SICCAFLUID GEL OFT 10G 2.5MG/G

SICCAFLUID 2.5 MG/G GEL OFTALMIC

active ingredients

Carbomero 974P 2.5 mg/g Excipient with known effect: Benzalconio chloride (0.06 mg/g) For the full list of excipients see paragraph 6.1

Excellent

Benzalconio chloride, sorbitol, lisina monohydrate, sodium acetate trihydrate, polyvinyl alcohol, water for injectable preparations.

Therapeutic indications

Syntomatic treatment of dry eye syndrome.

Contraindications

Hypersensitivity to one of the components of the product.

Population

Ophthalmic use Adults (including elderly) Instill a drop of ophthalmic gel in the lower joint bag, 1-4 times a day, depending on the degree of eye disorders. Children and teenagers up to 18 years: The safety and effectiveness of SICCAFLUID 2.5 mg/g ophthalmic gel in children and adolescents to recommended posology for adults have been established by clinical experience, but no data obtained from clinical studies are available. After instillation the bottle must be kept vertically with the cap facing downwards in order to facilitate the formation of drops for subsequent use. Avoid touching the eye with the end of the bottle. Close after use.

Conservation

Do not store above 25°C. Store the product inside the case in order to repair it from the light.

Warnings

This medicine contains 0.0015 mg of benzalconio chloride per drop. The benzalconio chloride is commonly used in ophthalmic products as a preservative and rarely have been reported cases of pointed keratopathy and/or ulcerative keratopathy. Eye irritation, dry eye, alteration of film and corneal surface have also been reported as a result of ophthalmic administration of benzalconium chloride. To be used with caution in patients with dry eye and with impairment of cornea. Patients should be monitored in case of prolonged use. Contact lenses: Benzalconio chloride can be absorbed by soft contact lenses and can lead to change of their color. Patients should be trained to remove contact lenses before using this medicine and wait 30 minutes before reapplying them. If the symptom persists or worsens, the patient must inform the doctor.

Interactions

In case of treatment with another colliery, wait 15 minutes between one instillation and the other. SICCAFLUID 2.5 mg/g, Ophthalmic Gel must be the last drug to be instilled.

Effects

As with other collieries, possibility of a slight and momentary itching or burning after instillation. A transient blurred vision may occur as a result of instillation before the gel is distributed evenly on the surface of the eye. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Any overdose that may occur after ocular administration or after oral intake is not of clinical relevance.

There are no experiences regarding the safety of the use of SICCAFLUID 2.5 mg/g, Ophthalmic Gel during pregnancy and nursing. It must be prescribed with caution to pregnant women and nursing.

Source: Farmadati