Ciprofloxacin Qualigen 1 mg ear drops solution in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CIPROFLOXACIN QUALIGEN 1 mg ear drops solution in single-dose container

Ciprofloxacin

Read all of this 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. Do not give it to other people, even if they have the same symptoms as yours, as it may harm them.
• If you think any of the side effects you experience is serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What CIPROFLOXACIN QUALIGEN is and what it is used for
2. What you need to know before using CIPROFLOXACIN QUALIGEN
3. How to use CIPROFLOXACIN QUALIGEN
4. Possible side effects
5. How to store CIPROFLOXACIN QUALIGEN
6. Contents of the pack and other information

1. What CIPROFLOXACINO QUALIGEN 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 over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the drain or in household waste.

CIPROFLOXACINO QUALIGEN 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 starting to use CIPROFLOXACIN QUALIGEN

Do not use CIPROFLOXACIN QUALIGEN

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 CIPROFLOXACIN QUALIGEN

• If you experience an allergic reaction to CIPROFLOXACIN QUALIGEN, 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 you do not experience improvement in your otitis, inform your doctor.
• If your eardrum (the membrane separating the outer ear from the middle ear) is perforated, 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 from sunbeds.

Use of other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. CIPROFLOXACIN QUALIGEN must not be administered together with other medicines administered by otic route (through the ear).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is preferable to avoid using CIPROFLOXACIN QUALIGEN during pregnancy. Inform your doctor if you plan to become pregnant.

Do not use CIPROFLOXACIN QUALIGEN during breastfeeding, as ciprofloxacin may pass into breast milk and could be harmful to your child.

Driving and using machines

Among the side effects reported with this medicine are vertigo (dizziness, possibly accompanied by discomfort, nausea, vomiting, etc.) and headache (see section 4). Therefore, make sure you know how you react to CIPROFLOXACIN QUALIGEN before driving or operating machinery. If in doubt, consult your doctor.

3. How to use CIPROFLOXACINO QUALIGEN

For children over 2 years of age, adolescents, and adults:

Follow exactly the administration instructions for CIPROFLOXACINO QUALIGEN provided by your doctor. Your doctor will precisely indicate how much CIPROFLOXACINO QUALIGEN you should receive, as well as how often and for how long, depending on the type and severity of the infection. If in doubt, consult your doctor or pharmacist again.

CIPROFLOXACINO QUALIGEN must be administered only by the otic route (through 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 the instructions below:

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 upwards.

6.- To facilitate the penetration of the otic solution into the ear, hold the ear by the upper part 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 administered, 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 treated ear to allow the 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 CIPROFLOXACINO QUALIGEN in children under 2 years of age; therefore, this medicine is not recommended for this age group.

If you use more CIPROFLOXACINO QUALIGEN than you should

In case of overdose or accidental ingestion, inform your doctor or pharmacist or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and amount ingested.

If you forget to use CIPROFLOXACINO QUALIGEN

Do not use a double dose to compensate for the missed dose.

If you stop using CIPROFLOXACINO QUALIGEN

It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop using this medicine too early, the infection may not be completely cured, and 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, CIPROFLOXACIN QUALIGEN may produce adverse effects, although not everyone experiences them.

If you experience a severe allergic reaction and develop any of the following problems, stop using ciprofloxacin immediately and inform your doctor right away: 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 or ulceration.

Frequent side effects (affects between 1 and 10 out of every 100 patients): overgrowth of microorganisms resistant to this medicine in the ear.

Uncommon side 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 side 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CIPROFLOXACIN QUALIGEN

Keep this medicine out of the sight and reach of children.

Store the unit-dose packages in the outer packaging to protect them from light.

Do not use CIPROFLOXACIN QUALIGEN after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused packages and medicines to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused packages and medicines. This will help protect the environment.

6. Additional Information

Composition of CIPROFLOXACIN QUALIGEN

• The active substance in CIPROFLOXACIN QUALIGEN is ciprofloxacin. Each 0.5 ml single-dose container 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.

Presentation and contents of the container

CIPROFLOXACIN QUALIGEN is supplied as sterile solution in 0.5 ml single-dose containers. Each cardboard carton contains 20 single-dose units.

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 leaflet: July 2013

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/