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.
Cetraxal 2mg/ml ear drops, solution single-dose container
⚠ 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 Ciprofloxacin 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
Cetraxal 2mg/ml ear drops solution is a solution for auricular use (in the ear) that contains ciprofloxacin, the active substance which is an antibacterial agent belonging to the group of fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections. Cetraxal 2mg/ml ear drops solution is indicated for the treatment of acute external otitis of bacterial origin in adults and children older than 1 year where the eardrum is still intact (see section 2. What you need to know before you use Cetraxal).
2.
What you need to know before you take it
E CETRAXAL
Do not use Cetraxal:
- if you are allergic (hypersensitive) to ciprofloxacin, to any member of the quinolone class of antimicrobial agents or any of the other ingredients of this medicine (listed in section 6). Warnings and Precautions
- Once treatment has begun, if you develop urticaria (hives), skin rash or any other allergic symptoms (e.g. sudden swelling of face, throat or eyelids, respiratory difficulty), you must stop treatment immediately and you should consult with your doctor. Serious hypersensitivity reactions may need immediate emergency treatment.
- This preparation should only be applied to the ear. It should not be swallowed, injected or inhaled. It should not be used in the eye.
- Tell the doctor if the symptoms do not improve within one week of starting treatment.
- As with all antibiotics, sometimes additional infections may occur caused by organisms which are not affected by ciprofloxacin. In case of such infection appropriate treatment should be started by your doctor.
- Cetraxal 2mg/ml ear drops solution should be used with caution in patients with known or suspected perforation, or where there is a risk of perforation of the tympanic membrane. Other medicines and Cetraxal Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Their use in conjunction with other ear preparations is not recommended. Pregnancy, breast-feeding and fertility Cetraxal can be used during pregnancy and during breast-feeding. 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. Driving and using machines Cetraxal does not affect the ability to drive vehicles or operate dangerous machinery.
3.
How to take it
CETRAXAL
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This medicine is intended to be administered into the ear. It should not be swallowed, injected or inhaled. Dosage The recommended dose is for children (age 1 year and older) and adults, the contents of 1 single ampoule should be instilled into the affected ear twice daily for seven days. Administration Warm the solution, by holding the ampoule in the hand for several minutes, to avoid the dizziness that may result from the instillation of a cold solution into the ear canal. Lie with the affected ear upward and then instil the drops pulling several times on the auricle. Maintain the position for around 5 minutes, to facilitate penetration of the drops into the ear. When you stand up again, some drops can fall out. You can dry them with a non-sterile absorbent paper. Repeat, if necessary, for the opposite ear. If the auditory canal is narrow, the medicine can be made to reach the eardrum by pulling the ear upwards. It is of the most importance to follow this instruction to have a good efficacy of the drug in your ear. When you instil ear drops, maintaining your head vertically or moving your head too rapidly will cause you to lose a part of the drug because drops are going to run down on your face and do not go into the depth of the auditory canal. Discard the single-dose container after the use. Do not keep it for subsequent use.
If you use more Cetraxal than you should Since this is a single-dose preparation, an accidental overdose is unlikely. In any case you should contact your doctor or pharmacist for advice. If you forget to use Cetraxal Do not use a double dose to make up for a missed one. If you forget to apply your drops, apply the correct dose when you remember or if it is close to your next application then wait until this time. If you stop using Cetraxal It is very important to use these eardrops for as long as the doctor has instructed, even if the symptoms improve. Do not interrupt your treatment before time, as the infection could return. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Uncommon: may affect up to 1 in 100 people:
- Ear pruritus (itching), ringing in the ears
- Headache
- Dizziness
- Local skin reactions or irritation (Dermatitis)
- Pain in the application site Very rare: may affect up to 1 in 10,000 people:
- Rash
- Blistering and tissue break down (Toxic epidermolysis)
- Redness and scaling of the skin (Exfoliative dermatitis)
- Serious allergic reaction with fever, red patches, joint pain and/or eye problems (Stevens-Johnson syndrome)
- Skin allergy with development of itchiness and wheals (Urticaria) If you consider that any of the side effects you suffer are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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 the 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.
5.
How to store it
CETRAXAL
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 package. The expiry date refers to the last day of that month. Store below 30°C in the original package, in order to protect from light. The ampoule contents should be used immediately after opening the single dose ampoule. Any unused contents should be discarded. Once the pouch is opened, use within 8 days. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines no longer required. These measures will help protect the environment.
6.
Contents of the pack and other information
What Cetraxal contains
- The active substance is ciprofloxacin as hydrochloride. 1ml solution contains 2mg of ciprofloxacin as hydrochloride. Each ampoule delivers 0.25ml of solution that contains 0.58mg of ciprofloxacin hydrochloride corresponding to 0.50mg of ciprofloxacin.
- The other ingredients are povidone-K-90-F (E1201), glycerol (E422), purified water and sodium hydroxide (E524) and/or lactic acid (E270) for pH-adjustment. What Cetraxal looks like and contents of the pack Cetraxal is a clear ear drops solution contained in ampoules. The ampoules are packed in an aluminium foil overwrap pouch for protection. Each pack contains 15 ampoules. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Aspire Pharma Ltd Unit 4, Rotherbrook Court Bedford Rd, Petersfield Hampshire, GU32 3QG United Kingdom Manufacturer Laboratorios SALVAT, S.A. C/ Gall, 30-36 08950 Esplugues de Llobregat Barcelona Spain This leaflet was last revised in 10/2017.
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Aspire Pharma Limited Cetraxal 2mg/ml ear drops solution Black Leaflet 375mm x 130mm Dimensions and style supplied 4 May 2017 COO-minor amends 2.3 4.10.17 As swatch(es) 8 on 9pt Times New Roman InDesign CC U173
Frequently asked questions about Cetraxal 2mg/ml ear drops, solution single-dose container
How do I take Cetraxal 2mg/ml ear drops, solution single-dose container?
