Package Insert: Information for the Patient

Ofloxacino POS 3 mg/ml Eye Drops Solution

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

• Keep this package insert, 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 alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3. How to use Ofloxacino POS

4. Possible adverse effects

5. Storage of Ofloxacino POS

6. Contents of the package and additional information

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

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

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

No use Ofloxacino POS

If you are allergic to ofloxacino, other quinolonas, 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 quinolona-type antibacterial agents
• If you have anomalies or ulcers on the surface of the eye

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

During treatment with ofloxacino-containing eye drops, avoid excessive exposure to sunlight or ultraviolet lamps (e.g. sunlamps, solarium, etc.) due to potential photosensitivity.

Do not use contact lenses during eye infection treatment.

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 especially careful with Ofloxacino POS

Before using Ofloxacino-POS

Heart problems

You should exercise caution when using this type of medication if you have been born or have a family history of prolonged QT interval (detected on ECG, heart electrical recording), if you have electrolyte imbalances 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 elderly patient or are using other medications that produce abnormal ECG changes (see section Using Ofloxacino POS with other medications).

Children and adolescents

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

Using Ofloxacino POS with other medications

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

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.Your doctor will assess whether you can use Ofloxacino POS. Do not use Ofloxacino POS during pregnancy.

Driving and operating machinery

You may notice blurred vision immediately after applying Ofloxacino POS. Do not drive or operate machinery until this effect has disappeared.

Ofloxacino POS contains benzalkonium chloride

This medication contains 0.125 mg of benzalkonium chloride in each 5 ml equivalent to 0.025 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the lenses. 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 at the front 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 of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dose

Instill one drop of Ofloxacino POS in 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.

Administration method

1. Wash your hands
2. Take a clean cloth and gently rub around the eyes to remove any moisture (diagram 1).
3. Remove the cap and check that the dropper is clean.
4. Incline your head slightly backward and pull your lower eyelid downward (diagram 2)
5. and place 1 or 2 drops in the inner corner of the lower eyelid (diagram 3). Be careful not to touch the eye with the dropper.
6. Release the lower eyelid and 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 across 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 allow the dropper tip to 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 drops in the eyes is very important. If you have any doubts, consult your doctor or pharmacist.

Treatment duration

The treatment duration 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.

If you use more Ofloxacino POS than you should

If too many drops have been put 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Ofloxacino POS

If you forgot a dose, 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 schedule.

Do not apply a double dose to compensate for the missed doses.

If you interrupt the treatment with Ofloxacino POS

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Severe side effects, unknown frequency (cannot be estimated from available data):

Cases of skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of ofloxacin eye drops, which may be potentially life-threatening, initially appearing as reddish-brown target-shaped spots or circular patches, frequently with central vesicles on the trunk.

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 susceptible to them is unknown.

Eye side effects:

•Eye redness/allergic reaction

•Itching

•Blurred vision

•Increased tear production

•Dry eyes

•Eye pain

•Light sensitivity

• Inflammation around the eyes (including eyelid inflammation)

Body side effects:

•Allergic reaction

•Dizziness

•Numbness

•Nausea

•Headache

•Cheek swelling

Cardiac problems:

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

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 and on the box after CAD. The expiration date is the last day of the month indicated.

Discard this eye drop solution at 4 weeks from the first opening, even if there is still solution remaining.

Do not store at a temperature above 25°C.

Store 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 disposed of through drains or trash. Deposit containers and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ofloxacino POS

The active ingredient is ofloxacin 3 mg/ml.

The other components are benzalkonium chloride, sodium chloride, hydrochloric acid, and sodium hydroxide (pH adjustment), and water for injection preparations.

Appearance of the product and contents of the packaging

Ofloxacino POS is a transparent, 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Responsible for manufacturing

URSAPHARM Arzneimittel GmbH,

Industriestraße,

66129 Saarbrücken,

Germany

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

CZOfloxacin-POS 3mg/ml ocní kapky, roztok

DEOfloxacin-POS 3 mg/ml Augentropfen, Lösung

ITVisuAb, collirio soluzione

ESOfloxacino POS 3 mg/ml colirio en solución

NLOfloxacine-POS 3 mg/ml, oogdruppels, oplossing

PLOfloxacin-POS

Last revision date of this leaflet:June 2020

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/