NAME OF THE MEDICAL PRODUCT
Bendaline (Bendazac Lysine Salt)

This drug is used in the treatment of cataracts and has been investigated by Angelini Investigation Institute; it is approved in different 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.

Bendaline protects these proteins from any changes and make them more resistant to cataratogenic factors.

Studies have demonstrated that this substance penetrates in the crystalline reaching effective concentrations, after sufficiently prolonged treatments. Such concentrations are more rapidly attained by oral route than by topic route. 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 degenerative forms where it is possible to observe in many cases an improvement in visual acuity, and sometimes, a regression of the crystalline’s opacity.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 ml contains:

Active substance:

Bendazac Lysine Salt ............................................. 500 mg

PHARMACEUTICAL FORM
Collyrium, solution. Vial containing 7 ml of ophthalmological solution at 0.5%.

PHARMACOTHERAPEUTIC CLASS
XVI -7 –Other medicines of topical application in Ophthalmology.

NAME OR DESIGNATION OF THE RESPONSIBLE FOR THE M.A.
L. Lepori, Lda
Rua João Chagas, 53, Piso 3
1495-072 Algés

THERAPEUTIC INDICATIONS
Coadjutant in the treatment of cataract (pre-senile degenerative cataract and senile cataract; juvenile cataract, diabetes cataract, opacification of the cortex or the crystalline nucleus resulting from several etiologies).

Bendazac Lysine Salt is also useful in the presence of pre-senile and senile cataract in patients with incipient cataract and in the prevention of secondary cataract (post-surgery opacification of the crystalline and capsules).

CONTRAINDICATIONS AND SIDE EFFECTS
There are no contraindications to the use of Bendaline, except in the cases of individual hypersensitivity. Bendaline collyrium has no systemic effect which makes it generally well tolerated locally. In the presence of an irritation in the conjunctiva, it may cause in the moment of the instillation, a mild and transient burning sensation.

DRUG INTERACTIONS AND OTHER FORMS OF INTERACTION
No interactions were reported with other drugs commonly used in relevant treatments.

SPECIAL PRECAUTIONS FOR USE
After the first opening of the vial, you should use the drops only for 1 month.
People wearing contact lens should remove them before the application of the collyrium.
Warning: This medicine contains benzalconium chloride , responsible for staining hydrophilic contact lens.

EFFECTS ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND PATIENTS WITH SPECIAL PATHOLOGIES
Although clinical studies performed in pregnant and breast-feeding women have not revealed any particular contraindications to the use of Bendaline, nor any undesirable effects on the mother and child, nevertheless it is recommended that pregnant and breast-feeding women only use the drug under medical control and when it is absolutely necessary.

No other effects are known in elderly patients and in patients with special pathologies.

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
No effects on the ability to drive and use machines were observed.

LIST OF EXCIPIENTS
Polyoxil 35, ricin oil, potassium chloride, hydroxypropylmethylcellulose, Boric acid, monohydrated L-Lysine, Sodium Edetate, Benzalcomium chloride, Water for injectables.

USUAL POSOLOGY, WITH REFERENCE TO MAXIMUM DOSE
Instil 2 drops in each eye, three times a day, according to the doctor’s prescription.

INDICATION OF THE MOST FAVOURABLE MOMENT FOR THE ADMINISTRATION OF THE MEDICINE
According to the doctor’s indication.

DURATION OF THE AVERAGE TREATMENT WHEN IT SHOULD BE LIMITED
The duration of the treatment depends on the clinical situation and its evolution.

INDICATION OF HOW TO DISCONTINUE THE TREATMENT WHEN ITS DISCONTINUATION CAUSES WITHDRAWAL EFFECTS
If you forget to administer one or more doses, treatment must be continued.

No special precaution is necessary to suspend the treatment.

MEASURES TO ADOPT IN CASE OF OVERDOSAGE AND/OR INTOXICATION, EMERGENCY SYMPTOMS AND ANTIDOTES
No cases of overdosage were reported with Bendaline.

In case of accidental ingestion, it will be useful to perform a stomach lavage, administration of activated carbon and forced diuresis.

ADVICE TO THE PATIENT
If you notice any side effect not mentioned in this leaflet, you should inform your doctor or pharmacist.

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
Normally, no special precaution is necessary for the storage of the product.

Do not store above 25ºC.

DATE OF THE REVISION OF THE LEAFLET: February 2004.

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