‫רופא‬
‫בעלון ללרופא‬
‫בטיחות) בעלון‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
)).102.50
.102.50 ‫(מעודכן‬
‫(מעודכן‬
213213102. ‫תאריך‬
Levitra 10mg orodispersible tablets ‫שם תכשיר באנגלית ומספר הרישום‬
146-52-33322-01, 146-52-33322-00 ‫שם בעל הרישום‬
! ‫טופס זה מיועד לפרוט ההחמרות בלבד‬
‫ההחמרות המבוקשות‬
‫טקסט חדש‬
‫טקסט נוכחי‬
‫פרק בעלון‬
Indication
contraindications
Levitra is contraindicated in patients who
have loss of vision in one eye because
of non-arteritic anterior
ischemic optic neuropathy (NAION),
regardless of whether this episode was
in connection or not with previous
phosphodiesterase 5 (PDE5) inhibitor
exposure (see section 4.4).
(Special Warnings and
Medicinal products for the treatment of
erectile dysfunction should generally not
be used in men for
whom sexual activity is inadvisable (e.g.
patients with severe cardiovascular
disorders such as unstable angina or
severe cardiac failure [New York Heart
Association III or IV]).
Precautions for use)
The safety of vardenafil has not been
studied in the following sub-groups of
patients and its use is
therefore contraindicated until further
information is available:
- severe hepatic impairment (Child-Pugh
C),
- end stage renal disease requiring
dialysis,
- hypotension (blood pressure <90/50
mmHg),
- recent history of stroke or myocardial
infarction (within the last 6 months),
The safety of Levitra has not been
studied in the following sub-groups
of patients and its use is therefore
not recommended: severe hepatic
impairment, endstage renal disease
requiring dialysis, hypotension,
resting systolic blood pressure of
<90 mm Hg, recent history of stroke
or myocardial infarction, within the
last 6 months, unstable angina and
known hereditary degenerative
retinal disorders such as retinitis
pigmentosa.
In men for whom sexual activity is
not recommendable because of
their underlying cardiovascular
status, agents for the treatment of
erectile dysfunction should
generally not be used.
- unstable angina, and known hereditary
retinal degenerative disorders such as
retinitis pigmentosa.
CYP Inhibitors
Concomitant use of vardenafil with the
potent CYP3A4 inhibitors ketoconazole
and itraconazole (oral
form) is contraindicated in men older
than 75 years.
The use of Levitra orodispersible
tablets in combination with
erythromycin, ketoconazole,
itraconazole, clarithromycin,
indinavir or ritonavir is
contraindicated.
Posology, dosage
& administration
Levitra 10 mg orodispersible tablet is not
bioequivalent to Levitra 10 mg filmcoated tablet (see section 5.1).
Special populations
Elderly population (≥65 years old)
Dose adjustments are not required in
elderly patients. However, an increase
to a maximum dose of
Levitra 20 mg film-coated tablets should
be carefully considered depending on
the individual tolerability (see sections
4.4 and 4.8).
Geriatric patients
Dose adjustment is not required in
elderly patients
Patients with hepatic impairment
Hepatic impairment
Levitra 10 mg orodispersible tablets are
not indicated as a starting dose in
patients with mild hepatic
impairment (Child-Pugh A).
Patients with mild hepatic impairment
should start treatment with Levitra 5 mg
film-coated tablets.
Based on tolerability and efficacy, the
dose may be increased to Levitra 10 mg
and 20 mg film-coated
tablets, or Levitra 10 mg orodispersible
tablets.
No dose adjustment is needed in
patients with mild hepatic
impairment, Child-Pugh A.
The maximum dose recommended in
patients with moderate hepatic
impairment (Child-Pugh B) is
Levitra 10 mg as film-coated tablets (see
section 5.2).
Patients with renal impairment
Renal impairment
No dose adjustment is required in
patients with mild to moderate renal
impairment.
In patients with severe renal impairment
(creatinine clearance <30 ml/min) a
starting dose of Levitra
5 mg film-coated tablets should be
considered. Based on tolerability and
efficacy, the dose may be
increased to Levitra 10 mg and 20 mg
film-coated tablets, or Levitra 10 mg
orodispersible tablets.
Levitra orodispersible tablet is not for
use in patients with end-stage renal
failure (see section 4.3).
No dose adjustment is needed in
patients with mild, CrCl > 50-80
mL/min, moderate, CrCl > 30-50
mL/min, or severe, CrCl < 30
mL/min, renal impairment.
The pharmacokinetics of vardenafil
has not been studied in patients
requiring dialysis. (See section
“Pharmacokinetic properties”).
Children and adolescents
Paediatric population
Levitra orodispersible tablets are not
indicated for individuals below 18 years
of age. There is no relevant indication
for use of Levitra orodispersible tablets
in children and adolescents.
Levitra is not indicated for use in
children.
Tolerability of the maximum dose of
Levitra 20 mg film-coated tablets may be
lower in elderly patients (≥ 65 years old)
(see sections 4.2 and 4.8).
Special
Warnings and
Special
Precautions for
Use
Concomitant use of CYP 3A4 inhibitors
Concomitant use of vardenafil with
potent CYP 3A4 inhibitors such as
itraconazole and ketoconazole
(oral form) should be avoided as very
high plasma concentrations of vardenafil
are reached if the
medicinal products are combined (see
sections 4.5 and 4.3).
Vardenafil dose adjustment might be
necessary if moderate CYP 3A4
inhibitors such as erythromycin
and clarithromycin, are given
concomitantly (see section 4.2 and 4.5).
Concomitant intake of grapefruit or
grapefruit juice is expected to increase
the plasma concentrations of
vardenafil. The combination should be
avoided (see section 4.5).
Concomitant intake of grapefruit
juice is expected to increase the
plasma concentration of vardenafil.
The combination should be
avoided.
Effect on QTc interval
Single oral doses of 10 mg and 80 mg of
vardenafil have been shown to prolong
the QTc interval by a
mean of 8 msec and 10 msec,
respectively. And single doses of 10 mg
vardenafil co-administered
concomitantly with 400 mg gatifloxacin,
an active substance with comparable
QT effect, showed an
additive QTc effect of 4 msec when
compared to either active substance
alone. The clinical impact of
In a study of the effect of Levitra on
QT interval, in 59 healthy male
volunteers, therapeutic and
supratherapeutic doses of Levitra, 10
and 80 mg, respectively, produced
increases in QTc interval (See section
“Pharmacodynamic properties”). A
postmarketing study evaluating the
effect of combining vardenafil with
another drug of comparable QT
effect showed an additive QT effect
when compared with either drug
alone (See section
“Pharmacodynamic properties”).
These observations should be
considered in clinical decisions
when prescribing Levitra to patients
with known history of QT
prolongation or patients who are
taking medications known to
prolong the QT interval. Patients
taking Class IA, e.g. quinidine,
procainamide or Class III, e.g.
amiodarone, sotalol, antiarrhythmic
medications or those with
congenital QT prolongation, should
avoid using Levitra.
these QT changes is unknown (see
section 5.1).
The clinical relevance of this finding is
unknown and cannot be generalised to
all patients under all
circumstances, as it will depend on the
individual risk factors and susceptibilities
that may be present at
any time in any given patient. Medicinal
products that may prolong QTc interval,
including vardenafil,
are best avoided in patients with
relevant risk factors, for example,
hypokalaemia, congenital QT
prolongation, concomitant administration
of antiarrhythmic medicinal products in
Class IA (e.g.quinidine, procainamide),
or Class III (e.g. amiodarone, sotalol).
Effect on vision
Visual defects and cases of non-arteritic
Transient vision loss and cases of
ischemic optic neuropathy (NAION)
have been reported in
connection with the intake of Levitra and
other PDE5 inhibitors. The patient
should be advised that in
the case of sudden visual defect, he
should stop taking Levitra orodispersible
tablets and consult immediately a
physician (see section 4.3).
