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.
Oftaquix 5 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 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
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). Oftaquix 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.
2.
What you need to know before you take it
e Oftaquix
Do not use Oftaquix 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 Oftaquix 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 Oftaquix-md-uk-20201126 [1B 038 excip]
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generally, no types of contact lenses should be worn when the eye is infected. Oftaquix contains the preservative benzalkonium chloride, which may cause eye irritation.
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 Oftaquix 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. Other medicines and Oftaquix 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 Oftaquix. If you are using other eye drops, you should wait at least 15 minutes between applying Oftaquix 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 taking this medicine. Oftaquix 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 take Oftaquix eye drops in this case. Your fertility (ability to become pregnant or to father a child) is not impaired when you apply Oftaquix following its instructions for use. Driving and using machines Oftaquix 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. Oftaquix contains benzalkonium chloride This medicine contains approximately 0.002 mg benzalkonium chloride in each drop which is equivalent to 0.05 mg/ml. 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.
3.
How to take it
Oftaquix
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Oftaquix 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: Oftaquix-md-uk-20201126 [1B 038 excip]
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 ≥ 1 year old and in adolescents. Oftaquix 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.
3)
Tilt your head backwards and hold the bottle upside down over the eye.
4)
Pull the lower eyelid downwards and look up. Gently squeeze the bottle and let one drop fall into the space between the lower eyelid and the eye.
5)
Close the 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.
6) 7)
Wipe off any excess solution from the skin around the eye. Put the cap back on and close the bottle tightly.
If another drop is needed, and when both eyes are to be treated, repeat steps 3 to 7. Oftaquix eye drops should not be injected into the interior part of the eyeball. Oftaquix-md-uk-20201126 [1B 038 excip]
If you use more Oftaquix than you should If you use more Oftaquix than you should, flush the eye(s) with water and tell your doctor or pharmacist. If you forget to use Oftaquix 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 Oftaquix 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 Oftaquix 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 Oftaquix. Most of these affect only the eye and may not last very long. If you have any severe or persistent side effect you should stop using these eye drops and seek urgent advice from your doctor. Very rarely this medicine can cause severe allergic reactions. The following symptoms can occur even after just one dose of Oftaquix: swelling and tightness in the throat breathing difficulties. In rare cases other allergic reactions can develop. Symptoms of such reactions are: worsening of redness and itching of the eyes increased or sudden swelling of eyelids. Stop using Oftaquix and contact a doctor immediately if any of these symptoms occurs. Common side effects (may affect up to 1 in 10 users) burning feeling in the eye decreased vision or mucus in the eye Uncommon side effects (may affect up to 1 in 100 users) 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 users) allergic reactions such as skin rash Very rare side effects (may affect less than 1 10,000 users) swelling and tightness in the throat breathing difficulty Oftaquix-md-uk-20201126 [1B 038 excip]
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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. 5.
How to store it
Oftaquix
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. This medicine does not require any special storage conditions. Keep the bottle tightly closed. 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 throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Oftaquix contains The active substance is levofloxacin. 1 ml contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg of levofloxacin. The other ingredients are benzalkonium chloride (0.05 mg in 1 ml eye drops, solution; preservative), sodium chloride, sodium hydroxide or hydrochloric acid and water for injections. What Oftaquix looks like and contents of the pack Oftaquix is a clear, light yellow to light greenish-yellow solution, free of visible particulate matter. It is supplied in a pack containing 1 white plastic bottle with 5 ml solution. The plastic bottle is closed with a screw cap. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Santen Oy Niittyhaankatu 20 33720 Tampere Finland Manufacturer Santen Oy Kelloportinkatu 1 33100 Tampere Finland Oftaquix-md-uk-20201126 [1B 038 excip]
This medicinal product is authorised in the Member States of the EEA under the following names: This medicinal product is authorised under the trade name Oftaquix in the following Member States of the EEA: Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Portugal, Romania, Slovakia, Sweden, United Kingdom. This leaflet was last revised in 10/2020
Oftaquix-md-uk-20201126 [1B 038 excip]
Frequently asked questions about Oftaquix 5 mg/ml eye drops, solution
How do I take Oftaquix 5 mg/ml eye drops, solution?
Oftaquix 5 mg/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 Oftaquix 5 mg/ml eye drops, solution?
The active substance in Oftaquix 5 mg/ml eye drops, solution is levofloxacin hemihydrate.
Are there equivalent medicines to Oftaquix 5 mg/ml eye drops, solution?
Medicines with the same active substance, strength and form include: Eyflox 5mg/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 Oftaquix 5 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 Oftaquix 5 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: 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
Oftaquix 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.
Oftaquix 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.
Oftaquix 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 Oftaquix in children aged ≥1 year have been established.
The safety and efficacy of Oftaquix in children < 1 year have not yet been established. No data are available.
Method of administration
Ocular use.
4.3. Contraindications
Hypersensitivity to the active substance levofloxacin, to other quinolones or to any of the excipients listed in section 6.1, e.g. benzalkonium chloride.
4.4. Special warnings and precautions for use
Oftaquix 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.
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.
Systemic fluoroquinolones have been associated with hypersensitivity reactions, even following a single dose. If an allergic reaction to levofloxacin occurs, discontinue the medication.
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 Oftaquix should be discontinued at the first sign of tendon inflammation (see section 4.8).
Oftaquix 5 mg/ml eye drops contain benzalkonium chloride as preservative. Contact lenses should be removed prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.
Patients with external bacterial ocular infections should not wear contact lenses.
Benzalkonium chloride has been reported to 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. Patients should be monitored in case of prolonged use.
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 Oftaquix 5 mg/ml 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 Oftaquix 5 mg/ml eye drops.
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. Oftaquix 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 Oftaquix no effects on the suckling child are anticipated. Oftaquix 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
Oftaquix 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.
As the product contains benzalkonium chloride, contact eczema and/or irritation may be due to the active component or to this preservative.
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 (Oftaquix 5 mg/ml Eye Drops and Oftaquix 5 mg/ml eye drops in single-dose container):
Immune system disorders
Rare (≥1/10,000 to <1/1,000): Extra-ocular allergic reactions, including skin rash.
Very rare (<1/10,000): Anaphylaxis.
Nervous system disorders
Uncommon (≥1/1,000 to <1/100): Headache.
Eye disorders
Common (≥1/100 to <1/10): Ocular burning, decreased vision and mucous strand.
Uncommon (≥1/1,000 to <1/100): 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 (≥1/1,000 to <1/100): Rhinitis.
Very rare (<1/10,000): Laryngeal oedema.
Additional adverse reactions that have been seen with the systemic use of the active substance (levofloxacin), and may potentially occur also with Oftaquix:
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 at: 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 Oftaquix 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 Oftaquix 5 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.
Medicines containing Levofloxacin hemihydrate
- Eyflox 5mg/ml eye drops, solution
- 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 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