Instructions Artelak eye drops 3.2 mg/ml bottle with dropper 10 ml
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.
Dosage form
Eye drops, solution.
Main physicochemical properties: colorless sterile transparent solution.
Pharmacotherapeutic group
Artificial tear fluid substitutes and other indifferent preparations. ATX code S01X A20.
Pharmacological properties
Pharmacodynamics
Hypromellose is partially methylated and hydroxypropylated cellulose.
Normally, the cornea should be moistened mainly by mucin produced by the conjunctiva. Mucin is adsorbed on the cornea and forms a hydrophilic surface. In dry eye syndrome, especially in cases of mucin deficiency, artificial tears should be prescribed.
Hypromellose is particularly suitable for this application due to its surface activity and adsorption capacity. Due to its physicochemical action, hypromellose in aqueous solution reduces surface tension and also increases viscosity. Hypromellose adheres well to the cornea and conjunctiva and ensures normal hydration. The symptoms of irritation caused by blinking caused by a deficiency of tear fluid are thus reduced, which prevents the occurrence of symptoms of epithelial drying.
Indication
For the symptomatic treatment of dryness of the cornea and mucous membrane of the eye (dry eye syndrome) caused by impaired tear secretion and tear function due to local or systemic diseases, as well as in case of insufficient or incomplete eyelid closure. For wetting and additional hydration of hard contact lenses.
Contraindication
Hypersensitivity to any component of the drug.
Interaction with other medicinal products and other types of interactions
Unknown.
Please note:
When using other topical ophthalmic agents, ARTELAK® should always be the last drug to be administered, with an interval of approximately 15 minutes, so that its residence on the surface of the eye, i.e. the moisturizing effect, is not reduced.
Application features
Before use, wash your hands thoroughly, and do not touch the eye or eyelids with the dropper tip when instilling. The bottle should be closed immediately after use.
Ability to influence reaction speed when driving vehicles or other mechanisms
Even when used as directed, this medicine may cause short-term blurred vision due to the formation of a band in the field of vision, so patients should wait until their vision clears before driving or operating other machinery.
Use during pregnancy or breastfeeding
There is no risk associated with the use of ARTELAC® during pregnancy or breastfeeding, as hypromellose is not absorbed and thus has no systemic effect.
Method of administration and doses
Treatment of dry eye syndrome requires individual dosing. Unless otherwise prescribed, depending on the need, 1 drop should be instilled into the conjunctival sac 3 to 5 or more times a day, tilting the head back, and pulling the lower eyelid down with the index finger of one hand. With the other hand, holding the bottle with the dispenser vertically above the eye (without touching the eye), drop one drop into the pulled conjunctival sac. Try to move the eyeball without closing the eye so that the liquid spreads well over it.
People who wear soft contact lenses should remove them before using ARTELAC® and wait 15 minutes before putting them back in.
ARTELAK ® can also be used to re-wet hard contact lenses.
In case of long-term use of ARTELAK ®, you should consult a doctor.
Children
There are no data on the use of the drug in children.
Overdose
Unknown and does not require any necessary action.
Adverse reactions
The following categories are used as the basis for data on the frequency of 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 the available data).
Hypersensitivity reactions are very rare. Burning, redness, foreign body sensation in the eye, blurred vision, tearing, swelling, itching, eye pain may occur.
Very rare cases of corneal calcification have been reported during treatment with phosphate-containing eye drops in patients with severe corneal defects.
Artelac® contains cetrimide as a preservative, which may cause eye irritation, especially with frequent and prolonged use, and may damage the cornea. Therefore, for long-term treatment of chronic keratoconjunctivitis sicca, preservative-free preparations should be preferred.
Expiration date
After first opening the bottle, use within 6 weeks.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 30 °C.
Packaging
10 ml of solution in a bottle with a dropper; 1 bottle with a dropper in a cardboard box.
Vacation category
Without a prescription.
Producer
Dr. Gerhard Mann, Chem.-pharm. Fabric GmbH, Germany/Dr. Gerhard Mann, Chem.-pharm. Fabric GmbH, Germany.
Location of the manufacturer and its business address
Brunsbutteler Damm 165-173, 13581 Berlin, Germany/ Brunsbutteler Damm 165-173, 13581 Berlin, Germany
