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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• 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 experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents

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

1. What Cetraflux is and what it is used for

Cetraflux is an eye drop solution.

Ciprofloxacin belongs to a group of antibiotics known as quinolones and to a subgroup called fluoroquinolones.

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

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

Do not use Cetraflux

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

Warnings and precautions

• Use this medicine only in your eye(s). Do not inject it or swallow it.

• If you experience severe allergic reactions, rash, hives, itching, or have difficulty breathing, stop treatment immediately and consult your doctor, as these may occur after the first dose.

• If symptoms worsen or recur quickly, consult your doctor. With use of this medicine, you may become more susceptible to other infections.

• If you experience pain, swelling, or inflammation of tendons during or shortly after using eye drops, stop treatment and consult your doctor.

• If you wear contact lenses:

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

• If you are taking any other medicine, see section "Use of Cetraflux with other medicines."

Use of Cetraflux with other medicines

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

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 this medicine during pregnancy unless the therapeutic benefit outweighs the potential risk to the fetus.

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

Driving and use of machines

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

Important information if you wear contact lenses

Wearing contact lenses is not advised during treatment of an eye infection, as your infection could worsen. Do not use the eye drops while 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 the use of Cetraflux, consult your doctor or pharmacist.

3. How to use Cetraflux

Follow exactly the administration instructions for this medicine given to you by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

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

Adults, newborns, children and adolescents

Corneal ulcers

The eye drops should be administered at the following intervals, including during the night.

• On the first day, instill two drops into the affected eye every 15 minutes for the first six hours, then two drops every 30 minutes for the remainder of the day.
• On the second day, instill two drops into the affected eye every hour.
• From day three to day 14, instill two drops into the affected eye every 4 hours.

If treatment with this medicine needs to continue beyond day 14, your doctor will instruct you accordingly.

Other eye infections:

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

Your doctor will determine the duration of treatment.

It is important that you continue treatment with Cetraflux for the full duration as instructed by your doctor.

Usage recommendations

Always use Cetraflux exactly as directed 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 the eyes with lukewarm water. Do not apply further drops until it is time again.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

If you forget to use Cetraflux eye drops

Do not use a double dose to make up for it. Apply a single dose as soon as you remember, and then return to your usual regimen. If it is almost time for the next dose, do not apply the missed dose and continue with the next dose according to your usual regimen.

4. Possible adverse effects

Like all medicines, Cetraflux can cause adverse effects, although not everyone will experience them.

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

Common (may affect up to 1 in 10 people): corneal deposits, ocular discomfort, ocular hyperemia (eye redness).

Uncommon (may affect up to 1 in 100 people): keratopathy (non-inflammatory disease of the cornea), corneal infiltrates, corneal staining, photophobia (sensitivity to light), decreased visual acuity (reduced vision), eyelid edema (swollen eyelid), blurred vision, eye pain, dry eye, eye swelling, ocular pruritus (itchy eye), foreign body sensation in the eyes (feeling of something in the eye), increased lacrimation (watery eyes), ocular discharge, crusting at the eyelid margin, eyelid peeling, conjunctival edema, eyelid erythema (redness of the inner eyelid).

Rare (may affect up to 1 in 1,000 people): ocular toxicity, punctate keratitis (damage to the outer areas of the cornea), keratitis (inflammation of the cornea), conjunctivitis, corneal disorder, corneal epithelial defect, diplopia (double vision), ocular hypoesthesia (reduced sensitivity stimulation of the eye), asthenopia (eye strain), 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 parts of your body such as:

Infections and infestations:

Rare (may affect up to 1 in 1,000 people): stye (hordeolum), rhinitis (inflammation of the mucous membrane inside the nose).

Immune system disorders:

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

Nervous system disorders:

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

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

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

Ear 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:

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

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

Skin disorders:

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

General disorders:

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

Investigations:

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

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.

If you experience an allergic reaction, stop using Cetraflux and consult your doctor.

5. Storage of Cetraflux

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

Do not store above 30°C. Keep the ampoule in the outer packaging to protect it from light.

Do not use this medicine after the expiry date (EXP) stated on the carton. The expiry date refers to the last day of the month indicated. The shelf life after opening the sachet is 90 days.

Expiry after opening the eye drop ampoule: the contents of the ampoule must be used immediately after opening. Any remaining solution should be discarded.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Cetraflux

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

Appearance of the product and contents of the container

Cetraflux is a sterile, preservative-free aqueous eye drop solution, transparent, colorless or slightly yellowish, supplied in packs of 40 single-dose units. Each single-dose unit provides 0.25 ml. The single-dose units must be kept within the pouch for protection.

Marketing Authorization Holder and Manufacturer

Laboratorios Salvat, S.A.

Gall 30 - 36

08950 Esplugues de Llobregat (Barcelona)

This medicinal product is authorized in the European Economic Area member states under the following names:

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

Date of the most recent revision of this leaflet: