))הודעה על החמרה (( מידע בטיחות
הודעה על החמרה מידע בטיחות
23.05.11 :תאריך
Prozac 20 MG :שם תכשיר באנגלית
046822622500 :מספר רישום
Eli Lilly Israel Ltd :שם בעל הרישום
השינויים בעלון מסומנים על רקע צהוב
בעלון לרופא
בעלון לרופא
פרטים על השינויים המבוקשים
טקסט חדש טקסט נוכחי פרק בעלון
In US fluoxetine clinical trials, 7% of… In US fluoxetine clinical trials as of 5.3 Allergic
May 8, 1995, 7% of… Reactions and Rash
In US PROZAC clinical trials, 0.7% of… In all US PROZAC clinical trials as of 5.4 Screening
May 8, 1995, 0.7% of… Patients for Bipolar
Disorder and
Monitoring for
Mania/Hypomania
In US PROZAC clinical trials, 0.2% of… In all US PROZAC clinical trials as of 5.5 Seizures
May 8, 1995, 0.2% of…
Multiple doses of PROZAC have been Multiple doses of PROZAC had been 6.1 Clinical Trials
administered to 10,782 patients with various administered to 10,782 patients with various Experience
diagnoses in US clinical trials. diagnoses in US clinical trials as of
May 8, 1995.
Table 3: Most Common Treatment-Emergent
Adverse Reactions: Incidence in Major Table 3: Most Common Treatment-
Depressive Disorder, OCD, Bulimia and Panic Emergent Adverse Reactions: Incidence in
1,2
Disorder Placebo-Controlled Clinical Trials Major Depressive Disorder, OCD, Bulimia,
1,2
Placebo-Controlled Clinical Trials
Cardiovascular System — Frequent: Cardiovascular System — Frequent: 6.2 Other
palpitation; Infrequent: arrhythmia, palpitation; Infrequent: arrhythmia. Reactions
1
hypotension . Nervous System — Frequent: emotional
Nervous System — Frequent: emotional lability; Infrequent: akathisia, ataxia,
lability; Infrequent: akathisia, ataxia, balance buccoglossal syndrome, euphoria,
1 1
disorder , bruxism ,buccoglossal syndrome, hypertonia, libido increased, myoclonus,
depersonalization, euphoria, hypertonia, libido paranoid reaction; Rare: delusions.
increased, myoclonus, paranoid reaction; Skin and Appendages — Rare: purpuric
Rare: delusions. rash.
Skin and Appendages — Infrequent: alopecia,
Rare: purpuric rash.
Urogenital System —Frequent: micturition
disorder; Infrequent: dysuria, gynecological
2
bleeding .
1
MedDRA dictionary term from integrated
database of placebo controlled trials of 15870
patients, of which 9673 patients received
fluoxetine.
2
Group term that includes individual MedDRA
terms: cervix hemorrhage uterine,
dysfunctional uterine bleeding, genital
hemorrhage, menometrorrhagia,
menorrhagia, metrorrhagia, polymenorrhea,
postmenopausal hemorrhage, uterine
hemorrhage, vaginal hemorrhage. Adjusted for
gender.
Treatment of Pregnant Women during the First Treatment of Pregnant Women During the 8.1 Pregnancy
Trimester — There are no adequate and well- First Trimester — There are no adequate and
controlled clinical studies on the use of well-controlled clinical studies on the use of
fluoxetine in pregnant women. Results of a fluoxetine in pregnant women. Results of a
number of published epidemiological studies number of epidemiological studies assessing
assessing the risk of fluoxetine exposure the risk of fluoxetine exposure in early
during the first trimester of pregnancy have pregnancy have been inconsistent and have
demonstrated inconsistent results. More than not provided conclusive evidence of an
10 cohort studies and case-control studies increased risk of congenital malformations.
failed to demonstrate an increased risk for However, one meta-analysis suggests a
congenital malformations overall. However, potential risk of cardiovascular defects in
one prospective cohort study conducted by infants of women exposed to fluoxetine
the European Network of Teratology during the first trimester of pregnancy
Information Services reported an increased compared to infants of women who were
risk of cardiovascular malformations in infants not exposed to fluoxetine.
born to women (N = 253) exposed to
fluoxetine during the first trimester of
pregnancy compared to infants of women (N =
1,359) who were not exposed to fluoxetine.
There was no specific pattern of cardiovascular
malformations. Overall, however, a causal
relationship has not been established.
Animal Data —In embryo-fetal development
Animal Data — In embryo-fetal development studies in rats and rabbits, there was no
studies in rats and rabbits, there was no evidence of teratogenicity following
evidence of teratogenicity following administration of up to 12.5…
administration of fluoxetine at doses up to
12.5…
® ®
Each Pulvule contains fluoxetine Each Pulvule contains fluoxetine 11. Description
hydrochloride equivalent to 20 mg (64.7 µmol) hydrochloride equivalent to
of fluoxetine. The Pulvules also contain starch 20 mg (64.7 µmol) of fluoxetine. The
flowable, gelatin, dimeticone, titanium Pulvules also contain starch flowable,
dioxide, iron oxide, and other inactive gelatin, dimeticone, titanium dioxide,
ingredients. The 20 mg Pulvules also contain hydrated ferric iron oxide (yellow), and
FD&C Blue No. 1. other inactive ingredients. The 20 mg
Pulvules also contain FD&C Blue No. 1.