Summary of medicine characteristics - CYCLOPENTOLATE HYDROCHLORIDE 1.0% W/V EYE DROPS SOLUTION, MYDRILATE 1.0% EYE DROPS
1 NAME OF THE MEDICINAL PRODUCT
Mydrilate 1.0% Eye Drops
Cyclopentolate Hydrochloride 1.0% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2 QUALITATIVE AND QUANTITATIVE COMPOSITIONCyclopentolate Hydrochloride BP 1.0 % w/v
Excipient(s) with known effect
Each millilitre contains 0.1 mg benzalkonium chloride.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Eye drops.
4. CLINICAL PARTICULARS
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. Contra-Indications
(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. Interactions 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 disorders3 | not known |
| Nervous system disorders | dizziness, convulsions’3, partial b seizures | 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 distension0, 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.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Cyclopentolate is an anti-muscarinic agent used topically in the eye as a mydriatic and cycloplegic. The effects are similar to those of atropine, but with a more rapid onset and a shorter duration of action.
5.2. Pharmacokinetic Properties
None stated.
5.3. Pre-clinical Safety Data
6.1. List of Excipients
6.2. Incompatibilities
None stated.
6.3 Shelf life
Unopened: 2 years
After first opening: 28 days
6.4 Special precautions for storage
Do not freeze. Keep the bottle in the outer carton in order to protect from light.
Before first opening: store at 2°C – 8°C in a refrigerator.
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 dilute or dispense from any container other than the original bottle.
6.5 Nature and contents of container
5 ml dropper bottle of 1.0% solution.
Bottle: LDPE, natural colour.
Cap: White plastic.
6.6. Instructions for Use, Handling and Disposal
6.6. Instructions for Use, Handling and DisposalWhen using the 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 unscrew the cap for use.
7 MARKETING AUTHORISATION HOLDER
Intrapharm Laboratories Limited
The Courtyard Barns
Choke Lane
Cookham Dean
Maidenhead
Berks SL6 6PT
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 17509/0008
9. DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
8 August 2001