SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Atropine Eye Drops BP 0.5% w/v Vistatropine Eye Drops 0.5% w/v

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Atropine sulphate BP 0.5% w/v

3. PHARMACEUTICAL FORM

Eye drops.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Atropine sulphate is an antimuscarinic agent used as a cycloplegic and mydriatic. The eye drops are used in the treatment of iritis and uveitis to immobilise the iris and ciliary muscle and to prevent or break down adhesions.

Since it is a powerful cycloplegic it is used in the determination of refraction in children below six years and children with convergent strabismus.

4.2 Posology and method of administration

For topical ocular use.

The depth of the angle of the anterior chamber should be assessed before the product is used.

Adults

Refraction:-    One or two drops to be instilled into the eye(s) one hour

before refracting.

Uveitis / iritis:- One or two drops to be instilled into the eye(s) to a maximum of 4 times daily.

Elderly

Mydriatics and cycloplegics should only be used with caution in the elderly and others who may have raised intra ocular pressure.

Children

Refraction:-    One drop to be instilled into each eye twice daily for 1 3

days prior to the examination.

Uveitis / iritis:- One drop to be instilled into each eye to a maximum of 3 times daily.

4.3 Contraindications

The product should not be used in patients with closed angle glaucoma.

It is also contraindicated in patients with narrow angle between the iris and the cornea since it may raise intra-ocular pressure and precipitate an acute attack of closed angle glaucoma.

It should not be used by patients with known hypersensitivity to any component of the preparation.

4.4 Special warnings and precautions for use

The product contains benzalkonium chloride solution and soft contact lenses must not be worn during the period of use.

Patients should be warned that antimuscarinic eye drops will temporarily impair vision.

Patients should wash hands after using the eye drops and great care should be taken to avoid getting the product into the mouth.

Due to the risk of provoking hyperpyrexia, atropine should only be used with great caution when the ambient temperature is high or the patient has a fever.

Care is also required in patients with conditions characterised by tachycardia.

Darkly pigmented iris is more resistant to pupillary dilation and caution should be exercised to avoid overdosage.

The eye drops should be discarded 4 weeks after first opening.

During use, care should be taken not to touch the dropper nozzle on to the eyelid or any other surface.

The product is for external use only and should be stored out of the reach and sight of children.

4.5 Interactions with other medicinal products and other forms of interaction

The effects of atropine may be enhanced by the concomitant use of other drugs with antimuscarinic properties. Studies have indicated that the absorption of atropine sulphate appears to be delayed by solutions of higher osmolarity.

4.6 Pregnancy and lactation

There is insufficient evidence as to the safety of the product during pregnancy and lactation. The product should therefore only be used if it is considered essential by the physician.

4.7 Effects on ability to drive and use machines

Patients should be advised not to drive or to operate any hazardous machinery whilst the pupils are dilated or vision is blurred.

4.8 Undesirable effects

Patients may experience photophobia and eyes should be protected from bright light while the pupils are dilated.

Prolonged use of atropine eye drops may lead to local irritation, transient stinging, hyperaemia, oedema and conjunctivitis. An increase in intra-ocular pressure may occur, especially in patients with closed angle glaucoma.

Hypersensitivity to atropine is not uncommon and may appear as a skin rash or conjunctivitis.

Systemic toxicity may be produced by the instillation of the eye drops especially in infants and the elderly. Reported symptoms include severe ataxia, restlessness, excitement and hallucinations.

Other adverse effects may include a dry mouth with difficulty in swallowing and talking, flushing and a dry skin, transient bradycardia followed by tachycardia, palpitations and arrhythmias, reduced bronchial secretions, urinary urgency and retention and constipation.

Side effects that occur occasionally include confusion (particularly in the elderly), nausea, vomiting and giddiness.

4.9 Overdose

Supportive therapy should be given as required.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Dilation of the pupil normally occurs within half an hour following local application and lasts for seven days or longer. Paralysis of accommodation in one to three hours with recovery in three to seven days.

5.2 Pharmacokinetic properties

Atropine is readily absorbed from the gastro-intestinal tract and mucous membranes, it is also absorbed from the eye.

It is incompletely metabolised in the liver and is excreted in the urine as unchanged drug and metabolites.

5.3 Preclinical safety data

No additional pre-clinical data of relevance to the prescriber.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Benzalkonium chloride solution BP Purified water BP

6.2 Incompatibilities

None known relevant to topical ocular use.

6.3 Shelf life

36 months (unopened) 28 days (once opened)

6.4 Special precautions for storage

Store upright below 25°C in a dry place and away from strong light.

6.5 Nature and contents of container

Low density polythene 10ml bottle with polythene insert and high density polythene tamper-evident cap.

6.6 Instructions for use/handling

None stated.

7. MARKETING AUTHORISATION HOLDER

Martindale Pharmaceuticals Ltd,

Bampton Road,

Harold Hill,

Romford RM3 8UG

8. MARKETING AUTHORISATION NUMBER

PL 0156/0043

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

First authorised: 6 June 1997

DATE OF REVISION OF TEXT

May 2004