DULCILARMES 1,5 % Collyre sol Fl/10ml

VIDAL
Medicines
Update of 04/03/2024

DULCILARMES^® bottle
povidone

Forms and presentations

Ophthalmic solution at 1,5 % :  Novelia dropper bottle^TM of 10 ml.

Composition

	p 100 ml
Povidone (INN)	1,5 g

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

Indications

Symptomatic treatment of dry eye syndrome in adults.

Dosage and administration

Topical use.

For ocular instillation.

Dosage

• In adults: 1 drop of eye drops in the affected eye or eyes, 4 to 6 times a day, depending on the severity of the symptoms.
  
• Paediatric population: no data are available.
  

Method of administration:

Instil into the lower conjunctival sac, gently pulling the lower eyelid downward and looking upward.

Contraindications

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

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 bottle.
  
• Recap the bottle after use.
  

Interactions

No interaction studies have been performed.

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); ATC code: S01.

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.

Preclinical safety

No data available.

Storage conditions

Store at a temperature not exceeding 30 °C.

HANDLING/DISPOSAL INSTRUCTIONS

For proper use of the eye drops, certain precautions must be taken:

• Wash hands thoroughly before proceeding with instillation.
  
• Avoid contact of the tip with the eye or eyelids.
  
• Instil one drop of eye drops into the lower conjunctival sac of the eye to be treated, looking upward and gently pulling the lower eyelid downward.
  
• Replace the cap on the bottle after use.
  

Prescription, supply and reimbursement

Marketing authorisation (AMM)

3400930081594 (2017, SmPC rev 11.10.2018).

Price:	4,52 euros (bottle of 10 ml).
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