Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cyclopentolate hydrochloride
Bausch & Lomb UK Ltd
S01FA04
Cyclopentolate hydrochloride
5mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11050000; GTIN: 5027519000609
Graphics&Packing Technology Section ICN POLFA RZESZÓW S.A. ULOTKA PIL Nazwa produktu Product Name MINIMS CYCLOPENTOLATE HYDROCHLORIDE 0,5% AND 1% DRP Kolor nadruku Colours Black Kraj Country (ISO) UNITED KINGDOM (UK) Nr wykrojnika Spec No 5338 Opracowane przez Designed by Kod Wytwórcy Manufacturer code 76897 Nr korekty Proof No 1 Data Date 24.07.2015 Kod farmaceutyczny Pharmacode - Kod wersji Valeant version code P1UK01 Inny kod Other code 76897 (DATA MATRIX) Rozmiar czcionki Font size MINIMUM 8 PT Wymiar ulotki PIL size 160 X 240 MM Krój czcionki Font used Frutiger Neue LT W1G Condensed FRUTIGER NEUE LT W1G CONDENSED BOLD Gramatura papieru Paper weight - G/M 2 Komentarze Comments (Reason for the change) TEXT REPLACED WITH CORRECT PRODUCT NAME & FORMATTING CHANGES (ADDITION OF BULLET) PMR_ICN-15-0692-A AND PMR_ICN-14-0749-A.PDF PACKING SITE: LABORATOIRE CHAUVIN, AUBENAS, FRANCE Akceptacja Techniczna Technical Approval Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval MINIMS® CYCLOPENTOLATE HYDROCHLORIDE 0.5% W/V MINIMS® CYCLOPENTOLATE HYDROCHLORIDE 1% W/V EYE DROPS, SOLUTION CYCLOPENTOLATE HYDROCHLORIDE IN THIS LEAFLET: 1. What Minims® Cyclopentolate Hydrochloride eye drops are and what they are used for 2. 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. Further information 1. WHAT MINIMS® CYCLOPENTOLATE HYDROCHLORIDE EYE DROPS ARE AND WHAT THEY ARE USED FOR Minims® Cyclopentolate Hydrochloride contains a mydriatic agent. 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. These eye drops are also used to treat some types of inflammation of the eye. This medicine is not indicated for babies under 28 days old. However, your doctor or eye specialist can use it if he/she decides that it is necessary. 2. BEFORE YOU USE YOUR EYE DROPS DO NOT USE THESE DROPS • if you are allergic to the active substance (cyclopentolate Soma hati kamili
OBJECT 1 MINIMS CYCLOPENTOLATE HYDROCHLORIDE 0.5%, EYE DROPS SOLUTION Summary of Product Characteristics Updated 29-Jul-2015 | Bausch & Lomb U.K Limited 1. Name of the medicinal product Minims Cyclopentolate Hydrochloride 0.5%. 2. Qualitative and quantitative composition Clear, colourless, sterile eye drops containing cyclopentolate hydrochloride BP 0.5% w/v. 3. Pharmaceutical form Single-use, sterile eye drops. 4. Clinical particulars 4.1 Therapeutic indications As a topical mydriatic and cycloplegic. 4.2 Posology and method of administration _Adults (including the elderly):_ Instil dropwise into eye according to the recommended dosage. One or two drops as required. Maximum effect is induced in 30 - 60 minutes after instillation. For refraction and examination of the back of the eye: 1 drop of solution, which may be repeated after five minutes, is usually sufficient. For anterior and posterior uveitis (if associated with signs of anterior uveitis) and for the breakdown of posterior synechiae: 1 - 2 drops are instilled every 6 - 8 hours. Resistance to cycloplegia can occur in young children, in patients with dark skin and/or patients with dark irides, therefore, the strength of cyclopentolate used should be adjusted accordingly. _Children _ < 3 months: Not recommended 3 months - 12 years: 1 drop of a 1% solution to each eye. 12 years - adult: 1 drop of 0.5% solution to each eye repeated after 10 minutes if necessary. Children should be observed for 45 minutes after instillation. 4.3 Contraindications Do not use in patients with a known hypersensitivity to any component of the preparation. Should not be used in neonates except where, on expert evaluation, the need is considered to be compelling. Do not use in patients with confirmed or suspected narrow-angle glaucoma as an acute attack may be precipitated. 4.4 Special warnings and precautions for use Recovery of accommodation occurs within 24 hours. Use with caution in very young children and other patients at special risk, such as debilitated or aged patients. Ca Soma hati kamili