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NAME
OF THE MEDICAL PRODUCT The active substance of Bendaline® is Bendazac Lysine Salt, or acid 1-(phenyl-methyl)-1H-indazole-3-oxiacetic), an original drug for the treatment of cataracts, discovered in the investigation laboratories Angelini F. and approved in the main countries. The cataract is a degenerative eye disease characterised by the opacification of the crystalline, which may result in vision impairment and subsequent blindness. Its causes may be varied: (senescence, traumas, excess of medicines, exposure to sunlight, diabetes and other dismetabolic diseases, etc), as well as its morphological expressions (capsular cataract, cortical cataract, etc). However, it is presently agreed that in most of the cases the cataract is due to a physical-chemical change in crystalline proteins. In fact, proteins may denature or aggregate and loose their characteristics that make them transparent to the light, under the influence of exogenous and endogenous toxic factors. Bendaline protects these proteins from any changes and make them more resistant to cataratogenic factors. Experimental studies showed that, after oral treatment, this substance penetrates in the crystalline and attains effective concentrations. Clinical studies showed that Bendaline is capable of preventing the evolution of several forms of cataracts. The most favourable results were obtained in the initial cortical forms where it is possible to observe in many cases an improvement in visual acuity, and sometimes, a regression of the crystalline’s opacity. In hyperlipemic patients, there was a tendency for anormalization of lipoprotein values. This fact is important because of the sometimes existing relationship between cataracts and patological changes of lipid values. QUALITATIVE
AND QUANTITATIVE COMPOSITION Active substance: Bendazac Lysine Salt ............................................. 500 mg
PHARMACEUTICAL FORM PHARMACOTHERAPEUTIC
CLASS NAME
OR DESIGNATION OF THE RESPONSIBLE FOR THE M.A. THERAPEUTIC
INDICATIONS CONTRAINDICATIONS
AND SIDE EFFECTS DRUG
INTERACTIONS AND OTHER FORMS OF INTERACTION SPECIAL
PRECAUTIONS FOR USE EFFECTS
ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND
PATIENTS WITH SPECIAL PATHOLOGIES EFFECTS
ON THE ABILITY TO DRIVE AND USE MACHINES LIST
OF EXCIPIENTS USUAL
POSOLOGY, WITH REFERENCE TO MAXIMUM DOSE Children: Half tablet three times a day, swallowed, after meals. It is recommended therapeutic cycles of 3-6 months, according to the doctor’s criterion. INDICATION
OF THE MOST FAVOURABLE MOMENT FOR THE ADMINISTRATION OF THE MEDICINE DURATION
OF THE AVERAGE TREATMENT WHEN IT SHOULD BE LIMITED INDICATION
OF HOW TO DISCONTINUE THE TREATMENT WHEN ITS DISCONTINUATION CAUSES WITHDRAWAL
EFFECTS No special precaution is necessary to suspend the treatment. MEASURES
TO ADOPT IN CASE OF OVERDOSAGE AND/OR INTOXICATION, EMERGENCY SYMPTOMS
AND ANTIDOTES ADVICE
TO THE PATIENT Check if the product is within the expiry date mentioned in the package. Always keep medicines out of reach and sight of children. SPECIAL
PRECAUTIONS FOR STORAGE AND INDICATION OF VISIBLE SIGNS OF DETERIORATION,
IF THEY EXIST Do not store above 25ºC. DATE OF THE REVISION OF THE LEAFLET: February 2004. |