ARTELAC 1,6 mg/0,5 mL Eye drops, single-dose container 60unit

VIDAL
Medicines
Update of the 04/09/2025

ARTELAC^®
hypromellose

Forms and presentations

Eye drops at 1,6 mg/0,5 ml:  Single-dose containers of 0,5 ml, box of 60.

Composition

	single-dose p
Hypromellose	1,60 mg

Excipients: sorbitol, disodium phosphate dodecahydrate, monosodium phosphate dihydrate, water for injections.

Excipients with known effect: phosphates.

This medicine contains 2,82 mg of phosphates per unit volume (0,5 mL).

Indications

Symptomatic treatment of dry eye syndrome.

Dosage and administration

Dosage

Ophthalmic use.

Instil 1 drop of eye drops into the lower conjunctival sac, looking upward and gently pulling the lower eyelid downward, 4 to 6 times a day, depending on the eye disorders.

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 given, wait 15 minutes between the two instillations.
  
• Discard the single-dose container immediately after use.
  
• After opening, do not keep the single-dose container for later use.
  
• This medicine contains phosphate (see Undesirable effects).
  

Interactions

If concomitant treatment with another eye drop is given, wait 15 minutes between the two instillations.

Fertility, pregnancy and breastfeeding

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

Driving and using machines

After instillation of the eye drops, vision may be blurred for a few minutes.

Adverse effects

Undesirable effects are classified according to their frequency, as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1 000, < 1/100), rare (≥ 1/10 000, < 1/1 000), very rare (< 1/10 000), frequency not known (cannot be estimated from the available data).

Eye disorders:

• Frequency not known: discomfort at the instillation site (stinging), ocular hyperaemia.
  
• Very rare: corneal calcification.
  

Descriptions of certain adverse effects:

A few very rare cases of corneal calcification have been reported in association with the use of phosphate-containing eye drops in certain patients with severely damaged corneas.

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 thoroughly with sterile physiological saline.

Pharmacodynamics

Pharmacotherapeutic class: artificial tears substitute, ATC code: S01X020 (S: sensory organs).

Storage conditions

Store at a temperature not exceeding 25 °C.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Prescription, supply and reimbursement

Marketing authorisation (AMM)

3400934035890 (1996, SmPC rev 24.06.2025).

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

CHAUVIN Laboratory
416, rue Samuel-Morse. CS 99535. 34961 Montpellier
Tel: 04 67 12 30 30