Ofloxamed

Package leaflet: Information for the user

Ofloxamed, 3 mg/ml, eye drops, solution
Ofloxacinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Ofloxamed is and what it is used for

Ofloxamed is a medicine in the form of eye drops, intended for the treatment of infections of the anterior segment of the eye caused by organisms sensitive to ofloxacin.
Ofloxacin belongs to a group of medicines called quinolone antibacterial agents.

2. Important information before using Ofloxamed

When not to use Ofloxamed:

• if the patient is allergic to ofloxacin, other quinolones, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Ofloxamed, speak to your doctor or pharmacist:

• if excessive exposure to sunlight or UV radiation (e.g. sunlamps, solarium, etc.) is expected during treatment with Ofloxamed. Both sources of light should be avoided due to the risk of photosensitivity reactions;
• if the patient is allergic to other quinolone antibacterial agents;
• if the patient wears soft contact lenses. Soft contact lenses should not be worn during an eye infection (see section "Ofloxamed contains benzalkonium chloride").

Caution should be exercised when using this medicine in patients with corneal damage or ulceration.
As with other antibiotics, prolonged use of Ofloxamed may result in overgrowth of resistant microorganisms. If such infections occur during treatment, the doctor will take appropriate measures.
Swelling and tendon rupture have been reported in patients taking oral or intravenous fluorquinolones, particularly in elderly patients and those receiving concomitant corticosteroid therapy. Treatment with Ofloxamed should be discontinued if tendon pain or swelling (tendinitis) occurs.

Children and adolescents
Safety and efficacy in infants under one year of age have not been established.
Consult a doctor before using this medicine in children.

Ofloxamed and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Since systemic exposure to ofloxacin after administration of Ofloxamed is very low, interactions with other medicines are not expected.
If other eye drops and/or eye ointments are used simultaneously, at least a 15-minute interval should be maintained between administration of each product. Eye ointments should always be applied last.

Pregnancy and breastfeeding
Inform the doctor if the patient is pregnant or breastfeeding. The doctor will advise whether this medicine can be used.

Driving and operating machinery
Use of Ofloxamed may cause blurred vision. These symptoms may last for several minutes. During this time, patients should not operate machinery, work without strong support, or drive vehicles.

Ofloxamed contains 0.025 mg of benzalkonium chloride per millilitre
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses should be removed before instillation of the drops and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or pain in the eye occur after using the medicine, consult a doctor.

3. How to use Ofloxamed

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
For patients of all age groups, the recommended dose is:
1 drop of Ofloxamed eye drops

• every 2-4 hours into the conjunctival sac of the infected eye(s) during the first two days,
• then four times daily.

If the infection worsens or there is no improvement after several days, consult your doctor.
Do not use this medicine for longer than 14 days.
Note: If you are using other eye drops and/or eye ointments at the same time, wait at least 15 minutes between applying each medicine. Eye ointments should always be used last.
Instructions for use
Do not use the contents of the bottle if the tamper-evident seal on the neck of the bottle is broken before first use. To open the bottle, unscrew the cap by turning it until the seal breaks.
To instill the drops, follow these steps:

• Wash your hands.
• Make sure the dropper tip does not touch the eye, eyelid, surrounding area, or any object to avoid contamination.
• Prepare a mirror and the Ofloxamed bottle.
• Open the bottle and hold it with the dropper pointing downwards.
• Tilt your head back and pull down the lower eyelid to create a pouch between the eyelid and the eye.

• Place the dropper tip very close to the eye. A mirror may be used if needed.
• Look upwards and gently squeeze the bottle to instill one drop into the conjunctival sac.

• Close the eye and press gently on the inner corner of the eye near the nose for about one minute. This helps prevent the medicine from draining through the tear duct into other parts of the body.

If treatment of both eyes is prescribed, repeat the above procedure for the second eye.
Immediately after use, close the bottle tightly with the cap to avoid contamination.
Wipe away any excess liquid on the cheek with a clean tissue.
Proper administration of eye drops is very important. If in doubt, consult your doctor or pharmacist.
Overdose of Ofloxamed
There have been no reported cases of overdose so far.
If systemic adverse reactions occur due to incorrect use or accidental overdose, systemic treatment should be initiated. In such cases, consult your doctor.
Missed dose of Ofloxamed
Do not use a double dose to make up for a missed dose. If you remember the missed dose, use it as soon as possible. Then continue using the medicine according to the dosing schedule above or as directed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If an allergic reaction occurs (including an allergic reaction of the eye), stop using the eye drops and contact your doctor immediately.
This adverse effect is very rare (may affect up to 1 in 10,000 patients).
During treatment with Ofloxamed, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported. These initially appear as reddish patches or oval lesions on the trunk, often with blisters in the center. The frequency of this adverse effect is unknown (cannot be estimated based on available data).
Hypersensitivity reactions such as redness of the conjunctiva and/or a burning sensation in the eye to which the medicine was administered may also occur, particularly in response to light. However, these symptoms are usually short-lived. The frequency of this adverse effect is unknown (cannot be estimated based on available data).

Other possible adverse effects include:
Common (may affect up to 1 in 10 people):

• eye irritation,
• sensation of discomfort in the eye.

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

• corneal deposits (especially in patients who previously had corneal diseases).

Frequency unknown (cannot be estimated based on available data):

• dizziness
• blurred vision
• photophobia (sensitivity to light)
• swelling of the eye, face or around the eyes (including eyelid swelling)
• sensation of a foreign body in the eye
• tearing
• dry eye
• eye pain
• itching of the eyes or eyelids
• redness of the eyes
• nausea
• conjunctivitis
• keratitis

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Email: [email protected]
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ofloxamed

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and label following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
Do not use more than 4 weeks after opening.
Store the bottle in the outer packaging to protect it from light.
Do not store above 25°C.
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 Ofloxamed contains

• The active substance is ofloxacin. 1 ml of solution contains 3.0 mg of ofloxacin. One dose (1 drop) contains 0.1 mg of ofloxacin.
• The other ingredients are: sodium chloride, benzalkonium chloride, hydrochloric acid, sodium hydroxide solution (for pH adjustment), and water for injections.

What Ofloxamed looks like and contents of the pack
Ofloxamed is a clear, yellowish solution.
Each bottle contains 5 ml of eye drops solution.
The product is available in the following pack sizes:
1 x 5 ml
3 x 5 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany