)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
________________/01//11001_______ ‫תאריך‬
_1356731279 ‫ מספר רישום‬Vesicare 5mg _‫שם תכשיר באנגלית‬
2831382138 ‫ מספר רישום‬Vesicare 10mg _‫שם תכשיר באנגלית‬
________CTS Ltd_________‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫רופא‬
‫בעלון ללרופא‬
‫בעלון‬
‫ים‬1‫ים המבוקש‬1‫פרטים על השינוי‬
‫טקסט חדש‬
Symptoms
Overdosage with solifenacin
succinate can potentially result in
severe anticholinergic effects. The
highest dose of solifenacin
succinate accidentally given to a
single patient was 280 mg in a 5
hour period, resulting in mental
status changes not requiring
hospitalization.
Treatment
In the event of overdose with
solifenacin succinate the patient
should be treated with activated
charcoal. Gastric lavage may be
performed is useful if performed
within 1 hour, but vomiting should
not be induced.
‫טקסט נוכחי‬
The highest dose of
solifenacin succinate
given to human
volunteers was
100 mg as a single
dose. At this dose,
the most frequent
adverse events were
headache (mild), dry
mouth (moderate),
dizziness
(moderate),
drowsiness (mild)
and blurred vision
(moderate).
‫פרק בעלון‬
4.9 Overdose
No cases of acute
overdose have been
reported.
In the event of
overdose with
solifenacin succinate
the patient should be
treated with activated
charcoal. Gastric
lavage may be
performed, but
vomiting should not
be induced.
4.8 Undesirable effects ‫פרק בעלון‬
‫טקסט נוכחי‬
The table below reflects the data obtained with Vesicare in clinical trials.
MedDRA system organ
class
Gastrointestinal disorders
Common
>1/100, <1/10
Constipation
Nausea
Dyspepsia
Abdominal pain
Infections and infestations
Nervous system disorders
Eye disorders
Blurred vision
General disorders and
administration site
conditions
Respiratory, thoracic and
mediastinal disorders
Skin and subcutaneous
tissue disorders
Renal and urinary disorders
Uncommon
>1/1000, <1/100
Rare
> 1/10000,
<1/1000
GastroColonic
oesophageal reflux obstruction
diseases
Faecal impaction
Dry throat
Urinary tract
infection
Cystitis
Somnolence
Dysgeusia
Dry eyes
Fatigue
Oedema lower limb
Nasal dryness
Dry skin
Difficulty in
micturition
Urinary retention
Allergic reactions were not observed during the clinical development. However, the
occurrence of allergic reactions can never be excluded.
‫טקסט חדש‬
MedDRA system
organ class
Very
common
≥1/10
Common
>1/100,
<1/10
Rare
> 1/10000,
<1/1000
Very rare
<1/10,000, not
known
(cannot be
estimated
from the
available data)
Urinary tract
infection
Cystitis
Infections and
infestations
Hallucinations*
Psychiatric
disorders
Nervous system
disorders
Eye disorders
Respiratory,
thoracic and
mediastinal
disorders
Gastrointestinal
disorders
Uncommon
>1/1000,
<1/100
Blurred
vision
Dizziness*,
Headache*
Somnolence
Dysgeusia
Dry eyes
Nasal
dryness
Dry mouth
Skin and
subcutaneous
tissue disorders
Renal and
urinary disorders
General disorders
and
administration
site conditions
* observed post-marketing
Constipation
Nausea
Dyspepsia
Abdominal
pain
Gastrooesophageal
reflux
diseases
Dry throat
Dry skin
Colonic
obstruction
Faecal
impaction
Difficulty in Urinary
micturition
retention
Fatigue
Peripheral
oedema
lower limb
Vomiting*
Pruritus*,
Rash*,
Urticaria*