CEREBONIN 120 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DRY EXTRACT FROM GINKGO BILOBA LEAVES (35-67:1)

Available from:

DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL

ATC code:

N06DX02

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DRY EXTRACT FROM GINKGO BILOBA LEAVES (35-67:1) 120 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DR. WILLMAR SCHWABE GMBH &CO. KG, GERMANY

Therapeutic area:

GINKGO BILOBA

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.• Vertigo of vascular and involutional origin.• Adjuvant treatment in case of tinnitus of vascular and involutional origin.The following note for the patient is included in the instruction leaflet:“Frequently occurring dizziness and tinnitus always need to be clarified by a physician. In case of sudden hearing deficit or hearing loss, you should immediately consult a physician.”

Authorization date:

2021-02-28

Patient Information leaflet

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATION
(PREPARATIONS)-1986
This medicine can be sold with a physician’s prescription only
CEREBONIN® 120 MG
Film-coated tablets
NAME OF THE MEDICINE, ITS FORM AND STRENGTH:
NAME OF THE MEDICINE: Cerebonin® 120 mg
FORM: Film-coated tablets
THE ACTIVE INGREDIENT AND ITS QUANTITY IN DOSAGE UNIT:
EACH FILM-COATED TABLET OF CEREBONIN® 120 MG CONTAINS: 120 mg dry
extract from
Ginkgo biloba leaves (35-67:1) (EGb 761
®
).
THE 120 MG DRY EXTRACT CONTAINS: Flavone glycosides 26.
4 - 32.4 mg, Terpene
lactones 6.48 - 7.92 mg, COMPRISING OF: ginkgolides A,B,C (3.36 - 4.08
mg) and of
bilobalide (3.12-3.84 mg). Ginkgolic acids less than 0.6 μg per
film-coated tablet.
For list of excipients and allergens in the medicine- see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, ask the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if you think that their medical condition is similar. The
medicine is
intended for adults above 18 years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine Cerebonin® 120 mg is intended:
•
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.
•
For the treatment of vertigo and dizziness of vascular origin (due to
disturbance in blood flow) or age related.
•
For the supportive treatment of tinnitus of vascular origin (due to
disturbance
in blood flow) or age related.
THERAPEUTIC GROUP: other anti-dementia drugs, peripheral vasodilators
2. BEFORE USING THIS MEDICINE:
X DO NOT USE THE MEDICINE:
•
If you are hypersensitive (allergic) to the plant Ginkgo biloba or to
any of the
additional ingredients that the medicine con

Summary of Product characteristics

- 1 - לע רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ
ודי
ב ץרמ
2016
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CEREBONIN® 120 MG
120 mg / Film-coated tablet
For adults aged 18 years and over
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains:
120 mg Dry extract from Ginkgo biloba leaves (35-67:1) (EGb 761®).
THE 120MG EXTRACT CONTAINS: Flavone glycosides 26.4 – 32.4 mg,
Terpene lactones 6.48 – 7.92 mg, COMPRISING OF: ginkgolides A, B, C
(3.36- 4.08 mg)
and of bilobalide (3.12-3.84 mg). Ginkgolic acids less than 0.6 μg
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.
-
Vertigo of vascular and involutional origin.
- Adjuvant treatment in case of tinnitus of vascular and involutional
origin.
_ _
_The following note for the patient is included in the instruction
leaflet: _
“Frequently occurring dizziness and tinnitus always need to be
clarified by a doctor. In
case of sudden hearing deficit or hearing loss, you should immediately
consult a doctor.”
- 2 -
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Dementia syndrome: _
Adults from 18 years on take 1 film-coated tablet (corresponding t