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Tebonin Forte

Tebonin Forte

ginkgo biloba

Manufacturer:

Dr Willmar Schwabe

Distributor:

Zuellig Pharma

Marketer:

A.Menarini
Full Prescribing Info
Contents
EGb 761 (Ginkgo biloba extract).
Description
One film-coated tablet contains 120 mg pharmaceutically active component EGb 761, a dry extract (50:1) from Ginkgo biloba leaves. EGb 761 is quantified to 26.4 - 32.4 mg flavone glycosides, 6.48 - 7.92 mg terpene lactones and contains less than 0.6 µg ginkgolic acids per film-coated tablet.
Action
Pharmacology: Mode of actions: Improvement of blood circulation and microcirculation by improving the elasticity of red blood cells and vessels.
Free radical scavenging that may result in neuroprotection.
Indications/Uses
Cerebral circulatory insufficiency. Disturbances of cerebral performance due to cerebral circulatory insufficiency.
Peripheral circulatory disorders.
Tinnitus (ringing in the ears) and vertigo (dizziness).
Peripheral arterial occlusive disease (PAOD).
Relief of symptoms of mild or moderate dementia and mixed form.
Symptomatic treatment of mild cognitive impairment (MCI).
Dosage/Direction for Use
Dosage instructions, mode and duration of application: Unless otherwise prescribed by the physician, Tebonin forte 120 mg tablets should be taken as directed as follows. The patient should adhere to the daily dosage instructions, otherwise Tebonin forte 120 mg may not have the desired effect.
Dosage of application: The normal dosage is 1 tablet of Tebonin forte 120 mg daily. For more intensive use, 1 tablet may be taken twice daily (240 mg per day). The intake of Tebonin forte 120 mg is independent of meals.
For the indication of mild cognitive impairment (MCI), 2 tablets may be taken once daily (240 mg per day).
Duration: The treatment duration should be at least 8 weeks. If no improvement occurs after 3 months of treatment, or if the pathological symptoms get worse, consult the doctor.
Contraindications
Tebonin forte 120 mg should not be used by patients with known hypersensitivity to Ginkgo extracts or to any of the excipients.
Special Precautions
Single reports indicate the possibility that Ginkgo-containing preparations could increase the bleeding tendency. Clinical studies do not deliver any evidence of an interference with blood coagulation.
It cannot be excluded that the application of Ginkgo preparations promotes the occurrence of seizures in epileptic patients.
Patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Tebonin forte 120 mg.
Use in Children: Tebonin forte 120 mg is not recommended for use in children and adolescents under the age of 18 years due to insufficient investigational data.
Use In Pregnancy & Lactation
There are no or limited amount of data from the use of Tebonin forte 120 mg in pregnant women. As a precautionary measure, it is preferable to avoid the use of Tebonin forte 120 mg during pregnancy.
As no sufficient investigations are available, this preparation should not be used during lactation. It is not known whether the extract components are excreted in human milk.
Animal studies do not reveal harmful effects of Tebonin forte 120 mg on fertility.
Adverse Reactions
There are no verified data on the frequency of the undesirable effects observed during treatment with Ginkgo biloba-containing preparations, since these undesirable effects have become known through single reports from patients, physicians or pharmacists.
According to these reports, the following undesirable effects may occur during treatment with Tebonin forte 120 mg: Gastrointestinal disorders: Mild gastrointestinal disturbances.
Skin and subcutaneous tissue disorders/Immune system disorders: Hypersensitivity reactions (reddening, swelling, itching).
Nervous system disorders: Headache.
Vascular disorders: Bleeding from single organs has been reported.
Drug Interactions
Specific clinical studies did not show any potentiation of the blood thinning effect of warfarin and aspirin. However, interactions with coagulation inhibiting drugs cannot be completely excluded.
Storage
Do not store above 30°C.
Patient Counseling Information
Please read carefully the instructions for use as they provide important information on what you should consider when taking this pharmaceutical preparation. Should you have any questions, please consult your physician or pharmacist.
MIMS Class
Peripheral Vasodilators & Cerebral Activators / Supplements & Adjuvant Therapy
ATC Classification
N06DX02 - Ginkgo folium ; Belongs to the class of other anti-dementia drugs.
Presentation/Packing
Form
Tebonin Forte FC tab 120 mg
Packing/Price
30's
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