Country: Israel
Language: English
Source: Ministry of Health
OFLOXACIN
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
S01AX11
OPHTHALMIC SOLUTION
OFLOXACIN 0.3 %
OCULAR
Required
ALLERGAN PHARMACEUTICALS IRELAND
OFLOXACIN
OFLOXACIN
For the treatment of external ocular infections caused by ofloxacin sensitive organisms.
2015-01-31
OFL APL MAR 23 CL PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only OFLOX ® OPHTHALMIC SOLUTION ACTIVE INGREDIENT AND CONCENTRATION: Ofloxacin 0.3% w/v Inactive ingredients and allergens in this medicine: See section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional Information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness/for you. Do not pass it on to others. It may harm them, even if it seems to you that their illness/medical condition is similar to yours. This medicine is not intended for children or adolescents. 1. WHAT IS THIS MEDICINE INTENDED FOR? OFLOX is for the treatment of external ocular infections caused by ofloxacin-sensitive organisms. THERAPEUTIC GROUP: anti-infective from the fluoroquinolone group. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient ofloxacin or to any of the other ingredients in this medicine that appear in section 6 (e.g. benzalkonium chloride) or other quinolones. • In children and adolescents. • You are pregnant or may be pregnant or breast-feeding. SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE USING OFLOX, TELL YOUR DOCTOR IF YOU HAVE OR YOU SUFFER FROM: • a defect or ulceration of the surface of the eye. • epilepsy or other brain or nerve disorders. • liver or kidney problems. • severe dehydration. Use of contact lenses is not recommended in patients receiving treatment for an eye infection. However if you do need to wear contact lenses, read the section 'Important information about some of this medicine’s ingredients'. serious skin problems have been reported when using other products that contain ofloxacin. Oflox may increase Read the complete document
Page 1 of 8 OFL API MAR ϯ Ϯ CL 1. NAME OF THE MEDICINAL PRODUCT OFLOX ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ofloxacin 0.3% w/v. Excipient with known effect: Each ml of solution contains 0.05 mg of benzalkonium chloride (0.005% w/v). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Ophthalmic solution Clear, pale to light yellow-green solution, practically free from visible particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OFLOX is indicated for the treatment of external ocular infections 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 OFLOX is contra-indicated in individuals who have shown hypersensitivity to ofloxacin, any of its excipients listed in section 6.1, or any other quinolones. OFLOX is not recommended for use in children or adolescents before epiphyseal closures. OFLOX should not be used during pregnancy or in women at risk of pregnancy, nor during lactation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE OFLOX 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. Page 2 of 8 OFL API MAR ϯ Ϯ CL If an allergic reaction to ofloxacin occurs, discontinue the drug. Use OFLOX with caution in patients who have exhibited sensitivities to other quinolones antibacterial agents. When using OFLOX eye drops the risk of rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance should be considered. As with other anti-infectives, prolonged use may Read the complete document