CIMIDONA 6.5mg

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DRY EXTRACT FROM CIMICIFUGAE RHIZOMA (BLACK COHOSH)

متاح من:

RAFA LABORATORIES LTD

ATC رمز:

G02CX04

الشكل الصيدلاني:

TABLETS

تركيب:

DRY EXTRACT FROM CIMICIFUGAE RHIZOMA (BLACK COHOSH) 6.5 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

MAX ZELLER SOHNE AG, SWITZERLAND

المجال العلاجي:

CIMICIFUGAE RHIZOMA

الخصائص العلاجية:

Alleviation of menopausal complaints.(hot flashes, excessive perspiration, sleep disorders, nervousness and depressive moods).

تاريخ الترخيص:

2020-04-30

نشرة المعلومات

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold without a doctor's prescription
CIMIDONA 6.5 MG
Tablets
ACTIVE INGREDIENT:
Each tablet of Cimidona 6.5 mg contains:
Dry extract from cimicifugae rhizoma (black cohosh) 6.5 mg
For a list of other ingredients see section 6.
See also 'Important information about some of the medicine's
ingredients' in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions,
please refer to your doctor
or pharmacist.
Use this preparation according to the instructions in the dosage
section in this leaflet.
Consult the pharmacist if you require additional information.
Refer to your doctor if the symptoms of the illness worsen or do not
improve after 6 weeks
(see also section 3).
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended to relieve menopausal symptoms (hot flashes,
excessive
perspiration, sleep disorders, nervousness and depressive moods).
THERAPEUTIC GROUP:
Gynecological drugs
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active substance, plants of the
buttercup family
(ranunculaceae) or any of the other ingredients that the medicine
contains (for a list of
the other ingredients, see section 6).
•
If you suffer or suffered in the past from liver disorder.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
•
Discontinue use of the medicine and seek medical attention immediately
if you develop symptoms
that may indicate liver injury (abnormal fatigue, lack of appetite,
weight loss, yellow coloration of
the skin and/or eyes, severe epigastric pain accompanied by nausea and
vomiting, diarrhea or
dark urine).
•
LIVER FUNCTIONS MONITORING WILL BE PERFORMED IN ACCORDANCE WITH THE
INSTRUCTIONS OF
THE DOCTOR.
See also “Tests and monitoring” and “Side effects”.
BEFORE STARTING TREATMENT WITH THE MEDICINE, TELL YOUR DOCTOR IF:
•
You have any oth

خصائص المنتج

1
NAME OF THE PRODUCT
Cimidona 6.5 mg
Cimidona Forte 13 mg
Tablet.
COMPOSITION
_Active substance_
:
Cimidona 6.5 mg: Dry extract from cimicifugae rhizoma (black cohosh)
6.5 mg
Cimidona Forte 13 mg: Dry extract from cimicifugae rhizoma (black
cohosh) 13 mg
THERAPEUTIC INDICATIONS:
Alleviation of menopausal complaints (hot flashes, excessive
perspiration, sleep
disorders, nervousness and depressive moods).
DOSAGE:
1 tablet to be taken once daily, unchewed, with some fluid, preferably
always at the
same time of the day (in the morning or in the evening). The intake of
the tablets does
not depend on meals.
The effect does not set in immediately. Intake of Cimidona is
recommended for a
period of at least 6 weeks.
It is recommended to take Cimidona over several months; however, it
should not be
used for more than 6 months without medical advice.
CONTRAINDICATIONS:
-
Hypersensitivity to the active substance, to Ranunculaceae (buttercup
plants) or to
any of the excipients
-
Cimidona is contraindicated for patients with a current or previous
liver
disorder.
SPECIAL WARNINGS AND PRECAUTIONS:
-
This preparation has an effect on physical and psychological
complaints during the
menopause. Since there is no clinical data so far with regard to a
positive effect on
bones, this preparation cannot be used for the prevention of
osteoporosis.
-
In prospective clinical trials involving more than 1200 patients,
black cohosh was
not associated with serum enzyme elevations during treatment and no
cases of
2
clinically apparent liver injury were reported. However, Products
labeled as black
cohosh have been linked to more than fifty instances of clinically
apparent liver
injury that have ranged in severity from symptomatic elevations in
serum
enzymes without jaundice, to acute self-limited hepatitis, prolonged
hepatitis with
cholestasis, autoimmune hepatitis, and acute liver failure requiring
liver
transplantation or with a fatal outcome. The latency to onset of liver
injury ranged
from 1 to 48 weeks, but was usually within 2 to 12 weeks.