PILOCARPINE Eye drops Ref.[7850] Active ingredients: Pilocarpine

Although rare, the possibility of systemic absorption should be considered especially in the treatment of acute closed-angle glaucoma where higher doses are administered. It should be used with caution in patients with bronchial asthma, peptic ulceration, urinary tract obstruction, Parkinson’s disease, acute heart failure and hypertension.

Fundus examination is advised in all patients before starting pilocarpine therapy since retinal detachment has been associated with the use of miotics in susceptible individuals and those with pre-existing retinal disease.

Regular monitoring of visual fields and intra-ocular pressure should be carried out in patients on long term therapy with pilocarpine for chronic simple glaucoma.

If systemic absorption occurs, pilocarpine may enhance the effects of alcohol and anticholinesterases and diminish the effects of anticholinergics. The effects of pilocarpine may be enhanced by anticholinesterases, MAOI’s, phenothiazines, antihistamines and tricyclic antidepressants. Adrenergic blockers may decrease the effects of pilocarpine.

Paediatric population

Interaction studies have only been performed in adults.

Pregnancy

Safety of pilocarpine for use during pregnancy has not been established. Ophthalmic pilocarpine may be systemically absorbed and mothers using the drug may give birth to infants with signs mimicking neonatal meningitis such as restlessness, convulsions, diaphoresis and hypothermia. Pilocarpine should therefore only be used during pregnancy when essential.

Breast-feeding

Safety of pilocarpine for use during lactation has not been established and it should therefore only be used when clearly indicated. It is not known whether pilocarpine is excreted in breast milk. The possibility of systemic absorption however, should be borne in mind.

The miotic effects of pilocarpine cause difficulty in adapting to the dark. Caution is therefore necessary if driving or operating machinery in poorly lit conditions. Pilocarpine impairs accommodation by paralysis or spasm and patients should not drive or operate machinery if they experience blurred vision.

Adverse drug reactions from clinical trials are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. In addition, the corresponding frequency category for each adverse drug reaction is based on 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).

Eye disorders

Common: decreased visual acuity in poor illumination (frequently experienced by older individuals and in those patients with lens opacity), itching, smarting (discomfort) and burning, sensitisation of the lids and conjunctival vascular congestion, superficial keratitis, ciliary spasm, blurred vision, induced myopia, transient myopia, lens changes with chronic use, increased pupillary block, vitreous haemorrhages, retinal detachments.

Rare: lacrimation

Nervous system disorder

Common: headache and browache(especially in younger patients who have recently initiated therapy)

Rare: sweating, increased salivation, tremor

Cardiac disorders

Rare: changes in cardiac rhythm

Vascular disorders

Rare: changes in blood pressure

Respiratory, thoracic and mediastinal disorders

Rare: bronchial spasm, pulmonary oedema

Gastrointestinal disorders

Rare: nausea, vomiting and diarrhoea

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 Website: http://www.mhra.gov.uk/yellowcard.

Soft contact lenses absorb water soluble compounds such as pilocarpine and its salts and the preservative benzalkonium chloride, and should therefore not be worn when administering pilocarpine eye drops.