Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Eyflox 5mg/ml eye drops, solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Levofloxacin hemihydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
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.
What you need to know before you take it
e Eyflox
Do not use Eyflox:
- if you are allergic to levofloxacin, or other quinolones, or any of the other ingredients of this medicine (listed in section 6). If you are not sure, ask your doctor or pharmacist first. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Eyflox:
- if an allergic reaction occurs, even after a single dose, stop using the medicine.
- if you observe worsening of your eye symptoms during treatment, please contact your doctor as soon as possible.
- if you do not see any sign of recovery within a certain treatment period agreed with your doctor, please contact your doctor as soon as possible.
- generally, no types of contact lenses should be worn when the eye is infected. 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). Children and adolescents The special warnings and precautions for using this medicine are the same in adults, adolescents and children aged 1 year or over. Other medicines and Eyflox 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. 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 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. Driving and using machines 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.
How to take it
Eyflox
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
- Use one to two drops in the affected eye(s) every two hours.
- Use a maximum of 8 times per day. DAYS 3 – 5
- Use one to two drops in the affected eye(s).
- Use a maximum of 4 times per day. 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. Use in children and adolescents 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. Method of administration 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:
- Wash your hands before opening the bottle.
- Do not use this medicine if you notice that the tamper-proof seal on the bottle neck is broken before you first use it.
- When using for the first time, before delivering a drop to the eye, you should first of all practice using the dropper bottle by squeezing it slowly to deliver one drop into the air, away from the eye.
- When you are confident that you can deliver one drop at a time, choose the position that you find most comfortable for the instillation of the drops (you can sit down, lie on your back, or stand in front of a mirror). Instillation: 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 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 Eyflox 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. If you swallow Eyflox by accident 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.
4. Possible side effects
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):
- burning feeling in the eye
- decreased vision or mucus in the eye Uncommon side effects (may affect up to 1 in 100 people):
- stinging or irritation of the eyes
- painful eyes
- dry or sore eyes
- swelling or redness (bloodshot eyes) of the conjunctivae (front covering of the eye) or eyelid
- sensitivity to light
- itchy eyes
- sticky eyelids
- headache
- rash around the eye
- stuffed or runny nose Rare side effects (may affect up to 1 in 1,000 people):
- allergic reactions such as skin rash Very rare side effects (may affect up to 1 in 10,000 people):
- swelling and tightness in the throat
- breathing difficulty Additional side effects in children and adolescents Frequency, type and severity of side effects in children and adolescents are expected to be the same as in adults. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible
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.
How to store it
Eyflox
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 250C. 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.
Contents of the pack and other information
What Eyflox contains
- The active substance is levofloxacin. 1ml contains 5.12mg of levofloxacin hemihydrate equivalent to 5mg of levofloxacin.
- The other ingredients of Eyflox are sodium chloride, sodium hydroxide or hydrochloric acid for pH adjustment and water for injections. What Eyflox looks like and contents of the pack
- Eyflox is a clear, light yellow to light greenish-yellow solution, free of visible particulate matter.
- 5ml of solution is supplied in a white opaque 5ml LDPE bottle with white Novelia nozzle (HDPE and silicone) and a white HDPE cap.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Aspire Pharma Limited Unit 4, Rotherbrook Court Bedford Road Petersfield Hampshire GU32 3QG United Kingdom
This leaflet was last revised in 04/2020.
1010505 – P1.8
Manufacturer Rafarm S.A. Agiou Louka Str. 19002 Paiania Attiki Greece
Frequently asked questions about Eyflox 5mg/ml eye drops, solution
How do I take Eyflox 5mg/ml eye drops, solution?
Eyflox 5mg/ml eye drops, solution comes as eye drops containing 5mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Eyflox 5mg/ml eye drops, solution?
The active substance in Eyflox 5mg/ml eye drops, solution is levofloxacin hemihydrate.
Are there equivalent medicines to Eyflox 5mg/ml eye drops, solution?
Medicines with the same active substance, strength and form include: Oftaquix 5 mg/ml eye drops, solution, Oftaquix Unit Dose 5 mg/ml eye drops, solution in single dose container, Oxalux Unit Dose 5 mg/ml eye drops in single-dose container. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Eyflox 5mg/ml eye drops, solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Eyflox 5mg/ml eye drops, solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: levofloxacin hemihydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Eyflox 5 mg/ml eye drops are indicated for the topical treatment of bacterial external ocular infections in patients ≥1 year of age caused by levofloxacin susceptible microorganisms (see also sections 4.4 and 5.1).
Considerations should be given to official guidance on the appropriate use of antibacterial agents.
Eyflox is indicated in adults, children aged ≥1 year to 12 years and adolescents aged 12 to 18 years.
4.2. Posology and method of administration
Posology
For all patients instil one to two drops in the affected eye(s) every two hours up to 8 times per day while awake for the first two days and then four times daily on days 3 through 5.
If different topical ocular medications are used concomitantly, at least a 15-minute interval is required between instillations.
To prevent contaminating the dropper tip and solution, the dropper tip should not come into contact with the eyelids or surrounding areas.
The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection. The usual treatment duration is 5 days.
Safety and efficacy in the treatment of corneal ulcer and ophthalmia neonatorum has not been established.
Levofloxacin is not recommended for use in children below age 1 year due to a lack of data on safety and efficacy.
Use in the elderly
No adjustment of dosage is required.
Paediatric population
The posology is the same in adults and children aged ≥ 1 year.
The safety and efficacy of Levofloxacin in children aged ≥1 year have been established.
The safety and efficacy of Levofloxacin in children < 1 year have not yet been established. No data are available.
Method of administration
Ocular use.
Before instillation of the eye drops
- Users should be instructed to wash their hands before opening the bottle.
- Users should also be instructed to not use this medicine if they notice that the tamper-proof seal on the bottle neck is broken before they first use it.
- When used for the first time, before delivering a drop to the eye, the patient should practise using the dropper bottle by squeezing it slowly to deliver one drop away from the eye.
- When the patient is confident they can deliver one drop at a time, the patient should adopt a position that is the most comfortable for the instillation of the drops (the patient can sit down, lie on their back, or stand in front of a mirror).
Instillation
1. The bottle should be held directly below the cap and the cap should be turned to open the bottle. To avoid contamination of the solution, the tip of the bottle must not touch anything.
2. The patient should tilt their head backwards and hold the bottle above their eye.
3. The patient should pull the lower eyelid down and look up. The bottle should be squeezed gently in the middle and a drop should be allowed to fall into the patient's eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. The bottle must not be squeezed too hard.
Patients should be instructed to seek advice from their doctor, pharmacist or nurse if they are not sure how to administer their medicine.
4. The patient should blink a few times so that the drop spreads over their eye.
5. After using Eyflox, the patient should be instructed to press a finger into the corner of the eye, by the nose for a few minutes. This helps to stop the eye drops getting into the rest of the body.
6. Instructions 2. – 5. should be repeated for delivery into the other eye, if required. The patient should be clearly instructed if one eye only requires treatment, and if so, which eye is affected.
7. After each 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.
8. At the end of the 28-day in-use shelf life of the medicine, there will be some levofloxacin left in the bottle. Using the excess medicine remaining in the bottle after the patient has completed the course of treatment should not be attempted. Patients must not use the eye drops for longer than 28 days after first opening the bottle.
4.3. Contraindications
Hypersensitivity to the active substance levofloxacin, to other quinolones or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Eyflox 5 mg/ml eye drops must not be injected sub-conjunctivally. The solution should not be introduced directly into the anterior chamber of the eye.
Systemic fluoroquinolones have been associated with hypersensitivity reactions, even following a single dose. If an allergic reaction to levofloxacin occurs, discontinue the medication.
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If worsening of infection occurs, or if a clinical improvement is not noted within a reasonable period, discontinue use and institute alternative therapy. Whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.
Patients with external bacterial ocular infections should not wear contact lenses.
