PILOCARPINE HYDROCHLORIDE

Posology One drop in the conjunctival sac of the affected eye, followed by one drop every 6 hours. No dosage adjustments are required in the elderly and in patients with mild to moderate renal or hepatic impairment based on data from oral pilocarpine, the expected very short duration of use and low systemic levels observed with ophthalmic pilocarpine.

Paediatric population:

Detailed reviews of the well-established safety profile of both topical and systemic pilocarpine did not reveal any significant differences in adverse effects in population groups. However, owing to theoretical pharmacokinetic considerations, treatment should be started with 1% pilocarpine in patients under 18 years of age.

Depending on the clinical response and tolerability, the dose may be increased up to 2% pilocarpine eye drops. Method of administration For ocular use. Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures.

Directly after administration of any dose, the lacrimal punctum should be occluded for one minute with a finger to limit systemic exposure.

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).

System Organ Class Frequency Undesirable effect Common Smarting, burning or stinging on instillation with itching and discomfort; conjunctival and ciliary congestion; decreased visual acuity in poor illumination (frequently experienced by older individuals and in those patients with lens opacity); induced myopia that is usually transient and may be associated with blurred vision.

Eye disorders Rare Conjunctival and lid sensitization (allergy), pupillary block, lacrimation, retinal detachment. Common Headache and brow ache (especially in younger patients who have recently initiated therapy). Nervous system disorder 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, bronchial mucus secretion Gastrointestinal disorders Rare Nausea, vomiting and diarrhoea Genito-urinary disorders Rare Urination Ear, Nose and Throat disorders Rare Rhinorrhea, Sneezing 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

1 Therapeutic indications Treatment of primary acute angle closure glaucoma, in conjunction with other medications / procedures to decrease intra-ocular pressure, after excluding secondary (lenticular and retrolenticular) causes of angle closure.

2 Posology and method of administration Posology One drop in the conjunctival sac of the affected eye, followed by one drop every 6 hours. No dosage adjustments are required in the elderly and in patients with mild to moderate renal or hepatic impairment based on data from oral pilocarpine, the expected very short duration of use and low systemic levels observed with ophthalmic pilocarpine.

Paediatric population:

Detailed reviews of the well-established safety profile of both topical and systemic pilocarpine did not reveal any significant differences in adverse effects in population groups. However, owing to theoretical pharmacokinetic considerations, treatment should be started with 1% pilocarpine in patients under 18 years of age.

Depending on the clinical response and tolerability, the dose may be increased up to 2% pilocarpine eye drops. Method of administration For ocular use. Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures.

Directly after administration of any dose, the lacrimal punctum should be occluded for one minute with a finger to limit systemic exposure. 1. g. topiramate uveal effusions; viterous or subretinal haemorrhage; inflammatory effusions; tumors) causes of acute glaucoma - Anterior uveitis - Secondary glaucoma following trauma, ocular neovascularization or inflammation such as uveitis - Soft contact lenses.

4 Special warnings and precautions for use The use of intensive pilocarpine eye drops is not advised. It should be used with caution in patients with darkly pigmented iris (may require a higher concentration or more frequent administration with care taken to avoid overdosage), conjunctival or corneal damage, pre-existing retinal disease since retinal detachment may occur, bronchial asthma, chronic bronchitis, chronic obstructive pulmonary disease, significant cardiovascular disease, hyperthyroidism, peptic ulceration, gastro-intestinal spasm, nephrolithiasis or urinary tract obstruction, cholelithiasis or biliary tract disease, epilepsy, Parkinson’s disease and psychiatric disturbances.

Adverse effects due to systemic absorption are rare, and more likely with higher concentrations of pilocarpine and/or more frequent dosing. Excipients Pilocarpine contains benzalkonium chloride which is known to discolour soft contact lenses.

Contact with soft contact lenses should be avoided. Patients must be instructed to remove contact lenses prior to application of pilocarpine and wait at least 15 minutes after instillation of the dose before reinsertion. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface.

Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

1. g. topiramate uveal effusions; viterous or subretinal haemorrhage; inflammatory effusions; tumors) causes of acute glaucoma - Anterior uveitis - Secondary glaucoma following trauma, ocular neovascularization or inflammation such as uveitis - Soft contact lenses.