国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Pilocarpine hydrochloride
Martindale Pharmaceuticals Ltd
S01EB; S01EB01
Pilocarpine hydrochloride
4 percent weight/volume
Eye drops, solution
Product subject to prescription which may be renewed (B)
Parasympathomimetics; pilocarpine
Not marketed
1988-09-01
PACKAGE LEAFLET: INFORMATION FOR THE USER PILOCARPINE 2% W/V EYE DROPS, SOLUTION PILOCARPINE 4% W/V EYE DROPS, SOLUTION Pilocarpine Hydrochloride (Referred to as Pilocarpine Eye Drops in this leaflet) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINES BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their signs of illness are the same as yours. • If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. . WHAT IS IN THIS LEAFLET: 1. What Pilocarpine Eye Drops are and what are they used for 2. What you need to know before you use Pilocarpine Eye Drops 3. How to use Pilocarpine Eye Drops 4. Possible side effects 5. How to store Pilocarpine Eye Drops 6. Contents of the pack and other information 1. WHAT PILOCARPINE EYE DROPS ARE AND WHAT ARE THEY USED FOR Pilocarpine Hydrochloride belongs to a group of medicines called miotics, these medicines affect muscles in the eye causing the pupil of the eye to get smaller. Pilocarpine Eye Drops are used to treat certain forms of glaucoma (an increase in the pressure within the eye) and to reverse the effect of drugs that cause the pupil of the eye to get bigger. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PILOCARPINE EYE DROPS DO NOT USE PILOCARPINE EYE DROPS IF: • you are allergic (hypersensitive) to Pilocarpine or any of the other ingredients in this medicine, which are listed in section 6 of this leaflet • you are suffering from inflammation of the coloured part of the eye (acute iritis or anterior uveitis) • you are suffering from eye disorders such as narrow angle glaucoma or secondary glaucoma. • you are wearing soft contact lenses. WARNINGS AND PRECAUTIONS: Talk to your doctor or pharmacists before taking Pilocarpine 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pilocarpine 4 % w/v Eye Drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipient(s) with known effect Pilocarpine Hydrochloride 40 mg/ml. Also contains Benzalkonium Chloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution (Eye Drops) Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a direct acting miotic in: Chronic simple glaucoma. Acute (closed angle) glaucoma alone, in conjunction with other agents, to decrease intraocular pressure prior to surgical treatment. Miosis to counter the effects of cycloplegic and mydriatic eye drops. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and the elderly The usual dose is 2 drops three times daily. 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. Currently available data are described in section 5.1 but no recommendation on a posology can be made. 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. Method of administration Eye drops for topical administration into the conjunctival sac. 4.3 CONTRAINDICATIONS • Miotics where constriction of the pupil is undesirable such as in acute iritis or anterior uveitis • Narrow angle glaucoma and some forms of secondary glaucoma • Hypersensitivity to Pilocarpine or any of the excipients listed in section 6.1 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 完全なドキュメントを読む