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.
Minims Cyclopentolate Hydrochloride 0.5%, 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 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 Minims® Cyclopentolate Hydrochloride contains a mydriatic agent. It is used to enlarge the pupil of the eye and to paralyse the lens temporarily. Your doctor or eye specialist may use it to examine your eye more closely. These eye drops are also used to treat some types of inflammation of the eye. This medicine is not indicated for babies under 28 days old. However, your doctor or eye specialist can use it if he/she decides that it is necessary.
What you need to know before you take it
e Minims® Cyclopentolate Hydrochloride eye drops Do not use Minims® Cyclopentolate Hydrochloride eye drops:
- if you are allergic to the active substance (cyclopentolate hydrochloride) or any of the other ingredients (listed in section 6).
- in babies under 28 days old (unless your doctor decides that it is necessary).
- if you suffer from glaucoma (high pressure of liquid inside the eye) or if you are at risk of having it (i.e. your close family suffered from glaucoma, you are over 60, or you had an eye surgery). The doctor or eye specialist will check to make sure that this problem does not affect you.
- in children with brain damage, particularly if they may have seizures or fits. Warnings and precautions Ask yourself the following questions:
- Are your eyes red or inflamed?
- Do you have heart problems (in particular a fast heart rate or heart failure)?
- Do you have urinary tract disorders?
- Do you have long-term condition that causes muscle weakness (myasthenia gravis)?
- Do you have dry mucous membranes in your nose (rhinitis sicca)?
- Is it to be used in very young children (under 1 year old)?
- Do you suffer from ataxia (condition causing unsteadiness and coordination problems)?
- Do you suffer from, or are prone to increased eye pressure (especially in elderly patients)?
- Are you or is your child susceptible to belladonna alkaloids (for example, drugs such as atropine)?
- Do you have epilepsy?
- Do you have memory disorders such as dementia?
- Do you suffer from, or have a history of blockage in the intestines (gastrointestinal obstruction)? If the answer to any of these questions is yes, tell your doctor or eye specialist. Other medicines and Minims® Cyclopentolate Hydrochloride Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following medicines are known to interact with Minims® Cyclopentolate Hydrochloride:
- antihistamines
- butyrophenones, used to treat various psychiatric disorders such as schizophrenia, as well used to prevent nausea and vomiting• medications for mental illness such as phenothiazines
- tricyclic and tetracyclic antidepressants
- amantadine, an antiviral drug used in the treatment of influenza A and Parkinson's disease
- quinidine and disopyramide, medicines for cardiac disorders
- oxybutynin, used to treat overactive bladder Cyclopentolate may interfere with the eye pressure lowering actions of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. Pregnancy and breast-feeding Tell your doctor or eye specialist, he/she may decide to use these drops or to prescribe you an alternative. Contact lenses Your doctor will ask you to remove your contact lenses prior to the administration of the drops. There is no information on the effect of this product on contact lenses. Therefore, do not wear your contact lenses until the effects of the drops have completely worn off. Driving and using machines As with all eye drops, your vision may be blurred after putting the drops in. Wait until your vision is clear before driving or using machines.
How to take it
Minims® Cyclopentolate Hydrochloride eye drops Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The drops are for single use only and provided in single use Minims units, to treat both eyes if necessary. Once opened, use immediately. Discard any unused portion. Dosage
- The normal adult dose is 1 or 2 drops of solution in each eye, as required. The administration of the drops can be repeated every 6-8 hours, depending on the treatment.
- The normal child dose (over 3 months old – 12 years) is 1 drop of Minims® Cyclopentolate Hydrochloride 1 % w/v in each eye. For children above 12 years, the same dose as adults is recommended. Children should be observed for 45 minutes after the administration of the drops.
Method of administration The doctor or eye specialist will normally put the drops in your eye for you, but if you are putting the eye drops in yourself, then follow these instructions carefully. 1. Wash your hands. 2. Use a mirror, this will help you to see what you are doing. 3. Carefully dry your eyes using a tissue, and twist off the cap from the Minims body of the unit. 4. Pull your lower eyelid down gently, and then carefully place 1 or 2 drops inside your lower eyelid. 5. Close your eye and blink a few times to make sure your eye is covered by the liquid. 6. Close the eyelids. It is advisable to press gently on the inner corner of your eyelid for 1 minute. This will help stop the solution draining into your nose and throat. This is especially advisable in children, the elderly and population at risk. 7. Repeat steps 4, 5 and 6 for the other eye if necessary, then throw away the Minims unit, even if some solution remains. If you use more Minims® Cyclopentolate Hydrochloride than you should, an overdose is very unlikely to occur. If you suddenly feel unwell after receiving the drops, tell your doctor or eye specialist or contact your nearest emergency department immediately. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. You should contact your doctor immediately if you experience collapse, affecting breathing, heart rate and blood pressure, seizures, hallucinations, mental disturbances or any symptoms of a severe allergic reaction/anaphylactic shock. The symptoms of severe allergic reactions/ anaphylactic shock are difficulty breathing or swallowing, swelling of the face, lips, throat or tongue and severe skin rash. The following side effects may occur: Rare (may affect up to 1 in 1,000 people) Immune system disorders:
- allergic reaction Side effects with not known frequency (frequency cannot be estimated from available data) Eye disorders:
- eye irritation
- accommodation disorder (an eye-focusing problem) increased pressure inside the eye
- eye pain
- ocular hyperaemia (excessive blood in the vessels of the eye)
- vision blurred conjunctivitis (commonly called "red eye"- inflammation of the outermost layer of the eye and inner surface of the eyelids) Gastrointestinal disorders:
- abdominal distension (bloating of the stomach) in infants
- constipation
- dry mouth
- nausea
- vomiting
- necrotising colitis (intestinal tissue death) in preterm infants
Immune system disorders:
- hypersensitivity (both local and systemic hypersensitivity reactions) including anaphylactic reaction and anaphylactic shock Nervous system disorders:
- gait disturbance (problems with walking normally)
- dizziness
- convulsions
- seizures (especially in children)
- cerebellar dysfunction (problems with walking, balance and coordination
- somnolence(drowsiness) Psychiatric disorders:
- hallucination
- abnormal behaviour
- psychotic disorders (including symptoms such as feeling restless, confusion and incoherent speech) Cardiac disorders: irregular heart rate (arrhythmia)
- collapse, affecting breathing, heart rate and blood pressure (cardiopulmonary failure)
- heart palpitations
- slow or faster heartbeat (tachycardia and bradycardia) Vascular disorders:
- flushing Skin and subcutaneous tissue disorders:
- dry skin
- rash Renal and urinary disorders:
- urinary retention (difficulty passing urine) If any of the side effects gets serious, please seek immediate medical attention. If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects UK: If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Minims® Cyclopentolate Hydrochloride eye drops 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 overwrap of each unit and on the carton after the letters "EXP". The expiry date refers to the last day of that month. Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light. The drops are for single use only and provided in single use Minims units, to treat both eyes if necessary. Once opened, use immediately. Discard any unused portion. Do not throw away any medicines wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Minims® Cyclopentolate Hydrochloride contains
- The active substance is cyclopentolate hydrochloride. Each Minims unit contains approximately 0.5 ml eye drops solution of cyclopentolate hydrochloride 0.5% w/v (2.5 mg) or 1% w/v (5 mg).
- The other ingredients are hydrochloric acid (for pH adjustment) and purified water. This medicine does not contain a preservative as it is a sterile single use unit. Contents of the pack Each carton contains 20 units. Marketing Authorisation Holder: UK: Bausch & Lomb UK LTD, 106 London Road, Kingston-Upon-Thames, Surrey, KT2 6TN, United Kingdom Manufacturer: Laboratoire Chauvin Zone Industrielle de Ripotier 50 Avenue Jean Monnet 07200 Aubenas France DATE OF PREPARATION: June 2024
Frequently asked questions about Minims Cyclopentolate Hydrochloride 0.5%, Eye drops solution
How do I take Minims Cyclopentolate Hydrochloride 0.5%, Eye drops solution?
Minims Cyclopentolate Hydrochloride 0.5%, 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 Minims Cyclopentolate Hydrochloride 0.5%, Eye drops solution?
The active substance in Minims Cyclopentolate Hydrochloride 0.5%, Eye drops solution is cyclopentolate hydrochloride.
Are there equivalent medicines to Minims Cyclopentolate Hydrochloride 0.5%, Eye drops solution?
Medicines with the same active substance, strength and form include: Minims Cyclopentolate Hydrochloride 1%, Eye drops solution, Mydrilate 0.5% Eye Drops, 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 Minims Cyclopentolate Hydrochloride 0.5%, 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 Minims Cyclopentolate Hydrochloride 0.5%, 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: 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
As a topical mydriatic and cycloplegic.
4.2. Posology and method of administration
Adults (including the elderly):
Instil dropwise into eye according to the recommended dosage.
One or two drops as required. Maximum effect is induced in 30 - 60 minutes after instillation.
For refraction and examination of the back of the eye: 1 drop of solution, which may be repeated after five minutes, is usually sufficient.
For anterior and posterior uveitis (if associated with signs of anterior uveitis) and for the breakdown of posterior synechiae: 1 - 2 drops are instilled every 6 - 8 hours.
Resistance to cycloplegia can occur in young children, in patients with dark skin and/or patients with dark irides, therefore, the strength of cyclopentolate used should be adjusted accordingly.
Children
< 3 months: Not recommended
3 months - 12 years: 1 drop of a 1% solution to each eye.
12 years - adult: 1 drop of 0.5% solution to each eye repeated after 10 minutes if necessary. Children should be observed for 45 minutes after instillation.
