Leaflet TOBREX 3mg / ml ophthalmic drops solution

Indicated for: bacterial infections

Route of administration: ophthalmic

Substance: tobramycin (aminoglycoside antibiotic)

ATC: S01AA12 (Sensory organs | Antiinfectives | Antibiotics)

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.

Nephrotoxicity
Nephrotoxicity

This medicine may affect the kidneys.

Ototoxicity
Ototoxicity

This medicine may affect hearing or balance.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Tobramycin is an aminoglycoside antibiotic used to treat severe bacterial infections caused by Gram-negative bacteria, such as Pseudomonas aeruginosa. It is commonly used for respiratory infections, skin infections, urinary tract infections, and eye infections. Tobramycin works by inhibiting bacterial protein synthesis, leading to bacterial destruction.

The medication is available in various forms, including injectable solutions, eye drops, and inhalation solutions (for pulmonary infections, such as those associated with cystic fibrosis). The dosage and route of administration depend on the type and severity of the infection.

Common side effects include local irritation (for topical use), nausea, vomiting, and skin rashes. When administered systemically, tobramycin can cause serious adverse effects, such as ototoxicity (hearing damage), nephrotoxicity (kidney damage), and neurotoxicity. For this reason, careful monitoring of kidney function and hearing is required during treatment. Tobramycin is contraindicated in patients with hypersensitivity to aminoglycosides.

General data about TOBREX 3mg / ml

  • Substance: tobramycin
  • Date of latest medicines list: 01-06-2026
  • Product code: W70667001
  • Concentration: 3mg / ml
  • Pharmaceutical form: ophthalmic drops solution
  • Packing volume: 5 ml
  • Product type: Original
  • Price: 10.15 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: ALCON COUVREUR NV - BELGIA
  • Holder: NOVARTIS EUROPHARM LIMITED - IRLANDA
  • Number: 8412/2015/01
  • Shelf life: 3 years-After packaging for sale;After first opening the bottle. - 28 days

Concentrations available for tobramycin

  • 0.3%
  • 300mg
  • 300mg/5ml
  • 3mg/g
  • 3mg/ml
  • 40mg/ml

Combinations with other substances

Compensation lists for TOBREX 3mg / ml Europharm

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

Price

Copayment

Patient

10.15 RON

5.08 RON

5.08 RON