DULCILARMES 1,5 % Collyre sol récip unidose 60unid

VIDAL
Medicines
Update of 04/03/2024

DULCILARMES^® single-dose containers
povidone

Forms and presentations

Ophthalmic solution at 1,5 % :  Single-dose container of 0,4 ml, in sachet, box of 60.

Composition

	single-dose container
Povidone (INN)	6 mg

Excipients: sodium hyaluronate, sodium chloride, disodium edetate, disodium phosphate dihydrate, monosodium phosphate dihydrate, water for injection.

Indications

Symptomatic treatment of dry eye syndrome.

Dosage and administration

Topical use.

For ocular instillation.

Instil into the lower conjunctival sac, gently pulling the lower eyelid down and looking upward, 1 drop of eye drops into the diseased eye or eyes, 4 to 6 times a day, depending on the severity of symptoms.

Contraindications

Hypersensitivity to any of the components.

Warnings and precautions

• If concomitant treatment with another eye drop is used, wait 15 minutes between the 2 instillations.
  
• Avoid touching the eye with the tip of the single-dose container.
  
• This eye drop solution is presented in single-use single-dose containers. There is therefore a risk of rapid bacterial contamination after opening.
  
• The single-dose container must be discarded immediately after use and must not be stored for later use.
  

Fertility, pregnancy and breastfeeding

No teratogenesis study is available in animals.

There are currently no sufficient data on a possible malformative or foetotoxic effect of povidone when administered during pregnancy.

However, penetration through the cornea seems unlikely due to the size of the molecule.

Consequently, the use of povidone should be considered during pregnancy only if necessary.

Driving and using machines

Patients with blurred vision must refrain from driving or operating machinery.

Adverse effects

Occasionally: transient burning sensation, eye feeling stuck.

Rarely: irritation or hypersensitivity reactions.

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.

Pharmacodynamics

Pharmacotherapeutic class: Lacrimal substitute (S: sense organs).

Povidone is a synthetic polymer containing linear chains of 1-vinyl-2-pyrrolidone.

This eye drop acts as a lubricant and wetting agent on the surface of the eye and temporarily compensates for insufficient tears.

Pharmacokinetics

Penetration through the cornea seems unlikely, due to the size of the molecule.

Storage conditions

Store at a temperature not exceeding 25 °C.

Any single-dose container that has been opened must be discarded immediately after use.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.

Prescription, supply and reimbursement

Marketing authorisation (AMM)

3400927956478 (2014).

Price:	5,50 euros (60 single-dose containers).
Reimbursed by Social Security at 65 %. Collective.

HORUS PHARMA
22, Allée Camille-Muffat
INEDI 5. 06200 Nice
Tel: 04 93 19 54 03. Fax: 04 93 19 54 09
https://www.horus-pharma.com