Vismed Multi SmPC

Prescribing Information

NAME OF PRODUCT:

VISMED® multi
Lubricant eye drops

INTENDED USE:

For lubrication of the eyes in case of moderate or severe sensations of dryness, burning and ocular fatigue, and other minor complaints of no pathological significance, induced, for example, by dust, smoke, dry heat, air conditioning, extended computer screen use or contact lens wear (rigid or soft).

COMPOSITION:

Active ingredient:
Sodium hyaluronate from fermentation 0.18%
Excipients:
Sodium chloride, potassium chloride, disodium-hydrogenphosphate, sodium citrate, magnesium chloride, calcium chloride and water for injection.
The solution is hypotonic (150 mOsm/l) and adjusted to pH 7.3.

PRESENTATION:

Sterile multidose container of 10 ml with an innovative dosage system containing 0.18% sodium hyaluronate for topical ophthalmic use. VISMED® multi is preservative-free.

DOSAGE AND ADMINISTRATION:

The VISMED® multi container is equipped with an innovative dosage system, which facilitates the instillation of the drop into the eye. After blinking, the solution will disperse and form a transparent and long lasting coating on the surface of the eye. VISMED® multi may also be used while wearing contact lenses (rigid or soft).

Before use remove the protective cap from the container. Do not touch the aperture. Prior to the first use, the mechanism has to be operated up to 10 times until ejection of the first drop of solution. In order to do this, apply pressure to the container with your index finger (Fig. 1).

Place the container upside down between thumb and index finger ensuring that the thumb is on the head of the container. Warning, your thumb must be parallel to the opening, but must not obstruct it! (Fig.2).

Pull down the lower lid of the eye with the fingers of your free hand. Position the container by resting your thumb onto the fingers of the other hand holding the lid, with the thumb towards your nose, ensuring that the aperture is directly over the opened eye (Fig. 3).

Tilt the container to an angle of approximately 45° to your face, as the drops will leave the container at this angle (Fig. 4). Apply a uniform downward pressure to the container with the index finger to instill a drop of solution into the eye.

If not otherwise recommended, place 1-2 drops of VISMED® multi into the eye as often as needed. Replace the protective cap after use. VISMED® multi can be used up to three months after first use.

CHARACTERISTICS AND MODE OF ACTION:

VISMED® multi contains a highly purified specific fraction of sodium salt of hyaluronic acid produced by bacterial fermentation. Hyaluronic acid is a natural polymer which is present throughout the human body and also in the structures of human eyes. Its main physical characteristic is viscoelasticity. This means that VISMED® multi has a high viscosity between blinks and a low viscosity during blinking, ensuring efficient coating of the surface of the eye.^1,2 Hyaluronic acid also possesses mucoadhesive properties³ and the ability to entrap water,⁴ thus resembling tear mucus glycoprotein.² This, together with the coating properties of hyaluronic acid results in an increased pre-corneal residence time⁵ and tear film break-up time ^6,7 and therefore a longer lubrication of the corneal surface. The protective coating of the eye surface offered by VISMED® multi helps prevent dryness and irritation.

The core mechanisms of dry eye are driven by tear hyperosmolarity and tear film in stability.⁸ The hypotonic solution VISMED® multi (150 mOsm/l) counteracts the hyperosmolarity of altered tear fluid thus limiting corneal damage.⁹

VISMED® multi has a uniquely patented formulation that contains the essential ions calcium, magnesium and potassium found in natural tears and important to maintain healthy structure and function of the cornea.^10,11

BIOCOMPATIBILITY:

Results of acute, sub-acute and chronic toxicity studies, together with the results of the foetal toxicity, fertility, peri- and post-natal toxicity studies show that hyaluronic acid is very well tolerated.^12,13 In addition, animal studies show that repeated topical ocular administration of hyaluronic acid is also well tolerated.¹⁴

INTERACTIONS:

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

STORAGE:

Store between 2°C and 25°C, in original packaging and away from heat sources and light.

SHELF-LIFE:

3 years if stored in original packaging.

PACKAGING:

VISMED® multi is presented in a preservative-free, multidose container of 10ml.

REFERENCES:

1. Bron AJ. Trans Ophthalmol Soc UK 1985; 104: 801-26.
2. Tiffany JM. Adv Exp Med Biol 1994; 350: 231-8.
3. Saettone MF et al. Int J Pharm 1989; 51: 203-12.
4. Balazs EA. Cosmetics Toiletries 1984; 99: 65-72.
5. Gurny R et al. Graefe's Arch Clin Exp Ophthalmol 1990; 228: 510-2.
6. Mengher LS et al. Br J Ophthalmol 1986; 70: 442-7.
7. Hamano T et al. Jpn J Ophthalmol 1996; 40: 62-5.
8. The Ocular Surface DEWS Definition and Classification 2007; 5(2): 75-92.
9. Gilbard JP, Kenyon KR. Ophthalmology 1985; 92: 646-50.
10. Reddy IK et al. In: Reddy K (ed) Ocular therapeutics and drug delivery.
A multidisciplinary approach Basel: Technomic Publications, 1996: 171-211.
11. Green K et al. Ophthalmic Res 1992; 24: 99-102.
12. Nozaki Y et al. Jpn Pharmacol Ther 1993; 21(2): 87-102.
13. Sawa M et al. J Jpn Ophthalmol 1993; 97: 448-54.
14. TRB Chemedica: Data on file.