Dacriogel Gel 0.3% Carbomer 30 vials 0.5ml

NAME
DACRIOGEL 0.3% OPHTHALMIC GEL

PHARMACOTHERAPEUTIC CATEGORY
Artificial tears and other indifferent preparations.

ACTIVE PRINCIPLES
Carbomer.

EXCIPIENTS
TUBE: sorbitol, benzalkonium chloride, sodium hydroxide to taste at pH 7.5, purified water. VIAL: sorbitol, sodium hydroxide to taste at pH 7.5, purified water.

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

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the listed excipients.

DOSAGE
For ophthalmic use only. Instill one drop in the conjunctival sac 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 dose.

STORAGE
Store at a temperature below 25 degrees C; do not use after the expiry date indicated on the outer package and inner label; the expiry date refers to the last day of the month; the expiry date refers to the product in intact packaging, correctly stored.

WARNINGS
The product is for external use only. Prolonged use of topical products can give rise to sensitization phenomena; in this case, discontinue treatment and institute appropriate therapy. In pediatric age use on prescription. Do not use for prolonged treatments: after a short period of treatment without appreciable results, consult your doctor. If eye pain, change in vision, eye irritation, persistent redness, or if the condition worsens or persists, patients should discontinue treatment and consult their physician. The drug contains banzalkonium chloride, which can cause eye irritation and is known to be able to discolour soft contact lenses. Patients should be instructed to remove contact lenses before applying the medicine and to wait at least 15 minutes after instillation of the dose before reinserting them.

INTERACTIONS
No clinically relevant interactions have been described. No interaction studies have been performed. If you are using more than one topical ocular drug, allow at least 5 minutes between instillation of each drug. Ophthalmic ointments and gels should be used last.

SIDE EFFECTS
In clinical trials, the most frequently reported adverse reactions were blurred vision, found in 11% of patients, and eyelid margin crusting, found in 7.79% of patients. carbomer 2 mg / ml and 3 mg / ml in clinical trials. and are classified according to the following convention: very common (> = 1/10), common (> = 1/100, up to <1/10), uncommon (> = 1/1000, up to <1/100), rare (> = 1 / 10,000, up to <1/1000), very rare (<1 / 10,000) or not known. Eye disorders. Very common: blurred vision; common: eye discomfort, eyelid margin crusting, eye irritation; uncommon: periorbital edema, conjunctival edema, eye pain, ocular pruritus, ocular hyperaemia, lacrimation increased. Skin and subcutaneous tissue disorders. Uncommon: contact dermatitis. >> Post-marketing experience. Immune system disorders: hypersensitivity '. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
There are no data on the effect of this drug on fertility 'male or female. There are no data from the use of carbomer in pregnant women. However, no effects are expected during pregnancy, since systemic exposure to carbomer should be negligible. Furthermore, carbomer is an inactive substance which exerts a protective effect on the ocular surface. The drug can be used in pregnancy. It is not known whether carbomer or any of the other components are excreted in human milk. Infections on infants are not expected, however, since systemic exposure to carbomer in breastfeeding women should be negligible. Furthermore, carbomer is an inactive substance which exerts a protective effect on the ocular surface. The medicine can 'be used during breastfeeding.