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.
Moxifloxacin 0.5 % w/v 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 Moxifloxacin hydrochloride 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
Moxifloxacin 0.5 % w/v eye drops, solution are used for the treatment of infections of the eye (conjunctivitis) when caused by bacteria. The active ingredient is moxifloxacin an ophthalmological anti-infective. 2.
What you need to know before you take it
e Moxifloxacin 0.5 % w/v eye drops, solution
Do not use Moxifloxacin 0.5 % w/v eye drops, solution •
If you are allergic (hypersensitive) to moxifloxacin, to other quinolones, or any of the other ingredients of this medicine.
Warnings and Precautions • •
•
Talk to your doctor or pharmacist: If you experience an allergic reaction to Moxifloxacin 0.5 % w/v eye drops, solution. Allergic reactions occur uncommonly and serious reactions occur rarely. If you experience any allergic (hypersensitivity) reaction or any side effect please refer to section 4. 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.
•
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 Moxifloxacin 0.5 % w/v eye drops, solution if you develop pain or swelling of the tendons (tendinitis).
As with any antibiotic, use of Moxifloxacin 0.5 % w/v eye drops, solution for a long time may lead to other infections. Other medicines and Moxifloxacin 0.5 % w/v eye drops, solution Tell your doctor or pharmacist if you are taking or have recently taken, or might take any other medicines, including medicines obtained without a prescription. 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 before using Moxifloxacin 0.5 % w/v eye drops, solution eye drops. Driving and using machines You may find that your vision is blurred for a short time just after you use Moxifloxacin 0.5 % w/v eye drops, solution. Do not drive or use machines until this has worn off. 3.
How to take it
Moxifloxacin 0.5 % w/v eye drops, solution
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose for Adults, including the older, and children: 1 drop in the affected eye or eyes, 3 times a day (in the morning, in the afternoon and at night). Moxifloxacin 0.5 % w/v eye drops, solution can be used in children, in patients over 65 years of age and patients with kidney or liver problems. There is only very limited information on the use of this medicine in the newborn and its use is not recommended in the newborn. Only use the medicine in both eyes if your doctor told you to. Only use Moxifloxacin 0.5 % w/v eye drops, solution for dropping in your eyes. The infection normally improves within 5 days. If no improvement is seen, contact your doctor. You should continue to use the drops for a further 2-3 days or as long as your doctor told you to. INSTRUCTIONS FOR USE Using the three piece container for the first time: Opening the bottle before first use
1. Before using the medication for the first time, be sure the tamper evident ring between the bottle and the cap is unbroken (Fig.1). You must not use the bottle if the tamper evident ring on the bottle neck is broken.
2. Before opening the bottle for the first time, tear off the tamper evident ring to break the seal (Fig.2).
3. To open the bottle, remove the cap by turning it in the counterclockwise direction (Fig.3).
4. Tighten the cap on the container after every use (Fig.4).
Using your eye drops 1. Wash your hands. 2. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and eye (picture 1)
3. Bring the bottle tip close to the eye. Don't touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops
4. Gently press the bottom of the bottle to release one drop of medicine at a time (picture 2).
5. After using Moxifloxacin eye drops, press a finger into the corner of your eye, by the nose for 2-3 minutes (picture 3). This helps to stop the medicine getting into the rest of the body and is important in young children.
6. If you are using the drops in both eyes, wash your hands before you repeat the steps for your other eye. This will help prevent spreading the infection from one eye to the other. 7. Close the bottle cap firmly immediately after use If a drop misses your eye, try again. If you use more medicine than you should, rinse it all out with warm water. Don't put in any more drops until it's time for your next regular dose. If you accidentally swallow Moxifloxacin 0.5 % w/v eye drops, solution contact your doctor or pharmacist for advice. If you forget to use the medicine, continue with the next dose as planned. Do not use a double dose to make up for a forgotten dose. If you are using other eye drops, leave at least 5 minutes between putting in Moxifloxacin 0.5 % w/v eye drops, solution and the other drops. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines Moxifloxacin 0.5 % w/v eye drops, solution can cause side effects although not everybody gets them. You can usually carry on taking the drops, unless the effects are serious or if you suffer a severe allergic reaction. If you experience a severe allergic reaction and any of the following happen, stop taking Moxifloxacin 0.5 % w/v eye drops, solution immediately and tell your doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing, rash or hives, large fluid-filled blisters, sores and ulceration.
Common side effects (May affect up to 1 in 10 people) Effects in the eye: eye pain, eye irritation, Uncommon side effects (May affect up to 1 in 100 people) 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 General side effects: headache and bad taste Rare side effects (May affect up to 1 in 1000 people) Effects in the eye: corneal disorder, blurred or reduced vision, inflammation or infection of the conjunctiva, eye strain, eye swelling General side effects: vomiting, nose discomfort, feeling of a lump in the throat, decreased iron in blood, abnormal liver blood tests, abnormal skin sensation, pain, throat irritation Not known (Frequency cannot be estimated from the available data) Effects in the eye: 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: shortness of breath, irregular heart rhythm, dizziness, increased allergic symptoms, itching, rash, skin redness, nausea and urticaria Reporting of side effects Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of benefit/risk balance of the medicinal product. Health care 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.
