VISMED LIGHT SmPC

Instructions for Use 

VISMED® LIGHT

Sodium hyaluronate from fermentation 0.1 %.
Lubricant eye drops.

COMPOSITION:

1 ml solution contains sodium hyaluronate 1.0 mg, sodium chloride, potassium chloride, sodium citrate, disodium phosphate, magnesium chloride, calcium chloride, sodium dihydrogen phosphate, water for injections, disodium edetate and polyhexanide as preservatives. The solution is hypotonic.

INDICATIONS:

Symptoms and signs of dry eye and/or ocular surface damage, due to diseases such as superficial keratitis, Sjögren's syndrome or primary dry eye syndrome. For lubrication of the eyes in case of sensation of dryness, burning and ocular fatigue and other minor complaints of no pathological significance induced, for example, by dust, smoke, dry heat, air conditioning, wind, cold, extended computer screen use or contact lens wear (rigid or soft).

CONTRA-INDICATIONS:

Individual hypersensitivity to any constituent of the product.

INTERACTIONS:

Do not use VISMED® LIGHT at the same time as any other drug or product applied to the eye as it may modify their effects.

UNDESIRABLE EFFECTS:

On very rare occassions transient disorders, such as irritation of the conjunctiva, foreign body sensation, redness or burning sensation of the eye, short-term blurred vision may occur.

DOSAGE AND ADMINISTRATION:

Before using for the first time turn the cap anticlockwise until the safety ring snaps. Twist off the screw cap. Tilt the head backwards and position the tip of the container above the eye to be treated. Move the lower eyelid down with the forefinger of one hand. Press the container and one drop of VISMED® LIGHT will easily flow out (see illustrations). If not otherwise recommended, instill 1 or 2 drops of VISMED® LIGHT onto the eye as often as needed. After blinking,
the solution will disperse and form a transparent and long lasting coating on the surface of the eye.
VISMED® LIGHT may also be used while wearing contact lenses (rigid or soft).

Before using for the first time turn the cap anticlockwise until the safety ring snaps.
Instill one or two drops onto the eye. 
Put the screw cap back on after administration. 


PRECAUTIONS:

Do not touch the tip of the opened container and do not touch the surface of the eye with the tip of the container. Put the screw cap back on after using VISMED® LIGHT. Do not use VISMED® LIGHT if the container is damaged. VISMED® LIGHT can be used up to 3 months after first use. Any solution not used within 3 months after opening must be discarded. Otherwise the sterility is no longer guaranteed and this may be associated with a risk of infection. Store below 30 °C! Do not freeze! Do not use VISMED® LIGHT after the expiry date indicated on the container and the folding box. If discomfort persists while using VISMED® LIGHT consult a physician. Keep out of reach of children!

CHARACTERISTICS AND MODE OF ACTION:

VISMED® LIGHT contains sodium hyaluronate, a natural polymer, which is also present in the structures of the human eye. The particular physical characteristics of sodium hyaluronate confer to VISMED® LIGHT its viscoelastic and water retaining properties. VISMED® LIGHT provides a stable coating on the surface of the eye which is only slowly eliminated by blinking. Therefore VISMED® LIGHT combines long lasting relief with maximum comfort. VISMED® LIGHT is well tolerated due to its unique composition. The particular composition of preservatives in VISMED® LIGHT guarantees the sterility of the solution in the open container for a period of 3 months.

PRESENTATION:

1 multidose container of 15 ml.
Last revision date: 2016-09

Manufactured by:

TRB CHEMEDICA AG
Otto-Lilienthal-Ring 26
85622 Feldkirchen/Munich, Germany

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