Lipovisc Ophthalmic Gel 2 mg/gr Carbomer Lubricant 10g

Carbomer based gel.

Therapeutic indications

Lipovisc Gel is used in the symptomatic treatment of dry eye syndrome.

Dosage and Posology

The drug should be taken according to the following doses and methods: the therapy of dry eye disorders requires an individual dosage regimen. Depending on the severity and intensity of symptoms, instill one drop in the conjunctival sac 3-5 times a day and approximately 30 minutes before bedtime (to avoid sticky eyelids).

There are no data available for the pediatric population. There is no relevant use of Lipovisc eye gel in children aged 10 to 18 years for the indication of dry eye syndrome. For the treatment of keratoconjunctivitis sicca, an ophthalmologist should generally be consulted as therapy is usually long-term or chronic.

A suitably sized drop is achieved by keeping the tube upright above the eye during instillation.

Overdose

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

Contraindications

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

Side effects

The following undesirable effects have been reported as eye disorders, very rare (<1 / 10,000): burning eyes, red eyes, eyelid eczema, foreign body sensation in the eye, giant papillary conjunctivitis, itchy eyes, feeling of sticky eyes, superficial punctate keratitis, excessive tearing, blurred vision.

These reactions can occur due to the preservative used (cetrimide) or as an effect of intolerance to one of the other components. Blurring of vision may occur after the instillation of Lipovisc due to its high viscosity. There was only one non-serious case of topical ocular adverse reaction (burning eyes) in clinical trials with Lipovisc.

No special data have been reported for the pediatric population.

Pregnancy and breastfeeding

No studies have been performed. There are no data on the use of carbomer in pregnant women available. Animal studies do not indicate direct toxicity on reproductive function. However, as a precaution, it is preferable to avoid the use of Lipovisc during pregnancy.

It is unknown whether carbomer or its metabolites are excreted in human milk. A risk to the newborns / infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from Lipovisc therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Special warnings

Contact lenses must be removed prior to administration and can be re-applied 30 minutes after instillation of Lipovisc. Lipovisc can prolong the contact time of topically applied ophthalmic drugs. Any ophthalmic drugs used concomitantly with this product should be administered 15 minutes prior to instillation of Lipovisc. If symptoms of dry eye persist or worsen, treatment should be discontinued and an ophthalmologist consulted.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Do not store above 25ºC.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

Each gram of Lipovisc Gel contains:

Active principle

2 mg of carbomer

Excipients

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