Mydriacyl 0.5%

1. Name Of The Medicinal Product

MYDRIACYL 0.5%

2. Qualitative And Quantitative Composition

Tropicamide 0.5% w/v

3. Pharmaceutical Form

Eye Drops, Solution

4. Clinical Particulars

4.1 Therapeutic Indications

Tropicamide is a short acting anticholinergic agent used as a mydriatic and cycloplegic. It is indicated for topical use for:

Diagnostic purposes for fundoscopy and cycloplegic refraction.

Use in pre- and post-operative states where a short acting mydriatic is required.

4.2 Posology And Method Of Administration

Adults, Elderly and children:

Fundoscopy:

One or two drops of 0.5% solution instilled into the eyes 15 to 20 minutes prior to examination.

Cycloplegic Refraction:

One or two drops of 1% solution repeated after 5 minutes. If the patient is not seen within 20 to 30 minutes an additional drop may be instilled to prolong the effect.

Use in Children:

Tropicamide has been reported to be inadequate for cycloplegia in children. A more powerful cycloplegic agent such as atropine may be required.

4.3 Contraindications

Glaucoma or a tendency towards glaucoma (e.g. Narrow anterior chamber angle). Hypersensitivity to any component. This preparation contains benzalkonium chloride and should not be used where soft contact lenses are worn.

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 angle of the anterior chamber should be made before use.

Extreme caution is advised for use in children and individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity. Parents should be warned of the oral toxicity of this preparation for children and advised to wash their hands after use.

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 one minute after instillation of the drops.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The effect of anti-muscarinic agents may be enhanced by the concomitant administration of other drugs with anti-muscarinic properties such as amantadine, some anti-histamines, butyrophenones, phenothiazines and tricyclic anti-depressants.

4.6 Pregnancy And Lactation

There is insufficient evidence as to drug safety in pregnancy and lactation. This product should be used during pregnancy only when it is considered essential by a physician.

4.7 Effects On Ability To Drive And Use Machines

May cause blurred vision and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities unless vision is clear. Complete recovery from the effects of tropicamide eyedrops may take up to six hours.

4.8 Undesirable Effects

Local: increased intraocular pressure, transient stinging and sensitivity to light secondary to pupillary dilation. Prolonged administration may lead to local irritation, hyperaemia, oedema and conjunctivitis.

Systemic: Systemic anti-cholinergic toxicity is manifested by dryness of the mouth, flushing, dryness of the skin, bradycardia followed by tachycardia with palpitations and arrythmias, urinary urgency, difficulty and retention, reduction in the tone and motility of the gastrointestinal tract leading to constipation.

Vomiting, giddiness and staggering may occur, a rash may be present in children and abdominal distention in infants.

Psychotic reactions, behavioural disturbances and cardio-respiratory collapse may occur in children.

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 distention in infants, convulsions and hallucinations and the loss of neuro-muscular 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

Ophthalmologicals; Mydriatics and Cycloplegics

ATC Code: S01F A06

Tropicamide is an anticholinergic which blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation thus dilating the pupil (mydriasis). At higher concentrations (1%), tropicamide also paralyses accommodation. This preparation acts rapidly and has a relatively short duration of action.

5.2 Pharmacokinetic Properties

Tropicamide administered topically to the human eye does not bind to tissues as firmly as does atropine. The wash out time for half recovery of carbachol responsiveness was shown to be less than 15 minutes for non-pigmented iris and 30 minutes for pigmented iris.

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

Benzalkonium chloride, Disodium edetate, Sodium chloride, Sodium Hydroxide and/or Hydrochloric acid and Purified water.

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months (unopened). 4 weeks (after first opening)

6.4 Special Precautions For Storage

Do not store above 25^oC.

Do not refrigerate or freeze.

Keep container in the outer carton.

Keep container tightly closed.

Discard contents 4 weeks after opening.

6.5 Nature And Contents Of Container

Pack size - 5 ml.

Drop-Tainer - Natural Low Density Polyethylene Bottle and Plug.

Polystyrene or Polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

Do not touch dropper tip to any surface as this may contaminate the contents.

7. Marketing Authorisation Holder

Alcon Laboratories (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

HP2 7UD.

8. Marketing Authorisation Number(S)

PL 0649/5917R

9. Date Of First Authorisation/Renewal Of The Authorisation

5^th February 2002

10. Date Of Revision Of The Text

April 2010