Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Oxybuprocaine hydrochloride
AGEPHA Pharma s.r.o.
S01HA02
Oxybuprocaine hydrochloride
Eye drops, solution
oxybuprocaine
Marketed
2023-01-27
PACKAGE LEAFLET: INFORMATION FOR THE USER OXYBUPROCAINE AGEPHA 4 MG/ML EYE DROPS, SOLUTION oxybuprocaine 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. - 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. WHAT IS IN THIS LEAFLET 1. What Oxybuprocaine Agepha is and what it is used for 2. What you need to know before you use Oxybuprocaine Agepha 3. How to use Oxybuprocaine Agepha 4. Possible side effects 5. How to store Oxybuprocaine Agepha 6. Contents of the pack and other information 1. WHAT OXYBUPROCAINE AGEPHA IS AND WHAT IT IS USED FOR This medicine is an anaesthetic for external use in adults. It is intended to locally anaesthetise the surface of the eye for short ophthalmological procedures. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXYBUPROCAINE AGEPHA DO NOT USE OXYBUPROCAINE AGEPHA - if you are hypersensitive (allergic) to oxybuprocaine or to any of the ingredients of Oxybuprocaine Agepha (listed in section 6); - if you are hypersensitive (allergic) to other local anaesthetics which belong to the same group of active substances (p-aminobenzoic acid). WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH OXYBUPROCAINE AGEPHA If you wear contact lenses; remove your contact lenses prior to instillation and wait until the anaesthetic effect has fully subsided before putting them back on the eye (also see 3. HOW TO USE OXYBUPROCAINE AGEPHA ). In patients with a history of allergies, heart diseases, asthma, overactive thyroid gland (hyperthyroidism) and liver diseases as well as in elderly patients. If you have an inflamed eye, as red eyes greatly increase the passage into the blood stream through the surface of the eyes. LONG-TERM AND REPEATED USE Oxybuprocaine Agepha is only intended for short-term use by a physi Les hele dokumentet
Health Products Regulatory Authority 30 January 2023 CRN00CRR0 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxybuprocaine Agepha 4 mg/ml eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 4 mg oxybuprocaine hydrochloride. Each drop contains approximately 0.133 mg of oxybuprocaine hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Clear, colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To produce local anaesthesia in the eye for short opthalmological procedures. Oxybuprocaine Agepha 4 mg/ml eye drops, solution is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1 drop before the procedure, repeated as needed. Since Oxybuprocaine hydrochloride is a fast-acting local anaesthetic, the envisaged intervention should be performed within 10 to 15 minutes following the last application of Oxybuprocaine Agepha 4 mg/ml. _Paediatric population_ The safety and efficacy of Oxybuprocaine Agepha in children and adolescents has not been established. Method of administration For use on the eye. Instil dropwise into the eye to be examined. Avoid touching the tip of the dropper insert with the fingers as well as direct contact with the eye. Lacrimal sac at the medial canthus should be compressed for 1-2 minutes in order to avoid a potential systemic effect. For other applicable measures, see section 4.4. People wearing contact lenses (see section 4.4) DURATION OF USE The duration of use must be limited to the intervention. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Known hypersensitivity to topical anaesthetics which belong to the group of active substances of p-aminobenzoic acid 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Health Products Regulatory Authority 30 January 2023 CRN00CRR0 Page 2 of 5 Not intended for long-term use as this may result in the risk of severe corneal damage. For externa Les hele dokumentet