SIKAPROTEKT

INSTRUCTIONS for medical use of the medicinal product SICCAPROTECT®

Composition:

Active substances: dexpanthenol, polyvinyl alcohol;

1 ml of solution contains 30 mg of dexpanthenol and 14 mg of polyvinyl alcohol;

Excipients: benzalkonium chloride, potassium hydrogen phosphate, potassium dihydrogen phosphate, water for injections.

Pharmaceutical form. Eye drops.

Main physicochemical properties: colorless solution.

Pharmacotherapeutic group. Agents used in ophthalmology. Dexpanthenol. ATC code S01XA12.

Pharmacological Properties.

Pharmacodynamics.

Sicaproprotect eye drops are a combination of a biological precursor of pantothenic acid (vitamin B5) and a non-ionic surfactant, which acts as artificial tears in the treatment of dry eye syndrome.

Pantothenic acid is a component of coenzyme A, which, in the form of acetyl-coenzyme A, is essential in the metabolism of fats, sugars, and various amino acids. Relatively high concentrations of coenzyme A are observed in all organs with intensive metabolism; its highest concentrations have been found in the skin. Since local deficiency of coenzyme A occurs in epithelial and deep tissue injuries, local application of dexpanthenol is particularly effective. Due to its anti-inflammatory and anti-pruritic properties, as well as its ability to accelerate granulation and re-epithelialization, dexpanthenol promotes healing of non-bacterial eye inflammations.

Polyvinyl alcohol has adhesive properties towards the cornea and increases the viscosity of Sicaproprotect eye drops, thereby prolonging the retention time of the preparation on the cornea.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

• Symptomatic treatment of dryness of the cornea and conjunctiva caused by reduced tear secretion, which may be associated with local or systemic diseases or mechanical inability to close the eyelids;
• ocular hydration during wear of rigid contact lenses.

Contraindications.

Hypersensitivity to the active substances or to any of the other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

No specific studies on drug interactions of the medicinal product have been conducted.

When using Sicaprotext simultaneously with other topical ophthalmic medicinal products, a 15-minute interval should be maintained between applications.

Special precautions for use.

Benzalkonium chloride, a preservative contained in the medicinal product, may cause eye irritation and discoloration of soft contact lenses. Therefore, the use of soft contact lenses during treatment is not permitted.

Rigid contact lenses should be removed before instilling the eye drops and may be reinserted no sooner than 15 minutes after using the product.

Use during pregnancy or breastfeeding.

Controlled studies on the use of the medicinal product during pregnancy or breastfeeding have not been conducted. Animal studies have not revealed any direct or indirect harmful effects of the product on pregnancy, embryonic/fetal development, parturition, or postnatal development.

During pregnancy or breastfeeding, the medicinal product should be used with caution only after careful assessment by a physician of the benefit-risk ratio of such use.

Ability to affect reaction speed while driving or operating machinery.

Immediately after administration, Sicaprotect may temporarily and slightly affect visual acuity and, consequently, reaction speed while driving or operating machinery.

Method of Administration and Dosage

For adults, instill 1 drop of the medication into the conjunctival sac of each eye up to 6 times daily. In severe cases, Sicapro Protect can be administered hourly.

The duration of treatment depends on the clinical picture and is determined individually by the physician. Usually, artificial tear preparations are used lifelong, except in cases when the corresponding symptoms are temporary and associated with the underlying disease or a reaction to drug therapy.

When instilling eye drops, avoid any contact between the dropper tip and the eye or skin.

Children.

There is no experience with the use of the drug for treatment in children.

Overdose.

There is no information regarding cases of overdose.

Side effects.

Hypersensitivity reactions may occur, including increased lacrimation, burning sensation, eye pain, and eye irritation.

In some patients with significant corneal damage, very rare cases of corneal calcification associated with the use of phosphate-containing eye drops have been reported.

Shelf life. 3 years.

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

Use within no more than 6 weeks after first opening the bottle.

Storage conditions.

Store at a temperature not exceeding 25°C in a light-protected place.

Keep out of reach of children.

Packaging.

10 ml of eye drop solution in dropper bottles closed with caps featuring a first-opening control. One dropper bottle per cardboard box.

Prescription category. Prescription only.

Manufacturer. URSAFARM Arzneimittel GmbH / URSAPHARM Arzneimittel GmbH.

Manufacturer's address and place of business.

Industriestrasse 35, 66129 Saarbrucken, Germany.