TEBOFORTIN – Ginko Biloba

Tebofortin used for the symptomatic treatment of disturbances in cerebral performance due to organic brain syndrome within the framework of a general therapeutic concept for demential syndrome.

Indications

For the symptomatic treatment of disturbances in cerebral performance due to organic brain syndrome within the framework of a general therapeutic concept for demential syndrome(decrease or loss in acquired mental abilities )having as major symptoms:

Deficient memory.
Disturbance of concentration.
Depressive mood.
Dizziness.
Tinnitus and headache.

Notes and consideration

Prior to starting treatment with Ginko extract, clarification should be obtained as to whether the pathological symptoms encountered are not based on an underlying disease requiring a specific treatment.

Improvement of pain free walking distance in peripheral arterial occlusive disease in FONTAINE stage (intermittent claudication) within the framework of physical therapeutical measures, in particular walking training.

Vertigo, tinnitus of vascular and involutional origin (dizziness, tinnitus as a result of circulatory disorder or aqe-related regressive phenomena.

As there are no sufficient examinations available concerning the application of this preparation in children, it should not be used in children under 12 years of age.

Since ginko biloba extracts have not yet been sufficiently investigated in case of depressive mood and headache not related to demential syndromes, Tebofortin may only be used for these symptoms when taking into consideration and applying all necessary precautions.

Contraindications

Hypersensitivity to Ginko biloba extracts.

Adverse Reactions

In very rare cases, slight gastrointestinal disturbances, headache or allergic skin reactions have been observed after administration of Tebofortin .

Drug Interactions

In a placebo controlled double blind study in subject, interactions of (egb 761) (daily dose24o mg) with acetyl salicylic acid (daily dose 500 mg ) could be demonstrated.

Dose

Demential syndrome

1 -2 film-coated tablets or 20 40 drops (corresponding to 40 80 mg Ginkgo extract) to be taken 3 times per day.

The duration of the treatment depends on the severity of symptoms and should last for at least 8 weeks in this chronic disease.

Peripheral arterial occlusive disease, vertigo, tinnitus

1 film-coated tablet or 20 drops (corresponding to 40 mg Ginkgo extract) to be taken 3 times per day or 2 film coated tablets (corresponding to 80 mg Ginkgo extract) to be taken 2 times per day.

The duration of the treatment should last for at least 6-8 weeks or as directed by physician.

Warning and precautions

• Tebofortin should not be used in children under 12 years of age.

• Since Ginkgo extracts have not yet been sufficiently investigated in case of depressive mood and headache not occurring in relation with demential syndromes, Tebofortin may only be used for these symptoms when taking into consideration and applying all necessary precautions.

• Keep out of reach of children

• Should not used during pregnancy ,Iactation& disease.

• Used with thrombolytic ,anticoagulant & anti platelet agents with precaution.

• Regarding Tebofortin drops: Do not use saccharin -containing products in liver patients ,as there are reports about the increase in liver enzymes in companion of using this ingredient even with small dose.

• Regarding Tebofortin drops: If you have been told by your doctor that you have intolerance to some sugars ,contact your doctor before taking this medicinal product.

Tablet composition

Each film coated tablet contain

Active ingredients│Dry extract from Ginkgo biloba leaves 40.00 mg Adjusted to 9.6 mg Ginkgo flavone glycoside and 2.4 mg Terpene lactones (ginkgolides,bilobalide).

Inactive Ingredients

Lactose monohydrate.
Microcrystalline cellulose.
Maize starch.
Silica.
Colloidal anhydrous .
Croscarmellose sodium.
Magnesium stearate.
Hypromellose ( viscosity smpas).
Macrogol 1500.
Anti-foaming agent SE2.
Iron oxide hydrate E 172.
Titanium dioxide E 171.
Talc.

Oral drops composition

TEBOFORTIN

Tebofortin 40 mg/l ml oral drops │Each 1 ml contains (corresponding to 20 drops):

Active ingredients │Ginkgo biloba extract 40.00 mg.( 1 ml ginko biloba solution correspond 1.070 g (density = 1.07- .80 g/ml). Dry extract from ginko biloba leaves (50 :1)adjusted to 9.6 ginko flavone glycoside and 2.4 terpene lactones (ginkolides, bilobalide).