Leaflet SPERSADEX COMP 5mg / 1mg / ml ophthalmic drops solution

Indicated for: eye infections with inflammation

Route of administration: ophthalmic

Substance: chloramphenicol + dexamethasone (antibacterial antibiotic + glucocorticoid)

ATC: S01CA01 (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.

Chloramphenicol and dexamethasone are used in combination in certain medications, particularly in the form of eye or ear drops, to treat bacterial infections associated with inflammation. This combination is indicated for conditions such as bacterial conjunctivitis, blepharitis, keratitis, or otitis externa, where both infection control and inflammation reduction are needed.

Chloramphenicol is a broad-spectrum antibiotic that inhibits bacterial protein synthesis, making it effective against a wide range of gram-positive and gram-negative bacteria. Dexamethasone is a potent corticosteroid with anti-inflammatory and immunosuppressive properties, which reduces inflammation, swelling, and allergic symptoms associated with infections.

While this combination is effective, its use requires caution. Chloramphenicol may cause rare side effects, such as hypersensitivity reactions or, in very rare cases, bone marrow aplasia (a serious bone marrow condition). Dexamethasone, if used long-term, can lead to systemic side effects, such as suppression of the hypothalamic-pituitary-adrenal axis, increased risk of secondary infections, or tissue thinning.

This combination should be used as directed by a doctor, and the duration of treatment should be limited to reduce the risk of side effects. It is important to avoid long-term use or use in cases where the infection is caused by viruses or fungi, as corticosteroids may worsen these infections. If severe side effects or persistent symptoms occur, immediate medical attention is necessary.

General data about SPERSADEX COMP 5mg / 1mg / ml

  • Substance: chloramphenicol + dexamethasone
  • Date of latest medicines list: 01-06-2026
  • Product code: W58786001
  • Concentration: 5mg / 1mg / ml
  • Pharmaceutical form: ophthalmic drops solution
  • Quantity: 1
  • Product type: Original
  • Price: 16.94 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: NOVARTIS PHARMA GMBH - GERMANIA
  • Holder: LABORATOIRES THEA - FRANTA
  • Number: 379/2007/01
  • Shelf life: 2 years

Compensation lists for SPERSADEX COMP 5mg / 1mg / ml Théa

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

Price

Copayment

Patient

16.94 RON

4.57 RON

12.37 RON