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.
EXOCIN® 3 mg/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 Ofloxacin 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 EXOCIN is an eye-drop used to treat external eye infections such as some types of conjunctivitis. EXOCIN belongs to a group of medicines called 4-quinolone antibacterial agents. EXOCIN is not recommended for use in infants below the age of one year.
What you need to know before you take it
e EXOCIN Do not use EXOCIN If you are allergic (hypersensitive) to ofloxacin, benzalkonium chloride, any of the other ingredients, or any other quinolones. Warnings and precautions This product should be used with caution in patients sensitive to other quinolone antibacterial agents. Long term use may result in a new bacterial infection which does not respond to EXOCIN. This product should be used with caution in patients with a defect or ulceration of the surface of the eye.
EXOCIN potentially increases sensitivity to sunlight. You should avoid exposure to direct sunlight or sun during use of EXOCIN. Heart problems: Caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called 'bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section Taking other medicines). Children There is limited experience of the use of EXOCIN in children. Talk to your doctor before you start using EXOCIN in children. Other medicines and EXOCIN Please tell your doctor or pharmacist if you are using or have recently used any other medicine, including medicines obtained without a prescription. You must tell your doctor if you are taking other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g. quindine, hydroquindine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics. Pregnancy and breast-feeding Tell your doctor before you start using EXOCIN if you are pregnant or if you are breast-feeding. Your doctor can then decide whether you can use EXOCIN. Ask your doctor or pharmacist for advice before using any medicine. Driving and using machines Your sight may become blurred for a short time just after using EXOCIN. You should not drive or use machines until your sight is clear again EXOCIN contains Benzalkonium Chloride This medicine contains 0.05mg of benzalkonium chloride in 1 ml of solution. 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. Benzalkonium chloride is a preservative which may be absorbed by soft contact lenses and may change the colour of the contact lenses. Normally you should not wear contact lenses whilst being treated with this product. However, there may be situations where use of contact lenses is unavoidable. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
How to take it
EXOCIN Always use EXOCIN exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is 1 or 2 drops into the affected eye(s) every 2 to 4 hours for the first 2 days and then 4 times a day from then on. To be effective EXOCIN must be taken regularly. The length of treatment should not exceed ten days. Instructions for use You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it. Apply your eye drops in the following way: 1. Wash your hands. Tilt your head back and look at the ceiling. 2. Gently pull the lower eyelid down until there is a small pocket 3. Turn the bottle upside down and squeeze it to release one or two drops into each eye that needs treatment. 4. Let go of the lower lid, and close your eye for 30 seconds
If a drop misses your eye, try again. To avoid contamination, do not let the tip of the dropper touch your eye or anything else. Replace and tighten the cap straight after use. The proper application of your eye drops is very important. If you have any questions ask your doctor or pharmacist. If you use more EXOCIN than you should If you have placed too many drops in your eye(s), wash the eye(s) with clean water. Apply your next dose at the normal time. If, by accident, anyone drinks this medicine, contact your doctor straight away. If you forget to use EXOCIN If you forget a dose apply it as soon as you remember, unless it is almost time for your next dose, in which case you should miss out the forgotten dose. Then apply your next dose as usual and continue with your normal routine. Do not use a double dose to make up for a forgotten dose. If you stop using EXOCIN
EXOCIN should be used as advised by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, EXOCIN can cause side effects, but not everyone gets them. Serious side effects: If you have one or more of the following side effects, you may have had a serious allergic reaction. Stop taking EXOCIN immediately and contact your physician. Allergic reactions: Frequency not known (cannot be estimated from available data) Allergic reactions in the eye (including itchiness of the eye and/or eyelid) Inflammation of the skin due to allergy (including: rash, itching or hives) Severe sudden life-threatening allergic reaction (Anaphylactic) presenting as swelling beneath the skin that can occur in areas such as the face, lips or other parts of the body, swelling of the mouth, tongue or throat that can obstruct the airways which may cause wheezing, difficulty swallowing, breathing or shortness of breath Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of EXOCIN, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. The following side effects are also known to occur: You should see your doctor if any of the following side effects prove troublesome or if they are long-lasting. Common side effects (may affect up to 1 in 10 people) Eye irritation Ocular discomfort Side effects where the frequency is not known (cannot be estimated from available data) Affecting the eye:
Visual disturbance Tearing Inflammation Redness Sensitivity to light A feeling that something is in your eye Eye swelling Swelling around the eyes (including eyelid swelling) Eye pain Dryness (mild stinging or burning)
Affecting the body:
Dizziness Nausea
Affecting the heart:
Abnormal fast heart rhythm Life-threatening irregular heart rhythm Alteration of the heart rhythm (called 'prolongation of QT interval', seen on ECG electrical activity of the heart)
Reporting of side effects 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: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
EXOCIN Keep out of the reach and sight of children. Once you have opened the bottle do not use it longer than 28 days, even if there is solution remaining. Do not use EXOCIN after the expiry date which is stated on the bottle label and the bottom of the carton after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Do not use EXOCIN if you notice the tamper-proof seal on the bottle is broken. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6.
