Please refer to Summary of Product Characteristics before prescribing. Further information about this product can be requested from the Marketing Authorisation Holder or may be found in the Summary of Product Characteristics.
Contains: Pilocarpine Nitrate 2.0% w/v.
Main Indications, Dosage and Administration: Pilocarpine is used as a miotic, for reversing the action of weaker mydriatics and in the emergency treatment of glaucoma. Adults (including the elderly): Instil dropwise into the eye according to the recommended dosage. To induce miosis, one or two drops should be used. In cases of emergency treatment of acute narrow-angle glaucoma, one drop should be used every five minutes until miosis is achieved. Paediatric population: Based on the infrequency of reports of adverse events in children, and the extensive experience of use of pilocarpine in childhood glaucoma, concentrations of up to 2% may be safely used in children. Treatment should be started with the lowest available dose and concentration in patients under 18 years of age. Depending on clinical response and tolerability, the dose may be increased up to the maximum recommended adult dosage of the 2% pilocarpine eye drop solution. Directly after administration of any dose, the lacrimal punctum should be occluded for one minute with a finger to limit systemic exposure.
Contraindications, Precautions and Warnings: Conditions where pupillary constriction is undesirable e.g. acute iritis, anterior uveitis and some forms of secondary glaucoma. Patients with soft contact lenses should not use this preparation. Systemic reactions rarely occur when treating chronic simple glaucoma at normal doses. However, in the treatment of acute closed-angle glaucoma the possibility of systemic reactions must be considered because of the higher doses given. Caution is particularly advised in patients with acute heart failure, bronchial asthma, peptic ulceration, hypertension, urinary tract obstruction, Parkinson's disease and corneal abrasions. Retinal detachments have been caused in susceptible individuals and those with pre-existing retinal disease; therefore, fundus examination is advised in all patients prior to the initiation of therapy. Patients with chronic glaucoma on long-term pilocarpine therapy should have regular monitoring of intraocular pressure and visual fields. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for one minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.) 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 miotics is not recommended because of inter-drug antagonism and the risk that unresponsiveness may develop to both drugs. Caution is necessary when night driving and when hazardous tasks are undertaken in poor illumination. May cause accommodation spasm. Advised not to drive or use machinery if vision is not clear.
Pregnancy and lactation: Safety for use in pregnancy and lactation has not been established, therefore, use only when clearly indicated.
Undesirable effects: Eye disorders (Not known): Burning, itching, smarting, blurring of vision, ciliary spasm, conjunctival vascular congestion, induced myopia, sensitisation of the lids and conjunctiva, reduced visual acuity in poor illumination, lens changes with chronic use, increased papillary block, retinal detachments and vitreous haemorrhages. Lacrimation. Nervous system disorders (Not known): Browache and headache (especially in younger patients who have just started therapy). Sweating, salivation. Cardiac disorders (Not known): bradycardia. Vascular disorders (Not known): hypotension. Respiratory, thoracic and mediastinal disorders (Not known): pulmonary oedema, bronchial spasm. Gastrointestinal disorders (Not known): nausea, vomiting and diarrhoea.
Legal Category: POM
UK PL No: 03468/0078 Basic NHS Price: £ 13.74
Marketing Authorisation Holder: Bausch & Lomb UK Limited, Bausch & Lomb House, 106 London Road, Kingston-Upon-Thames, Surrey, UK, KT2 6TN
Date of Revision: March 2023
Exemption Level: 2
Evocative Code: PIL 2.0
PIP Code: 018-0778
United Kingdom (UK)
