Ciprotic

Given that it has not been confirmed whether Ciprotic passes into breast milk, caution should be exercised when using Ciprotic during breastfeeding.

Driving and using machines

Considering the form and route of administration, Ciprotic does not affect the ability to drive or operate machinery.

Ciprotic contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late-type reactions).

3. How to use Ciprotic

Ciprotic is intended for administration into the ear (otic use) only.

Always use Ciprotic exactly as the doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

The recommended dose for adults and children is 6 to 8 drops into the affected ear, twice a day, for 7 days.

Administer Ciprotic into both ears only if advised by a doctor.

The doctor will determine how long to use Ciprotic. To avoid recurrence of infection, do not stop treatment too early, even if the ear symptoms have improved.

Method of administration

The person applying Ciprotic should wash their hands.

• 1. Warm the drops by holding the bottle in your hands for a few minutes to avoid dizziness that may occur when administering a cold solution into the ear canal.

• 2. Tilt your head to the side so that the affected ear is facing upwards.

• 3. Administer the drops into the ear using the dropper. Do not touch the dropper to the ear or fingers to avoid contaminating the drops.
• 4. After administering the drops into the ear, follow the instructions below for the specific ear infection of the patient: For patients with otitis media with ventilation tube insertion: The patient lies on their side, and the person administering Ciprotic should gently press the skin at the entrance to the ear canal (see figure 4a) 4 times with a pumping motion. This allows the drops to pass through the drainage in the eardrum into the middle ear.

For patients with otitis externa:

The patient lies on their side, and the person administering Ciprotic should gently pull the auricle upwards and backwards (figure 4b). This allows the drops to flow into the ear canal.

• 5. Keep your head tilted for about 1 minute to allow the drops to flow into the ear.
• 6. If necessary, repeat the procedure for the other ear. To ensure the effectiveness of the medicine in the ear, follow the administration instructions. During administration, it is not recommended to keep the head in an upright position or move it too vigorously, as this may lead to loss of part of the medicine, as the drops will flow down the face instead of penetrating the ear canal. Store the bottle until the end of treatment. Do not use the medicine for later treatment.

Using more than the recommended dose of Ciprotic

There are no known symptoms of overdose.

In case of overdose or accidental ingestion, immediately consult a doctor or pharmacist, or contact the toxicology information center by phone at 42 63 14 724/25, providing the name of the medicine and the amount taken.

Missing a dose of Ciprotic

Do not take a double dose to make up for a missed dose. Take the next dose according to the adopted treatment schedule.

Stopping the use of Ciprotic

Do not stop using Ciprotic without consulting a doctor or pharmacist. It is crucial to use these ear drops for the period prescribed by the doctor, even if symptoms improve earlier. If treatment is stopped too early, the infection may recur, symptoms may return, or even worsen. Resistance to the antibiotic may also develop.

In case of any further doubts about the use of the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ciprotic can cause side effects, although not everybody gets them.

If serious allergic reactions or any of the following side effects occur, discontinue the use of the medicine and consult a doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth, throat, or tongue, difficulty swallowing or breathing, rash or hives, wounds, or ulcers.

Common: may affect up to 1 in 10 people.

• Local side effects in the ear: discomfort, pain, itching.
• General side effects: taste disturbances.

Uncommon: may affect up to 1 in 100 people.

• Local side effects in the ear: ringing, presence of drug residue, drainage obstruction, tingling, redness, hearing impairment, rash, inflammation, fungal infection of the outer ear, ear discharge, swelling, eardrum disturbances, granuloma, otitis media of the other ear.
• General side effects: fungal infection with Candida, irritability, excessive tear production, dizziness, skin redness, headache, vomiting, fatigue.

Unknown (frequency cannot be estimated from the available data):

Vision disturbances: blurred vision.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Reporting side effects will help gather more information on the safety of the medicine.

If any of the side effects get worse, or if you notice any side effects not listed in the leaflet, inform your doctor or pharmacist.

5. How to store Ciprotic

Store in a place inaccessible and invisible to children.

Store at a temperature below 25°C. Do not store in the refrigerator or freeze.

Do not use Ciprotic after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the given month.

Shelf life after first opening the bottle: 28 days.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist what to do with medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ciprotic contains

The active substances are:

• Ciprofloxacin in the form of ciprofloxacin hydrochloride and fluocinolone acetonide.

1 ml of Ciprotic contains 3 mg of ciprofloxacin (in the form of ciprofloxacin hydrochloride) and 0.25 mg of fluocinolone acetonide.

• The other ingredients are: povidone K90, glycereth-26 (glycerol and ethylene oxide), diethylene glycol monoethyl ether, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), purified water.

What Ciprotic looks like and contents of the pack

Ciprotic is a clear ear drop solution. The packaging consists of an LDPE bottle with an LDPE dropper, closed with an HDPE cap with a tamper-evident ring, in a cardboard box.

Each bottle contains 10 ml of solution.

Medical advice and education

Antibiotics are used to treat bacterial infections. They are not effective in treating viral infections.

If a doctor has prescribed an antibiotic, its use is necessary due to the specific disease currently affecting the patient to whom it was prescribed.

Despite the use of antibiotics, some bacteria may survive or multiply. This phenomenon is called resistance: treatment with some antibiotics becomes ineffective.

Improper use of antibiotics leads to increased resistance. The patient may even contribute to the development of bacterial resistance and thus delay their recovery or reduce the effectiveness of the antibiotic if they do not follow the proper:

• dosage,
• treatment schedule,
• duration of treatment.

Therefore, to avoid reducing the effectiveness of this medicine, follow these recommendations:

• Use antibiotics only when prescribed.
• Strictly follow the doctor's instructions.
• Do not use antibiotics again without consulting a doctor, even if the symptoms of the disease are similar.
• Never give your antibiotic to another person; it may not be suitable for treating their disease.
• After completing the treatment, return any unused medicine to the pharmacy, which will ensure its proper disposal.

Marketing Authorization Holder:

Solinea Sp. z o.o, Elizówka, ul. Szafranowa 6, 21-003 Ciecierzyn, Poland

Manufacturers:

Mako Pharma Sp. z o. o., Ul. Władysława Reymonta 2, 05-092 Dziekanów Leśny, Poland

Medicofarma S.A., ul. Tarnobrzeska 13, 26-613 Radom, Poland

Date of last revision of the leaflet:

• 05.2025