מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Cyclopentolate hydrochloride
Esteve Pharmaceuticals GmbH
S01FA; S01FA04
Cyclopentolate hydrochloride
0.5 percent weight/volume
Eye drops, solution
Anticholinergics; cyclopentolate
Not marketed
1979-04-01
PATIENT INFORMATION LEAFLET MYDRILATE ® 0.5% W/V EYE DROPS MYDRILATE ® 1.0% W/V EYE DROPS cyclopentolate hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Mydrilate eye drops are and what they are used for 2. Before you use Mydrilate eye drops 3. How to use Mydrilate eye drops 4. Possible side effects 5. How to store Mydrilate eye drops 6. Further information 1. WHAT MYDRILATE EYE DROPS ARE AND WHAT THEY ARE USED FOR Mydrilate eye drops are prescription eye drops containing the active ingredient cyclopentolate hydrochloride. They are available in two strengths, 0.5% and 1%. They belong to a group of medicines known as mydriatic (used for pupil dilation) and cycloplegic (used to block the muscles of the eye that control the shape of the lens). Mydrilate eye drops are applied on the surface of the eyes for diagnostic purposes during eye examinations and refraction tests. They can also be used to treat some types of eye inflammation (iritis and uveitis). 2. BEFORE YOU USE MYDRILATE EYE DROPS DO NOT USE MYDRILATE EYE DROPS • if you are ALLERGIC (HYPERSENSITIVE) TO CYCLOPENTOLATE HYDROCHLORIDE, BENZALKONIUM CHLORIDE or any other ingredients listed in section 6 • if you suffer from GLAUCOMA (high pressure in the eyeball) or if you are at risk of having it (i.e. your close family suffered from glaucoma, you are over 60, you have increased pressure in the eye, you had an eye injury) • if you wear SOFT CONTACT LENSES - wait at least 15 minutes after removal of contact l קרא את המסמך השלם
Health Products Regulatory Authority 24 May 2022 CRN00CXWV Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mydrilate 0.5% w/v Eye Drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cyclopentolate Hydrochloride 0.5% w/v. Contains 5 mg cyclopentolate hydrochloride per 1 ml. Excipient(s)with known effect Each millilitre contains 0.1 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye Drop Solution. (Eye Drops). Clear colourless or almost colourless liquid. 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 POSOLOGY _(I)_ _REFRACTION / FUNDOSCOPY_ _ADULTS (AND THE ELDERLY):_ One drop of 0.5% w/v 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% w/v solution. NB: maximum effect is reached after 30-60 minutes. _CHILDREN _6-16 _YEARS:_ One drop of 1% w/v 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% w/v 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% w/v solution instilled into the eye up to 4 times daily or as required. Health Products Regulatory Authority 24 May 2022 CRN00CXWV Page 2 of 5 Deeply pigmented eyes may require the use of a 1% w/v solution. _CHILDREN:_ At the discretion of the physician. _Paediatric population _ 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. The lowest possible dose and קרא את המסמך השלם