DACRIOGEL GEL TUBO 10G 0.3%

DACRIOGEL 0.3% GEL OFTALMIC

active ingredients

1 gram of gel contains: Active ingredient: carbomer 3 mg The 1O g tube contains an excipient with a known effect: benzalconio chloride. For the full list of excipients, see paragraph 6.1

Excellent

TUBO: Serbitol, benzalconio chloride, hydroxide sodium q.b. pH 7.5, purified water. FIALA: sorbitol, sodium hydroxide q.b. pH 7.5, purified water.

Therapeutic indications

Treatment of all conditions characterized by insufficient or defective hydration of the eye surface, from the red eye to the dry eye.

Contraindications

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

Population

Only for ophthalmic use. Instill in the joint sack a drop up to 4 times a day. The product can be instilled several times a day, according to the doctor's judgment. Do not exceed the recommended doses. Children and teenagers up to 18 years old: Security and effectiveness of DACRIOGEL in children and adolescents to the recommended posology for adults were established by clinical experience, but no data obtained from clinical studies are available.

Conservation

Store at a temperature below 25°C. Do not use after the expiry date indicated on the external packaging and on the internal label. The expiry date refers to the last day of the month. The expiry date refers to the product in intact packaging, properly preserved. For storage conditions after first opening see paragraph 6.3.

Warnings

The product is only for external use. Prolonged use of topical products can give rise to awareness-raising phenomena; in this case, stop the treatment and consult your doctor to establish an ion therapy. In pediatric age use after prescription. Do not use for prolonged treatments: after short period of treatment without appreciable results, consult your doctor. If eye pain, vision variation, eye irritation, persistent redness, or if the condition worsens or persists, patients must stop treatment and consult the doctor. Keep the medicine out of sight and reach of children. Dacriogel 10 g tube contains benzalconio chloride, which can cause irritation of the eye and of which it is known the ability to decode soft contact lenses. Patients should be given instruction to remove contact lenses before the application of 10 g Dacriogel tube and wait at least 15 minutes after the instillation of the dose before reinserting them.

Interactions

No clinically relevant interactions have been described. No interaction studies have been carried out. If you are using more than one topical eye medication, let it pass at least 5 minutes between the instillation of each drug. Ophthalmic ointments and gels must be used for last.

Effects

Summary of the safety profile In clinical studies, the most frequently reported adverse reactions were blurred vision, detected in 11% of patients, and formation of palpebral margin crusts, detected in 7,79% of patients. The adverse reactions listed in the following table were reported with carbomer 2 mg/ml and 3 mg/ml during clinical studies. and are classified according to the following convention: very common (≥1/10), common (≥1/100, up to Classification for systems and organs Adverse reactions Pathologies of the eye Very common: blurred vision. City: eye discomfort, crusts of the eyelid margin, eye irritation. Not common: periorbital edema, joint edema, eye pain, eye itching, eye hyperemia, increased tearing. Pathologies of skin and subcutaneous tissue Not common: contact dermatitis. The following table shows further adverse reactions detected during the post-marketing experience. Frequency cannot be assessed on the basis of available data.

Classification for systems and organs	Adverse reactions
Immune system disorders	Hypersensitivity.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Due to the characteristics of the product, no toxic effects are expected with ophthalmic overdose and even in case of accidental ingestion of the content of a tube or a single-dose fial pack.

Fertility

Data about the effect of this drug on male or female fertility are not available.

Pregnancy

There is no data on the use of carbomer in pregnant women. However, no effects are expected during pregnancy, as systemic exposure to carbomer should be negligible. In addition, carbomer is an inactive substance that exerts a protective effect of the eye surface. Dacriogel can be used in pregnancy.

Food

It is not known whether carbomer or any of the other components are excreted in breast milk. They are not expected to be affected by infants, since the systemic exposure to carbomer for nursing women should be negligible. In addition, carbomer is an inactive substance that exerts a protective effect of the eye surface. Dacriogel can be used during lactation.

Source: Farmadati