LIPOVISC GEL OFT 10G 2MG/G

LIPOVISC, 2MG/G, GEL OFTALMICO

active ingredients

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

Excellent

Cetrimid, preservative Sorbitol, Medium Chain Triglycerides, Hydroxide Sodium (for pH correction), Water for injectable preparations

Therapeutic indications

Syntomatic treatment of dry eye syndrome.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population The therapy of dry eye disorders requires an individual dosing regimen. Depending on the severity and intensity of the symptoms, instill a drop in the joint sack 3-5 times a day and approximately 30 minutes before bedtime (to avoid sticky eyelids). Children and teenagers up to 18 years old In children and adolescents the safety and effectiveness of Lipovisc, recommended for adults, have been established on the basis of clinical experience, but clinical studies are not available. Method of administration Ophthalmic use. For the treatment of sicca keratoconjunntivitis generally you should consult an ophthalmologist since, usually, the therapy is long-term or chronic. A drop of adequate size is achieved by keeping the tube vertically above the eye during instillation.

Conservation

Do not store at temperature above 25°C.

Warnings

Contact lenses must be removed before administration and can be applied again 30 minutes after Lipovisc instillation. Lipovisc may extend the contact time of ophthalmic drugs applied by topical means. Any ophthalmic drugs used in conjunction with this product must be administered 15 minutes before Lipovisc instillation (see paragraph 4.5). If the symptoms of dryness of the eye persist or worsen, the treatment must be stopped and you must consult an ophthalmologist.

Interactions

No interaction studies have been carried out.

Effects

Adverse reactions were classified in frequency terms, using the following convention: Very common (≥1/10); Common (from ≥1/100 to Very rare eye pathologies ( burning in the eyes, redness of the eyes, eczema palpebrale, sensation of foreign body in the eyes, conjunctivitis papillare gigante, itching in the eyes, feeling of sticky eyes, keratitis superficial episode, 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. A sight blur may occur after Lipovisc instillation due to its high viscosity. In clinical studies conducted with Lipovisc there was only one non-serious case of eye-topic reaction (burn in the eyes). Pediatric population No particular data has been reported. 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported. Pediatric population Particular data has not been reported for the pediatric population.

No studies have been made.

Pregnancy

: There are no data on the use of carbomer in pregnant women. Animal studies do not indicate direct toxicity on reproductive function (see paragraph 5.3). However, for precaution, it is preferable to avoid the use of Lipovisc during pregnancy.

Food

It is not known whether carbomer or metabolites are excreted in breast milk. The risk for infants/ infants cannot be excluded. The decision must be taken if you stop breastfeeding or stop therapy/ refrain from therapy with Lipovisc taking into consideration the benefit of breastfeeding for the child and the benefit of the therapy for the woman.

Fertility

No studies have been made.

Source: Farmadati