SEDACOLLYRE CETYLPYRIDINIUM 0,025 % Collyre récip unidose 10unid/0,4mL

Cetylpyridinium (chloride) ............................................................ 0,10 mg

Adjunctive antiseptic treatment of superficial affections of the eye and its adnexa.

Topical use.

FOR OCULAR INSTILLATION

Instil 1 drop of eye drops into the lower conjunctival sac of the eye (or eyes) to be treated, gently pulling the lower eyelid downward and looking upward, 3 to 4 times a day, for 7 days on average.

Do not touch the eye or eyelids with the tip of the single-dose container.

Discard the single-dose container after use.

Hypersensitivity to any of the constituents of the eye drops or to another quaternary ammonium.

Warnings

Do not inject, do not swallow.

The eye drops must not be administered by peri- or intra-ocular injection.

The treatment must not include several antiseptics.

The single-dose container must be discarded immediately after use and must not be kept for reuse during subsequent administrations.

Do not touch the eye with the tip of the single-dose container.

Precautions for use

• In case of hypersensitivity, discontinue the treatment.
• Treatment is usually limited to 7 days: intensive or prolonged use may cause alterations of the conjunctival and/or corneal epithelium. Caution is required particularly in cases of epithelial abnormalities.
• Avoid use in contact lens wearers: quaternary ammoniums may be absorbed by hydrophilic contact lenses and cause local intolerance.
• In case of concomitant treatment with another eye drops containing a different active ingredient, space the instillations by 15 minutes.

Quaternary ammoniums are incompatible with fluorescein, pilocarpine nitrate, silver salts, boric acid, salicylates.

No teratogenesis study is available in animals.

In clinical practice, no particular malformative or foetotoxic effect has appeared to date.

However, the follow-up of pregnancies exposed to cetylpyridinium is insufficient to rule out any risk.

Consequently, as a precautionary measure, it is preferable not to use cetylpyridinium during pregnancy.

Possibility of a transient irritation reaction, or local intolerance.

Risk of hypersensitivity reaction.

LOCAL ANTISEPTIC FOR OPHTHALMOLOGICAL USE (S = organs of sense).

Cetylpyridinium is a cationic antiseptic belonging to the class of quaternary ammoniums.

The wetting properties of quaternary ammoniums promote their passage through the cornea.

1 year.

This medicine must be stored at a temperature below 25 °C.

This medicine must be discarded after use and not be kept after opening.

• To open a single-dose container, make a complete rotation of its end in order to break the seal.
• Invert the single-dose container in order to bring the contents down toward the open end.
• Instillation is then performed by gently squeezing the single-dose container.
• It is recommended to use a new single-dose container for each application to ensure instillation of an eye drop solution that is always sterile.

[To be completed later by the holder]