Genfloc 5 mg Solution

GENFLOC eye drops are used for the treatment of infections of the eye (conjunctivitis) when caused by bacteria. The active ingredient is moxifloxacin, an anti-infective belonging to a group of antibiotics called fluoroquinolones.

Do not use GENFLOC if you are allergic (hypersensitive) to moxifloxacin, to other quinolones, or any of the other ingredients of GENFLOC (listed in section 6).

Warnings and precautions

Special care should be taken with GENFLOC:

• If you experience any allergic (hypersensitivity) reaction.
• If you wear contact lenses – stop wearing your lenses if you have any signs or symptoms of an eye infection. Wear your glasses instead. Do not start wearing your lenses again until the signs and symptoms of the infection have cleared and until you have stopped using the medicine.
• If you develop pain or swelling of the tendons (tendinitis) stop taking GENFLOC. Tendon swelling and rupture have happened in people taking oral or intravenous fluoroquinolones, particularly in older patients and in those treated concurrently with corticosteroids.
• Use of GENFLOC for a long time may lead to other infections.

Children and adolescents

GENFLOC is not recommended for the treatment of eye infections caused by Chlamydia trachomatis (a bacterial infection) in patients less than 2 years of age. Patients older than 2 years of age should receive injectable treatment.

Other medicines and GENFLOC

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.) GENFLOC is unlikely to interact with other medicines because it is administered into the eye and therefore very little is absorbed into the blood.

Do not share medicines prescribed for you with any other person. Always use GENFLOC exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is 1 drop in the affected eye or eyes, 3 times a day for 4 days. Your doctor will tell you how long your treatment with GENFLOC will last. Do not stop treatment earlier than advised by your doctor or pharmacist. If you have the impression that the effect of GENFLOC is too strong or too weak, tell your doctor or pharmacist. If you are using GENFLOC in combination with another eye drop medicine, wait 5-15 minutes before applying the second eye drop.

Instructions for use:

(Please also refer to pictograms at the end of the leaflet)

• First wash your hands.
• Avoid touching the eye (or any other surface) with the tip of the bottle.
• If you wear contact lenses, they should be removed before using the eye drops. Wait until the signs and symptoms of the infection have cleared and until you have stopped using the medicine before you wear your contact lenses.
• These drops are supplied as a sealed bottle. Twist off the cap.
• Tilt your head back and look upward.
• Pull the lower eyelid gently downwards.
• Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop into your eye.
• Keep the affected eye closed and press your fingertip against the inside corner of the closed eye, and hold for 1 minute.
• Repeat for the other eye if necessary.
• Replace and tighten the cap immediately after use.

If you use more GENFLOC than you should rinse it all out with warm water. Do not put in any more drops until it is time for your next regular dose. If you forget to use GENFLOC continue with the next dose as planned. Do not use a double dose to make up for a forgotten dose. If you stop using GENFLOC to be effective GENFLOC must be used every day. Do not stop using this medicine until your doctor tells you so. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

GENFLOC can have side effects. Not all side effects reported for GENFLOC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using GENFLOC, please consult your healthcare provider for advice. If any of the following happens, stop using GENFLOC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing, blueness of the skin.
• rash or hives.

These are all very serious side effects. If you have them, you may have had a serious reaction to GENFLOC. You may need urgent medical attention or hospitalisation. Tell your doctor if you notice any of the following:

Frequent side effects:

eye pain, eye irritation.

Less frequent side effects:

Effects in the eye dry eye, itchy eye, redness of the eye, eye surface inflammation or scarring, broken blood vessel in eye, abnormal eye sensation, eyelid abnormality, itching, redness or swelling, corneal disorder, blurred or reduced vision, inflammation or infection of the conjunctiva, eye strain, eye swelling, infection in the eye, eye surface becomes cloudy, corneal swelling, deposits on the eye surface, increased pressure in eye, scratch on surface of eye, eye allergy, eye discharge, increased tear production, sensitivity to light.

General side effects:

Headache, bad taste, vomiting, nose discomfort, feeling of a lump in the throat, decreased iron in blood, abnormal liver blood tests, abnormal skin sensation, pain, throat irritation, shortness of breath, irregular heart rhythm, dizziness, increased allergic symptoms, itching, rash, skin redness, nausea and urticaria.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you experience side effects, talk to your doctor or pharmacist. You can report side effects to Gen-Eye (Pty) Ltd via email: [email protected] or telephonically on 011 312 3812. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of GENFLOC.

Store all medicines out of reach of children. Store at or below 25 ºC. Keep the container well-closed and in the outer carton. Protect from light. Do not use more than 28 days after opening. Do not use after the expiry date stated on the bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).