देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
CYCLOPENTOLATE HYDROCHLORIDE
Bausch & Lomb UK Limited
S01FA04
CYCLOPENTOLATE HYDROCHLORIDE
1.0 %w/v
Eye Drops Solution
Product subject to prescription which may be renewed (B)
cyclopentolate
Marketed
1979-04-01
MINIMS® CYCLOPENTOLATE HYDROCHLORIDE 1% W/V EYE DROPS, SOLUTION CYCLOPENTOLATE HYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Minims® Cyclopentolate Hydrochloride eye drops are and what they are used for 2. What you need to know before you use your eye drops 3. How to use your eye drops 4. Possible side effects 5. How to store your eye drops 6. Contents of the pack and other information 1. WHAT MINIMS® CYCLOPENTOLATE HYDROCHLORIDE EYE DROPS ARE AND WHAT THEY ARE USED FOR Minims® Cyclopentolate Hydrochloride is a mydriatic and cycloplegic drug. It is used to enlarge the pupil of the eye and to paralyse the lens temporarily. Your doctor or eye specialist may use it to examine your eye more closely and/or prepare the eye for an operation. These eye drops are also used to treat some types of inflammation of the eye. This medicine is not indicated for neonates (babies under 28 days old) however, your doctor or eye specialist can use it if he/she decides that it is necessary. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE YOUR EYE DROPS DO NOT USE MINIMS® CYCLOPENTOLATE HYDROCHLORIDE EYE DROPS: • if you are allergic to the active substance (cyclopentolate hydrochloride) or any of the other ingredients of this medicine (listed in section 6). • if you have high pressure of liquid inside the eye (closed angle glaucoma). • in babies under 28 days old (unless your doctor decides that it is necessary). • if you are at risk of having an increased pressure in the eye, especially if you are elderl पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Cyclopentolate Hydrochloride 1% w/v Eye Drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cyclopentolate Hydrochloride 1.0% w/v. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye drops, solution Single-use, clear, colourless, sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical mydriatic and cycloplegic agent. Preoperative use in ophthalmic surgery. Refraction and treatment of iritis and iridocyclitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly)_ Instil dropwise into eye according to the recommended dosage. For mydriasis: the recommended dosage in adults is one drop of the 1% solution. For refraction: 1 drop of solution, which may be repeated after five minutes, is usually sufficient. For iritis and iridocyclitis: 1-2 drops are instilled every six to eight hours. _Children and adolescents_ < 3 months: Not recommended 3 months - 18 years: To be used only at the discretion of the physician. Method of administration Ocular use. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. This blocks the passage of the drops via the nasolacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _0_ _/_ _0_ _4_ _/_ पूरा दस्तावेज़ पढ़ें