THEA, Siccafluid 2.5 mg/g 10 g THEA

“Composition
Active ingredients:Carbomer 974P 2.5 mg/g Excipient: benzalkonium chloride (0.06 mg/g). For a full list of excipients, see section 6.1.
Excipients:Benzalkonium chloride, sorbitol, lysine monohydrate, sodium acetate trihydrate, polyvinyl alcohol, water for injection.

Therapeutic indications
Symptomatic treatment of dry eye syndrome.

Dosage
Ophthalmic use
Adults (including the elderly) Instill one drop of eye gel into the lower conjunctival sac 1-4 times daily depending on the severity of eye disorders.
Children: special studies with SICCAFLUID 2.5 mg/g ophthalmic gel have not been conducted. It is not recommended to use SICCAFLUID 2.5 mg/g ophthalmic gel in children until more data are available.

After instillation, the bottle should be stored upright with the cap down to facilitate the formation of drops for subsequent use. Do not touch the tip of the bottle to the eye. Re-close after use.

Warnings
Benzalkonium chloride is commonly used in ophthalmic products as a preservative and cases of punctate keratopathy and/or ulcerative keratopathy have been reported rarely.
Contact lenses. Benzalkonium chloride may be absorbed and discolour contact lenses, so patients should be advised to wait up to 30 minutes after instillation of SICCAFLUID 2.5 mg/g ophthalmic gel before inserting contact lenses. If the symptom persists or worsens, the patient should inform the physician.

Storage
Do not store above 25°C. Keep the product in the case to protect it from light.

Interactions
When using other eye drops at the same time, wait 15 minutes between instillations. SICCAFLUID 2.5 mg/g eye gel should be instilled last.

Side effects
As with other eye drops, mild and temporary itching or burning may occur after instillation. Temporary blurred vision may occur after instillation before the gel is evenly distributed over the surface of the eye.

Contraindications/Side effects
Hypersensitivity to one of the components of the product.

Overdose
Any overdose that may occur after ocular use or oral administration is of no clinical significance.

Pregnancy and breastfeeding
There is no experience regarding the safety of SICCAFLUID 2.5 mg/g ophthalmic gel during pregnancy and breastfeeding. The drug should be administered with caution to pregnant and lactating women.”

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