NERVEN

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

HAWTHORN LEAF AND FLOWER NATIVE EXTRACT; HOP NATIVE EXTRACT; PASSION FLOWER HOWTHORN BERRIES (2.8:1) NATIVE EXTRACT; VALERIAN NATIVE EXTRACT

Tilgjengelig fra:

NEOPHARM (ISRAEL) 1996 LTD

ATC-kode:

N05CM

Legemiddelform:

DRAGEE

Sammensetning:

VALERIAN NATIVE EXTRACT 67.5 MG; HOP NATIVE EXTRACT 29.4 MG; PASSION FLOWER HOWTHORN BERRIES (2.8:1) NATIVE EXTRACT 81 MG; HAWTHORN LEAF AND FLOWER NATIVE EXTRACT 81 MG

Administreringsrute:

PER OS

Resept typen:

Not required

Produsert av:

MAX ZELLER SOHNE AG, SWITZERLAND

Terapeutisk gruppe:

OTHER HYPNOTICS AND SEDATIVES

Indikasjoner:

Sedative, anxiety and tension states, insomnia.

Autorisasjon dato:

2020-05-31

Preparatomtale

NERVEN DRAGEE
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Nerven
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film coated tablet contains:
Valerian native extract
67.5 mg
Hop native extract
29.4 mg
Passion flower Hawthorn berries (2.8:1) native extract 81.0 mg
Hawthorn leaf and flower native extract
81.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dragee (film coated tablet)
Round, white, biconvex film coated tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sedative, anxiety and tension states, insomnia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
For sedative, anxiety and tension states: 1-2 film coated tablet 3
times daily with some
water.
For insomnia: single dose of 2 film coated tablets one hour before bed
time.
Not for use in children below the age of 12 years (see section 4.4).
Method of administration
Oral use.
4.3
CONTRAINDICATION
Hypersensitivity to the active substances or to any of the excipients
of Nerven.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use of Nerven is not recommended in children below the age of 12
years due to a
lack of data on safety and efficacy. Combination with other sedatives
requires medical
diagnosis and supervision. If the symptoms worsen during the use of
the medicinal
product, a doctor or a pharmacist should be consulted.In the case that
irregular heart
rate, strong palpitations, acute pain in the cardiac region, and
shortage of breath are
common or of longer duration, it is necessary to determine whether the
heart or blood
vessels are physically diseased or if the complaints are due to a
nervous condition.
When used as intended, special precautionary measures are not
necessary.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No data on pharmacological interactions with other medicinal products
is available.
4.6
FERTILITY, PREGNANCY AND LACTATION
Safety during pregnancy and lactation has not been established. In the
absence of
sufficient data, use during pregnancy and la