MENOPRET

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

DRY EXTRACT FROM CIMICIFUGA RACEMOSA (L.) NUTT, RHIZOMA (BLACK COHOSH) (5-10:1) EXTRACTION SOLVENT: ETHANOL 58% (V/V)

Disponível em:

DR.SAMUELOV IMPORTING & MARKETING LTD

Código ATC:

G02CX04

Forma farmacêutica:

FILM COATED TABLETS

Composição:

DRY EXTRACT FROM CIMICIFUGA RACEMOSA (L.) NUTT, RHIZOMA (BLACK COHOSH) (5-10:1) EXTRACTION SOLVENT: ETHANOL 58% (V/V) 2.8 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

BIONORICA SE, GERMANY

Área terapêutica:

CIMICIFUGAE RHIZOMA

Indicações terapêuticas:

Herbal medicinal product indicated in female adults for the relief of menopausal complaints such as hot flushes and profuse sweating

Data de autorização:

2020-07-20

Características técnicas

Page 1 of 6
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Menopret
®
Film-coated tablet_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains
2.8 mg dry extract from Cimicifuga rhizoma (Black cohosh) (5-10:1)
Extraction solvent: ethanol 58 % (V/V)
Excipients with known effect:
Lactose monohydrate 17.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
The film-coated tablets are terracotta-coloured, round, biconvex with
smooth surface.
The film-coated tablet has a diameter of 7.0-7.2 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Herbal medicinal product indicated in female adults for the relief of
menopausal complaints such as
hot flushes and profuse sweating.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Female adults in the menopause _
Daily dose: 2 times daily (morning and evening) 1 film-coated tablet.
If the symptoms persist during the use of the medicinal product, a
doctor or a pharmacist should be
consulted.
Menopret
®
Film-coated tablets should not be taken for more than 6 months without
medical advice.
Paediatric population
There is no relevant use of Menopret
®
Film-coated tablets in the paediatric population.
Special populations
No data are available for a dosing instruction in case of impaired
renal function.
In the package leaflet patients with a history of liver disorder are
informed not to take Menopret
®
Film-coated tablets without medical advice (see section 4.4 ‘Special
warnings and precautions for
use’ and 4.8 ‘Undesirable effects’).
Page 2 of 6
Method of administration:
For oral use. Take film-coated tablets with some liquid. Do not chew
or suck.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Menopret
®
Film-coated tablets is contraindicated for patients with a current or
previous liver
disorder.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In prospective clinical trials involving more than 1200 patients,
black cohosh was not associated
wit