Patients with a history of contact hypersensitivity to silver should not use this product as dispensed drops may contain traces of silver.
Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including levofloxacin, particularly in older patients and those treated concurrently with corticosteroids. Therefore, caution should be exercised and treatment with Eyflox should be discontinued at the first sign of tendon inflammation (see section 4.8).
Paediatric population
The special warnings and precautions for use are the same in adults and children aged ≥1 year.
4.5. Interaction with other medicinal products and other forms of interaction
Specific drug interaction studies have not been conducted with levofloxacin eye drops.
Since maximum plasma concentrations of levofloxacin after ocular administration are at least 1000 times lower than those reported after standard oral doses, interactions mentioned for systemic use are unlikely to be clinically relevant when using Eyflox 5 mg/ml eye drops.
If different topical ocular medications are used concomitantly, at least a 15-minute interval is required between instillations.
Paediatric population
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). The potential risk for humans is unknown.
Eyflox 5 mg/ml eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Breastfeeding
Levofloxacin is excreted in human milk. However, at therapeutic doses of Levofloxacin no effects on the suckling child are anticipated. Eyflox 5 mg/ml eye drops should be used during lactation only if the potential benefit justifies any potential risk to the nursing child.
Fertility
Levofloxacin caused no impairment of fertility in rats at exposures considerably in excess of the maximum human exposure after ocular administration (see section 5.3).
4.7. Effects on ability to drive and use machines
Levofloxacin has minor influence on the ability to drive and use machines.
If there are any transient effects on vision, the patient should be advised to wait until this clears before driving or operating machinery.
4.8. Undesirable effects
Approximately 10% of patients can be expected to experience adverse reactions.
The reactions are usually graded as mild or moderate, are transient, and are generally restricted to the eye.
Tabulated list of adverse reactions
The following undesirable effects assessed as definitely, probably or possibly related to treatment were reported during clinical trials and post-marketing experience with levofloxacin containing eye drops.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
System organ Class
Frequency
Adverse reaction
Immune system disorders
Rare
Extra-ocular allergic reactions, including skin rash.
Very rare
Anaphylaxis.
Nervous system disorders
Uncommon
Headache.
Eye disorders
Common
Ocular burning, decreased vision and mucous strand.
Uncommon
Lid matting, chemosis, conjunctival papillary reaction, lid oedema, ocular discomfort, ocular itching, ocular pain, conjunctival injection, conjunctival follicles, ocular dryness, lid erythema, and photophobia.
No corneal precipitates were observed in clinical studies.
Respiratory, thoracic and mediastinal disorders
Uncommon
Rhinitis
Very rare, not known (cannot be estimated from the available data)
Laryngeal oedema
Ruptures of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones. Studies and post marketing experience with systemic quinolones indicate that a risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including Achilles tendon (see section 4.4).
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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).
4.9. Overdose
The total amount of levofloxacin in a bottle of eye drops is too small to induce toxic effects after an accidental oral intake. If considered necessary, the patient can be observed clinically and supportive measures can be undertaken. After a local overdose with Eyflox 5 mg/ml eye drops, the eyes can be flushed with clean (tap) water at room temperature.
Paediatric population
Actions to be taken in case of overdose are the same in adults and in children aged ≥1 year.
💬 Ask about this leaflet
Ask anything about Eyflox 5mg/ml eye drops, solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Levofloxacin hemihydrate
- Levofloxacin 250mg tablets
- Levofloxacin 5 mg/ml solution for infusion
- Levofloxacin 500mg tablets
- Levofloxacin 500mg/100ml solution for infusion bags (5mg/ml)
- Levofloxacin 500mg/100ml solution for infusion vials (5mg/ml)
- Levofloxacin 5mg/ml eye drops solution
- Oftaquix 5 mg/ml eye drops, solution
- Oftaquix Unit Dose 5 mg/ml eye drops, solution in single dose container
- Oxalux Unit Dose 5 mg/ml eye drops in single-dose container
- Quinsair 240 mg nebuliser solution