Vismed Multi SmPC

Sodium hyaluronate from fermentation 0.18 %.
Lubricant eye drops.
Sterile, free from preservatives.

Composition: 1 ml solution contains sodium hyaluronate 1.8 mg, sodium chloride, potassium 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 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® MULTI at the same time as any drug or other product applied to the eye since 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: Tear off the tamper-evident seal before the first administration. Remove the protective 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® MULTI will easily flow out (see illustrations). If not otherwise recommended, instill 1 or 2 drops of VISMED® MULTI onto the eye as often as needed. After blinking, the solution will disperse and form a transparent and longlasting coating on the surface of the eye. VISMED® MULTI may also be used while wearing contact lenses (rigid or soft).

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 protective cap back on after using VISMED® MULTI. Do not use VISMED® MULTI if the container is damaged. VISMED® MULTI can be used up to 3 months after first use.
Store between 2 °C and 25 °C! Do not use VISMED® MULTI after the expiry date indicated on the container and the folding box. If discomfort persists while using VISMED® MULTI consult a physician. Keep out of reach of children.

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

Presentation: 10 ml solution in a multidose container.

Last revision date: March 2011.

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