Effects of other medicinal products on
vardenafil
In vivo studies
Although specific interaction studies
have not been conducted, the
concomitant use of other potent
CYP3A4 inhibitors (such as
itraconazole) can be expected to
produce vardenafil plasma levels
comparable to those produced by
ketoconazole. Concomitant use of
vardenafil with potent CYP 3A4
inhibitors such as itraconazole and
ketoconazole (oral use) should be
avoided (see sections 4.3 and 4.4).
In men older than 75 years the
concomitant use of vardenafil with
itraconazole or ketoconazole is
contraindicated (see section 4.3).
Grapefruit juice being a weak inhibitor of
CYP3A4 gut wall metabolism, may give
rise to modest increases in plasma
levels of vardenafil (see section 4.4).
The pharmacokinetics of vardenafil (20
mg) was not affected by coadministration with the H2-antagonist
ranitidine (150 mg twice daily), digoxin,
warfarin, glibenclamide, alcohol (mean
maximum blood alcohol level of 73
mg/dl) or single doses of antacid
(magnesium hydroxide/aluminium
hydroxide).
Although specific interaction studies
were not conducted for all medicinal
products, population pharmacokinetic
analysis showed no effect on vardenafil
pharmacokinetics of the following
concomitant medicinal products:
acetylsalicylic acid, ACE-inhibitors, betablockers, weak CYP 3A4 inhibitors,
diuretics and medicinal products for the
treatment of diabetes (sulfonylureas and
metformin).
non-arteritic ischemic optic
neuropathy (NAION) have been
reported in connection with the
intake of PDE5 inhibitors, including
Levitra. The patient should be
advised that in the case of sudden
vision loss, he should stop taking
Levitra and immediately consult a
physician (See section
“Undesirable Effects”).
Interaction with
Other
Medicaments
and Other
Forms of
Interaction
Effects of vardenafil on other medicinal
products
In vivo studies
Since alpha-blocker monotherapy can
cause marked lowering of blood
pressure, especially postural
hypotension and syncope, interaction
studies were conducted with vardenafil.
In two interaction studies with healthy
normotensive volunteers after forced
titration of the alpha-blockers tamsulosin
or terazosin to high doses, hypotension
(in some cases symptomatic) was
reported in a significant number of
subjects after co-administration of
vardenafil. Among subjects treated with
terazosin, hypotension was observed
more frequently when vardenafil and
terazosin were given simultaneously
than when the dosing was separated by
a time interval of 6 hours.
Based on the results of interaction
studies conducted with vardenafil in
patients with benign prostatic
hyperplasia (BPH) on stable tamsulosin,
terazosin or alfuzosin therapy:



When vardenafil (film-coated
tablets) was given at doses of 5,
10 or 20 mg on a background of
stable therapy with tamsulosin,
there was no symptomatic
reduction in blood pressure,
although 3/21 tamsulosin
treated subjects exhibited
transient standing systolic blood
pressures of less than 85
mmHg..
When vardenafil 5 mg (filmcoated tablets) was given
simultaneously with terazosin 5
or 10 mg,
one of 21 patients experienced
symptomatic postural
hypotension. Hypotension was
not observed when vardenafil 5
mg and terazosin administration
was separated by 6 hours.
When vardenafil (film-coated
tablets) was given at doses of 5
or 10 mg on a background of
stable therapy with alfuzosin,
compared to placebo, there was
no symptomatic reduction in
blood pressure.
Therefore, concomitant treatment should
be initiated only if the patient is stable on
his alpha-blocker therapy. In those
patients who are stable on alpha-blocker
therapy, vardenafil should be initiated at
Since alpha-blocker monotherapy
can cause marked lowering of
blood pressure, especially postural
hypotension and syncope,
interaction studies were conducted
with Levitra film-coated tablets [in
normotensive volunteers after
short-term alpha-blockade and in
patients with benign prostatic
hyperplasia (BPH) on stable alphablocker therapy].
Hypotension, in some cases
symptomatic, was reported in a
significant number of subjects after
co-administration of Levitra filmcoated tablets to healthy
normotensive volunteers forced
titrated, over a period of 14 days or
less, to high doses of the alphablockers tamsulosin or terazosin.
When Levitra film-coated tablets
were given at doses of 5 mg, 10 mg
or 20 mg on a background of stable
therapy with tamsulosin, there was
no clinically relevant mean maximal
additional reduction in blood
pressure. When Levitra 5 mg filmcoated tablets were dosed
simultaneously with tamsulosin
0.4 mg, 2 of 21 patients
experienced a standing systolic
blood pressure <85 mm Hg. When
Levitra 5 mg film-coated tablets
were dosed 6 hours after
tamsulosin administration, 2 of 21
patients experienced a standing
systolic blood pressure <85 mm Hg.
Among subjects treated with
terazosin, hypotension, standing
systolic blood pressure
<85 mm Hg, was observed more
frequently when vardenafil and
terazosin were given to achieve
Cmax simultaneously than when the
doses were administered to
separate Cmax by 6 hours. Because
these studies were conducted using
healthy volunteers, after forced
titration of the alpha-blocker to high
doses, these studies may have
limited clinical relevance.
Three interaction studies were
conducted with Levitra film-coated
tablets in patients with benign
prostatic hyperplasia (BPH) on
stable alpha-blocker therapy using
the lowest recommended starting dose
of 5mg. Levitra may be administered at
any time with tamsulosin or alfuzosin.
With other alpha-blockers a time
separation of dosing should be
considered when vardenafil is
prescribed concomitantly (see section
4.4).
alfuzosin, tamsulosin or terazosin.
Levitra film-coated tablets, 5 mg or
10 mg, were administered four
hours after alfuzosin dosing. The
four-hour dosing interval was
chosen to elicit the maximum
potential interaction. No clinically
relevant mean maximal additional
reduction in blood pressure was
observed over the 10-hour interval
following dosing with vardenafil 4
hours after alfuzosin. Two patients,
one dosed with Levitra 5 mg filmcoated tablets and the other with
Levitra 10 mg film-coated tablets,
experienced decreases from
baseline in standing systolic blood
pressure >30 mm Hg. No
instances of standing systolic blood
pressure <85 mm Hg were
observed during this study. Four
patients, one dosed with placebo,
two dosed with Levitra 5 mg filmcoated tablets and one dosed with
Levitra 10 mg film-coated tablets,
reported dizziness. Based on these
results no time interval between
dosing with alfuzosin and Levitra is
required.
In a subsequent study in patients
with BPH, when Levitra 10 mg and
20 mg film-coated tablets were
dosed simultaneously with 0.4 mg
or 0.8 mg of tamsulosin no cases of
standing systolic blood pressure
<85 mm Hg were observed. Based
on these results no time interval
between dosing with tamsulosin
and Levitra is required.
When Levitra 5 mg film-coated
tablets were dosed simultaneously
with 5 mg or 10 mg of terazosin,
1 out of 21 patients experienced
symptomatic postural hypotension.
Hypotension was not observed
when vardenafil was dosed 6 hours
after terazosin was administered.
This should be considered when
deciding about a time separation of
dosing between Levitra and
terazosin. No cases of syncope in
this study or in the earlier alfuzosin
or terazosin studies.
Concomitant treatment should be
initiated only if the patient is stable
on his alpha-blocker therapy. In
those patients who are stable on
alpha-blocker therapy, Levitra
should be initiated at the lowest
recommended starting dose.
Patients treated with alpha-blockers
should not use Levitra 10 mg
orodispersible tablets to initiate
therapy. Levitra may be
administered at any time with
alfuzosin or tamsulosin. With
terazosin and other alpha-blockers
an appropriate time interval
between dosing should be
considered when Levitra is
prescribed concomitantly (See
section “Special warnings and
precautions for use”).
No significant interactions were shown
when warfarin (25 mg), which is
metabolised by CYP2C9, or digoxin
(0.375 mg) was co-administered with
vardenafil (20 mg film-coated tablets).
The relative bioavailability of
glibenclamide (3.5 mg) was not affected
when co-administered with vardenafil
(20 mg). In a specific study, where
vardenafil (20 mg) was co-administered
with slow release nifedipine (30 mg or
60 mg) in hypertensive patients, there
was an additional reduction on supine
systolic blood pressure of 6 mmHg and
supine diastolic blood pressure of 5
mmHg accompanied with an increase in
heart rate of 4 bpm.
Lack of pharmacokinetic interaction
was shown when Levitra 20 mg
film-coated tablets were coadministered to patients receiving
0.375 mg of digoxin, at steady
state, every other day for 14 days.
There was no evidence that
vardenafil pharmacokinetics were
altered by co-administration of
digoxin.
When Levitra 20 mg film-coated
tablets were co-administered with
3.5 mg of glibenclamide, Glyburide,
the relative bioavailability of
glibenclamide was not affected.
There was no evidence that
vardenafil pharmacokinetics were
altered by co-administration of
glibenclamide.
No pharmacological, e.g.
prothrombin time and clotting
factor II, VII and X, interaction was
shown when 25 mg of warfarin was
co-administered with Levitra 20 mg
film-coated tablets. Vardenafil
pharmacokinetics was not affected
by co-administration of warfarin.
No relevant pharmacodynamic or
pharmacokinetic interaction was
shown when Levitra 20 mg filmcoated tablets were coadministered with 30 mg or 60 mg
of nifedipine. Compared to
placebo, Levitra film-coated tablets
produced mean additional blood
pressure reductions of 5.9 mm Hg
and 5.2 mm Hg for supine systolic
and diastolic blood pressure,
respectively.
Vardenafil (10 mg) did not potentiate the
increase in bleeding time caused by
acetylsalicylic acid (2 x 81 mg).
Levitra 10 mg and 20 mg filmcoated tablets did not influence the
bleeding time when taken alone or
in combination with low dose
acetylsalicylic acid (2 x 81 mg
tablets).
Undesirable Effects
The adverse reactions reported with
Levitra film-coated tablets or 10 mg
orodispersible tablets in
clinical trials were generally transient
and mild to moderate in nature. The
most commonly reported
adverse drug reaction occurring in 
10% of patients is headache.
Undesirable Effects
Tabulated list of adverse
reactions
All Clinical trials (ADRs)
The frequencies of ADRs reported
with Levitra are summarized in the
table below. Within each frequency
grouping, undesirable effects are
presented in order of decreasing
seriousness. Frequencies are
defined as very common (≥ 1/10),
common (≥ 1/100 to < 1/10),
uncommon (≥ 1/1,000 to < 1/100),
rare (≥ 1/10,000 to < 1/1,000), very
rare (< 1/10,000).
The ADRs identified only during
post marketing surveillance and for
which a frequency could not be
estimated, are listed under “not
known”.
Adverse drug reactions reported in
patients in all clinical trials worldwide which are either reported as
drug-related in ≥ 0.1% of the
patients or rare and considered
serious in their nature <critical term
according to BSP GPV critical term
list>
‫אנא ראה טבלת תופעות לוואי מצורפת‬
Penile haemorrhage, haematospermia
and haematuria have been reported in
clinical trials and spontaneous postmarketing data with the use of all PDE5
inhibitors, including vardenafil.
At a dose of 20 mg Levitra film-coated
tablets, elderly ( 65 years old) patients
had higher frequencies
of headaches (16.2% versus 11.8%)
and dizziness (3.7% versus 0.7%) than
younger patients (<65 years
old). In general, the incidence of
adverse reactions (especially
“dizziness”) has been shown to be
slightly higher in patients with a history
of hypertension.
Post-marketing reports of another
medicinal product of this class
Vascular disorders
‫אנא ראה טבלת תופעות לוואי מצורפת‬
Fertility,
pregnancy and
Lactation
Adverse events
Serious cardiovascular reactions,
including cerebrovascular haemorrhage,
sudden cardiac death,
transient ischaemic attack, unstable
angina and ventricular arrhythmia have
been reported
post-marketing in temporal association
with another medicinal product in this
class.
