 0.5% Eye Drops 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: cyclopentolate hydrochloride
- 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
(i) Diagnostic purposes for fundoscopy and cycloplegic refraction.
(ii) Dilating the pupil in inflammatory conditions of the iris and uveal tract.
4.2. Posology and method of administration
(i) Refraction / Fundoscopy
Adults (and the elderly):
One drop of 0.5 % solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination.
Deeply pigmented eyes may require the use of a 1 % solution.
NB: Maximum effect is reached after 30-60 minutes,
Children 6-16 years:
One drop of 1 % solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination
Children under 6 years:
One or two drops of 1 % solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination.
(ii) For Uveitis, Iritis and Iridocyclitis:
Adults and the elderly:
One or two drops of 0.5 % solution instilled into the eye up to 4 times daily or as required.
Deeply pigmented eyes may require the use of a 1 % solution.
Children:
At the discretion of the physician
Do not use during the first three months of life due to possible association between the cycloplegia produced and the development of amblyopia and also the increased risks of systemic toxicity in neonates.
Cycloplegia following administration is quick in onset and short-lived. Maximal cycloplegia is achieved within 15 - 45 minutes of instillation and lasts on average about 20 minutes. Recovery normally takes place in about 4 hours, but very occasionally some effect persists for up to 24 hours.
Mydriasis is produced very rapidly and an average pupil diameter of 7 mm is usually reached 15 - 30 minutes after instillation of one drop of 0.5 % solution. Complete recovery from the mydriatic effect generally occurs spontaneously in not more than 20 hours.
No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.
4.3. Contraindications
(i) Use in narrow-angle glaucoma or those with a tendency towards glaucoma e.g. patients with a shallow anterior chamber.
(ii) Hypersensitivity to cyclopentolate hydrochloride, benzalkonium chloride or any other components of the formulation.
(iii) This preparation contains benzalkonium chloride and should not be used whilst soft contact lenses are being worn.
(iv) Use in patients with paralytic ileus.
(v) Use in children with organic brain syndromes, including congenital or neuro- developmental abnormalities, particularly those predisposing to epileptic seizures.
4.4. Special warnings and precautions for use
Because of the risk of precipitating angle-closure glaucoma in the elderly and others prone to raised intraocular pressure, an estimate of the depth of the anterior chamber should be made before use, particularly if therapy is likely to be intense or protracted.
Caution should be observed when drugs of this group are administered to patients with prostatic enlargement, coronary insufficiency or cardiac failure, or ataxia. Atropine-like effects have been reported as side-effects.
Extreme caution is advised for use in children and individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity.
Patients should be warned of the oral toxicity of this preparation, and advised to wash their hands after use. If accidentally swallowed, patients should be advised to seek medical attention.
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 canthus by digital pressure for at least two minutes after instillation of the drops.
Paediatric population
Use of mydriatic agents has been associated in preterm infants with feed intolerance, abdominal distention, increased gastric aspirate and rare cases of necrotising enterocolitis.
Convulsions in children have also been reported in association with the use of cyclopentolate (see section 4.8).
4.5. Interaction with other medicinal products and other forms of interaction
The effects of anti-muscarinic agents may be enhanced by the concomitant administration of other drugs with anti-muscarinic properties such as some antihistamines, butyrophenones, phenothiazines, tricyclic antidepressants and amantadine.
4.6. Pregnancy and lactation
There is insufficient evidence as to drug safety in pregnancy and lactation. This product should not be used during pregnancy unless it is considered essential by a physician.
4.7. Effects on ability to drive and use machines
May cause blurred vision, difficulty in focusing and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities (including climbing ladders and scaffolding) unless vision is clear. Complete recovery from the effects of Mydrilate Eye Drops may take up to 24 hours.
4.8. Undesirable effects
Frequencies are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
System organ class
Adverse reactions
Frequency
Psychiatric disorders
abnormal behavioura, psychotic disordersa
not known
Nervous system disorders
dizziness, convulsionsb, partial seizuresb
not known
Eye disorders
eye pain, increased intraocular pressure, eye oedema1, eye irritation (stinging)1, ocular hyperaemia1, conjunctivitis1, photophobia2
not known
Cardiac disorders
bradycardia, tachycardia, palpitations, arrhythmia, cardiopulmonary failurea
not known
Vascular disorders
flushing
not known
Gastrointestinal disorders
dry mouth, vomiting, gastrointestinal hypomotility and constipation, abdominal distensionc, necrotising enterocolitisd
not known
Skin and subcutaneous disorders
dry skin, skin rasha
not known
Renal and urinary disorders
urinary urgency, urinary retention, dysuria
not known
General disorders and administration site conditions
gait disturbance
not known
Notes
General
1. Following prolonged administration
2. Secondary to pupillary dilation
Paediatric population
a. Abnormal behaviour, psychotic disorders, cardiopulmonary failure and skin rashes have been reported in the paediatric population.
b. Convulsions and partial seizures have been reported in children, although the cases reported to date have been low in number or isolated.
c. Cases of abdominal distension have been reported in infants.
d. Necrotising enterocolitis has been reported in preterm infants.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
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 distension in infants, convulsions and hallucinations and the loss of neuromuscular co-ordination.
Treatment is 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 Mydrilate 0.5% Eye Drops. 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.