Valocordin drops oral (solution)

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

ethylbromisovalerate, phenobarbital

Disponibil de la:

Krewel Meuselbach GmbH

Codul ATC:

N05CB02

INN (nume internaţional):

ethylbromisovalerate, phenobarbital

Dozare:

18,4mg/ml+ 18,4mg/ml

Forma farmaceutică:

drops oral (solution)

Unități în pachet:

20ml and 50ml glass bottle

Tip de prescriptie medicala:

OTC

Statutul autorizaţiei:

Registered

Data de autorizare:

2022-03-23

Caracteristicilor produsului

1
SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1.
NAME OF THE MEDICINAL PRODUCT
VALOCORDIN
®
oral drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml (= 30 drops) contains:
Phenobarbital 18.40 mg
Ethylbromisovalerate 18.40 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral drops, solution
- clear colourless solution
- aromatic odour
- bitter flavour
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As part of complex therapy as a symptomatic remedy for functional
disorders of the
nervous system (neurasthenia and sleep disturbances).
The drug is intended for short-term use due to the risk of addiction
and dependence.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Doses
and
duration
of
treatment
should
be
decided
by
the
doctor
individually.
Valocordin® is prescribed orally before food intake 3 times a day,
22-30 drops each,
previously dissolved in a small amount of water. For sleep
disturbances the dose can
be increased up to 45 drops.
The drug is intended for short-term use due to the risk of addiction
and dependence.
4.3
CONTRAINDICATIONS
-
hypersensitivity to bromine or any component of the drug;
-
renal and / or hepatic impairment;
-
porphyria;
-
alcoholism, epilepsy, traumatic brain injury and other brain diseases
with the seizure
in anamnesis;
-
pregnancy, lactation period;
-
children under 18 years of age.
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The medicinal product contains 56 % ethyl alcohol, the content of
ethyl alcohol in the
maximum single dose (45 drops) is 663 mg.
The
drug
should
not
be
taken
by
patients
with
alcoholism,
pregnant
women
breastfeeding women, children under 18 years of age, patients with
liver disease and
epilepsy.
The
simultaneous
use
of
alcohol
with
Valocordin®
should
be
avoided.
The
simultaneous intake of alcohol increases the toxicity of
phenobarbital.
Avoid prescribing the drug to patients with depressive disorders,
suicidal tendencies,
people with drug addiction.
Elderly and debilitated patients may respond to phenobarbital by
developi