Page 151 - MEMENTO THERAPEUTIQUE RCP 2024

FR/H/0411/001/II/020 - Approved SPC

1. NAME OF THE MEDICINAL PRODUCT

ZABAK 0.25 mg/ml, eye drops, solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains 0.345 mg ketotifen hydrogen fumarate corresponding to 0.25 mg
ketotifen.
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Eye drops, solution.
Clear, colourless to faintly brown yellow solution

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Symptomatic treatment of seasonal allergic conjunctivitis.

4.2 Posology and method of administration
Posology
Adults, elderly and children (age 3 and older):
One drop of ZABAK into the conjunctival sac twice a day.

Method of administration
Patients should be instructed:
- prior to first use, to discard the 5 first drops. Except for this first time, it is not
necessary to discard the 5 first drops,
- to wash carefully their hands prior to instillation,
- to avoid contamination of drops, and not to touch eye or eyelids or any surface
with the dropper tip.
- to close the eyelid and to use nasolacrimal occlusion for 1-2 minutes. This will help
to reduce systemic absorption.
- to close the bottle after use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

No special warning.

4.5 Interaction with other medicinal products and other forms of interaction

If ZABAK is used concomitantly with other eye medications there must be an interval of
at least 5 minutes between the two medications.