Summary of medicine characteristics - MINIMS CYCLOPENTOLATE HYDROCHLORIDE 1.0%W/V
1. NAME OF THE MEDICINAL PRODUCT Minims Cyclopentolate Hydrochloride 0.5%.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clear, colourless, sterile eye drops containing cyclopentolate hydrochloride BP 1% w/v.
3 PHARMACEUTICAL FORM
Single-use, sterile eye drops.
4 CLINICAL PARTICULARS
4 CLINICAL PARTICULARS4.1 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
Do not use in patients with a known hypersensitivity to any component of the preparation.
Should not be used in neonates except where, on expert evaluation, the need is considered to be compelling.
Do not use in patients with confirmed or suspected narrow-angle glaucoma as an acute attack may be precipitated.
4.4 Special warnings and precautions for use
Recovery of accommodation occurs within 24 hours.
Use with caution in very young children and other patients at special risk, such as debilitated or aged patients.
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.)
4.5 Interaction with other medicinal products and other forms of interaction None known.
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.
4.7 Effects on ability to drive and use machines
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).
| MedDRA system organ class | Adverse reaction |
| Eye disorders | |
| Not known | Eye irritation |
| Gastrointestinal disorders | |
| Not known | Necrotising colitis (in preterm infants) |
| Immune system disorders | |
| Rare | Allergic reaction |
| Not known | Anaphylactic reaction, Anaphylactic shock |
| Investigations | |
| Not known | Increased intraocular pressure |
| Nervous system disorders | |
| Not known | Seizures (especially in children), Cerebellar dysfunction |
| Psychiatric disorders | |
| Not known | Hallucination |
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.
Peripheral effects typical of anti-cholinergics, such as flushing or dryness of the skin and mucous membranes, have not been observed with topical cyclopentolate in children or adults. Temperature, pulse and blood pressure are not normally affected.
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. Treatment is supportive.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Ophtalmologicals, mydriatics and cycloplegics, Anticholinergics ATC code: SO1FA04
Cyclopentolate hydrochloride is a synthetic tertiary amine, antimuscarinic compound with actions similar to atropine.
5.2 Pharmacokinetic properties
As a group, the synthetic tertiary amine antimuscarinic compounds are well absorbed following oral administration. Cyclopentolate may be absorbed systemically either by transcorneal absorption, direct topical absorption through the skin or by absorption from the nasal or naso lacrimal system.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydrochloric acid
Purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
15 months.
6.4 Special precautions for storage
Store below 25°C. Do not freeze. Protect from light.
6.5 Nature and contents of container
A sealed, conical shaped container fitted with a twist and pull-off cap. Each Minims unit is overwrapped in an individual polypropylene/paper pouch. Each container holds approximately 0.5ml of solution.
6.6 Special precautions for disposal and other handling
6.6 Special precautions for disposal and other handlingEach Minims unit should be discarded after a single use.