Package leaflet: Information for the user GENTAMICIN VISION 3 mg/ml eye drops, solution Gentamicin Read all of this leaflet carefully before you start taking 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. What is in this leaflet 1. What Gentamicin Vision is and what it is used for 2. What you need to know before you use Gentamicin Vision 3. How to use Gentamicin Vision 4. Possible side effects 5. How to store Gentamicin Vision 6. Contents of the pack and other information 1. What Gentamicin Vision is and what it is used for Gentamicin is an antibiotic of the group of aminoglycosides, which is active against a large number of microorganisms causing frequently infections of the eyes. Gentamicin Vision eye drops is used in adults and children for the treatment of infections of the eye and adjacent tissues, caused by bacteria, susceptible to its action: inflammation of the eyelid; sty; inflammation of the tear sac; conjunctivitis; inflammation of the cornea, ulcer of the cornea; secondary infections following ulcer or herpes infection of the cornea. 1
2. What you need to know before you use Gentamicin Vision Do not use Gentamicin Vision if you are allergic to gentamicin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Gentamicin Vision. If you experience itching and swelling of the eyelids, redness of the eye, tearing, skin rash, stop using Gentamicin Vision and contact your attending physician. These symptoms might be the signs of an allergic reaction. It is good to know that if you have or have had allergy to other antibiotics of this group (for example, tobramycin) an allergic reaction is more likely to occur. Prolonged use of Gentamicin Vision, as well as other antibiotic products, may result in development of an additional infection with bacteria or fungi, non-susceptible to the antibiotic. Apply Gentamicin Vision as long as prescribed. In more severe infections, the ocular application of this medicine can be combined with the use of other antibiotics that are taken orally or applied by other appropriate means. Gentamicin Vision contains benzalkonium chloride, which may precipitate on the contact lens surface or decolourise it. It is good to know that you should not wear contact lenses in the presence of eye infection. Other medicines and Gentamicin Vision Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. Co-administration of Gentamicin Vision with other medicines that can potentially harm the kidneys or hearing should be avoided, except in the case of emergency, established by the attending physician. In concomitant treatment with other aminoglycoside antibiotics, it is recommended to monitor their total concentration in the blood to maintain an appropriate level. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The treatment with aminoglycoside antibiotics may damage the auditory nerve and lead to deafness of the baby. During ocular use, the penetration of gentamicin into the blood is low and the risk with the use of Gentamicin Vision is considered low as well. However, the use of the product during 2
pregnancy and breast-feeding may be considered if only clearly needed and after careful evaluation of the benefit for the mother and the risk for the foetus/newborn. Driving and using machines As with all products for ocular use, transient blurring of vision or other disturbances may influence the ability to drive and use machines. You should wait until your vision clears, before you start driving or operating machines. Gentamicin Vision contains benzalkonium chloride In its composition, Gentamicin Vision contains benzalkonium chloride, which may induce irritation of the eyes. Avoid the contact with soft contact lenses. Prior to applying the eye drops, remove the contact lenses and let an interval of at least 15 minutes before re-inserting. It is known that benzalkonium chloride decolourises soft contact lenses. Benzalkonium chloride is an irritating substance and may cause skin reactions upon topical use. 3. How to use Gentamicin Vision Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Children, adults and elderly (over 65 years) 1-2 drops are instilled 5-6 times daily in the affected eye or more frequently, if needed. In severe infections, the medicine may be initially applied in 1-2 drops every 15-20 minutes and after managing the infection, the frequency of instillations can be gradually reduced. The duration of treatment depends on the type and severity of infection. Usually, it is 7-10 days. During co-administration with other product for ocular use, the interval between the two applications should be at least 10 minutes. Keeping hygiene during the instillation of the drops is of importance. Avoid the contact between the tip of the vial and the eye or surrounding objects, since the tip may be contaminated, thus leading to development of an eye infection with serious sequels for the eye, even to loss of vision. Always wash your hands before using the medicine! If you think that your vial is contaminated, contact your doctor before continuing the application of this medicine. 3
Instructions for use 1. Before you start using Gentamicin Vision, make sure that the protective strip between the cap and the vial is not broken. Wash your hands and unscrew the cap. 2. Tilt your head slightly backwards and pull the lower eyelid downwards. Thus, a pouch is formed between the eyelid and the eye. The eye drop will fall just into this place. 3. Hold the vial downwards. Put its tip close to the eye. Use a mirror, if helpful. 4. Pay attention not to touch the tip of the vial to the eye, eyelid or adjacent surfaces. Press carefully the vial base to let fall a drop of the solution. Only a light pressure on the bottom is required. 5. After you have instilled the medicine, close the eyelid and by using your finger, press at the corner of your eye near your nose. This will prevent the solution from passing into the nose or running out. 6. If it is necessary to apply the medicine in both eyes, repeat all previously described steps for the other eye. If the eye drop fails to fall in the eye, try again. Use this vial of Gentamicin Vision for your eyes only! If you use more Gentamicin Vision than you should If you instill more Gentamicin Vision in the eye/eyes, rinse thoroughly with lukewarm water. If you forget to use Gentamicin Vision Apply the forgotten dose as soon as you remember. If it is almost the time for your next dose, continue according to your usual regimen. Do not apply a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Gentamicin Vision can cause side effects, although not everybody gets them. There are reports of side effects, possibly related with the administration of the medicine, but these are minor and quickly resolve after discontinuation of the treatment. Upon administration of gentamicin in the eye, allergic reactions may develop. Other common side effects include conjunctivitis (inflammation of the lining of the eye the conjunctiva), appearance of superficial defects of the conjunctiva and redness of the eyes. 4
Eye disorders Common itching in the eyelids, redness of the eyes, lacrimation (tearing); Uncommon ocular allergic reactions, discharge of secretion, discomfort in the eyes, swelling and redness of the eyelid, conjunctival oedema, corneal inflammation with pinpoint defects. Systemic disorders Usually, there are no generalised reactions. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. 5. How to store Gentamicin vision Keep this medicine out of the sight and reach of children. Store below 25 С. Shelf-life after first opening: 28 days at a temperature below 25ºС in a well-closed vial. Discard the vial 28 days after opening, to avoid any infection and contamination. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not use this medicine if you notice changes in the colour or consistency of the eye drops. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Gentamicin Vision contains The active substance is gentamicin sulfate, equivalent to 3 mg gentamicin. The other ingredients are benzalkonium chloride; sodium dihydrogen phosphate, dihydrate; disodium phosphate dihydrate; sodium chloride; disodium edetate; sodium hydroxide; water for injections. What Gentamicin Vision looks like and contents of the pack Eye drops, solution. Clear, colourless to pale yellow liquid. White plastic bottle fitted with a plastic dropper-applicator and sealed with a screw cap with a tamper-evident ring. 1 (one) bottle with a patient leaflet is inserted in a cardboard carton. 5
Marketing Authorisation Holder Antibiotic-Razgrad AD Office 201, 68 Aprilsko vastanie Blvd. 7200, Razgrad, Bulgaria Tel.: +359 (84) 613 301 Fax: +359 (84) 634 272 Е-mail: office@antibiotic.bg Manufacturer Balkanpharma-Razgrad AD 68 Aprilsko vastanie Blvd. 7200, Razgrad, Bulgaria For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Antibiotic-Razgrad AD Office 201, 68 Aprilsko vastanie Blvd. 7200, Razgrad, Bulgaria This leaflet was last revised in May 2012. 6