Leaflet: information for the user

EXOCIN 3 mg/ml eye drops solution

Ofloxacino

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Exocin is and for what it is used

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

3. How to use Exocin

4. Possible side effects

5. Storage of Exocin

6. Contents of the pack and additional information

Exocin belongs to a group of medications called type 4-quinolone antibacterial agents.

Exocin is an eye drop used to treat external ocular infections, such as conjunctivitis and keratoconjunctivitis, in adults and children over one year old, caused by sensitive organisms to this medication. It is also used for the treatment of bacterial corneal ulceration in adults and children.

No use Exocin if:

You are allergic (hypersensitive) to ofloxacino, other quinolonas, or to any of the other components of this medication (listed in section 6).

Warnings and precautions:

This product should be used with caution in patients with an allergy (hypersensitivity) to other antibacterial agents of the quinolona type. If during treatment a skin rash or any other sign of allergic reaction appears, discontinue treatment and consult your doctor.

This product should be used with caution in patients who present an anomaly or ulceration of the eye surface. If this is your case, consult with your doctor. The prolonged use of ofloxacino may cause a new bacterial infection in the eye, which may not be treated satisfactorily with Exocin.

Exocin may increase sensitivity to sunlight. Avoid direct exposure to sunlight while using Exocin.

Heart problems

You should exercise caution when using this type of medication if you were born or have a family history of prolonged QT interval (detected in ECG, heart electrical recording), if you have electrolyte imbalance in the blood (mainly low levels of potassium or magnesium in the blood), if you have a very slow heart rate (denominated “bradycardia”), if you have weakened heart (heart failure), if you have a history of heart attacks (myocardial infarction), if you are a woman or an elderly patient, or if you are using other medications that produce abnormal ECG changes (see section Use of other medications).

Children and adolescents:

Exocin is not recommended for use in children under one year. Exocin is not recommended for use in newborns.

Other medications and Exocin

Inform your doctor or pharmacist if you are using, or have recently used other medications, including those purchased without a prescription.

You should inform your doctor if you are using other medications that may alter heart rhythm: medications belonging to the group of antiarrhythmics (for example quinidina, hidroquinidina, disopiramida, amiodarona, sotalol, dofetilida, ibutilida), tricyclic antidepressants, some antibiotics (those belonging to the group of macrólidos), some antipsychotics.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Exocin is not recommended for use during pregnancy and breastfeeding. If necessary, your doctor will evaluate the convenience or not of its use.

Driving and operating machinery

No studies have been conducted on the effect of Exocin on the ability to drive and operate machinery. Due to the possibility of producing blurred vision, wait for this to disappear before driving or operating machinery.

Exocin contains benzalkonium chloride

This medication contains 0.05 mg of benzalkonium chloride in each ml of solution.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer of the front part of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions for Exocin indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Exocin is administered via the eye. The normal dose is:

For the treatment of external eye infections in adults and children over one year old: Apply one or two drops in the affected eye(s) every two to four hours during the first two days and then four times a day.

For the treatment of bacterial corneal ulceration in adults and children: During the first two days, apply one or two drops every 30 minutes while awake. At night, apply one or two drops at four and six hours after going to bed. From day 3 to day 7 or 9, apply one or two drops every hour while awake. From day 7 or 9 to the end of treatment, apply one or two drops four times a day.

Usage Instructions

Do not use the product if the neck seal of the container is broken before opening it for the first time.

Apply the eye drops as follows:

1.2.3.4.

1. Wash your hands before opening the container. Tilt your head back and look up.

2. Gently pull down the lower eyelid until a small space is created.

3. Press the inverted container to release one or two drops into each eye.

4. While keeping the eye closed, press your finger against the corner (the part of the eye closest to the nose) and hold it for 30 seconds.

5. Repeat steps 2, 3, and 4 for the other eye if treatment is also needed.

If a drop falls outside the eye, repeat the procedure.

To avoid eye contamination, do not allow the tip of the dropper to touch the eye or any other surface. Put the container back upright, replace the cap, and press it to close the container. Wipe away any excess liquid from your cheek with a clean tissue.

After opening the container (breaking the seal), do not use the eye drops for more than 28 days.

If you have any doubts, consult your doctor or pharmacist.

Use in Children

There is very limited information on the use of Exocin in children.

If your doctor has prescribed Exocin for your child and you want to obtain more information about this medication, please consult your doctor again. If your child becomes ill during treatment with Exocin, please contact your doctor immediately.

Using More Exocin Than You Should

If you have put too many drops in the eye(s), rinse your eyes with fresh water. Then, apply the eye drops following the usual routine.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Missing a Dose

If you forget to useExocin, apply it as soon as you remember, unless it is almost time for the next dose, in which case forget the missed dose. Apply your next dose and continue with your usual routine. Do not use a double dose to compensate for the missed dose.

Stopping Treatment with Exocin

Do not stop treatment with Exocin or reduce the amount you are using until your doctor tells you to. Otherwise, your symptoms may worsen.

If you have any other doubts about using this product, ask your doctor or pharmacist.

Treatment Duration

Your doctor will tell you the duration of your treatment with Exocin. Do not stop treatment before, as the medication may not have the desired effect.

The treatment of external eye infections should not exceed 10 days, unless your doctor tells you otherwise.

Like all medications,Exocinmay have adverse effects, although not all people may experience them. It is known that the following adverse effects can occur, but their exact frequency may vary.

Cases of skin eruption (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Exocin, which can be potentially fatal, initially appearing as reddish-brown circular patches or patches with central vesicles on the trunk.

Frequent (may affect up to 1 in 10 people):

Affecting the eye: Eye irritation; eye discomfort

Unknown frequency (cannot be estimated from available data):

Affecting the eye: Blurred vision, light sensitivity, eye redness, itching, allergic reaction in the eye (including eye and eyelid itching), sensation of a foreign body in the eye, increased tearing, inflammation around the eyes (including eyelid inflammation), dry eye, eye pain.

Affecting the body: Dizziness, nausea, allergic reactions (including swelling under the skin that may occur in areas such as the face, lips, or other parts of the body; rash, itching, or urticaria; swelling of the mouth, tongue, or throat that may obstruct breathing and cause wheezing, difficulty swallowing, breathing, or shortness of breath; a sudden, severe, and life-threatening allergic reaction), facial swelling.

Affecting the heart:Abnormally fast heart rate, life-threatening irregular heart rhythm, alteration of heart rhythm (designated as “prolongation of the QT interval,”detected on ECG, heart electrical recording)

Reporting Adverse Effects

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

Keep this medication out of the sight and reach of children. Do not use this medication after the expiration date that appears on the label of the container and on the box, after “EXP”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25º C.

Do not use Exocin if you observe a change in color or if turbidity occurs in its content.

Dispose of the medication 28 days after opening it,although there may still be some solution left. To help you remember, write the opening date in the space provided for it on the carton.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you do not need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of Exocin

• The active ingredient is ofloxacino 3 mg/ml

• The other components are: benzalkonium chloride, sodium chloride, sodium hydroxide (to adjust the pH), hydrochloric acid (to adjust the pH) and purified water.

Appearance of Exocin and contents of the packaging

Exocin is a solution in a plastic bottle with a dropper and screw cap. Each bottle contains 5 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid

Spain

Responsible for manufacturing:

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

Ireland

This leaflet was approved in November 2020

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.es.