Leaflet FLOXAL 3mg / g ophthalmic ointment

Indicated for: bacterial infections

Route of administration: ophthalmic

Substance: ofloxacin (fluoroquinolone antibiotic)

ATC: S01AE01 (Sensory organs | Antiinfectives | Fluoroquinolones)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Colitis / severe diarrhea
Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Avoid milk, calcium, iron, or antacids
Avoid milk, calcium, iron, or antacids

Do not take with milk, calcium, iron, magnesium, or antacids if separation is recommended.

Photosensitivity
Photosensitivity

Avoid excessive exposure to sunlight or UV radiation.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Neuropathy / neurotoxicity
Neuropathy / neurotoxicity

This medicine may affect the nerves or nervous system.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Seizure risk
Seizure risk

This medicine may increase the risk of seizures.

Tendonitis / tendon rupture
Tendonitis / tendon rupture

Stop treatment and seek medical advice if tendon pain occurs.

Ofloxacin is a fluoroquinolone antibiotic used for the treatment of bacterial infections, including urinary tract infections, respiratory infections, skin infections, and eye infections. It works by inhibiting bacterial DNA gyrase, preventing bacterial DNA replication.

The medication is available in the form of tablets, injectable solutions, or eye drops and should be used as directed by a doctor. The dosage and duration of treatment are adjusted based on the type and severity of the infection.

Patients should be aware of potential side effects, such as nausea, diarrhea, or allergic reactions. It is important to inform the doctor of any unusual symptoms or the use of other medications.

Common side effects include nausea, diarrhea, dizziness, and headaches. In rare cases, severe reactions such as tendinitis, tendon rupture, or severe allergic reactions may occur. Patients should be informed of these risks before starting treatment.

General data about FLOXAL 3mg / g

  • Substance: ofloxacin
  • Date of latest medicines list: 01-06-2026
  • Product code: W41890001
  • Concentration: 3mg / g
  • Pharmaceutical form: ophthalmic ointment
  • Quantity: 1
  • Product type: Generic medicine
  • Price: 18.28 RON
  • Prescription status: P-6L - Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

  • Manufacturer: DR. GERHARD MANN CHEM-PHARM. FABRIK GMBH - GERMANIA
  • Holder: DR. GERHARD MANN CHEM-PHARM. FABRIK GMBH - GERMANIA
  • Number: 8456/2015/01
  • Shelf life: 3 years-after packing for marketing; after the first opening of the tube-6 weeks

Concentrations available for ofloxacin

  • 0.3%
  • 200mg
  • 200mg/100ml
  • 3mg/g
  • 3mg/ml
  • 400mg

Compensation lists for FLOXAL 3mg / g Dr. Gerhard

B - Sublist B with 50% discount from the reference price

Price

Copayment

Patient

18.28 RON

9.14 RON

9.14 RON