.‫ שבו מסומנות ההחמרות המבוקשות על רקע צהוב‬,‫מצ"ב העלון‬
‫ יש לסמן רק תוכן מהותי ולא שינויים במיקום‬.‫שינויים שאינם בגדר החמרות סומנו (בעלון) בצבע שונה‬
.‫הטקסט‬
System Organ
Class
Very common
(1/10)
Infection and
Infestations
Immune System
Disorders
Psychiatric
Disorders
Nervous System Headache
Disorders
Common
(1/100 to
<1/10)
Dizziness
Eye Disorders
Ear and
Labyrinth
Disorders
Cardiac
Disorders
Vascular
Disorders
Respiratory,
Thoracic and
Mediastinal
Disorders
Gastrointestinal
Disorders
Hepatobiliary
Disorder
Skin and
Subcutaneous
Tissue
Disorders
Musculoskeletal
and Connective
Tissue
Disorders
Flushing
Nasal
congestion
Uncommon
(1/1,000 to
<1/100)
Not Known
Rare
(can not be
(1/10,000 to estimated from
the available
<1/1,000)
data)
Conjunctivitis
Allergic oedema
and angioedema
Sleep disorder
Allergic reaction
Somnolence
paraesthesia and
dysesthesia
Syncope
Seizure
Amnesia
Visual disturbance
Ocular hyperaemia
Visual colour
distortions
Eye pain and eye
discomfort
Photophobia
TInnitus
Vertigo
Increase in
intraocular
pressure
Lacrimation
increased
Palpitation
Tachycardia
Myocardial
infarction
Ventricular tachyarrhythmias
Angina pectoris
Dyspnoea
Sinus congestion
Anxiety
Sudden deafness
Hypotension
Hypertension
Epistaxis
Dyspepsia
Gastrooesophageal reflux
disease
Gastritis
Gastointestinal
and abdominal
pain
Diarrhoea
Vomiting
Nausea
Dry mouth
Increase in
Increase in
transaminases
gamma-glutamyl
transferase
Erythema
Photosensitivity
Rash
reaction
Back pain
Increase in
creatine
phosphokinase
Myalgia
Increased muscle
tone and cramping
Non-arteritic
anterior ischemic
optic neuropathy
Visual defects
Renal and
urinary
disorders
Reproductive
System and
Breast
Disorders
General
Disorders and
Administration
Site Conditions
Haematuria
Increase in
erection
Priapism
Feeling unwell
Chest pain
Penile
Haemorrhage
Haematospermia
‫לצרכן‬
‫בעלון לצרכן‬
‫בטיחות) בעלון‬
‫מידע בטיחות)‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
‫‪)).102.50‬‬
‫(מעודכן ‪.102.50‬‬
‫(מעודכן‬
‫תאריך ‪213213102.‬‬
‫שם תכשיר באנגלית ומספר הרישום ‪Levitra 10mg orodispersible tablets‬‬
‫שם בעל הרישום ‪146-52-33322-01, 146-52-33322-00‬‬
‫טופס זה מיועד לפרוט ההחמרות בלבד !‬
‫ההחמרות המבוקשות‬
‫פרק בעלון‬
