Label: information for the user

CIPROFLOXACINO QUALIGEN 1mg ophthalmic solution in single-dose container

Ciprofloxacin

Read this label carefully before starting to use this medication.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any effect not mentioned in this label, inform your doctor or pharmacist.

The active ingredient of the medication is ciprofloxacin, an antibiotic that belongs to a group of antibacterians known as quinolones. Ciprofloxacin prevents the growth of certain microorganisms that cause infections.

Antibiotics are used to treat bacterial infections and do not serve to treat viral infections.

It is essential that you follow the instructions regarding the dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If once the treatment is completed you have leftover antibiotic, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.

CIPROFLOXACINO QUALIGEN is used for topical treatment in adults and children two years of age or older for the following bacterial ear infections: chronic suppurative otitis media and acute external otitis.

Do not use CIPROFLOXACINO QUALIGEN

If you are allergic to ciprofloxacin, to other quinolones, or to any of the other components of this medication (see section 6).

Be careful with CIPROFLOXACINO QUALIGEN

• If you experience an allergic reaction to CIPROFLOXACINO QUALIGEN, stop treatment and inform your doctor. Allergic reactions are rare and rarely severe (see section 4 of this leaflet).
• Prolonged treatment with this medication may cause the proliferation of resistant microorganisms. If you do not experience an improvement in your otitis, inform your doctor.
• If you have a perforated eardrum, it is possible that the medication may penetrate into the oral cavity.
• If your skin becomes more sensitive to sunlight or ultraviolet (UV) light while taking ciprofloxacin, avoid exposure to intense sunlight or artificial UV light such as that from sunbeds.

Use of other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication. CIPROFLOXACINO QUALIGEN should not be administered with other medications given through the ear.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

It is preferable to avoid the use of CIPROFLOXACINO QUALIGEN during pregnancy. Inform your doctor if you plan to become pregnant.

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

Driving and operating machines

Among the side effects described with this medication are vertigo (a sensation of dizziness that may be accompanied by discomfort, nausea, and vomiting, etc.) and headache (see section 4). Therefore, make sure you know how you react to CIPROFLOXACINO QUALIGEN before driving a vehicle or operating machines. If in doubt, consult your doctor.

For children over 2 years, adolescents, and adults:

Follow exactly the administration instructions for CIPROFLOXACINO QUALIGEN indicated by your doctor. Your doctor will inform you precisely how much CIPROFLOXACINO QUALIGEN you should receive, as well as how often and for how long, depending on the type of infections you have and their severity. In case of doubt, consult your doctor or pharmacist again.

CIPROFLOXACINO QUALIGEN should only be administered via the otic route (through the ear). The usual dose is as follows:

• Acute external otitis: 1 mg (one single-dose vial of 0.5 ml) every 12 hours for 7 days.
• Chronic suppurative otitis media: 1 mg (one single-dose vial of 0.5 ml) every 12 hours for 15 days.

Patients over 65 years old

For patients over 65 years old, the dose is the same. If unsure, consult your doctor or pharmacist.

For proper administration, follow the following instructions:

1.-Remove one unit from the strip of vials.

2.-Check that the vial is not damaged.

3.- Hold the vial between the index and thumb of one hand.

With the index and thumb of the other hand, perform a slight lever action on the winged piece to open it. Do not twist to break.

4.-Remove the winged piece.

5.- To apply the otic solution correctly, 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 top and pull it back. In this position, the contents of the vial will be emptied into the ear by pressing several times on the single-dose vial. The amount of solution contained in the single-dose vial guarantees the correct dose (0.5 ml) even if a very small amount remains inside after emptying.

7.- Once the otic solution has been applied, press several times on the prominence of the ear located in front of the external auditory canal (called the tragus), in order to facilitate the penetration of the otic solution into the ear.

8.- The otic solution should be kept in the ear for about 5 minutes.

9.- Afterwards, sit up and tilt your head to the side of the treated ear to allow the excess otic solution to drain.

It is not recommended to "plug" the ear with a cotton ball or similar, as this can prolong the duration of the infection.

Use in children

There is no information on the use of CIPROFLOXACINO QUALIGEN in children under 2 years old, therefore, this medication 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 Toxicological Information Service, phone: 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 interrupt the treatment with CIPROFLOXACINO QUALIGEN

It is essential to complete the treatment cycle even if you start feeling better after a few days. If you stop using this medication too soon, it is possible that the infection will not be fully cured and symptoms may return or worsen. Additionally, antibiotic resistance may be generated.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, CIPROFLOXACINO QUALIGEN can produce adverse effects, although not all people will experience them.

If you experience a severe allergic reaction and notice 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 that may cause difficulty swallowing or breathing, skin rash or urticaria, large blisters filled with fluid, pain, and ulceration.

Frequent side effects (affecting between 1 and 10 of every 100 patients): proliferation of resistant microorganisms in the ear.

Infrequent side effects (affecting between 1 and 10 of every 1,000 patients): dizziness and headache. It may also cause localized itching, pain, and a burning or stinging sensation at the site of administration.

Rare side effects (affecting between 1 and 10 of every 10,000 patients): allergic reactions that can affect the entire body.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication 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 CIPROFLOXACINO QUALIGEN after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the designated pharmacy drop-off point.In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of CIPROFLOXACINO QUALIGEN

• The active ingredient of CIPROFLOXACINO QUALIGEN is ciprofloxacin. Each single-dose vial of 0.5ml contains 1mg of ciprofloxacin (as hydrochloride).
• The other components are glycerol (E422), polisorbate 20, sodium acetate, glacial acetic acid, methylcellulose (E461), sodium hydroxide or hydrochloric acid, and water for injection preparations.

Product aspects and packaging contents

CIPROFLOXACINO QUALIGEN is supplied in single-dose vials of 0.5ml of sterile solution. Each carton contains 20 single-dose vials.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for Manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: July 2013

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/