Tebonin Forte 120 mg Film-Coated Tablet

Country: Philippines

Language: English

Source: FDA (Food And Drug Administration)

Active ingredient:

Ginkgo Biloba EGb 761

Available from:

N/A; Importer: A. Menarini Philippines, Inc.; Distributor: N/A

INN (International Name):

Ginkgo Biloba EGb 761

Dosage:

120 mg

Pharmaceutical form:

Film-Coated Tablet

Units in package:

Clear PVC/PVDC/Alu Blister Pack x 15's (Box of 30's)

Manufactured by:

Dr. Willmar Schwabe GmbH & Co. KG, Germany

Authorization date:

2023-01-18

Patient Information leaflet

Tebonin® intens 120 mg
Date:
24.02.2014
Version:
020
INFORMATION FOR THE USER
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. Nevertheless you
still need to use Tebonin®
intens 120 mg carefully to get the best result from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if your need more information or advice.
-
You must contact a doctor if your symptoms worsen or if you do not
achieve any
improvement.
This _leaflet_ contains the following information:
1.
WHAT _TEBONIN® INTENS 120 MG _IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE _TEBONIN® INTENS 120 MG _
3.
HOW TO TAKE _TEBONIN® INTENS 120 MG _
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE _TEBONIN® INTENS 120 MG _
6.
COMPOSITION AND PACK SIZES OF _TEBONIN® INTENS 120 MG _
7.
MANUFACTURER/DISTRIBUTOR OF _TEBONIN® INTENS 120 MG _
TEBONIN® INTENS 120 MG®
120 mg / film-coated tablet
For adults from 18 years on
ACTIVE SUBSTANCE: DRY EXTRACT FROM GINKGO BILOBA LEAVES
1.
WHAT TEBONIN® INTENS 120 MG IS AND WHAT IT IS USED FOR
1.1
TEBONIN® INTENS 120 MG CONTAINS AN EXTRACT FROM GINKGO LEAVES
1.2
TEBONIN® INTENS 120 MG IS USED
-
For the symptomatic treatment of mental losses due to organic brain
syndrome within
the framework of a general therapeutic concept in case of progressive
impairment or
loss of mental capacities (dementia syndrome) having as major
symptoms: Deficient
memory, disturbances of concentration, depressive mood, dizziness,
tinnitus and
headache.
Individual response to the treatment cannot be predicted.
Prior to starting treatment with this preparation, clarification
should be obtained as to
whether the pathological symptoms encountered are not based on an
underlying
disease requiring a specific treatment.
- 1 -
Tebonin® intens 120 mg
Date:
24.02.2014
Version:
020
-
Improvement of the pain-free walking distance in peripheral arterial
occlusive disease
in FONTAINE stage II (intermittent claudication) within the framework
of ph

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
TEBONIN® INTENS 120 MG
1.
NAME OF THE MEDICINAL PRODUCT
TEBONIN® INTENS 120 MG
120 mg / film-coated tablet
For adults from 18 years on
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains:
Pharmaceutically active constituent: Dry extract from Ginkgo biloba
leaves (35-67:1) 120
mg; extraction agent: acetone 60% (w/w).
The extract is quantified to 26.4 – 32.4 mg flavonoids, calculated
as flavone glycosides,
and 6.0 – 8.4 mg terpene lactones of which 3.36 – 4.08 mg
ginkgolides A, B, C as well
as 3.12 – 3.84 mg bilobalide, and contains less than 0.6 µg
ginkgolic acids per film-
coated tablet.
Contains lactose.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
-
For the symptomatic treatment of mental losses due to organic brain
syndrome within
the framework of a general therapeutic concept for dementia syndromes
having as
major symptoms:
Deficient memory, disturbances of concentration, depressive mood,
dizziness,
tinnitus and headache.
The primary target group includes patients with demential syndrome in
primary
degenerative dementia, vascular dementia and mixed forms of both.
Individual response to the treatment cannot be predicted.
Note:
Prior to starting treatment with Ginkgo 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 the pain-free walking distance in peripheral arterial
occlusive disease
in FONTAINE stage II (intermittent claudication) within the framework
of physical
therapeutic measures, in particular walking training.
Tebonin intens 120 mg - version: 020 / 24.02.2014
- 1 -
SUMMARY OF PRODUCT CHARACTERISTICS
TEBONIN® INTENS 120 MG
-
Vertigo of vascular and involutional origin.
Adjuvant treatment in the case of tinnitus of vascular and
involutional origin.
_The following note for the patient is included in the instruct