Lipovisc gel eye 10g 2mg/g

Active ingredients

Each gram of gel contains 2 mg of carbomer. For the complete list of excipients, see paragraph 6.1

Excipients

Cetrimide, preservative Sorbitol, Medium-chain triglycerides, Sodium hydroxide (for pH adjustment), Purified water.

Therapeutic indications

Symptomatic treatment of dry eye syndrome.

Contraindications/Side effects

Hypersensitivity to the active ingredient or to any of the excipients.

Dosage

Dosage The therapy for dry eye disorders requires an individual dosing regimen. Depending on the severity and intensity of symptoms, instill one drop into the conjunctival sac 3-5 times a day and approximately 30 minutes before bedtime (to avoid sticky eyelids). Pediatric population No data available. There is no significant use of Lipovisc ophthalmic gel in children aged 10 to 18 years regarding the indication of dry eye syndrome. Method of administration For the treatment of dry keratoconjunctivitis, it is generally advisable to consult an ophthalmologist since the therapy is usually long-term or chronic. A properly sized drop is obtained by holding the tube vertically above the eye during instillation.

Storage

Do not store above 25 °C.

Warnings

Contact lenses must be removed before administration and can be reapplied 30 minutes after instillation of Lipovisc. Lipovisc may prolong the contact time of topically applied ophthalmic drugs. Any ophthalmic medications used concurrently with this product should be administered 15 minutes before instillation of Lipovisc (see paragraph 4.5). If symptoms of dry eye persist or worsen, treatment should be discontinued and an ophthalmologist should be consulted.

Interactions

No interaction studies have been conducted.

Side effects

The following side effects have been reported as eye disorders, with very rare frequency (< 1/10,000):• burning eyes • redness of the eyes • eyelid eczema • sensation of a foreign body in the eyes • giant papillary conjunctivitis • itching eyes • sensation of sticky eyes • superficial punctate keratitis • excessive tearing • blurred vision These reactions may occur due to the preservative used (cetrimide) or as an effect of intolerance to one of the other components. Blurred vision may occur after instillation of Lipovisc due to its high viscosity. In clinical studies conducted with Lipovisc, only one non-serious case of ocular topical adverse reaction (burning eyes) was reported. Pediatric population No specific data have been reported.

Overdose

No cases of overdose have been reported. No specific data have been reported for the pediatric population.

Pregnancy and breastfeeding

No studies have been conducted. Pregnancy No data are available regarding the use of carbomer in pregnant women. Studies conducted in animals do not indicate direct toxicity to reproductive function (see paragraph 5.3). However, as a precaution, it is preferable to avoid the use of Lipovisc during pregnancy. Breastfeeding It is not known whether carbomer or its metabolites are excreted in breast milk. The risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue therapy/avoid therapy with Lipovisc considering the benefit of breastfeeding for the child and the benefit of therapy for the woman. Fertility No studies have been conducted.

La terapia dei disturbi da occhio secco necessita di un regime di dosa ggio individuale. In base alla gravita' ed all'intensita' dei sintomi, instillare una goccia nel sacco congiuntivale 3-5 volte al giorno ed approssimativamente circa 30 minuti prima di coricarsi (per evitare pa lpebre appiccicose). Bambini e adolescenti fino a 18 anni. Nei bambini e negli adolescenti la sicurezza e l'efficacia, alla posologia raccom andata per gli adulti, sono state stabilite sulla base dell'esperienza clinica, ma non sono disponibili studi clinici. Modo di somministrazi one. Uso oftalmico. Per il trattamento della cheratocongiuntivite secc a generalmente si deve consultare un oculista dato che, di solito, la terapia risulta essere a lungo termine o cronica. Una goccia di dimens ioni adeguate si ottiene mantenendo il tubo in posizione verticale sop ra l'occhio durante l'instillazione.

Ogni grammo di gel oftalmico contiene 2 mg di carbomer.