Ophthalmic gel.
Indications
Symptomatic treatment of dry eye syndrome.
Composition
Each gram of gel contains 2 mg of carbomer. Excipients: Cetrimide, preservative Sorbitol, Medium chain triglycerides, Sodium hydroxide (for pH adjustment), Purified water.
Dosage and method of use
The treatment of dry eye disorders requires an individual dosage 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).
For the treatment of keratoconjunctivitis sicca, an ophthalmologist should generally be consulted, as therapy is usually long-term or chronic. An adequately sized drop is obtained by holding the tube vertically over the eye during instillation.
Paediatric population
There are no data available. There is no data available. Lipovisc ophthalmic gel has been shown to be relevant in children aged 10 to 18 years for the indication of dry eye syndrome.
Warnings
Contact lenses should be removed before administration and may be reinserted 30 minutes after instillation of Lipovisc. Lipovisc may prolong the contact time of topically applied ophthalmic medications. Any ophthalmic medications used concomitantly with this product should be administered 15 minutes before instillation of Lipovisc (see section 4.5). If symptoms of dry eye persist or worsen, treatment should be discontinued and an ophthalmologist should be consulted.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Interactions
No interaction studies have been performed.
Undesirable effects
The following undesirable effects have been reported as eye disorders, with a very rare frequency (<1/10,000):
- burning eyes;
- redness of the eyes;
- eczema of the eyelids;
- sensation of a foreign body in the eyes;
- giant papillary conjunctivitis;
- itching of the eyes;
- sensation of sticky eyes;
- superficial punctate keratitis;
- excessive lacrimation;
- blurred vision.
These reactions may occur due to the preservative used (cetrimide) or as a result 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 topical ocular adverse reaction (burning eyes) occurred.
Paediatric population
No particular data have been reported.
Pregnancy and breastfeeding
No studies have been performed. Pregnancy There are no data available regarding the use of carbomer in pregnant women. Studies conducted in animals do not indicate direct toxicity on reproductive function. 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 human milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Lipovisc therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Fertility: No studies have been performed.
Format
Ophthalmic gel 2 mg/g.
Product Code:FRCM046307
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