)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה ((מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
6026 ‫ ביוני‬62 :‫תאריך‬
Sifrol Tablets 0.25 mg, 1 mg :‫שם תכשיר באנגלית‬
126 17 30500, 126 16 30501 :‫מספר רישום‬
‫ מעבדות רפא בע"מ‬:‫שם בעל הרישום‬
.‫ כחול=שינוי מקום‬,‫ ירוק=מחיקה‬,‫ צהוב=הוספה‬- ‫השינויים בעלון מסומנים בצבע‬
‫רופא‬
‫בעלון ללרופא‬
‫בעלון‬
‫טקסט חדש‬
‫טקסט נוכחי‬
‫פרק בעלון‬
Sifrol is indicated in adults for treatment of the
Sifrol is indicated for treatment of the
Therapeutic
signs and symptoms of idiopathic Parkinson's
signs and symptoms of idiopathic
disease, it may be used as monotherapy or in
Parkinson's disease, it may be used
combination with alone (without levodopa) or in
as monotherapy or in combination
combination with levodopa., i.e. over the course
with levodopa, i.e. over the course of
of the disease, through to late stages when the
the disease, through to late stages
effect of levodopa wears off or becomes
when the effect of levodopa wears
inconsistent and fluctuations of the therapeutic
off or becomes inconsistent and
effect occur (end of dose or “on off” fluctuations).
fluctuations of the therapeutic effect
Sifrol is indicated in adults for symptomatic
occur (end of dose or “on off”
treatment of moderate to severe idiopathic
fluctuations).
Restless Legs Syndrome in doses up to 0.75 mg
Sifrol is indicated for symptomatic
of salt (0.54 mg of base) (see section 4.2).
treatment of moderate to severe
Indication
idiopathic Restless Legs Syndrome.
Posology
Parkinson’s disease:
Posology and
Parkinson’s disease:
The tablets should be taken orally,
method of
The tablets should be taken orally, swallowed
swallowed with water, and can be
administration
with water, and can be taken either with or
taken either with or without food. The
without food. The daily dosage is administered
daily dosage is administered in
in equally divided doses 3 times a day.
equally divided doses 3 times a day.
Initial treatment
Initial treatment
Dosages should be increased gradually from a
Dosages should be increased
starting-dose of 0.375 mg salt (0.264 mg of
gradually from a starting-dose of
base) per day and then increased every 5-7
0.375 mg salt (0.264 mg base) per
days. Providing patients do not experience
day and then increased every 5-7
intolerable side- undesirable effects, the dosage
days. Providing patients do not
should be titrated to achieve a maximal
experience intolerable side- effects,
therapeutic effect.
the dosage should be titrated to
achieve a maximal therapeutic
Ascending – Dose Schedule of SIFROL table –
1 of 21
no significant changes
effect.
If a further dose increase is necessary the daily
Ascending – Dose Schedule of
dose should be increased by 0.75 mg of salt
SIFROL table
(0.54 mg base) at weekly intervals up to a
maximum dose of 4.5 mg of salt (3.3 mg of
If a further dose increase is
base) per day.
necessary the daily dose should be
However, it should be noted that the incidence
increased by 0.75 mg salt (0.54 mg
of somnolence is increased at doses higher than
base) at weekly intervals up to a
1.5 mg (of salt) / per day (see section 4.8).
maximum dose of 4.5 mg salt (3.3
Maintenance treatment
mg of base) per day.
The individual dose of pramipexole should be in
However, it should be noted that the
the range of 0.375 mg salt (0.264 mg base) to a
incidence of somnolence is
maximum of 4.5 mg salt (3.3 mg base) per day.
increased at doses higher than 1.5
During dose escalation in three pivotal studies,
mg salt a day (see section 4.8).
