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Eyflox 5mg/ml eye drops, solution
eyflox 5mg/ml eye drops, solution
Eyflox Eye Drops are contained within a novel multi-dose eye drop bottle, which allows for the solution not to contain any preservatives. Due to the design of the container, administration with these eye drops is not the same as standard eye drop bottles.
Please read the full instructions on the correct use of this product in Section 3 of the leaflet (‘‘How to use Eyflox’’), before using these eye drops.
1. What Eyflox is and what it is used for
2. What you need to know before you use Eyflox
3. How to use Eyflox
4. Possible side effects
5. How to store Eyflox
6. Contents of the pack and other information
Eyflox contains a medicine called levofloxacin. Levofloxacin is an antibiotic of the type called fluoroquinolones (sometimes shortened to quinolones). It works by killing some types of bacteria that can cause infections.
When levofloxacin is given in eye drops, it is used in children aged 1 year or over and in adults to treat bacterial infections that affect the front surfaces of the eye.
One type of infection in this area is called bacterial conjunctivitis, which is an infection of the covering of the front of the eye (conjunctiva).
Eyflox is not recommended to be used in children aged below 1 year.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days.
If you are not sure, ask your doctor or pharmacist first.
Talk to your doctor, pharmacist or nurse before using Eyflox:
If you have a history of contact hypersensitivity to silver, you should not use this product.
Tendon swelling and rupture have happened in people taking oral or intravenous fluoroquinolones, particularly in older patients and in those treated concurrently with corticosteroids. Stop taking Eyflox if you develop pain or swelling of the tendons (tendinitis).
The special warnings and precautions for using this medicine are the same in adults, adolescents and children aged 1 year or over.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, tell your doctor or pharmacist if you are applying any other type of eye drop or eye ointment before you start to use Eyflox.
If you are using other eye drops, you should wait at least 15 minutes between applying Eyflox and any other type of eye drop.
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 using this medicine.
Eyflox eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the growing baby.
Although very small amounts of levofloxacin reach the blood and the breast milk, respectively, after instilling eye drops it is very unlikely that the eye drops would harm the growing baby. Your doctor is informed about the potential risk and will advise you whether to use Eyflox eye drops in this case.
Your fertility (ability to become pregnant or to father a child) is not impaired when you apply Eyflox following its instructions for use.
Eyflox has minor influence on the ability to drive and use machines.
If the eye drops cause blurring of your sight when you use them, you should wait until this clears before driving or operating machinery.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Eyflox eye drops are for ocular use and have to be applied to the outer surface of the eye. For patients above 1 year of age, the recommended dose is as follows:
DAYS 1 - 2
DAYS 3 - 5
In elderly patients no adjustment of the recommended dose is required.
The usual total treatment course is five days. Your doctor will advise you how long to apply the drops. If you are putting any other medicine in your eye, you should wait at least 15 minutes between applying the different types of drops.
No dosage modification is required in children over 1 year of age and in adolescents. Eyflox is not recommended to be used in children aged below 1 year.
Ocular use: this medicine is eye drops which are intended to be used in the eye.
Do not allow the tip of the multi-dose bottle to touch the eye or areas around the eye. It could cause injury to your eye. The eye drops solution may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision.
To avoid possible contamination of the multi-dose bottle, keep the tip of the multi-dose bottle away from contact with any surface.
Before instillation of the eye drops:
1) Hold the bottle directly below the cap and turn the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contamination of the solution.
2) Tilt your head backwards and hold the bottle above your eye.
3) Pull the lower eyelid down and look up. Squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard. If you are not sure how to administer your medicine, ask your doctor, pharmacist or nurse.
4) Blink a few times so that the drop spreads over the eye.
5) After using Eyflox, press a finger into the corner of your eye, by the nose for a few minutes. This helps to stop the eye drops getting into the rest of your body.
6) Repeat the instructions 2 – 5 to deliver a drop into the other eye also, if your doctor has instructed you to do this. Sometimes only one eye needs to be treated and your doctor will advise if this applies to you and which eye needs treatment.
7) After use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual liquid on the tip. This is necessary in order to ensure delivery of subsequent drops.
After you have used all doses there will be some Eyflox left in the bottle. You should not be concerned since an extra amount of Eyflox has been added and you will get the full amount of Eyflox that your doctor has prescribed. Do not attempt to use the excess medicine remaining in the bottle after you have completed the course of treatment.
Eyflox eye drops should not be injected into the interior part of the eyeball.
If you use more Eyflox than you should, flush the eye(s) with water and tell your doctor or pharmacist.
If you forget to use the eye drops, put in the next dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.
The amount of levofloxacin in the provided bottle is too small to cause side effects. However, if you are concerned, tell your doctor or pharmacist who will advise you on any necessary measures.
If you stop using Eyflox earlier than instructed, it may delay the healing process. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
About one in ten people have a side effect when using Eyflox. Most of these affect only the eye and may not last very long. If you have any severe or persistent side effects you should stop using Eyflox eye drops and seek urgent advice from your doctor.
It is possible, even though rare, to develop an allergic reaction to Eyflox even after just one dose. You notice this because your eyes may become red or itchy, or the lids may be swollen. If this should happen, stop using Eyflox and contact your doctor immediately.
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Very rare side effects (may affect up to 1 in 10,000 people):
Frequency, type and severity of side effects in children and adolescents are expected to be the same as in adults.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle label and carton after “EXP”. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the plastic film around the cap and neck is missing or broken before you start a new bottle.
Do not use this medicine if you notice insoluble parts in the solution.
Store below 25°C.
Keep the bottle tightly closed. Keep the bottle in the outer carton in order to protect from light.
To prevent infections, you must throw away the bottle 28 days after you first opened it and use a new bottle.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Marketing Authorisation Holder
This leaflet was last revised in 04/2020.
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