Cetraxal

PATIENT INFORMATION LEAFLET: USER INFORMATION

Cetraxal, 2 mg/ml, ear drops, solution

Ciprofloxacin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Cetraxal and what is it used for
• 2. Important information before using Cetraxal
• 3. How to use Cetraxal
• 4. Possible side effects
• 5. How to store Cetraxal
• 6. Contents of the pack and other information

1. What is Cetraxal and what is it used for

Cetraxal is a medicine in the form of a solution for administration into the ear, which contains ciprofloxacin, an active substance that is an antibacterial agent belonging to the group of fluoroquinolones. Ciprofloxacin acts bactericidally on bacteria that cause infections. Cetraxal is indicated for the treatment of acute external otitis media of bacterial origin, when the eardrum is not damaged (see section 2. Important information before using Cetraxal), in adults and children over one year of age.

2. Important information before using Cetraxal

When not to use Cetraxal

• If you are allergic (hypersensitive) to ciprofloxacin or any other quinolone antibacterial agent or any of the other ingredients of Cetraxal (listed in section 6).

Warnings and precautions

• If you experience hives, rash, or any other allergic symptoms (e.g. sudden swelling of the face, throat, or eyelids, difficulty breathing) after starting treatment, stop using the medicine and contact your doctor immediately. Severe allergic reactions require immediate emergency treatment.
• This medicine is for use in the ears only. Do not swallow, inject, or inhale it. Do not use it in the eyes.
• Tell your doctor if your symptoms do not improve within one week of starting treatment.
• As with any antibiotic, additional infections may occur that are not affected by ciprofloxacin. If such an infection occurs, your doctor should start appropriate treatment.
• Cetraxal should be used with caution in patients who have been diagnosed with or are suspected of having a perforated eardrum, or when there is a risk of this.

Cetraxal and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription. It is not recommended to use this medicine in combination with other ear drops.

Pregnancy, breastfeeding, and fertility

Cetraxal may be used during pregnancy and breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Cetraxal does not affect the ability to drive and use machines.

3. How to use Cetraxal

Always use Cetraxal exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Cetraxal is for use in the ears only. Do not swallow, inject, or inhale it. Dosage The recommended dose for adults and children over 1 year of age is to instill the contents of one ampoule into the affected ear twice daily for 7 days. Method of administration Warm the solution by holding the ampoule in your hands for a few minutes to avoid dizziness that may occur when cold solution is instilled into the ear canal. Lie down with the affected ear facing upwards and instill the drops, gently pulling the outer ear in different directions. Stay in this position for about 5 minutes to facilitate the penetration of the drops into the ear. When you sit up again, some drops may run out. You can wipe them away with a sterile absorbent paper. Repeat the procedure if necessary for the other ear. If the ear canal is narrow, the delivery of the medicine to the eardrum can be improved by gently pulling the ear upwards. Following these instructions is very important for achieving good efficacy of the medicine in the patient's ear. When instilling the drops into the ear, keeping the head in an upright position or moving it too quickly can cause loss of the medicine, as the drops will run down the face instead of into the ear canal. After using the medicine, discard the single-dose ampoule. Do not store it for later use.

Using more Cetraxal than you should

Since the medicine is prepared in single-dose form, accidental overdose is unlikely. In any case, contact your doctor or pharmacist for advice.

Forgetting to use Cetraxal

Do not use a double dose to make up for a forgotten dose. If you forget to use the drops, use the correct dose as soon as you remember or wait until the next dose is due.

Stopping the use of Cetraxal

It is very important to use these drops for the entire period of time prescribed by your doctor, even if your symptoms improve. Do not stop treatment prematurely, as the infection may return. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cetraxal can cause side effects, although not everybody gets them. Uncommon side effects (occurring in at least 1 in 1000 patients):

• itching (pruritus) of the ear, ringing in the ears
• headache
• dizziness
• local skin reactions or skin irritation (dermatitis)
• pain at the application site

Rare side effects (occurring in less than 1 in 10,000 patients):

• rash
• blistering and peeling of the skin (toxic epidermal necrolysis)
• redness and peeling of the skin (exfoliative dermatitis)
• severe allergic reaction with fever, red spots, joint pain, and/or eye problems (Stevens-Johnson syndrome)
• skin allergy with itching and blistering (urticaria)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of suspected adverse reactions After authorization of the medicinal product, it is important to report any suspected adverse reaction. This allows for continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181 C 02-222 Warsaw Phone: (+48 22) 49-21-301 Fax: (+48 22) 49-21-309 Website: https://smz.ezdrowie.gov.pl Adverse reactions can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cetraxal

Keep the medicine out of the sight and reach of children. Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. Store in a temperature below 30°C in the original packaging to protect from light. The contents of the ampoule should be used immediately after opening a single dose. Discard any unused contents of the ampoule. Shelf-life of the ampoules after opening the sachet: 8 days. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cetraxal contains

The active substance is ciprofloxacin in the form of monohydrate hydrochloride. 1 ml of solution contains 2 mg of ciprofloxacin in the form of hydrochloride. Each ampoule contains 0.25 ml of solution, which contains 0.58 mg of ciprofloxacin hydrochloride, equivalent to 0.50 mg of ciprofloxacin. The other ingredients are: povidone K-90-F (E1201), glycerol (E422), purified water, and sodium hydroxide (E524) and lactic acid (E270) to adjust the pH.

What Cetraxal looks like and contents of the pack

Cetraxal, ear drops, is a clear solution in ampoules. For protection, the ampoules are packed in sachets made of aluminum foil. Each pack contains 15 ampoules.

Marketing authorization holder

TACTICA Pharmaceuticals Sp. z o.o. ul. Królowej Jadwigi 148a/1a 30-212 Kraków, Poland tel.: +48 889 388 538

Manufacturer

Laboratorios SALVAT, S.A. C/ Gall, 30-36. 08950 Esplugues de Llobregat Barcelona Spain

Manufacturer for the German market

InfectoPharm Arzneimittel und Consilium GmbH Von-Humboldt-Str. 1 64646 Heppenheim Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark Cetraxal 2 mg/ml Øredråber opløsning Finland Cetraxal 2 mg/ml Korvatipat, liuos France Cetraxal 2 mg/ml solution pour instillation auriculaire Germany InfectoCipro 2 mg/ml Ohrentropfen, Lösung Greece Cetraxal 2 mg/ml Ωτικές σταγόνες, διάλυµα Iceland Cetraxal 2 mg/ml eyrnadropar, lausn Italy UNICEXAL 2 mg/ml gocce auricolari, soluzione Netherlands Cetraxal 2 mg/ml oordruppels, oplossing Norway Cetraxal Poland Cetraxal Sweden Cetraxal 2 mg/ml örondroppar, lösning United Kingdom Cetraxal 2 mg/ml ear drops solution Date of revision of the leaflet:09/2024