Minims Cyclopentolate Hydrochloride 1.0%W/V
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Cyclopentolate Hydrochloride 1%.
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
4.1 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
Local Effects
Local irritation may result following the use of this product. The frequency of this effect occurring is dependant on the concentration instilled.
Increased intraocular pressure may occur in predisposed patients.
Allergic reactions may rarely occur, manifesting as diffusely red eyes with lacrimation and stringy white mucus discharge.
Systemic Effects
Systemic cyclopentolate toxicity is dose-related and is uncommon following administration of 1% solution and would not be expected to occur following instillation of 0.5% solution. Children are, however, more susceptible to such reactions than adults. Toxicity is usually transient and is manifest mainly by CNS disturbances. Any CNS disturbances are characterised by signs and symptoms of cerebellar dysfunction and visual and tactile hallucinations.
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.
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
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.
6.1 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
Each Minims unit should be discarded after a single use.
7 MARKETING AUTHORISATION HOLDER
Bausch & Lomb UK Limited Bausch & Lomb House 106 London Road Kingston-Upon-Thames Surrey, UK KT2 6TN
8 MARKETING AUTHORISATION NUMBER(S)
PL 03468/0071
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/06/1987/ 25/07/1997
10 DATE OF REVISION OF THE TEXT
27/03/2015