Oflodinex

Package Leaflet: Information for the User

Oflodinex, 3 mg/ml, Eye Drops, Solution

Ofloxacin

Read the Package Leaflet Carefully Before Using the Medicinal Product

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Oflodinex and What is it Used For
• 2. Important Information Before Using Oflodinex
• 3. How to Use Oflodinex
• 4. Possible Side Effects
• 5. How to Store Oflodinex
• 6. Contents of the Package and Other Information

1. What is Oflodinex and What is it Used For

Oflodinex is a medicinal product in the form of eye drops intended for the treatment of superficial eye infections, such as:

• conjunctivitis
• keratitis.

Ofloxacin belongs to a group of medicines called quinolone antibacterials.

2. Important Information Before Using Oflodinex

When Not to Use Oflodinex

• if you are allergic to ofloxacin, other quinolones, or any of the other ingredients of this medicinal product (listed in section 6).

Warnings and Precautions

Before starting treatment with Oflodinex, discuss with your doctor or pharmacist:

• if you are exposed to excessive sunlight or UV radiation (e.g., quartz lamps, solarium, etc.) during treatment with Oflodinex. You should avoid both sources of light due to the risk of photosensitivity;
• if you are allergic to other quinolone antibacterials;
• if you wear contact lenses. During treatment with Oflodinex eye drops, solution, do not wear contact lenses (see "Oflodinex contains benzalkonium chloride").

Caution should be exercised when using the medicinal product in patients with damaged or ulcerated eye surface.
As with other antibiotics, prolonged use of Oflodinex may lead to the growth of non-susceptible microorganisms. If such an infection occurs during treatment, the doctor will take appropriate measures.
Tendinitis and tendon rupture have occurred in patients taking fluoroquinolones orally or intravenously, especially in older patients and those treated with corticosteroids at the same time. Treatment with Oflodinex should be discontinued if pain or tenderness of the tendon (tendinitis) occurs.

Children and Adolescents

There is limited experience with the use of ofloxacin eye drops in children.
Before using the medicinal product in children, consult a doctor.

Oflodinex and Other Medicinal Products

Tell your doctor about all medicines you are taking or have recently taken, as well as medicines you plan to take.
In case of concomitant use of other eye drops and/or eye ointments, maintain an interval of at least 15 minutes between administration of the individual medicinal products. Eye ointments should always be used last.

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant or breastfeeding. The doctor will advise you whether you can use this medicinal product.

Driving and Using Machines

Using Oflodinex may cause blurred vision. These symptoms may persist for a few minutes. During this time, do not operate machines, work without strong support, or drive vehicles.

Oflodinex Contains Benzalkonium Chloride

The medicinal product contains 0.025 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before instillation and wait at least 15 minutes before reinserting.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicinal product, consult a doctor.
Using contact lenses during eye infection treatment is not recommended.

3. How to Use Oflodinex

This medicinal product should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
For patients in all age groups, the recommended dose is:
1 dropof Oflodinex

• every 2 - 4 hoursinto the conjunctival sac of the infected eye (eyes) for the first two days
• and then 4 times a day.

In case of worsening of the infection or lack of improvement after a few days, consult a doctor.

Duration of Treatment

Do not use the medicinal product for more than 14 days.

Using More Than the Recommended Dose of Oflodinex

No cases of overdose have been reported to date. In case of accidental instillation of too many drops into the eye (eyes), rinse the eye with clean water.
In case of systemic side effects after incorrect use of the medicinal product or accidental overdose or ingestion, initiate systemic treatment. In this case, consult a doctor.

Missing a Dose of Oflodinex

Do not use a double dose to make up for a missed dose. Use the next dose as soon as you remember. Then use the medicinal product as described in the dosing schedule above or as advised by your doctor.
If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.
Frequency not known (cannot be estimated from the available data):
During treatment with ofloxacin eye drops, life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially appearing as red, often itchy patches or blisters on the trunk, sometimes with blisters in the mouth.
In case of an allergic reaction (including eye allergic reactions), discontinue use of the eye drops and consult a doctor immediately. The frequency of this side effect is not known (cannot be estimated from the available data).
The following side effects have been reported:

• eye irritation
• eye discomfort

Very rare (less than 1 in 10,000 people):

• allergic reactions (including severe allergic reactions, which cause swelling of the face, lips, tongue, or throat, or other parts of the body, rash, and itching, difficulty breathing or dizziness, anaphylactic shock)

Frequency not known (cannot be estimated from the available data):

• dizziness
• eye inflammation
• blurred vision
• photosensitivity
• eye, face, or periorbital edema (including eyelid edema)
• foreign body sensation in the eye
• tearing
• dry eye
• eye pain
• eye allergic reactions (including itchy eyes or eyelids)
• eye redness
• nausea

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Oflodinex

Keep the medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Shelf life after first opening: 4 weeks.
Do not store above 25°C. Do not store in the refrigerator or freeze.
Keep the bottle in the outer packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What Oflodinex Contains

• The active substance is ofloxacin. 1 ml of solution contains 3 mg of ofloxacin.
• The other ingredients are: benzalkonium chloride; sodium chloride; hydrochloric acid and sodium hydroxide - solution (to adjust pH); water for injections.

What Oflodinex Looks Like and Contents of the Package

Oflodinex eye drops are a clear, greenish-yellow solution.
The package contains 1 LDPE container with a dropper cap, containing 5 ml of eye drops, or 3 containers with a dropper cap, each containing 5 ml of eye drops.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln, Germany
Date of Last Revision of the Package Leaflet: