Држава: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cyclopentolate hydrochloride
Esteve Pharmaceuticals Ltd
S01FA04
Cyclopentolate hydrochloride
10mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11050000; GTIN: 5039021059853
REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE MYDRILATE EYE DROPS KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not freeze. Store in the original package in order to protect from light. Before first opening: Store in a refrigerator (between 2°C - 8°C). Prior to first opening: Remove from refrigerator and store at room temperature for 30 minutes. After first opening: Do not store above 25°C. Do not refrigerate. Discard 28 days after first opening. Do not use the eye drops after the expiry date which you will find printed on the packaging. 6. FURTHER INFORMATION WHAT MYDRILATE EYE DROPS CONTAIN: Mydrilate eye drops 5 ml dropper bottle contain either 0.5% or 1% of the active ingredient Cyclopentolate Hydrochloride. Each solution also contains the inactive ingredients: boric acid, potassium chloride, benzalkonium chloride solution and purified water. WHAT MYDRILATE EYE DROPS LOOK LIKE: The eye drops are available in 5 ml dropper bottles. MARKETING AUTHORISATION HOLDER AND EU BATCH RELEASE SITE: Intrapharm Laboratories Ltd. The Granary, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire SL6 6PT MANUFACTURER: Holopack Verpackungstechnik GmbH, Bahnhofstrasse, 74429 Sulzbach-Laufen, Germany This leaflet was last revised in March 2018. Like all medicines, Mydrilate eye drops can cause side effects although not everybody gets them. If you experience the following side effects, you should stop using Mydrilate Eye Drops immediately and seek urgent medical advice: • irregular heart rate • urinary retention (difficulty passing urine) The following side effects have been observed in children or infants. If they occur, treatment should be stopped immediately and urgent medical Прочитајте комплетан документ
OBJECT 1 MYDRILATE 1.0% EYE DROPS Summary of Product Characteristics Updated 04-Apr-2018 | Intrapharm Laboratories Limited 1. Name of the medicinal product Mydrilate 1.0% Eye Drops Cyclopentolate Hydrochloride 1.0% w/v Eye Drops, Solution 2. Qualitative and quantitative composition Cyclopentolate Hydrochloride BP 1.0 % w/v. 3. Pharmaceutical form Eye drops. 4. Clinical particulars 4.1 Therapeutic indications (i) Diagnostic purposes for fundoscopy and cycloplegic refraction. (ii) Dilating the pupil in inflammatory conditions of the iris and uveal tract. 4.2 Posology and method of administration _(I) REFRACTION / FUNDOSCOPY _ _ADULTS (AND THE ELDERLY):_ One drop of 0.5% solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination. Deeply pigmented eyes may require the use of a 1% solution. N.B. Maximum effect is reached after 30-60 minutes. _CHILDREN 6-16 YEARS:_ One drop of 1% solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination. _CHILDREN UNDER 6 YEARS:_ One or two drops of 1% solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination. _(II) FOR UVEITIS, IRITIS AND IRIDOCYCLITIS: _ _ADULTS AND THE ELDERLY:_ One or two drops of 0.5% solution instilled into the eye, up to 4 times daily or as required. Deeply pigmented eyes may require the use of a 1% solution. _CHILDREN:_ At the discretion of the physician. Do not use during the first three months of life due to possible association between the cycloplegia produced and the development of amblyopia and also the increased risks of systemic toxicity in neonates. Cycloplegia following administration is quick in onset and short-lived. Maximal cycloplegia is achieved within 15-45 minutes of instillation and lasts on average about 20 minutes. Recovery normally takes place in about 4 hours, but very occasionally some effect persists for up to 24 hours. Mydriasis is produced very rapidly and an aver Прочитајте комплетан документ