Vaginorm-C

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Last ned Preparatomtale (SPC)
20-11-2013

Aktiv ingrediens:

ascorbic acid

Tilgjengelig fra:

Artesan Pharma GmbH & Co. KG

INN (International Name):

ascorbic acid

Dosering :

250mg

Legemiddelform:

tablets vaginal

Resept typen:

OTC

Preparatomtale

                                SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE ME
DICINAL PRODUCT
Vagi
norm-C
®
Active substance: Ascorbic acid
2. PRESCRIPTION STATUS / PHARMACY LINK
Only available in pharmacies
3. COMPOSITION OF MEDICINAL PRODUCT
3.1 Substance or Indication Group
Vaginal therapy
3.2 Active substance
1 Vaginal tablet contains 250.0 mg ascorbic acid.
3.3 Other components
Silicone resin, lactose monohydrate, hydroxypropylmethylcellulose,
magnesium stearate
4. INDICATIONS
For
chronic
or
recurrent
bacterial
colpitis
(bacterial
vaginosis,
non-specific
colpitis),
of
moderate or intermediate severity. To normalise disturbed vaginal
flora.
5. CONTRAINDICATIONS
Patients with candidal colpitis, as this is not cured by vitamin C and
the symptoms may be
exacerbated by acidification.
This medicinal product may not be used in patients with
hypersensitivity to any of the
components of Vagi
norm-C
®
.
_Use in pregnancy and breast feeding: _
There are no reservations of any sort related to the use of Vaginorm-C
®
during any stage of
pregnancy or during bre
ast feeding.
6. SIDE EFFECTS
In occasional cases (fewer than 1 patient in 100, but more than 1
patient in 1000), patients
may
suffer
from
vaginal
burning
or
itching
after
administration
of
Vagi
norm-C
®
.
This
is
a
phenomenon which is observed to a greater or lesser extent with all
vaginal
therapeutic products.
Some of these symptoms are caused by symptomatic fungal infections. It
is known
that about 10% of all women suffer from asymptomatic yeast infection.
Disturbed vaginal
flora with high concentrations of specific anaerobes may suppress
yeast multiplication, as
these anaerobes produce substances such as diphenylamine which inhibit
yeasts.
After normalisation of vaginal flora, yeast multiplication may be
enhanced in some cases and
this can lead to symptomatic fungal infection. In very rare cases
(fewer than 1 in 10000
patients,
including
case
reports),
patients
may
exhibit
hypersensitivity
to
one
of
the
components of the medicinal product. The preparation should be
discontinued in t
                                
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