5.
How to store it
Moxifloxacin 0.5 % w/v eye drops, solution
Keep out of the sight and reach of children. Don't use the drops after the expiry date which is stated on the bottle and the carton after 'Exp'. The expiry date refers to the last day of that month. This medicine does not need any special storage conditions.
Stop using the bottle 4 weeks after first opening. This is to prevent infections. Do not dispose of medicines into the water supply or in household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment. 6.
Contents of the pack and other information
What Moxifloxacin 0.5% w/v eye drops, solution contains The active substance is moxifloxacin. One ml of eye drops contains 5 mg of moxifloxacin (as moxifloxacin hydrochloride, 5.45 mg). The other ingredients are: sodium chloride, boric acid, sodium hydroxide, hydrochloric acid and water for injections What Moxifloxacin 0.5 % w/v eye drops, solution looks like and the contents of the pack The medicine is a clear, greenish yellow solution supplied in a 5 ml plastic bottle with a screw cap. Each bottle contains 5 ml of this medicine. Marketing Authorisation Holder and Manufacturer Brown & Burk UK Ltd 5 Marryat Close Hounslow West Middlesex TW4 5DQ United Kingdom This leaflet was last revised in 09/2021
Frequently asked questions about Moxifloxacin 0.5 % w/v eye drops, solution
How do I take Moxifloxacin 0.5 % w/v eye drops, solution?
Moxifloxacin 0.5 % w/v eye drops, solution comes as eye drops. 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 Moxifloxacin 0.5 % w/v eye drops, solution?
The active substance in Moxifloxacin 0.5 % w/v eye drops, solution is moxifloxacin hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Moxifloxacin 0.5 % w/v 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 Moxifloxacin 0.5 % w/v 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: moxifloxacin hydrochloride
- 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
Topical treatment of purulent bacterial conjunctivitis, caused by moxifloxacin susceptible strains (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2. Posology and method of administration
Use in adults including the elderly (≥ 65 years)
The dose is one drop in the affected eye(s) 3 times a day.
The infection normally improves within 5 days and treatment should then be continued for a further 2-3 days. If no improvement is observed within 5 days of initiating therapy, the diagnosis and/or treatment should be reconsidered. The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection.
Paediatric patients
No dosage adjustment is necessary.
Use in hepatic and renal impairment
No dosage adjustment is necessary.
Method of administration
For ocular use only. Not for injection. Moxifloxacin 0.5 % w/v eye drops, solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
In order to prevent the drops from being absorbed via the nasal mucosa, particularly in new-born infants or children, the nasolacrimal ducts should be held closed for 2 to 3 minutes with the fingers after administering the drops. After cap is removed, if tamper evident snap collar is loose, remove before using the product.
If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart. Eye ointments should be administered last.
4.3. Contraindications
Hypersensitivity to the active substance, to other quinolones, or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
In patients receiving systemically administered quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching (see section 4.8).
If an allergic reaction to Moxifloxacin 5 mg/ml eye drops, solution occurs, discontinue use of the medicinal product. Serious acute hypersensitivity reactions to moxifloxacin or any other product ingredient may require immediate emergency treatment. Oxygen and airway management should be administered where clinically indicated.
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.
Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including moxifloxacin, particularly in older patients and those treated concurrently with corticosteroid. Following ophthalmic administration of Moxifloxacin 0.5 % w/v eye drops, solution plasma concentrations of moxifloxacin are much lower than after therapeutic oral doses of moxifloxacin (see section 4.5 and 5.2), however caution should be exercised and treatment with Moxifloxacin 0.5 % w/v eye drops, solution should be discontinued at the first sign of tendon inflammation (see section 4.8).
Moxifloxacin 5 mg/ml eye drops, solution should not be used for the prophylaxis or empiric treatment of gonococcal conjunctivitis, including gonococcal ophthalmia neonatorum, because of the prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae. Patients with eye infections caused by Neisseria gonorrhoeae should receive appropriate systemic treatment.
Patients should be advised not to wear contact lenses if they have signs and symptoms of a bacterial ocular infection.
Paediatric population
Data are very limited to establish efficacy and safety of moxifloxacin 0.5 % w/v eye drops, solution, in the treatment of conjunctivitis in neonates. Therefore use of this medicinal product to treat conjunctivitis in neonates is not recommended.
Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition, e.g. systemic treatment in cases caused by Chlamydia trachomitis or Neisseria gonorrhoeae.
The medicinal product is not recommended for the treatment of Chlamydia trachomatis in patients less than 2 years of age as it has not been evaluated in such patients. Patients older than 2 years of age with eye infections caused by Chlamydia trachomitis should receive appropriate systemic treatment.
