Patient Leaflet Updated 01-Dec-2021 | Aspire Pharma Ltd
Levofloxacin 5mg/ml eye drops solution
Levofloxacin 5mg/ml eye drops solution
Levofloxacin (as hemihydrate)
1. What Levofloxacin eye drops is and what it is used for
2. What you need to know before you use Levofloxacin eye drops
3. How to use Levofloxacin eye drops
4. Possible side effects
5. How to store Levofloxacin eye drops
6. Contents of the pack and other information
One bottle of Levofloxacin eye drops contains 5ml solution with levofloxacin as the active ingredient.
For the theoretical volume of one drop equivalent to 0.05ml the amount of drug substance is 0.256mg levofloxacin hemihydrate equivalent to 0.250mg of 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).
Levofloxacin eye drops is not suitable for treating eye infections that have spread in the deeper layers of the eye coverings or into the fluid within the eyeball. Antibiotic tablets or injections are needed to treat these deeper and more serious infections.
Levofloxacin eye drops 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.
Talk to your doctor, pharmacist or nurse before taking Levofloxacin eye drops:
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 Levofloxacin eye drops if you develop pain or swelling of the tendons (tendinitis).
The special warnings and precautions for using this medicine are the same for adults, adolescents and children aged 1 year or over.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines – even those not prescribed.
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 Levofloxacin eye drops.
If you are taking other eye drops, you should wait at least 15 minutes between applying Levofloxacin eye drops 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 taking this medicine.
Levofloxacin 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, after instilling eye drops, it is very unlikely that the eye drops will harm the growing baby.
Your doctor is informed about the potential risk and will advise you whether to take Levofloxacin eye drops in this case.
Your fertility (ability to become pregnant or to father a child) is not impaired when you apply Levofloxacin eye drops following its instructions for use.
Levofloxacin 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.
Levofloxacin eye drops contains benzalkonium chloride
This medicine contains 0.05mg benzalkonium chloride in each millilitre of solution, which is equivalent to 0.25mg per 5ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Levofloxacin eye drops are for ocular use and have to be applied to the outer surface of the eye.
For patients above 1-year-old, the recommended dose is as follows:
DAYS 1 - 2
DAYS 3 - 5
In elderly patients no adjustment of the usual 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-old and in adolescents.
Levofloxacin eye drops is not recommended to be used in children aged below 1 year.
Before applying the drops:
If possible, ask someone else to apply the drops for you. Ask them to read these instructions with you before applying the drops.
1) Wash your hands.
2) Open the bottle. Take special care that the tip of the dropper bottle does not touch your eye, the skin around your eye or your fingers. If this happens by accident you should tell your doctor or pharmacist so that you can obtain a clean bottle. Tilt your head backwards while seated, or lie down on your back.
3) Place the tip of the bottle close to your eye.
4) Pull the lower eyelid downwards and look up.
5) Press the bottle slightly and let one drop fall into the space between the lower eyelid and the eye.
6) Close your eye and press the inner corner of the eye with your finger for about one minute. Thus you can prevent the eye drop from draining down the tear duct.
7) Wipe off any excess solution from the skin around your eye.
If another drop is needed, and when both eyes are to be treated, repeat steps 3 to 6.
Replace the cap securely after use.
Levofloxacin eye drops should not be injected into the interior part of the eyeball.
If you use more Levofloxacin eye drops 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 use 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 Levofloxacin eye drops earlier than instructed, it may delay the healing process.
If you have any further questions on the use of this medicine or wish to stop your treatment, 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 Levofloxacin eye drops. 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 Levofloxacin eye drops and seek urgent advice from your doctor.
The frequency of possible side effects is defined as following:
very common affects more than 1 user in 10
common affects 1 to 10 users in 100
uncommon affects 1 to 10 users in 1,000
rare affects 1 to 10 users in 10,000
very rare affects less than 1 user in 10,000
not known frequency cannot be estimated from the available data
Very rarely this medicine can cause severe allergic reactions.
The following symptoms can occur even after just one dose of Levofloxacin eye drops:
In rare cases other allergic reactions can develop. Symptoms of such reactions are:
Stop using Levofloxacin eye drops and contact a doctor immediately if any of these symptoms occur.
Common side effects (affect 1 to 10 users in 100):
Uncommon side effects (affect 1 to 10 users in 1,000):
Rare side effects (affect 1 to 10 users in 10,000)
Very rare side effects (affect less than 1 user in 10,000)
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.
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 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.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.
Levofloxacin eye drops are to be used within 28 days after first opening the bottle.
Any remaining solution should be returned to your pharmacist for safe disposal.
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.
Clear green yellowish aqueous solution.
5ml of solution is supplied in a 5ml LDPE (low-density polyethylene) bottle with a LDPE dropper and a HDPE (high-density polyethylene) or HDPE/ LDPE cap.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 10/2020.
1010350-P3.4
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
http://www.aspirepharma.co.uk
+44 (0)1730 231148
+44 (0)1730 231148