Contents of the pack and other information
What EXOCIN contains The active substance is Ofloxacin 0.3% w/v. The other ingredients are benzalkonium chloride, sodium chloride, sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH) and purified water What EXOCIN looks like and contents of the pack EXOCIN is an eye drop solution in a plastic bottle. Each carton contains 1 plastic bottle with a screw cap.
Marketing Authorisation Holder AbbVie Ltd. Maidenhead SL6 4UB UK
Tel: 01628 561090 [email protected] Manufacturer Allergan Pharmaceuticals Ireland Westport Co. Mayo Ireland This leaflet was last revised in February 2022
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only). Please be ready to give the following information: Ofloxacin 0.3% reference number PL 41042/0064. This is a service provided by the Royal National Institute of Blind People.
Frequently asked questions about EXOCIN® 3 mg/ml Eye Drops, Solution.
How do I take EXOCIN® 3 mg/ml Eye Drops, Solution.?
EXOCIN® 3 mg/ml Eye Drops, Solution. comes as eye drops containing 3mg/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 EXOCIN® 3 mg/ml Eye Drops, Solution.?
The active substance in EXOCIN® 3 mg/ml Eye Drops, Solution. is ofloxacin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for EXOCIN® 3 mg/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 EXOCIN® 3 mg/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: ofloxacin
- 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
EXOCIN® is indicated for the topical treatment of external ocular infections (such as conjunctivitis and keratoconjunctivitis) in adults and children caused by ofloxacin - sensitive organisms. Safety and efficacy in the treatment of ophthalmia neonatorum has not been established.
4.2. Posology and method of administration
Topical ocular instillation.
For all ages: one to two drops in the affected eye(s) every two to four hours for the first two days and then four times daily. The length of treatment should not exceed ten days.
4.3. Contraindications
EXOCIN® is contra-indicated in individuals who have shown hypersensitivity to ofloxacin, any of its excipients or any other quinolones.
4.4. Special warnings and precautions for use
EXOCIN® is not for injection.
Safety and effectiveness in infants below the age of one year have not been established.
Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching.
If an allergic reaction to EXOCIN® occurs, discontinue the drug. Use EXOCIN® with caution in patients who have exhibited sensitivities to other quinolones antibacterial agents.
When using EXOCIN® the risk of rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance should be considered. As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms.
If worsening infection occurs, or if clinical improvement is not noted within a reasonable period, discontinue use and institute alternative therapy.
Cardiac disorders
Caution should be taken when using fluoroquinolones, including EXOCIN® in patients with known risk factors for prolongation of the QT interval such as, for example:
- congenital long QT syndrome
- concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics)
- uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia)
- cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)
(See section 4.2 Elderly, section 4.5, section 4.8, section 4.9).
Elderly patients and women may be more sensitive to QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including EXOCIN®, in these populations.
Use EXOCIN® with caution in patients who have exhibited sensitivities to other quinolone antibacterial agents.
Data are very limited to establish efficacy and safety of EXOCIN® eye drops 0.3% in the treatment of conjunctivitis in neonates.
The use of EXOCIN® eye drops in neonates with ophthalmia neonatorum caused by Neisseria gonorrhoeae or Chlamydia trachomatis is not recommended as it has not been evaluated in such patients.
Use in elderly: No comparative data are available with topical dosing in elderly versus other age groups.
Clinical and non-clinical publications have reported the occurrence of corneal perforation in patients with pre-existing corneal epithelial defect or corneal ulcer, when treated with topical fluoroquinolone antibiotics. However, significant confounding factors were involved in many of these reports, including advanced age, presence of large ulcers, concomitant ocular conditions (e.g. severe dry eye), systemic inflammatory diseases (e.g. rheumatoid arthritis), and concomitant use of ocular steroids or non-steroidal anti-inflammatory drugs. Nevertheless, it is necessary to advise caution regarding the risk of corneal perforation when using product to treat patients with corneal epithelial defects or corneal ulcers.
Corneal precipitates have been reported during treatment with topical ophthalmic ofloxacin. However, a causal relationship has not been established.
Long-term, high-dose use of other fluoroquinolones in experimental animals has caused lenticular opacities. However, this effect has not been reported in human patients, nor has it been noted following topical ophthalmic treatment with ofloxacin for up to six months in animal studies including studies in monkeys.
EXOCIN® contains the preservative benzalkonium chloride which may cause eye irritation, symptoms of dry eyes, and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.
Use of contact lenses is not recommended in patients receiving treatment for an eye infection. Patients should remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.
Patients should be monitored in case of prolonged use.
Sun or UV-exposition should be avoided during use of ofloxacin due to the potential for photosensitivity.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
It has been shown that the systemic administration of some quinolones inhibits the metabolic clearance of caffeine and theophylline. Drug interaction studies conducted with systemic ofloxacin have demonstrated that metabolic clearance of caffeine and theophylline are not significantly affected by ofloxacin.
Although there have been reports of an increased prevalence of CNS toxicity with systemic dosing of fluoroquinolones when used concomitantly with systemic nonsteroidal anti-inflammatory drugs (NSAIDs), this has not been reported with the concomitant systemic use of NSAIDs and ofloxacin.
EXOCIN®, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section 4.4).
4.6. Pregnancy and lactation
Pregnancy
There have been no adequate and well-controlled studies performed in pregnant women. Since systemic quinolones have been shown to cause arthropathy in immature animals, it is recommended that EXOCIN® not be used in pregnant women.
Breastfeeding
Because ofloxacin and other quinolones taken systemically are excreted in breast milk, and there is potential for harm to nursing infants, a decision should be made whether to temporarily discontinue nursing or not to administer the drug, taking into account the importance of the drug to the mother.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Transient blurring of vision may occur on instillation of eye drops. Do not drive or operate hazardous machinery unless vision is clear.
4.8. Undesirable effects
General
Serious reactions after use of systemic ofloxacin are rare and most symptoms are reversible. Since a small amount of ofloxacin is systemically absorbed after topical administration, side-effects reported with systemic use could possibly occur.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The following terminologies have been used in order to classify the occurrence of undesirable effects:
Frequency categories: 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) and not known (cannot be estimated from the available data):
Immune System Disorders
Not Known: Hypersensitivity reaction including signs or symptoms of Eye allergy (such as Eye pruritus and Eyelid pruritus) and Anaphylactic reactions (such as angioedema, dyspnea, anaphylactic shock, oropharyngeal swelling, facial oedema and tongue swollen)
Nervous System Disorders
Not known: Dizziness
Eye Disorders
Common: Eye irritation; Ocular discomfort
Not known: Keratitis; Conjunctivitis; Vision blurred; Photophobia; Eye oedema; Foreign body sensation in eyes; Lacrimation increased; Dry eye; Eye pain; Ocular hyperaemia; Periorbital oedema (including eyelid oedema)
Cardiac disorders
Not known: ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation); ECG QT prolonged (see section 4.4 and 4.9)
Gastrointestinal Disorders
Not known: Nausea
Skin and Subcutaneous Tissue Disorders
Not Known: Stevens-Johnson syndrome; Toxic epidermal necrolysis
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:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9. Overdose
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- UNIFLOX 3 mg/ml prescriptionOFLOXACINUM · eye / ear / nose
- FLOXAL 3 mg/ml prescriptionOFLOXACINUM · eye / ear / nose
- FLOXAL 3 mg/g prescriptionOFLOXACINUM · 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
- FloxalOfloxacinum · eye / ear / nose
- Ofloxacin-POSOfloxacinum · eye / ear / nose
- OflodinexOfloxacinum · eye / ear / nose
- OfloxamedOfloxacinum · eye / ear / nose
- VisioFloxOfloxacinum · 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 EXOCIN® 3 mg/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.