VISMED GEL SmPC

Instructions for Use 

VISMED® GEL

Sodium hyaluronate from fermentation 0.3 %.
Hydrogel for sustained lubrication of the eyes. Sterile, free from preservatives.

Available on the NHS (FP10)

COMPOSITION:

1 ml solution contains sodium hyaluronate 3.0 mg, sodium chloride, potas sium chloride, disodium phosphate, sodium citrate, magnesium chloride, calcium chloride and water for injections. 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 sustained 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, contact lens wear (rigid or soft) or by ophthalmological screening methods.

CONTRA-INDICATIONS:

Individual hypersensitivity to any constituent of the product.

INTERACTIONS:

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

UNDESIRABLE EFFECTS:

On very rare occasions 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:

Twist off the tab. 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® GEL will easily flow out (see illustrations). If not otherwise recommended, instill 1 or 2 drops of VISMED® GEL 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® GEL may also be used while wearing contact lenses (rigid or soft).

 

1. Twist off cap
2. Instill solution into eye
3. Do not reuse!


PRECAUTIONS:

Do not touch the tip of the opened container and do not touch the surface of the eye with the tip of the opened container. Otherwise the container should be discarded immediately after use. Reclose the container after use. As VISMED® GEL does not contain preservatives, the solution should be used within 12 hours after opening. Any solution not used within 12 hours after opening must be discarded. Otherwise the sterility is no longer guaranteed and this may be associated with a risk of infection. Do not use VISMED® GEL if the container is damaged. Store below 30 °C! Do not freeze! Do not use VISMED® GEL after the expiry date indicated on the container and the folding box. If discomfort persists while using VISMED® GEL consult a physician. Keep out of reach of children!

CHARACTERISTICS AND MODE OF ACTION:

VISMED® GEL 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® GEL its viscoelastic and water retaining properties. VISMED® GEL provides a stable coating on the surface of the eye which is only slowly eliminated by blinking. Therefore VISMED® GEL combines long lasting relief with maximum comfort. VISMED® GEL is well tolerated due to its unique composition. VISMED® GEL is free from preservatives.

PRESENTATION:

20 single-dose containers of 0.45 ml.

Last revision date: 2016-12

Manufactured by: 

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

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