REMOTIV 500

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

HYPERICI HERBA EXTRACTUM SICCUM

Disponível em:

RAFA LABORATORIES LTD

Forma farmacêutica:

FILM COATED TABLETS

Composição:

HYPERICI HERBA EXTRACTUM SICCUM 500 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

MAX ZELLER SOHNE AG, SWITZERLAND

Indicações terapêuticas:

Symptoms of mild to moderate depression including: dejected mood, mood lability, inner restlessness, anxiety, states of tension and the difficulty in falling asleep and sleeping through the night which is associated with these conditions.Treatment is recommended for up to 24 weeks.

Data de autorização:

2015-07-07

Características técnicas

Remotiv-SPC-November 2023
1. REMOTIV
® 250
REMOTIV
® 500
Film coated tablets
Herbal medicinal product
2. COMPOSITION
Composition
Active substance of Remotiv 250 mg: St. John's wort (Hypericum
perforatum), dry extract. One film-coated tablet contains 250mg of the
standardized dry extract (Ze 117), standardized to 0.5mg total
hypericin.
The unique patented extraction process (extraction solvent: ethanol
50%
w/w; drug-extract ratio: 4-7:1) guarantees a consistently high-quality
product, which has a very low hyperforin content (see below “Drug
interactions”).
Active
substance
of
Remotiv
500mg:
St.
John's
wort
(Hypericum
perforatum), dry extract. One film-coated tablet contains 500mg of the
standardized dry extract (Ze 117), standardized to 1mg total
hypericin.
The unique patented extraction process (extraction solvent: ethanol
50%
w/w; drug-extract ratio: 4-7:1) guarantees a consistently high-quality
product, which has a very low hyperforin content (see below “Drug
interactions”).
For list of excipients: see section 6.1
This medicine contains approx. 120 mg digestible carbohydrates per
single dose. The medicine is suitable for diabetics.
3. PHARMACEUTICAL FORM
GALENIC FORM AND ACTIVE SUBSTANCE PER UNIT
Film coated tablets.
Herbal medicinal product
Remotiv 250:
1 film coated tablet contains 250 mg of the quantified dry extract
from
St. John’s
wort
(corresponding
to
0.25 - 0.75 mg
total
hypericins
(calculated as hypericin) and maximum 0.5 mg hyperforin.
Remotiv 500:
1 film coated tablet contains 500 mg of the quantified dry extract
from
St. John’s
wort
(corresponding
to
0.5 - 1.5 mg
total
hypericins
(calculated as hypericin) and maximum 1 mg hyperforin.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
For the treatment of symptoms of mild to moderate depression
including dejected mood, mood lability, anxiety, inner restlessness,
states of tension, and difficulty in falling asleep and sleeping
through
the night which is associated with these conditions. Treatment is
recommended for up to 24 weeks.
4.2