Leaflet BETABIOPTAL 1.3mg / 2.5mg / g ophthalmic gel

Indicated for: eye or ear infections with inflammation

Route of administration: ophthalmic

Substance: betamethasone + chloramphenicol (glucocorticoid + antibacterial antibiotic)

ATC: S01CA05 (Sensory organs | Antiinflammatory agents and antiinfectives in combination | Corticosteroids and antiinfectives in combination)

Precautions:
Anaphylaxis
Anaphylaxis

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

Glaucoma warning
Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Vision disturbances
Vision disturbances

This medicine may cause vision disturbances.

The combination of betamethasone and chloramphenicol is used to treat inflammatory skin infections caused by susceptible bacteria. Betamethasone is a potent corticosteroid that reduces inflammation, itching, and redness, while chloramphenicol is a broad-spectrum antibiotic that fights bacterial infections. This combination is indicated for conditions such as infected dermatitis, superinfected eczema, or other bacterial dermatoses.

The medication is available as a cream or ointment and is applied topically to the affected area, usually 1-2 times daily, as directed by a doctor. It is important to avoid using it on broken skin, the face, or sensitive areas unless specifically advised by a doctor.

Side effects may include local irritation, burning sensation, dryness, or, in rare cases, allergic reactions. Prolonged or excessive use of the corticosteroid may lead to skin thinning, stretch marks, or systemic absorption, potentially causing systemic side effects.

This combination is contraindicated in viral, fungal, or tuberculous skin infections, as well as in cases of hypersensitivity to any of the components. Use during pregnancy or breastfeeding should be done with caution and only under medical advice. Patients must strictly follow their doctor’s instructions to avoid adverse effects and ensure the effectiveness of the treatment.

General data about BETABIOPTAL 1.3mg / 2.5mg / g

  • Substance: betamethasone + chloramphenicol
  • Date of latest medicines list: 01-06-2026
  • Product code: W60088001
  • Concentration: 1.3mg / 2.5mg / g
  • Pharmaceutical form: ophthalmic gel
  • Quantity: 1
  • Product type: Generic medicine
  • Price: 72.91 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: FARMILA-THEA FARMACEUTICI S.P.A. - ITALIA
  • Holder: THEA FARMA S.P.A. - ITALIA
  • Number: 12728/2019/01
  • Shelf life: 2 years-after packing for marketing;after the first opening-4 weeks

Pharmaceutical forms available for betamethasone + chloramphenicol

Concentrations available for betamethasone + chloramphenicol

  • 1.3mg/2.5mg/g
  • 2mg/5mg/ml
  • 2mg/g+5mg/g

Compensation lists for BETABIOPTAL 1.3mg / 2.5mg / g Théa

A - Sublist A with 90% discount from the reference price

Price

Copayment

Patient

72.91 RON

45.92 RON

26.99 RON