Prospect: information for the user

CETRAFLUX 3 mg/ml eye drops in solution in single-dose container

{Active principle(s)}

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.

1. What is Cetraflux and what is it used for

2. What you need to know before starting to use Cetraflux

3. How to use Cetraflux

4. Possible adverse effects

5. Storage of Cetraflux

6. Contents of the container and additional information

Cetraflux is an eye drop.

Ciprofloxacino belongs to a group of antibiotics called quinolones and to a subgroup called fluoroquinolones.

Cetraflux is used for the treatment of infections caused by bacteria in the eye(s): purulent bacterial conjunctivitis, bacterial keratitis (bacterial inflammation of the cornea), corneal ulcers, and corneal abscesses.

Do not use Cetraflux

If you are allergic to ciprofloxacin or any of the other components of this medication (listed in section 6).

Warnings and precautions

• Only use this medication in your eye(s). Do not inject it, do not swallow it.
• If you experience severe allergic reactions, rash, itching, or difficulty breathing, stop using the medication immediately and consult your doctor, as this may occur after the first dose.
• If your symptoms worsen or reappear quickly, consult your doctor. Using this medication may make you more sensitive to other infections.
• If you experience pain, swelling, or inflammation of the tendons during or shortly after using eye drops, stop treatment and consult your doctor.
• If you wear contact lenses:

• Wearing contact lenses (hard or soft) is not recommended during treatment of an eye infection.

• If you are taking any other medication, see the section on Using Cetraflux with other medications.

Using Cetraflux with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

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

It is preferable to avoid this medication during pregnancy unless the therapeutic benefit outweighs the potential risk to the fetus.

Ciprofloxacin passes into breast milk. If you are breastfeeding a baby, consult your doctor before using Cetraflux.

Driving and operating machinery

If you notice any change in your vision after using Cetraflux, do not drive or operate machinery.

Important information if you wear contact lenses

It is not recommended to wear contact lenses during treatment of an eye infection, as your infection may worsen. Do not use the eye drops if you are wearing contact lenses.

Wait at least 15 minutes after using the eye drops before reinserting your contact lenses.

If you have any further questions about using Cetraflux, consult your doctor or pharmacist.

Followexactlytheadministrationinstructionsforthismedicationindicatedbyyour doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose will be different depending on whether you are being treated for corneal abscesses or other bacterial infections in your eyes..

Adults, newborns, children, and adolescents

Corneal abscesses

The eye drops should be administered according to the following intervals, even at night.

• On the first day, instill two drops in the affected eye every 15 minutes for the first six hours, and then two drops every 30 minutes for the rest of the day.
• On the second day, instill two drops in the affected eye every hour.
• From the third day to the 14th, instill two drops in the affected eye every 4 hours.

If you need to continue treatment with this medication after the 14th day, your doctor will indicate it.

Other eye infections:

• For the first two days, instill one or two drops in the affected eye(s) every 2 hours during the day, while awake.
• From the third day, instill one or two drops every 4 hours during the day.

Your doctor will indicate the duration of treatment.

It is essential to continue treatment with Cetraflux until the end as indicated by your doctor.

Usage recommendations

Always use Cetraflux exactly as instructed by your doctor.

Consult your doctor or pharmacist if you have any doubts.

If a drop falls outside the eye, try again.

If you use more Cetraflux eye drops than you should

You can remove it by rinsing your eyes with warm water. Do not apply more drops until you touch base again.

Ifyouhaveanyotherdoubtsabouttheuseofthismedication,askyourdoctoror pharmacist.

If you forgot to use Cetraflux eye drops

Do not use a double dose to compensate. Apply one dose as soon as you remember, and then return to your regular schedule. If it is almost time for your next dose, do not apply the missed dose and continue with your regular schedule.

Like all medications, Cetraflux can produce adverse effects, although not all people may experience them.

You may experience some or all of the following adverse effects in your eye:

Frequent (may affect up to 1 in 10 people):deposits on the cornea, eye discomfort, ocular hyperemia (redness of the eye).

Infrequent (may affect up to 1 in 100 people):keratopathy (non-inflammatory corneal disease), corneal infiltrates, corneal staining, photophobia (sensitivity to light), decreased visual acuity (decreased vision), eyelid edema (swollen eyelid), blurred vision, eye pain, dry eye, eye swelling, ocular pruritus (itching in the eye), sensation of a foreign body in the eye (sensation of having something in the eye), increased tear production (tearful eyes), ocular secretion, crusts on the eyelid margin, eyelid exfoliation, conjunctival edema, eyelid erythema (redness of the inner eyelid).

Rare (may affect up to 1 in 1,000 people):ocular toxicity, punctate keratitis (destruction of the outer areas of the cornea), keratitis (inflammation of the cornea), conjunctivitis, corneal disorder, corneal epithelial defect, diplopia (double vision), decreased ocular sensitivity, asthenopia (fatigued vision), ocular irritation, ocular inflammation, conjunctival hyperemia. If you notice white particles in your eyes, continue using Cetraflux but inform your doctor immediately.

You may experience effects in other areas of your body such as:

Infections and infestations:

Rare (may affect up to 1 in 1,000 people): otitis media, rhinitis (inflammation of the nasal mucous membrane).

Immunological disorders:

Rare (may affect up to 1 in 1,000 people): allergic reactions such as skin rash, itching, swelling, difficulty breathing).

Nervous system disorders:

Frequent (may affect up to 1 in 10 people): bad taste in the mouth.

Infrequent (may affect up to 1 in 100 people): headache.

Rare (may affect up to 1 in 1,000 people): dizziness.

Auditory disorders:

Rare (may affect up to 1 in 1,000 people): ear pain.

Respiratory disorders:

Rare (may affect up to 1 in 1,000 people): hypersecretion of the paranasal sinuses.

Gastrointestinal disorders:

Infrequent (may affect up to 1 in 100 people): nausea.

Rare (may affect up to 1 in 1,000 people): diarrhea, abdominal pain.

Dermatological disorders:

Rare (may affect up to 1 in 1,000 people): dermatitis (inflammation of the skin).

General disorders:

Rare (may affect up to 1 in 1,000 people): drug intolerance.

Complementary examinations:

Rare (may affect up to 1 in 1,000 people): abnormal laboratory test results.

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

If you experience an allergic reaction, do not use Cetraflux again and consult your doctor.

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

Do not store at a temperature above 86°F (30°C). Store the ampule in the outer packaging to protect it from light.

Do not use this medication after the expiration date (EXP) printed on the box. The expiration date is the last day of the month indicated. Once the blister pack is opened, the expiration date is 90 days.

Expiration date after opening the ampule of eye drops: the contents of the ampule must be used immediately once opened. Any amount left over must be discarded.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Cetraflux

• The active principle is ciprofloxacin. Each ml of solution contains 3 mg of ciprofloxacin (as hydrochloride).
• The other components are mannitol, disodium edetate, glacial acetic acid, sodium trihydrate acetate, chlorhidric acid, and purified water.

Appearance of the product and contents of the packaging

Cetraflux is a sterile, preservative-free, aqueous solution eye drop, transparent, colorless, or slightly yellowish, presented in formats of 40 ampoules. Each ampoule provides 0.25 ml. The ampoules must be kept inside the bag for protection.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Salvat, S.A.

Gall 30 - 36

08950 Esplugues de Llobregat (Barcelona)

This medicine is authorized in the member states of the European Economic Area with the following names:

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

Last review date of this leaflet: