Page 143 - MEMENTO THERAPEUTIQUE RCP 2024

Approved SPC FR/H/296/01/II/18

1. NAME OF THE MEDICINAL PRODUCT

VOLTARENOPHTABAK 1 mg/ml, eye drops, solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Diclofenac sodium.............................................................................................................1 mg/ml
Excipients with known effect: macrogolglycerol ricinoleate 50 mg /ml
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Eye drops, solution.
Slightly yellow and opalescent liquid.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

- Inhibition of miosis during cataract surgery.
- Prevention of inflammation in cataract and anterior eye segment surgeries (see section 5.1).
- Treatment of ocular pain in photorefractive keratectomy surgery for up to the 24 first post-operative
hours.

4.2 Posology and method of administration

Posology

Adults:
Inhibition of miosis during cataract surgery
- Pre-operatively: one drop up to five times during the three hours before surgery;

Prevention of inflammation in cataract and anterior eye segment surgeries:
- Pre-operatively: one drop up to five times during the three hours before surgery;
- Post-operatively: one drop three times immediately after surgery and then one drop three to five times
daily. A treatment duration exceeding 4 weeks is not recommended.

Treatment of ocular pain in photorefractive keratectomy surgery for up to the 24 first post-operative hours:
- Pre-operatively: two drops within the hour prior to surgery;
- Post-operatively: two drops within the hour following surgery and then four drops within the 24 post-
operative hours.

Children:
No specific studies have been performed.

Elderly:
No dosage adjustment is necessary.

Method of administration
Ocular use.

Patients should be instructed: