Septocipro Otico 1 mg ear drops solution in single-dose container
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
SEPTOCIPRO OTIC 1mg ear drops solution in single-dose container
Ciprofloxacin
Read the entire leaflet carefully before you start using this medicine.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents
- What SEPTOCIPRO OTIC is and what it is used for
- What you need to know before using SEPTOCIPRO OTIC
- How to use SEPTOCIPRO OTIC
- Possible side effects
- How to store SEPTOCIPRO OTIC
- Contents of the pack and other information
1. What SEPTOCIPRO OTIC is and what it is used for
The active substance in this medicine is ciprofloxacin, an antibiotic belonging to a group of antibacterial agents known as quinolones. Ciprofloxacin prevents the growth of certain microorganisms that cause infections.
Antibiotics are used to treat bacterial infections and are not effective against viral infections.
It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of down the drain or in household waste.
SEPTOCIPRO OTIC is used for topical treatment in adults and children aged two years and older for the following bacterial ear infections: chronic suppurative otitis media and acute otitis externa.
2. What you need to know before using SEPTOCIPRO OTIC
Do not use SEPTOCIPRO OTIC
If you are allergic to ciprofloxacin, to other quinolones, or to any of the other components of this medicine (see section 6).
Take special care with SEPTOCIPRO OTIC
- If you experience an allergic reaction to SEPTOCIPRO OTIC, stop treatment and inform your doctor. Allergic reactions are uncommon and serious reactions occur rarely (see section 4 of this leaflet).
- Prolonged treatment with this medicine may lead to the overgrowth of resistant microorganisms. If your otitis does not improve, inform your doctor.
- If you have a perforated eardrum (the membrane separating the outer ear from the middle ear), the medicine may pass into the oral cavity.
- If your skin becomes more sensitive to sunlight or ultraviolet (UV) light while taking ciprofloxacin, avoid exposure to strong sunlight or artificial UV light, such as sunbeds.
Using other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. SEPTOCIPRO OTIC should not be administered together with other medicines given by otic route (through the ear).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It is preferable to avoid the use of SEPTOCIPRO OTIC during pregnancy. Inform your doctor if you are planning to become pregnant.
Do not use SEPTOCIPRO OTIC during breastfeeding, as ciprofloxacin may pass into breast milk and could be harmful to your baby.
Driving and using machines
Dizziness (a sensation of spinning or lightheadedness that may be accompanied by discomfort, nausea, and vomiting, etc.) and headache are among the side effects reported with this medicine (see section 4). Therefore, make sure you know how you react to SEPTOCIPRO OTIC before driving or operating machinery. If in doubt, consult your doctor.
3. How to use SEPTOCIPRO OTIC
For children over 2 years of age, adolescents, and adults:
Follow exactly the administration instructions for SEPTOCIPRO OTIC provided by your doctor. Your doctor will tell you precisely how much SEPTOCIPRO OTIC you should receive, how often, and for how long, depending on the type and severity of your infection. If in doubt, consult your doctor or pharmacist again.
SEPTOCIPRO OTIC must be administered only by otic route (into the ear). The usual dosage is as follows:
- Acute external otitis: 1 mg (one single-dose container of 0.5 ml) every 12 hours for 7 days.
- Chronic suppurative otitis media: 1 mg (one single-dose container of 0.5 ml) every 12 hours for 15 days.
Elderly patients
For patients over 65 years of age, the dosage is the same. If you are unsure, consult your doctor or pharmacist.
For correct administration, follow these instructions:
1.- Detach one unit from the strip of containers.
2.- Check that the container is not damaged.
3.- Hold the container between the index finger and thumb of one hand.
With the index finger and thumb of the other hand, gently lever the winged piece to open it. Do not twist to break.
4.- Remove the winged piece.
5.- To correctly apply the otic solution, lie down with the ear to be treated facing upward.
6.- To facilitate penetration of the otic solution into the ear, grasp the upper part of the ear and pull it backward. In this position, empty the contents of the container into the ear by squeezing the single-dose unit several times. The amount of solution contained in the single-dose unit ensures the correct dose (0.5 ml) is delivered, even if a very small amount remains inside after emptying.
7.- After applying the otic solution, press several times on the prominence of the ear located in front of the external auditory canal (called the tragus) to help the otic solution penetrate into the ear.
8.- Keep the otic solution in the ear for about 5 minutes.
9.- Afterwards, sit up and tilt your head toward the side of the treated ear to allow excess otic solution to drain out.
It is not recommended to "plug" the ear with cotton or a similar material, as this may prolong the duration of the infection.
Use in children
There is no information available on the use of SEPTOCIPRO OTIC in children under 2 years of age; therefore, this medicinal product is not recommended for this age group.
If you use more SEPTOCIPRO OTIC than you should
In case of overdose or accidental ingestion, inform your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the name of the medicine and the amount ingested.
If you forget to use SEPTOCIPRO OTIC
Do not use a double dose to make up for the missed dose.
If you stop using SEPTOCIPRO OTIC
It is important that you complete the full course of treatment, even if you start feeling better after a few days. If you stop using this medicine too early, the infection may not be completely cured, symptoms may return, or even worsen. Antibiotic resistance could also develop.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, SEPTOCIPRO OTIC may cause adverse effects, although not everyone experiences them.
If you experience a severe allergic reaction and develop any of the following symptoms, stop using ciprofloxacin immediately and inform your doctor without delay: swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty swallowing or breathing, skin rash or hives, large fluid-filled blisters, pain and ulceration.
Frequent adverse effects (affects between 1 and 10 out of every 100 patients): overgrowth of microorganisms resistant to this medicine in the ear.
Uncommon adverse effects (affects between 1 and 10 out of every 1,000 patients): dizziness and headache. Localized itching, pain, and a burning or stinging sensation at the site of administration may also occur.
Rare adverse effects (affects between 1 and 10 out of every 10,000 patients): allergic reactions that may affect the entire body.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of SEPTOCIPRO OTIC
Keep this medicine out of the sight and reach of children.
Store the single-dose containers in the outer packaging to protect them from light.
Do not use SEPTOCIPRO OTIC after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Additional Information
Composition of SEPTOCIPRO OTIC
- The active substance of SEPTOCIPRO OTIC is ciprofloxacin. Each single-dose container of 0.5 ml contains 1 mg of ciprofloxacin (as hydrochloride).
- The other components are glycerol (E422), polysorbate 20, sodium acetate, glacial acetic acid, methylcellulose (E461), sodium hydroxide or hydrochloric acid, and water for injections.
Nature and content of the container
SEPTOCIPRO OTIC is supplied in single-dose containers of 0.5 ml of sterile solution. Each cardboard box contains 20 single doses.
Marketing Authorization Holder
Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona – Spain
Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona)
Spain
Date of the most recent review of this summary: July 2013
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/