Pilogel Ophthalmic Gel 4%w/w

Pilocarpine Hydrochloride 4.0% w/w

For excipients, see section 6.1.

Eye gel

A clear, colourless, sterile, hypertonic, viscous gel, free from visible particles.

Pilogel is indicated for the control of intraocular pressure in patients with ocular hypertension and chronic open-angle glaucoma. It may be used in combination with other miotics, beta-blockers, carbonic anhydrase inhibitors, sympathomimetics or hyperosmotic agents.

Route of Administration: For topical instillation into the eye.

Adults:

Apply a 1.0-1.5 cm (½ inch) ribbon of gel under the lower eyelid of the eye(s) to be treated once a day at bedtime. After the gel has been instilled, close the eye, hold the lid shut and move the eye in several different directions.

Elderly:

There are no special dosage modifications required for the elderly.

Children:

Pilogel is not recommended for use in children.

Miotics are contraindicated where constriction of the pupil is undesirable such as in acute iritis, in those persons showing hypersensitivity to any of the components and in pupillary block glaucoma.

For topical use only. This product contains benzalkonium chloride and is not recommended for use when soft contact lenses are worn. As with all miotics rare cases of retinal detachment have been reported when used in certain susceptible individuals and those with pre-existing retinal disease, therefore, fundus examination is advised in all patients prior to the initiation of therapy.

The miosis usually causes difficulty in dark adaptation. Patients should be advised to exercise caution in night driving and other hazardous occupations in poor illumination.

Although clinically not proven, the miotic effects of pilocarpine may be antagonised by long term topical or systemic corticosteroid therapy, systemic anticholinergics, antihistamines, pethidine, sympathomimetics or tricyclic antidepressants. Concomitant administration of two different miotic drugs is not recommended because of potential interdrug antagonism and potential development of unresponsiveness to both drugs.

There is insufficient evidence as to the drug safety in human pregnancy. This product should, therefore, only be used during pregnancy if considered essential by the physician.

It is not known whether this drug is excreted in human milk. Because many Drugs are excreted in human milk, caution should be exercised when Pilocarpine is administered to a nursing woman.

Pilogel causes miosis which usually results in difficulty in dark adaptation. Patients should be advised to exercise caution in night driving and other hazardous occupations in poor illumination.

The following adverse reactions associated with pilocarpine therapy have been reported:

Nervous System Disorders

Rare (> 0.01 % < 0.1 %): headache (including browache; especially in younger patients who have recently started

therapy.

Eye Disorders

Ocular reactions usually occur during initiation of therapy and often will not persist with continued therapy.

Common (> 1% < 10%): eye irritation (burning or smarting upon instillation), eye pruritus, vision blurred.

Uncommon (> 0.1 % < 1 %): ciliary muscle spasm, conjunctival hyperaemia, myopia (induced), eye allergy (sensitisation of the lids and conjunctiva), visual acuity reduced (in poor illumination).

Rare (> 0.01 % < 0.1%): lacrimation increased, lens disorder (lens changes with chronic use), angle closure glaucoma (increased pupillary block), retinal detachment, vitreous haemorrhage.

Cardiac Disorders

Rare (> 0.01% < 0.1%): bradycardia.

Vascular Disorders

Rare (> 0.01 % < 0.1%): hypotension.

Respiratory. Thoracic and Mediastinal Disorders

Rare (> 0.01% < 0.1%): bronchospasm, pulmonary oedema.

Gastrointestinal Disorders

Rare (> 0.01 % < 0.1%): salivary hypersecretion, nausea, vomiting, diarrhoea.

Skin and Subcutaneous Tissue Disorders

Rare (> 0.01 % < 0.1 %): hyperhidrosis.

Systemic reactions following topical administration are extremely rare. If accidentally ingested, induce emesis or perform gastric lavage. Observe for signs of toxicity (salivation, lacrimation, sweating, nausea, vomiting and diarrhoea). If these occur, therapy with anti-cholinergic agents, such as atropine, may be necessary.

Pharmacotherapeutic Group: Parasympathomimetic

ATC Code: SO1E B

Pilocarpine is a direct acting cholinergic parasympathomimetic agent. It acts through a direct stimulation of muscarinic receptors in the iris sphincter pupillae muscle and the ciliary muscle both of which receive parasympathetic innervation. Contraction of the sphincter pupillae muscle causes miosis (constriction of the pupil) whilst contraction of the ciliary muscle increases tension on the scleral spur, opening trabecular meshwork spaces to facilitate outflow of aqueous humor and thus lower intraocular pressure.

Pilocarpine has been used as an ophthalmic medication for many years and the toxicity profile of pilocarpine has been well documented. All the excipients used in Pilogel have been widely used in pharmaceutical preparations. In addition acute, sub-acute and chronic ocular toxicity studies have demonstrated that Pilogel has a low potential for ocular irritation and toxicity.

Not applicable.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Not applicable

2 years (unopened), 1 month (after first opening)

Do not store above 25°C. Do not freeze. Discard one month after opening.

Polyfoil laminate collapsible tube (HDPE:Copolymer:Al foil:Copolymer:LDPE) with an HDPE closure and dispensing tip, containing 5 g.

No special requirements.

Alcon Laboratories (UK) Ltd.

Pentagon Park

Boundary Way

Hemel Hempstead

Herts

HP2 7UD

UK

PL 00649/0115

23/01/2006

23/01/2006