BIOCIDAN 0,1 mg/0,4 ml Collyre récip unidose 10unid/0,4ml

VIDAL
Medicines
Update of 04/03/2024

BIOCIDAN^® eye drops
cethexonium

Forms and presentations

Eye drops: Single-dose containers of 0,4 ml, box of 10.

Composition

	per single dose
Cethexonium (INN) bromide	0,1 mg

Excipients: sodium chloride, water for injectable preparations.

Indications

Antiseptic treatment of superficial conditions of the eye and its adnexa.

Dosage and administration

For ocular instillation.

Instil 1 drop into the lower conjunctival sac, gently pulling the lower eyelid downward and looking upward, 3 to 4 times a day, for 7 days on average.

Contraindications

History of allergy to cethexonium or other quaternary ammoniums.

Warnings and precautions

• In case of hypersensitivity, discontinue treatment.
  
• Treatment must be limited to 15 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 adsorbed by hydrophilic lenses and cause local intolerance.
  
• In case of concomitant treatment with an eye drop containing a different active ingredient, space the instillations by 15 minutes.
  
• 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.
  

Interactions

Do not combine two antiseptics.

In case of concomitant treatment with an eye drop containing a different active ingredient, space the instillations by 15 minutes.

Fertility, pregnancy and breastfeeding

Given the available data, use in pregnant or breastfeeding women is possible.

Driving and using machines

A transient visual disturbance may be felt after instillation of the eye drops in solution. In this case, it is advised not to drive or use machinery until normal vision returns.

Adverse effects

• Possibility of a local intolerance reaction (see Warnings and Precautions for Use).
  
• Risk of a hypersensitivity reaction.
  

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Overdose

In case of overdose, rinse with sterile physiological saline.

Pharmacodynamics

Pharmacotherapeutic class: Local antiseptic reserved for ophthalmic use.

Cethexonium is an antiseptic belonging to the class of quaternary ammoniums.

Pharmacokinetics

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

Storage conditions

HANDLING/DISPOSAL INSTRUCTIONS

Each single-dose container contains approximately 10 drops.

To use the single dose, proceed as follows:

• at first use, open the envelope in which a strip of single doses is packaged;
  
• remove the strip from its protective envelope and detach one single dose;
  
• to open the single dose, vigorously make a complete rotation of the flat part in order to break the seal;
  
• invert the single dose, so as to make the contents descend towards the open end;
  
• instil the eye drops into the eye or eyes to be treated by lightly squeezing the single dose.
  

Prescription, supply and reimbursement

Marketing authorisation (AMM)

3400933834968 (1994, SmPC rev 23.08.2023) 10 single-dose vials.

Not reimbursed by Social Security.

MENARINI FRANCE
1, rue du Jura. PO Box 40528. 94633 Rungis cdx
Tel: 01 45 60 77 20
http://www.menarini.fr