Stugeron 25mg tablets

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ficha técnica Ficha técnica (SPC)
24-04-2015

Ingredientes activos:

cinnarizine

Disponible desde:

Gedeon Richter OJSC

Código ATC:

N07CA02

Designación común internacional (DCI):

cinnarizine

Dosis:

25mg

formulario farmacéutico:

tablets

Unidades en paquete:

(50/2x25/) blisters

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2015-04-16

Ficha técnica

                                1.
NAME
OF
THE
MEDICINAL PRODUCT
Stugeron 25 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tabl
et
contains 25
mg
cinnarizine.
Excipients: This medicinal product also contains
1.75
mg lactose monohydrate in each tablet.
For a full list
of
excipients, see section
6 .
1.
3.
PHARMACEUTICAL
FORM
Tablets: Almost white, practically odourless, flat, disc-shaped and
cut-edged tablets with
"STUGERON" inscription
on
the one side and half-scored inscription
on
the other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Maintenance therapy for symptoms
of
Meniere's disease
of
labyrinthine origin, including
vertigo, nausea, vomiting, tinnitus and nystagmus.
Prophylaxis
of
motion sickness.
Prophy !axis
of
migraine.
Maintenance therapy for symptoms
of
cerebrovascular origin, including vertigo, tinnitus,
vascular headache, irritability disorders, unsociability, memory and
concentration disorders.
Maintenance therapy for symptoms
of
peripheral circulatory disorders, including Raynaud's
disease, acrocyanosis, intermittent claudication, microcirculatory
disorders, trophic venous
ulcers, paraesthesia, nocturnal cramps, cold extremities.
4.2
Posology and method
of
administration
Hypersensitivity to the active substance or
to
any
of
the excipients.
4.4
Special warnings and precautions for use
2217
8/5
5/08
19019/41/08
1201782
As with other antihistamines Stugeron may cause epigastric distress;
taking it after meals may
diminish gastric irritation.
In
patients with Parkinson's disease Stugeron
is
recommended only in that case
if
the advantages
outweigh the possible risk
of
aggravating this disease.
121/782
Since Stugeron may cause drowsiness at the beginning
of
treatment, caution should be exercised when
alcohol or CNS depressants are used concomitantly.
In case
of
lactose intolerance it should be taken into consideration that each
tablet contains 175.00 mg
lactose monohydrate as well.
Patients with rare hereditary problems
of
galactose intolerance, the Lapp lactase deficiency or glucose-
galactose malabsorption s
                                
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