Cetraxal 2mg/ml ear drops, solution single-dose container comes as ear drops containing 2mg/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 Cetraxal 2mg/ml ear drops, solution single-dose container?
The active substance in Cetraxal 2mg/ml ear drops, solution single-dose container is ciprofloxacin hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Cetraxal 2mg/ml ear drops, solution single-dose container, 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 Cetraxal 2mg/ml ear drops, solution single-dose container 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: ciprofloxacin 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
Cetraxal 2 mg/ml ear drops solution is indicated for the treatment of acute otitis externa in adults and children older than 1 year with an intact tympanic membrane, caused by ciprofloxacin susceptible microorganisms (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
Adults and children aged one year and older
Instil the contents of one single ampoule into the affected ear twice daily for seven days.
Paediatric patients less than one year
The safety and efficacy of Cetraxal in children aged below 1 year of age have not been established. No data are available. See section 4.4.
Method of administration
Precautions to be taken before handling or administering the medicinal product
▪ The solution should be warmed, by holding the ampoule in the hand for several minutes, to avoid the dizziness that may result from the instillation of a cold solution into the ear canal.
▪ The patient should lie with the affected ear upward and then the drops should be instilled, pulling several times on the auricle. This position should be maintained for around 5 minutes to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.
▪ The patient should be advised to discard the single-dose container after the use, and not keep it for subsequent use.
▪ In case an otowick/tampon is used to facilitate administration, the first dose should be doubled (2 ampoules instead of 1).
Renal/ hepatic impairment
Since the drug plasma concentration is anticipated to be undetectable, no dosage adjustment for these patient groups is deemed necessary.
4.3. Contraindications
Hypersensitivity to the active substance ciprofloxacin or any member of the quinolone class of antimicrobial agents or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
This medicinal product is for auricular use, not for ophthalmic use, inhalation or injection.
In otic use meticulous medical monitoring is required in order to be able to determine in a timely manner the possible necessity of other therapeutic measures.
Paediatric population
The safety and efficacy of this product have been established in paediatric patients 1 year and older in controlled clinical trials. Although very limited data are available in patients less than age 1 year treated for acute otitis externa, there are no differences in the disease process itself, in this patient population, which would preclude use of this product in patients less than one year of age. Based upon the very limited data, the prescribing physician should weigh the clinical benefits of use against the known and possibly unknown risks when prescribing in patients less than age 1 year.
The safety and efficacy of Cetraxal have not been studied in the presence of a perforated tympanic membrane. Therefore, Cetraxal should be used with caution in patients with known or suspected perforation, or where there is a risk of perforation of the tympanic membrane.
Cetraxal should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Serious acute hypersensitivity reactions may require immediate emergency treatment.
As with other antibiotic preparation, the use of this product may result in overgrowth of non-susceptible organisms, including bacterial strains, yeast and fungi. If superinfection occurs, appropriate therapy should be initiated.
If after one week of therapy some signs and symptoms persist, further evaluation is recommended to reassess the disease and the treatment.
Some patients taking systemic quinolones have shown moderate to severe skin sensitivity to sun. Due to the site of administration, it is unlikely that this product may show photoallergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Cetraxal.
Due to low plasma level anticipated after application in the ear, it is unlikely that ciprofloxacin may show systemic interaction with other drugs.
It is recommended not to use other ear preparations concomitantly.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data on the use of ciprofloxacin otic solution 0.2% in pregnant women. There are moderate amount of data from the use oral ciprofloxacin in pregnant women. No reproductive toxicity has been performed after otic administration. However after systemic exposure, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Since systemic exposure to ciprofloxacin is negligible after otic administration, thus no effects are anticipated during pregnancy. Cetraxal can be used during pregnancy.
Lactation
Ciprofloxacin is excreted in human milk after systemic use. It is not known whether ciprofloxacin is excreted in human milk after otic use. No effects on the breast-fed newborn are anticipated since the systemic exposure of the breast-feeding woman to ciprofloxacin is negligible. Cetraxal can be used during breast-feeding.
Fertility
Studies in animals with oral administration of ciprofloxacin do not indicate any effects on fertility.
4.7. Effects on ability to drive and use machines
Cetraxal has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
In a Phase III clinical trial, a total of 319 patients were treated with Cetraxal.
The most commonly reported adverse reactions are: ear pruritus occurring in 0.9% of patients treated with ciprofloxacin, and headache and application site pain, both occurring in approximately 0.6 % of patients.
All treatment related adverse reactions are uncommon (≥1/1000 to <1/100) and are listed below.
Ear and Labyrinth Disorders
Uncommon: Ear pruritus, tinnitus
Nervous System Disorders
Uncommon: Dizziness, headache
Skin and subcutaneous disorders
Uncommon: Dermatitis
General Disorders and Administration Site Conditions
Uncommon: Application Site Pain
With locally applied fluoroquinolones (generalized) rash, toxic epidermolysis, dermatitis exfoliative, Stevens-Johnson syndrome, and urticaria occur very rarely.
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 (www.mhra.gov.uk/yellowcard).
4.9. Overdose
The potential risk of overdose with this single-dose preparation is negligible since the total amount of ciprofloxacin per pack is 7.5 mg.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- CIPROFLOXACIN ROMPHARM 3mg/ml prescriptionCIPROFLOXACINUM · 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
- Cipronex 0,3%Ciprofloxacinum · eye / ear / nose
- CiloxanCiprofloxacinum · eye / ear / nose
- CetraxalCiprofloxacinum · 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 Cetraxal 2mg/ml ear drops, solution single-dose container. 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.