4.3. Contraindications
Hypersensitivity to cyclopentolate or to any of the excipients listed in section 6.1.
Use in patients with narrow-angle glaucoma or those with a tendency towards glaucoma e.g., patients with a shallow anterior chamber (see section 4.4).
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
Tachycardia and cardiac symptoms are sometimes observed therefore the product should only be used with caution in patients with cardiovascular disease (e.g. tachycardias, heart failure).
Caution should be observed when cyclopentolate is administered to patients with epilepsy, ataxia, dementia, rhinitis sicca, gastrointestinal obstruction, toxic megacolon, myasthenia gravis, and obstructive urinary tract disorders.
Recovery of accommodation occurs within 24 hours (see section 4.7 and 5.1).
Caution is also advised in hyperaemia as increased systemic absorption may occur.
Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children).
Caution is advised in case of open-angle glaucoma. 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 (see section 4.3).
Paediatric population
Extreme caution is advised for use in individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity. Atropine-like effects have been reported as side effects. The product should be used with caution in infants under the age of 1 year due to the increased risk of systemic toxicity.
Consider withholding feeding for four (4) hours after examination. Observe infants closely for at least 30 minutes.
Convulsions in children have also been reported in association with the use of cyclopentolate (see section 4.8).
Necrotic colitis in premature children
Particular caution should be observed for use in children because cases of necrotic colitis have been reported following administration of cyclopentolate eye drops in premature babies (see section 4.8). Early symptoms may include, but are not limited to, bradycardia, vomiting, food intolerance, increased stomach residues, abdominal distension, and bloody stools. In such a case, immediate medical evaluation is needed.
4.5. Interaction with other medicinal products and other forms of interaction
Since systemic cyclopentolate effects cannot be excluded even with topical application, the anticholinergic effects of other pharmaceuticals with anticholinergic activity could be increased (including but not limited to: antihistamines, butyrophenones, phenothiazines, tricyclic and tetracyclic antidepressants, amantadine, quinidine, disopyramide, oxybutynin).
Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
4.6. Fertility, pregnancy and lactation
The safety for use in pregnancy and lactation has not been established, therefore, use only when considered essential by the physician.
Pregnancy
There are no or limited amount of data from the use of cyclopentolate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of cyclopentolate eye drops during pregnancy.
Breast-feeding
It is not known how much cyclopentolate passes into breast milk. Infants can be very sensitive to anticholinergics. Therefore, the preparation should not be used during breastfeeding.
4.7. Effects on ability to drive and use machines
Cyclopentolate has major influence on the ability to drive and use machines. Cyclopentolate may cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear
4.8. Undesirable effects
Adverse reactions are listed in the table in frequency categories under MedDRA system/organ classes. The frequency of adverse reactions is defined using 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 reaction
Eye disorders
Not known
Eye irritation, accommodation disorder, eye pain, ocular hyperaemia, vision blurred, increased intraocular pressure, conjunctivitis
Gastrointestinal disorders
Not known
Abdominal distension a, constipation, dry mouth, nausea, vomiting, necrotising colitis b
Immune system disorders
Rare
Allergic reaction
Not known
Hypersensitivity (both local and systemic hypersensitivity reactions)
Nervous system disorders
Not known
Gait disturbance, dizziness, convulsions c, seizures c, cerebellar dysfunction, somnolence
Psychiatric disorders
Not known
Hallucination, abnormal behaviour d, psychotic disorder d,
Cardiac disorders
Not known
Arrhythmia, bradycardia, cardiopulmonary failure d, palpitations, tachycardia
Vascular disorders
Not known
Flushing
Skin and subcutaneous tissue disorders
Not known
Dry skin, rash d
Renal and urinary disorders
Not known
Urinary retention
a. Cases of abdominal distension have been reported in infants.
b. Necrotising colitis has been reported in preterm infants.
c. Convulsions and seizures have been reported in children.
d. Abnormal behaviour, psychotic disorders, cardiopulmonary failure and rash have been reported in the paediatric population.
Systemic cyclopentolate toxicity is dose-related and would be less likely to occur following administration of 0.5% solution than following instillation of 1% solution.
Children are, however, more susceptible to such reactions than adults.
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
Overdose is rare but symptoms can include those mentioned in Section 4.8 above.
Symptoms
In isolated cases, ocular topical application of eye drops containing cyclopentolate can lead to central nervous system disorders and general systemic manifestations, especially in children.
a) Central nervous manifestations: abnormal behaviour (restlessness, incoherent speech, disorientation), hallucinations, memory loss, gait disturbance, seizures, somnolence.
b) General systemic manifestations: dry mouth, flushing, tachycardia, increase in temperature, urinary blockage.
Treatment
Treatment is supportive and symptomatic.
💬 Ask about this leaflet
Ask anything about Minims Cyclopentolate Hydrochloride 0.5%, 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.