OFLOXACIN POS 3 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Ofloxacino POS 3 mg/ml Eye Drops Solution

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ofloxacino POS and what is it used for
2. What you need to know before starting to use Ofloxacino POS
3. How to use Ofloxacino POS
4. Possible side effects
5. Storage of Ofloxacino POS
6. Package Contents and Additional Information

1. What is Ofloxacino POS and what is it used for

Ofloxacino POS is an eye drop used to treat external eye infections, such as conjunctivitis (inflammation of the conjunctiva) and keratitis (inflammation of the cornea) in adults and children, caused by organisms sensitive to ofloxacin.

Ofloxacino POS belongs to the group of medications known as antibacterial agents of the 4-quinolone type.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

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

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

2. What you need to know before starting to use Ofloxacino POS

Do not use Ofloxacino POS

if you are allergic to ofloxacin, other quinolones, or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication.

• if you are sensitive to other antibacterial agents of the quinolone type
• if you have anomalies or ulcers on the surface of the eye

Prolonged use may lead to a new bacterial infection that may not respond to Ofloxacino POS.

During treatment with eye drops containing ofloxacin, avoid excessive exposure to sunlight or ultraviolet lamps (e.g., solar lamps, sunbeds, etc.) due to potential photosensitivity.

The use of contact lenses is not recommended during the treatment of an eye infection.

There have been cases of swelling and tendon rupture in people taking oral or intravenous fluoroquinolones, especially in elderly patients and those treated concomitantly with corticosteroids. Stop taking this medication if you develop pain or swelling in the tendons (tendinitis).

Be careful with Ofloxacino POS

Before using Ofloxacino-POS

Heart Problems

You should be cautious when using this type of medication if you have been born with or have a family history of prolonged QT interval (detected in ECG, heart electrical recording), if you have an electrolyte imbalance in the blood (mainly low potassium or magnesium levels in the blood), if you have a very slow heart rate (called "bradycardia"), if you have a 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 Ofloxacino POS with other medications).

Children and Adolescents

This medication can be used in children. The safety and efficacy have not been established in children under one year of age.

Use of Ofloxacino POS with other medications

Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or may need to take/use any other medication.

You should inform your doctor if you are using other medications that can alter the heart rhythm: medications that belong to the group of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antibiotics (those belonging to the macrolide group), some antipsychotics.

If you use other eye drops or ointments in addition to Ofloxacino POS, you should maintain a 15-minute interval between the applications of each medication. Eye ointments should always be applied last.

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 medication. Your doctor will assess whether you can use Ofloxacino POS. The use of Ofloxacino POS is not recommended during pregnancy.

Driving and Using Machines

You may experience blurred vision immediately after applying Ofloxacino POS. Do not drive or use machines until this effect has disappeared.

Ofloxacino POS contains benzalkonium chloride

This medication contains 0.125 mg of benzalkonium chloride per 5 ml, equivalent to 0.025 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter their color. Remove contact lenses before using this medication and wait 15 minutes before putting them back.

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

3. How to use Ofloxacino POS

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

Instill one drop of Ofloxacino POS into the affected eye(s) every two to four hours during the first two days and then four times a day. For Ofloxacino POS to be effective, it must be used regularly.

Method of Administration

1. Wash your hands
2. Take a clean cloth and gently rub around the eyes to remove any moisture (diagram 1).
3. Unscrew the bottle and check that the dropper is clean.
4. Tilt your head slightly backwards and gently pull down the lower eyelid (diagram 2)
5. and place 1 or 2 drops inside the lower eyelid (diagram 3). Be careful not to touch the eye with the dropper.
6. Release the lower eyelid and gently press the inner corner of the eye against the bridge of the nose (diagram 4). Then, keeping your finger pressed against the nose, blink gently a couple of times to spread the drop over the surface of the eye.
7. Clean up any excess medication.
8. Repeat this procedure for the other eye.

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

To avoid contamination, do not let the tip of the dropper touch your eye or any other surface. Put the cap back on and tighten it to close the container after use.

The correct application of the drops in the eyes is very important. If you have any doubts, consult your doctor or pharmacist.

Duration of Treatment

The duration of treatment should not exceed 14 days. If symptoms persist after this time, consult your doctor.

Use in Children

This medication can be used in children. The safety and efficacy have not been established in children under one year of age.

If you use more Ofloxacino POS than you should

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

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

If you forget to use Ofloxacino POS

If you forget a dose, apply it as soon as you remember, unless it is almost time for the next dose, in which case you should skip the missed dose.

Apply your next dose and continue with your usual schedule.

Do not apply a double dose to make up for missed doses.

If you interrupt treatment with Ofloxacino POS

Ofloxacino POS should be used according to your doctor's instructions.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If an allergic reaction occurs (including skin inflammation, mucous membrane inflammation, throat and/or tongue inflammation, difficulty breathing), stop administering the eye drops and contact your doctor immediately.

Serious side effects, frequency not known (cannot be estimated from available data):

There have been reports of skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis) with the use of eye drops containing ofloxacin, which can be potentially life-threatening, initially appearing as red, target-shaped patches or circular patches, often with central blisters on the trunk.

Eye irritation and eye discomfort are common side effects (may affect up to 1 in 10 people).

The following side effects may occur, although the number of people affected is unknown.

Side effects affecting the eye:

• eye redness/eye allergy
• itching
• blurred vision
• increased tearing
• dry eye
• eye pain
• light sensitivity
• inflammation around the eyes (including eyelid inflammation)

Side effects affecting the body:

• allergic reaction
• dizziness
• numbness
• nausea
• headache
• face swelling

Heart problems:

Frequency not known: Abnormally fast heart rate, life-threatening irregular heart rhythm, alteration of heart rhythm (called "prolongation of the QT interval", detected in ECG, heart electrical recording).

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ofloxacino POS

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the label and carton after EXP. The expiration date is the last day of the month indicated.

Discard this eye drop solution 4 weeks after the first opening, even if there is still solution left.

Do not store above 25°C.

Keep the container in the original outer packaging to protect it from light.

If the solution becomes a stronger yellow-green color, the product should be discarded.

Medications should not be thrown away down the drain or in the trash. Deposit the containers and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ofloxacino POS

The active ingredient is ofloxacin 3 mg/ml.

The other ingredients are benzalkonium chloride, sodium chloride, hydrochloric acid, and sodium hydroxide (pH adjuster), water for injectable preparations.

Appearance of the Product and Package Contents

Ofloxacino POS is a clear, colorless to slightly yellow-green solution and is presented in a plastic bottle with a dropper and screw cap.

Each box contains 1 plastic bottle with 5 ml of solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Manufacturer

URSAPHARM Arzneimittel GmbH,

Industriestraße,

66129 Saarbrücken,

Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

CZ Ofloxacin-POS 3mg/ml eye drops, solution

DE Ofloxacin-POS 3 mg/ml eye drops, solution

IT VisuAb, eye drop solution

ES Ofloxacino POS 3 mg/ml eye drops solution

NL Ofloxacine-POS 3 mg/ml, eye drops, solution

PL Ofloxacin-POS

Date of the last revision of this package leaflet:June 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/