Artelac

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARLATEC®

Composition:

Active ingredient: hypromellose;

1 ml of solution contains: hypromellose 3.2 mg;

Excipients: cetrimide; disodium edetate; sodium hydrogen phosphate, dodecahydrate; sodium dihydrogen phosphate, dihydrate; sorbitol (E 420); water for injections.

Pharmaceutical form. Eye drops, solution.

Main physicochemical properties: colorless, sterile, clear solution.

Pharmacotherapeutic group. Artificial tear substitutes and other indifferent preparations. ATC code S01X A20.

Pharmacological properties.

Pharmacodynamics.

Hypromellose is a partially methylated and hydroxypropylated cellulose.

Under normal conditions, the cornea should be moistened primarily by mucin produced by the conjunctiva. Mucin is adsorbed onto the cornea and forms a hydrophilic surface. In dry eye syndrome, especially in cases of mucin deficiency, artificial tear fluid should be administered.

Hypromellose is particularly suitable for this purpose due to its surface activity and adsorption capacity. Through its physicochemical action, hypromellose in aqueous solution reduces surface tension and increases viscosity. Hypromellose adheres well to the cornea and conjunctiva, ensuring adequate hydration. Thus, irritation symptoms caused by blinking due to tear deficiency are reduced, preventing the occurrence of epithelial drying symptoms.

Clinical characteristics.

Indications.

For symptomatic treatment of corneal and conjunctival dryness symptoms (dry eye syndrome) caused by impaired tear secretion and lacrimal excretion function due to local or systemic diseases, as well as in cases of insufficient or incomplete eyelid closure. For wetting and additional hydration of rigid contact lenses.

Contraindications.

Hypersensitivity to any component of the product.

Interaction with other medicinal products and other forms of interactions.

Unknown.

Note the following:

When using other topical ophthalmic agents, ARTELAК® should always be administered last, with an interval of approximately 15 minutes, so that its residence time on the ocular surface, i.e. the moisturizing effect, is not shortened.

Special precautions for use.

Before application, hands should be thoroughly washed. During instillation, the dropper tip must not touch the eye or eyelids. The bottle should be closed immediately after use.

Use during pregnancy or breastfeeding.

There is no risk associated with the use of ARTeLAC® during pregnancy or breastfeeding, since hypromellose is not absorbed and therefore has no systemic effect.

Ability to influence reaction speed when driving or operating machinery.

Even when used as directed, this medicinal product may cause transient blurred vision due to the formation of a visual streak, therefore patients should wait until vision clears before driving or operating machinery.

Method of administration and dosage.

Treatment of dry eye syndrome requires individual dosing. Unless otherwise prescribed, instill 1 drop into the conjunctival sac 3 to 5 times or more daily, as needed. Tilt the head backward and with the index finger of one hand, gently pull the lower eyelid downward. With the other hand, holding the bottle with the dropper vertically above the eye (without touching the eye), instill one drop into the lower conjunctival sac. Try to move the eyeball without closing the eye to ensure proper distribution of the liquid.

Individuals wearing soft contact lenses should remove them before using ARTELAК® and wait 15 minutes before reinserting the lenses.

ARTELAК® can also be used to re-wet rigid contact lenses.

In case of prolonged use of ARTELAК®, consult a physician.

Children.

There is no data available regarding the use of the drug in children.

Overdose.

Not known and requires no specific measures.

Adverse reactions

The following frequency categories were used as the basis for data on possible side effects:

• Very common (≥ 1/10)
• Common (≥ 1/100 to <1/10)
• Uncommon (≥ 1/1000 to <1/100)
• Rare (≥ 1/10,000 to <1/1000)
• Very rare (< 1/10,000)
• Not known (frequency cannot be estimated from available data).

Hypersensitivity reactions are very rare. Burning, redness, foreign body sensation in the eye, blurred vision, tearing, swelling, itching, and eye pain may occur.

Very rare cases of corneal calcification have been reported during treatment with phosphate-containing eye drops in patients with significant corneal defects.

ArteLac® contains cetrimide as a preservative, which may cause eye irritation, particularly with frequent and prolonged use, and may damage the cornea. Therefore, preservative-free medicinal products should be preferred for long-term treatment of chronic dry keratoconjunctivitis.

Shelf life. 24 months.

After first opening of the bottle, do not use for more than 6 weeks.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions. Store at temperatures not exceeding 25 °C.

Packaging. 10 ml of solution in a bottle with dropper; 1 bottle with dropper in a cardboard box.

Classification for supply. Over-the-counter (without prescription).

Manufacturer.

Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH

Manufacturer's location and address of place of business.

Brunsbütteler Damm 165/173, 13581 Berlin, Germany