DROP tonic® 5% SmPC

 

DROP tonic® 5% is a hypertonic ophthalmic solution intended for the treatment of corneal oedema occurring as a result of mechanical, toxic, dystrophic or inflammatory damage. By making the tear film hypertonic, DROP tonic® 5% draws excess water out of the corneal tissue by an osmotic effect, thereby reducing its tendency to form oedema.

INDICATIONS

DROP tonic® 5% is indicated for cases of visual discomfort, burning, and eye irritation caused by corneal oedema. Abnormal accumulation of fluid caused by corneal oedema, with or without associated inflammation or blunt trauma, following refractive or ophthalmic surgery, cataract surgery, transplantation, retinal detachment, corneal grafting, corneal endothelial decompensation, and in all forms of dystrophic, mechanical, toxic, and inflammatory corneal decompensation.

INSTRUCTIONS FOR USE

1. Open the bottle and remove the protective cap. 
2. Gently squeeze the bottle and apply 2 drops in each eye; repeat as required. Close the bottle immediately after use; the remaining contents can be used for up to 3 months after opening.

COMPOSITION

Riboflavin sodium phosphate (0.000075%), sodium chloride (5%), vitamin E TPGS, sodium hyaluronate, L-proline, L-glycine, L-leucine, L-lysine hydrochloride, disodium phosphate dodecahydrate, monosodium phosphate c, purified water. Preservative-free. 

WARNINGS AND PRECAUTIONS

The product is intended for external ophthalmic use only. The product is intended for a single patient. Never use it in case of intolerance or known hypersensitivity to its components. Do not use the product if its packaging is damaged or improperly closed when opening it for the first time. Do not use the product after the expiry date which is stated on the packaging. If problems occur during use, discontinue treatment and consult a doctor. When applying the product, do not touch the eye or any other surface with the tip of the bottle. The expiry date refers to the intact and properly stored product. Before use, carefully read the instructions provided in the leaflet. Keep out of the reach of children. After use, do not dispose of the packaging in the environment. The solution may stain surfaces and fabrics. In rare cases, corneal microcalcification has been observed in patients with pre-existing corneal disease treated with ophthalmic preparations containing phosphates. In this case, it is recommended to use the product under the supervision of your doctor. In case of contact with skin or clothing, it is easily removed. Adverse events should be be reported to the manufacturer at info@iromedgroup.com. By reporting adverse events, you can contribute to the safety of this product. Any serious incident must be reported to the manufacturer and the competent authority of the country in which this product was used.

CONTENTS

10 ml multidose vial, preservative-free.

STORAGE

Close the bottle after use: the remaining contents can be used up to 3 months after first opening. 

Keep away from heat sources and at a temperature below 25°C.

EXPIRY DATE

When the packaging is intact, do not exceed the expiry date indicated on the box and on the vial.

Do not separate the contents of the outer packaging and the instructions, as they provide all the necessary information for the product's proper use.