This information is intended for use by health professionals

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

Cyclopentolate Hydrochloride BP 1.0 % w/v.

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.

N.B. 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 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.

4.5 Interaction with other medicinal products and other forms of interaction

The effects of antimuscarinic agents may be enhanced by the concomitant administration of other drugs with antimuscarinic properties such as some antihistamines, butyrophenones, phenothiazines, tricyclic antidepressants and amantadine.

4.6 Fertility, 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 focussing 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 (≥1/100), common ≥1/100 to 1/10, uncommon ≥1/1,000 to <1/100, rare (≥11/10,000 to <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 behaviour, psychotic disorders

not known

Nervous system disorders

dizziness, convulsionsa, partial seizuresa

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

not known

Vascular disorders

flushing, cardiopulmonary failureb

not known

Gastrointestinal disorders

dry mouth, vomiting, gastrointestinal hypomotility and constipation, abdominal distensionc

not known

Skin and subcutaneous disorders

dry skin, skin rashb

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. Convulsions and partial seizures have been reported in children, although the cases reported to date have been low in number or isolated.

b. Cardiopulmonary failure and skin rashes have been reported in the paediatric population.

c. Cases of abdominal distension have been reported in 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.

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 antimuscarinic 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 Preclinical safety data

None stated.

6. Pharmaceutical particulars
6.1 List of excipients

Boric acid Potassium chloride

Benzalkonium chloride solution

Purified water

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 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:

Cap:

LDPE, natural colour.

White plastic.

6.6 Special precautions for disposal and other handling

When using the product for the first time, remove both the cap and the collar. Replace the cap and screw down firmly to pierce the seal at the tip of the plastic nozzle.

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 the authorisation

8 August 2001

10. Date of revision of the text

28/03/2018