Leaflet OTIS-T 5mg / ml+0.5mg / ml+10mg / ml ear drops solution

Indicated for: ear infections; inflammation; local pain

Route of administration: auricular

Substance: chloramphenicol + fluocinolone + lidocaine (antibacterial antibiotic + glucocorticoid + local anesthetic)

ATC: S02CA05 (Sensory organs | Corticosteroids and antiinfectives in combination)

Precautions:
Anaphylaxis
Anaphylaxis

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

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

This combination of active substances, including chloramphenicol, fluocinolone, and lidocaine, is used to treat bacterial infections of the external ear accompanied by inflammation and pain. Chloramphenicol is a broad-spectrum antibiotic, fluocinolone is a corticosteroid that reduces inflammation, and lidocaine is a local anesthetic that relieves pain.

The medication is administered as ear drops, as directed by a doctor. The dosage and duration of treatment are adjusted based on the severity of the infection and the patient's response.

Patients should strictly follow their doctor's instructions and avoid prolonged use of the medication to prevent bacterial resistance or other complications. Contact with the eyes should be avoided.

Side effects may include local irritation, a burning sensation, or allergic reactions. In rare cases, severe reactions such as hypersensitivity or secondary fungal infections may occur. Patients should inform their doctor of any unusual symptoms.

General data about OTIS-T 5mg / ml+0.5mg / ml+10mg / ml

  • Substance: chloramphenicol + fluocinolone + lidocaine
  • Date of latest medicines list: 01-06-2026
  • Product code: W02268001
  • Concentration: 5mg / ml+0.5mg / ml+10mg / ml
  • Pharmaceutical form: ear drops solution
  • Packing volume: 10ml
  • Product type: Generic medicine
  • Price: 9.47 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: TIS FARMACEUTIC SA - ROMANIA
  • Holder: TIS FARMACEUTIC SA - ROMANIA
  • Number: 7743/2006/01
  • Shelf life: 3 years

Compensation lists for OTIS-T 5mg / ml+0.5mg / ml+10mg / ml TIS

C3 - Sublist C - section C3 (children, pregnant women and postpartum women) with 100% discount from the reference price

Price

Copayment

Patient

9.47 RON

9.47 RON

0.00 RON