Leaflet LEVOFLOXACINA ACTAVIS 5mg / ml ophthalmic drops solution


Indicated for: bacterial infections

Route of administration: ophthalmic

Substance: levofloxacin (fluoroquinolone antibiotic)

ATC: S01AE05 (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.

Levofloxacin is an antibiotic from the fluoroquinolone class, used to treat a wide range of bacterial infections. It is effective against respiratory tract infections (such as pneumonia and acute exacerbations of chronic bronchitis), urinary tract infections, pyelonephritis, skin and soft tissue infections, and certain sinus infections.

This medication works by inhibiting bacterial enzymes essential for DNA replication, leading to the destruction of bacteria. It is important to use levofloxacin only for bacterial infections and not for viral infections, such as the common cold or flu.

Side effects may include nausea, diarrhea, dizziness, headache, or insomnia. In rare cases, more serious reactions can occur, such as tendinitis, tendon rupture, severe allergic reactions, or central nervous system disturbances. It is essential to take the medication as prescribed by a doctor, and patients should avoid excessive sun exposure during treatment, as it may increase skin sensitivity.

General data about LEVOFLOXACINA ACTAVIS 5mg / ml

  • Substance: levofloxacin
  • Date of last drug list: 01-04-2017
  • Commercial code: W62775001
  • Concentration: 5mg / ml
  • Pharmaceutical form: ophthalmic drops solution
  • Quantity: 1
  • Product type: generic
  • Prescription restrictions: P-6L - Medicines prescription that isn't retained in the pharmacy (can be renewed); the prescription can be used for 6 months from the moment of release.

Marketing authorisation

  • Manufacturer: BALKANPHARMA-RAZGRAD AD - BULGARIA
  • Holder: ACTAVIS GROUP PTC EHF. - ISLANDA
  • Number: 13820/2021/01
  • Shelf life: 3 years-after packing for marketing;after the first opening of the bottle-4 weeks

Pharmaceutical forms available for levofloxacin

Concentrations available for levofloxacin

  • 250mg
  • 250mg/50ml
  • 500mg
  • 500mg/100ml
  • 5mg/ml

Combinations with other substances