‫לצרכן‬
‫בעלון לצרכן‬
‫בטיחות) בעלון‬
‫מידע בטיחות)‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
‫תאריך‪24.10.07 :‬‬
‫שם תכשיר באנגלית‪Cialis 10mg & 20mg :‬‬
‫מספרי רישום‪1281930677, 1282030678 :‬‬
‫שם בעל הרישום‪Eli Lilly Israel Ltd :‬‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫לצרכן‬
‫בעלון לצרכן‬
‫בעלון‬
‫פרטים על השינוי‪/‬ים המבוקש‪/‬ים‬
‫פרק בעלון‬
‫רכיבים בלתי‬
‫פעילים‪:‬‬
‫תופעות לוואי‪:‬‬
‫טקסט חדש‬
‫טקסט נוכחי‬
‫‪Croscarmellose sodium, hydroxypropyl‬‬
‫‪cellulose, hypromellose, iron‬‬
‫‪oxide, lactose monohydrate,‬‬
‫‪magnesium stearate,‬‬
‫‪microcrystalline cellulose, sodium‬‬
‫‪lauryl sulfate, talc, titanium‬‬
‫‪dioxide, and triacetin.‬‬
‫תופעות המחייבות‬
‫התייחסות‬
‫מיוחדת‪:‬‬
‫( ‪ ) X‬ירידה פתאומית בראייה‬
‫או איבוד ראייה בעין אחת או‬
‫שתי העיניים ( ‪( ) X‬נדיר)‪:‬‬
‫הפסק הטיפול ופנה לרופא מיד‬
‫תופעות הלוואי הבאות דווחו בעת השימוש‬
‫בתרופות מהקבוצה לה שייכת סיאליס‪ ,‬כולל‬
‫סיאליס‪:‬‬
‫( ‪ ) X‬ירידה פתאומית בראייה או איבוד‬
‫ראייה בעין אחת או שתי העיניים ( ‪) X‬‬
‫(נדיר)‪ :‬הפסק הטיפול ופנה לרופא מיד‬
‫(‪ ) X‬ירידה פתאומית בשמיעה או אובדן‬
‫השמיעה שלעיתים מלווה בצלצול באוזניים‬
‫או בסחרחורת (נדיר)‪ .‬בכל מקרה של הופעת‬
‫סימנים אלו יש להפסיק הטיפול ולפנות‬
‫לרופא מיד‪.‬‬
‫אחסנה‬
‫לאחסן במקום קריר‪ ,‬ויבש‪.‬‬
‫לאחסן באריזה מקורית‪ ,‬מתחת ל – ‪03 ° C‬‬
‫רופא‬
‫בעלון ללרופא‬
‫בעלון‬
‫פרטים על השינויים המבוקשים‬
‫פרק בעלון‬
‫טקסט נוכחי‬
‫טקסט חדש‬
‫‪Tadalafil 10 and 20mg is intended for use prior to‬‬
‫‪Continuous daily use of the medication is strongly Posology & method of‬‬
‫‪anticipated sexual activity and is not recommended for discouraged because the long-term safety after‬‬
‫‪of administration‬‬
‫‪continuous daily use.‬‬
‫‪prolonged daily dosing has not been established and Use in adult men‬‬
‫‪also because the effect of tadalafil usually lasts for‬‬
‫‪longer than one day. See sections 4.4 Special‬‬
‫‪warnings and special precautions for use last‬‬
‫‪paragraph and 5.1 Pharmacodynamic properties.‬‬
Physicians should advise patients to stop taking
PDE5 inhibitors, including CIALIS, and seek prompt
medical attention in the event of sudden decrease or
loss of hearing. These events, which may be
accompanied by tinnitus and dizziness, have been
reported in temporal association to the intake of
PDE5 inhibitors, including CIALIS. It is not possible
to determine whether these events are related directly
to the use of PDE5 inhibitors or to other factors (see
section 4.8 Undesirable effects - Postmarketing
surveillance).
In postmarketing surveillance, adverse reactions
that have been reported in patients taking tadalafil
include:
In dogs given tadalafil daily for 6 to 12 months at
doses of 25mg/kg/day (resulting in at least a 3-fold
greater exposure [range 3.7-18.6] than seen in
humans at a 20mg single dose) and above, there was
regression of the seminiferous tubular epithelium
that resulted in a decrease in spermatogenesis in
some dogs. Results from two 6-month studies in
volunteers suggest that this effect is unlikely in
humans (see section 5.1 Pharmacodynamic
properties). The effects of longer-term daily dosing
have not been established. Therefore, daily use of
the medication is strongly discouraged.
In postmarketing surveillance, adverse
events/reactions that have been very rarely
reported in patients taking tadalafil include:
Special warnings
and precautions
for use
Undesirable effects
Nervous system: migraine.
Eye disorders: blurred vision, visual field defect,
retinal vascular occlusion.
Non-arteritic anterior ischemic optic neuropathy
(NAION), a cause of decreased vision including
permanent loss of vision, has been reported at an
unknown frequency, postmarketing in temporal
association with the use of phosphodiesterase type 5
(PDE5) inhibitors, including CIALIS.
Ophtalmologic: visual field defect, retinal vein
occlusion.
Non-arteritic anterior ischemic optic neuropathy
(NAION), a cause of decreased vision including
permanent loss of vision, has been reported rarely
postmarketing in temporal association with the use
of phosphodiesterase type 5 (PDE5) inhibitors,
including CIALIS.
Otologic: sudden decrease or loss of hearing,
tinnitus. Cases of sudden decrease or loss of
hearing have been reported postmarketing in
temporal association with the use of PDE5
inhibitors, including CIALIS. In some of the cases,
medical conditions and other factors were reported
that may have also played a role in the otologic
adverse events. In many cases, medical follow-up
information was limited. It is not possible to
determine whether these reported events are related
directly to the use of CIALIS, to the patient’s
underlying risk factors for hearing loss, a
combination of these factors, or to other factors (see
Special warnings and precautions for use).
Respiratory system: epistaxis.
Three studies were conducted in men to assess the
potential effect on spermatogenesis of Cialis 10 mg
(one 6-month study) and 20mg (one 6-month and
one 9-month study) administered daily. In two of
these studies decreases were obsereved in sperm
count and concentration related to tadalafil
treatment of unlikely clinical relevance. These
effects were not associated with changes in other
parameters such as motility, morphology and FSH.
Two studies were conducted in men to assess the
potential effect of CIALIS 10mg and 20mg
administered daily for 6 months on
spermatogenesis. The results of these studies
demonstrate no difference from placebo with
respect to the proportion of men showing a 50% or
greater decrease in sperm concentration. In
addition, in comparison with placebo, there were
no adverse effects observed with respect to mean
change in sperm count, sperm morphology, or
sperm motility at either dose. However, in the
study of 10mg CIALIS taken daily for 6 months,
results showed a decrease in mean sperm
concentration relative to placebo. This effect was
not seen in the study where the higher dose, 20mg,
CIALIS was taken daily for 6 months. In addition,
there was no effect on mean concentrations of
testosterone, luteinizing hormone or follicle
stimulating hormone with either 10 or 20mg of
CIALIS compared to placebo. The effects of
longer-term daily dosing have not been
Pharmacodynamic
properties
established. See also Sections 4.4 Special
warnings and special precautions for use and 5.3
Preclinical safety data.
Non-clinical data reveal no special hazard for humans Preclinical data reveal no special hazard for
based on conventional studies of safety pharmacology, humans based on conventional studies of safety
pharmacology, genotoxicity, carcinogenic
genotoxicity, carcinogenic potential, and toxicity to
potential, and toxicity to reproduction.
reproduction.
Preclinical safety
data