Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Gentamicin Sulfate
Amdipharm Limited
S02AA; S02AA14
Gentamicin Sulfate
0.3 percent weight/volume
Ear/eye drops, solution
Product subject to prescription which may not be renewed (A)
Antiinfectives; gentamicin
Marketed
1995-04-20
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ GENTICIN 0.3% W/V EYE/EAR DROPS, SOLUTION Gentamicin 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 possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Genticin 0.3% w/v Eye/Ear Drops Solution is and what it is used for 2. What you need to know before you use Genticin 0.3% w/v Eye/Ear Drops Solution 3. How to use Genticin 0.3% w/v Eye/Ear Drops Solution 4. Possible side effects 5. How to store Genticin 0.3% w/v Eye/Ear Drops Solution 6. Contents of the pack and other information 1. WHAT GENTICIN 0.3% W/V EYE/EAR DROPS SOLUTION IS AND WHAT IT IS USED FOR_ _ _ _ The name of your medicine is Genticin 0.3% w/v Eye/Ear Drops Solution. This medicine contains the active ingredient gentamicin which belongs to a group of medicines called antibiotics. Genticin 0.3% w/v Eye/Ear Drops Solution is used in adults and children to treat bacterial infections in the eye or ear and to prevent infections in an injured eye or ear. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GENTICIN 0.3% W/V EYE/EAR DROPS SOLUTION_ _ DO NOT USE GENTICIN 0.3% W/V EYE/EAR DROPS SOLUTION IF YOU: - are allergic to gentamicin, any of the other ingredients of Genticin 0.3% w/v Eye/Ear Drops Solution (listed in section 6), or to a similar medicine containing an aminoglycoside antibiotic; - have or suspect you have a burst ear drum, if you are being treated for a problem with your ear; - suffer from myasthenia gravis, a disease causing muscle weakness. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE Read the complete document
Health Products Regulatory Authority 10 May 2021 CRN00C8V3 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Genticin 0.3% w/v Eye/Ear Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains Gentamicin sulfate equivalent to 0.3% w/v gentamicin base in 10 ml of solution Excipients with known effect: Benzalkonium chloride 0.020% w/v For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye/Ear drops, solution. A clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Genticin eye/ear drops are indicated in adults and children: 1. For the treatment of superficial eye and ear infections caused by organisms sensitive to gentamicin. 2. For prophylaxis against infection in trauma of the eye or ear. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, the elderly and the paediatric population_ _Eyes:_ 1 or 2 drops should be instilled in the affected eye up to six times a day, or more frequently if required. (Severe infections may require 1 or 2 drops every fifteen to twenty minutes initially, reducing the frequency of instillation gradually as the infection is controlled). _Ears:_ The area should be cleaned and 2 - 3 drops instilled in the affected ear three to four times a day and at night, or more frequently if required. Method of administration Auricular and ocular use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Myasthenia gravis Known or suspected perforation of the ear drum. Health Products Regulatory Authority 10 May 2021 CRN00C8V3 Page 2 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Long-term continuous topical therapy should be avoided. Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. Cross sensitivity with other aminoglycoside antibiotics may occur. In severe infections, topical use of gentamicin should be supplemented with appropriate systemic antibiotic treatment. Gentamicin may cause irreversible parti Read the complete document