Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Ofloxacin
AbbVie Limited
S01AE; S01AE01
Ofloxacin
Eye drops, solution
Fluoroquinolones; ofloxacin
Marketed
1991-06-10
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EXOCIN: OFLOXACIN 0.3% W/V EYE DROPS, SOLUTION 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 side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What EXOCIN is and what it is used for 2. What you need to know before you use EXOCIN 3. How to use EXOCIN 4. Possible side effects 5. How to store EXOCIN 6. Contents of the pack and other information 1. WHAT EXOCIN IS AND WHAT IT IS USED FOR EXOCIN is for the topical treatment of external eye infections such as conjunctivitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EXOCIN DO NOT USE EXOCIN - If you are allergic (hypersensitive) to ofloxacin, or any of the other ingredients of EXOCIN listed in section 6 (e.g. Benzalkonium chloride), or any other quinolones. - in children and adolescents. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using EXOCIN. Take special care with EXOCIN if you have or suffer from: a defect or ulceration of the surface of the eye epilepsy or other brain disorders or nerve conditions liver or kidney problems severe dehydration 2 Use of contact lenses is not recommended in patients receiving treatment for an eye infection, however if you do need to wear contact lenses, please see section Important information about some of the ingredients of EXOCIN. Severe skin conditions have been reported with other products containing ofloxacin. EXOCIN potentially increases sensitivity to sunlight. You should avoid exposure to direct sunlight or sun during use of EXOCIN. HEART PROBLEMS : Caution should be taken when using this kin Read the complete document
Health Products Regulatory Authority 01 April 2022 CRN00CNH2 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT EXOCIN (Ofloxacin) 0.3% w/v Eye Drops Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 3.0 mg ofloxacin (0.3% w/v). Excipient with known effect: Each ml of solution contains 0.05mg of benzalkonium chloride (0.005% w/v). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Clear, pale to light yellow-green solution, practically free from visible particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EXOCIN is indicated for the topical treatment of external ocular infections (such as conjunctivitis and keratoconjunctivitis) caused by ofloxacin-sensitive organisms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults only: One to two drops in the affected eye(s) three or four times daily. The length of treatment should not exceed 10 days without an ophthalmic review. 4.3 CONTRAINDICATIONS EXOCIN is contra-indicated in individuals who have shown hypersensitivity to ofloxacin, any of its excipients listed in section 6.1, or any other quinolones. EXOCIN is not recommended for use in children or adolescents before epiphyseal closures. EXOCIN should not be used during pregnancy or in women at risk of pregnancy, nor during lactation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE EXOCIN is not for injection. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching. If an allergic reaction to ofloxacin occurs, discontinue the drug. Use EXOCIN with caution in patients who have exhibited sensitivities to other quinolones antibacterial agents. _ _ When using EXOCIN eye drops the risk Read the complete document