‫טקסט חדש‬
‫טקסט נוכחי‬
‫התוויות‬
‫מתי אין להשתמש‬
‫בתכשיר?‬
‫אין להשתמש בתרופה אם הנך‬
‫נוטל ניטרטים (כגון גליצרול‬
‫טריניטראט לטיפול באנגינה‪ ,‬או‬
‫תורמי ניטריק אוקסיד כגון אמיל‬
‫ניטריט)‪.‬‬
‫אם הנך חווה ירידה בראיה או אובדן‬
‫ראיה פתאומיים‪ ,‬הפסק את נטילת‬
‫לויטרה ופנה לרופא שלך מיד‪.‬‬
‫אזהרות מיוחדות‬
‫הנוגעות לשימוש‬
‫בתרופה‪:‬‬
‫אין להשתמש‬
‫בתרופה מבלי‬
‫להיוועץ ברופא לפני‬
‫התחלת הטיפול‪:‬‬
‫תגובות בין‬
‫תרופותיות‪:‬‬
‫‪ ‬הנך נוטל תרופות המכילות‬
‫ניטראטים (כגון גליצרול טריניטראט‬
‫לטיפול באנגינה‪ ,‬או תורמי ניטריק‬
‫אוקסיד (‪ )NO‬כגון אמיל ניטריט)‪.‬‬
‫נטילת תרופות אלה במקביל‬
‫ללויטרה יכולה להשפיע על לחץ‬
‫הדם שלך באופן חמור‪.‬‬
‫‪‬‬
‫ניטרטים (כגון גליצרול‬
‫טריניטראט לטיפול‬
‫באנגינה‪ ,‬או תורמי ניטריק‬
‫אוקסיד כגון אמיל ניטריט)‪,‬‬
‫עקב השפעתם המשולבת‬
‫על לחץ הדם‪.‬‬
‫‪‬‬
‫תרופות לטיפול בנגיף‬
‫האיידס (כגון אינדינאויר‪,‬‬
‫ריטונאויר);‬
‫שימוש בתרופה ומזון‬
‫אין ליטול את התרופה עם מיץ‬
‫אשכוליות‬
‫‪‬‬
‫ניטראטים לטיפול באנגינה או‬
‫תורמי ניטריק אוקסיד כגון אמיל‬
‫ניטריט עקב ההשפעה החמורה‬
‫של השילוב שלהם על לחץ הדם‬
‫– אין ליטול לויטרה‪.‬‬
‫‪‬‬
‫אינדינאויר או ריטונאויר לטיפול‬
‫בנגיף האיידס – אין ליטול לויטרה‪.‬‬
‫שימוש בתרופה ומזון‬
‫אל תצרוך מיץ אשכוליות כאשר‬
‫אתה משתמש בלויטרה‪ ,‬הצריכה‬
‫עלולה להפריע להשפעה הסדירה‬
‫של התרופה‪.‬‬
‫איך תשפיע התרופה על חיי היום יום‬
‫שלך?‬
‫השימוש בתרופה זו עלול לגרום‬
‫לסחרחורת וטשטוש ראייה וכן‬
‫לפגום בערנות‪ ,‬על כן מחייב‬
‫זהירות בנהיגה ברכב‪ ,‬בהפעלת‬
‫נהיגה והפעלת מכונות‬
‫לגרום‬
‫עלול‬
‫בלויטרה‬
‫השימוש‬
‫לסחרחורת וטשטוש ראייה‪ .‬אם אתה‬
‫חש בסחרחורת או אם ראיתך מושפעת‬
‫לאחר נטילת לויטרה‪ ,‬אל תנהג ואל‬
‫תפעיל מכונות או מכשירים‪.‬‬
‫מכונות מסוכנות ובכל פעילות‬
‫המחייבת ערנות‪.‬‬
‫הריון והנקה‪:‬‬
‫כיצד תשתמש‬
‫בתרופה‪:‬‬
‫תופעות לוואי‪:‬‬
‫טבליה מסיסה אחת‪ ,‬כשעה לפני‬
‫קיום יחסי מין‪.‬‬
‫יש ליטול טבליה מסיסה אחת‪ ,‬כ‪ 52 -‬עד‬
‫‪ 06‬דקות לפני קיום יחסי מין‪.‬‬
‫תופעות לוואי נדירות מאוד או‬
‫ששכיחותן אינה ידועה‪( :‬יתכן וישפיעו‬
‫על מטופל אחד מתוך ‪06666‬‬
‫מטופלים)‬
‫‪ ‬דם בשתן (המטוריה)‬
‫‪ ‬דימום מאיבר המין‬
‫‪ ‬הופעת דם בנוזל הזרע‬
‫מצ"ב העלון‪ ,‬שבו מסומנות ההחמרות המבוקשות על רקע צהוב‪.‬‬
‫שינויים שאינם בגדר החמרות סומנו (בעלון) בצבע שונה‪ .‬יש לסמן רק תוכן מהותי ולא שינויים במיקום‬
‫הטקסט‪.‬‬