4.5. Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been performed with Moxifloxacin 0.5 % w/v eye drops, solution. Given the low systemic concentration of moxifloxacin following topical ocular administration of the medicinal product (see Section 5.2), drug interactions are unlikely to occur.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of Moxifloxacin 0.5 % w/v eye drops, solution in pregnant women. However, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin is negligible. The medicinal product can be used during pregnancy.
Breastfeeding
It is unknown whether moxifloxacin/metabolites are excreted in human milk. Animal studies have shown excretion of low levels in breast milk after oral administration of moxifloxacin. However, at therapeutic doses of Moxifloxacin 0.5 % w/v eye drops, solution no effects on the suckling child are anticipated. The medicinal product can be used during breast-feeding.
Fertility
Studies have not been performed to evaluate the effect of ocular administration of Moxifloxacin 0.5 % w/v eye drops, solution on fertility.
4.7. Effects on ability to drive and use machines
Moxifloxacin 0.5 % w/v eye drops, solution has no or negligible influence on the ability to drive and use machines, however, as with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient should wait until their vision clears before driving or using machinery.
4.8. Undesirable effects
Summary of the safety profile
In clinical studies involving 2,252 patients, Moxifloxacin 0.5 % w/v eye drops, solution was administered up to 8 times a day, with over 1,900 of these patients receiving treatment 3 times daily. The overall safety population that received the medicinal product consisted of 1,389 patients from the United States and Canada, 586 patients from Japan and 277 patients from India. No serious ophthalmic or systemic undesirable effects related to the medicinal product were reported in any of the clinical studies. The most frequently reported treatment-related undesirable effects with the medicinal product were eye irritation and eye pain, occurring at an overall incidence of 1 to 2%. These reactions were mild in 96% of those patients who experienced them, with only 1 patient discontinuing therapy as a result.
The following adverse reactions are classified according to the following convention: 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) or not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.
System Organ Classification
Frequency
Adverse reactions
Blood and lymphatic system disorders
Rare
haemoglobin decreased
Immune system disorders
Not known
Hypersensitivity
Nervous system disorders
Uncommon
Rare
Not known
headache
paresthesia
dizziness
Eye disorders
Common
Uncommon
Rare
Not known
eye pain, eye irritation
punctate keratitis, dry eye, conjunctival haemorrhage, ocularhyperaemia, eye pruritus, eyelidoedema, ocular discomfort,
corneal epithelium defect, corneal disorder, conjunctivitis, blepharitis, eye swelling, conjunctival oedema, vision blurred, visual acuity reduced, asthenopia, erythema of eyelid
endophthalmitis, ulcerative keratitis, corneal erosion, corneal abrasion, intraocular pressure increased, corneal opacity, corneal infiltrates, corneal deposits, eye allergy, keratitis, corneal oedema, photophobia, eyelid oedema, lacrimation increased, eye discharge, foreign body sensation in eyes
Cardiac disorders
Not known
palpitations
Respiratory, thoracic and mediastinal disorders
Rare
Not known
nasal discomfort, pharyngolaryngeal pain, sensation of foreign body (throat)
dyspnoea
Gastrointestional disorders
Uncommon
Rare
Not known
dysgeusia
vomiting
nausea
Hepatobiliary disorders
Rare
alanine aminotransferase increased, gamma-glutamyltransferase increased
Skin and subcutaneous tissue disorders
Not known
erythema, rash, pruritus, urticaria
Description of selected adverse reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria and itching (see section 4.4).
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
In clinical trials, Moxifloxacin 0.5 % w/v eye drops, solution has shown to be safe in paediatric patients, including neonates. In patients under 18 years old, the two most frequent adverse reactions were eye irritation and eye pain, both occurring at an incidence rate of 0.9%.
Based on data from clinical trials involving paediatric patients, including neonates (see section 5.1), the type and severity of adverse reactions in the paediatric population are similar to those in adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of benefit/risk balance of the medicinal product. Health care 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 limited holding capacity of the conjunctival sac for ophthalmic products practically precludes any overdosing of the medicinal product.
The total amount of moxifloxacin in a single container is too small to induce adverse effects after accidental ingestion.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- MOXIFLOXACINA ROMPHARM 5 mg/ml prescriptionMOXIFLOXACINUM · eye / ear / nose
- MOXIFLOXACINA MISOM 5 mg/ml prescriptionMOXIFLOXACINUM · eye / ear / nose
- VIGAMOX 5 mg/ml prescriptionMOXIFLOXACINUM · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- VigamoxMoxifloxacinum · eye / ear / nose
- MonafoxMoxifloxacinum · eye / ear / nose
- XiflodropMoxifloxacinum · eye / ear / nose
- Floxamic NeoMoxifloxacinum · eye / ear / nose
- FlomixaMoxifloxacinum · eye / ear / nose
- Moxifloxacinum StullnMoxifloxacinum · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Moxifloxacin 0.5 % w/v 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.