efficacy was observed starting at a daily dose of
Maintenance treatment
1.5 mg salt (1.05 mg base). Further dose
The individual dose should be in the
adjustments should be done based on the
range of 0.375 mg salt (0.264 mg
clinical response and the occurrence of
base) to a maximum of 4.5 mg salt
undesirable effects adverse reactions. In clinical
(3.3 mg base) per day. During dose
trials approximately 5% of patients were treated
escalation in three pivotal studies,
at doses below 1.5 mg salt (1.05 mg base). In
efficacy was observed starting at a
advanced Parkinson's disease, pramipexole
daily dose of 1.5 mg salt (1.05 mg
doses higher than 1.5 mg salt (1.05 mg base)
base). Further dose adjustments
per day can be useful in patients where a
should be done based on the clinical
reduction of the levodopa therapy is intended. It
response and the occurrence of
is recommended that the dosage of levodopa is
undesirable effects . In clinical trials
reduced during both the dose escalation and the
approximately 5% of patients were
maintenance treatment with SIFROL, depending
treated at doses below 1.5 mg salt
on reactions in individual patients (see section
(1.05 mg base). In advanced
4.5).
Parkinson's disease,doses higher
Treatment discontinuation
than 1.5 mg salt (1.05 mg base) per
Abrupt discontinuation of dopaminergic therapy
day can be useful in patients where
can lead to the development of a neuroleptic
a reduction of the levodopa therapy
malignant syndrome. Therefore, pPramipexole
is intended. It is recommended that
should be tapered off at a rate of 0.75 mg salt
the dosage of levodopa is reduced
(0.54 mg base) per day until the daily dose has
during both the dose escalation and
been reduced to 0.75 mg salt (0.54 mg base).
the maintenance treatment with
Thereafter the dose should be reduced by 0.375
SIFROL, depending on reactions in
mg salt (0.264 mg base) per day (see section
individual patients.
4.4).
2 of 21
Dosing in patients with renal impairment
Treatment discontinuation
The elimination of pramipexole is dependent on
Abrupt discontinuation of
renal function. The following dosage schedule is
dopaminergic therapy can lead to
suggested for initiation of therapy:
the development of neuroleptic
Patients with a creatinine clearance above 50
malignant syndrome. Therefore,
ml/min require no reduction in daily dose or
pramipexole should be tapered off at
dosing frequency.
a rate of 0.75 mg salt (0.54 mg base)
In patients with a creatinine clearance between
per day until the daily dose has been
20 and 50 ml/min, the initial daily dose of
reduced to 0.75 mg salt (0.54 mg
SIFROL should be administered in two divided
base). Thereafter the dose should be
doses, starting at 0.125 mg salt (0.088 mg base)
reduced by 0.375 mg salt (0.264 mg
twice a day (0.25 mg salt/0.176 mg base daily).
base) per day (see section 4.4).
A maximum daily dose of 2.25 mg salt (1.57 mg
Dosing in patients with renal
base) should not be exceeded.
impairment
In patients with a creatinine clearance less than
The elimination of pramipexole is
20 ml/min, the daily dose of SIFROL should be
dependent on renal function. The
administered in a single dose, starting at 0.125
following dosage schedule is
mg salt (0.088 mg base) daily. A maximum daily
suggested for initiation of therapy:
dose of 1.5 mg salt (1.05 mg base) should not
Patients with a creatinine clearance
be exceeded.
above 50 ml/min require no
reduction in daily dose.
If renal function declines during maintenance
In patients with a creatinine
therapy the reduce SIFROL daily dose should
clearance between 20 and 50
be reduced by the same percentage as the
ml/min, the initial daily dose of
decline in creatinine clearance, i.e. if creatinine
SIFROL should be administered in
clearance declines by 30%, then reduce the
two divided doses, starting at 0.125
SIFROL daily dose should be reduced by 30%.
mg salt (0.088 mg base) twice a day
The daily dose can be administered in two
(0.25 mg salt/0.176 mg base daily).
divided doses if creatinine clearance is between
20 and 50 ml/min and as a single daily dose if
In patients with a creatinine
creatinine clearance is less than 20 ml/min.
clearance less than 20 ml/min, the
Dosing in patients with hepatic impairment
daily dose of SIFROL should be
Dose adjustment in patients with hepatic failure
administered in a single dose,
is probably not necessary, as approx. 90% of
starting at 0.125 mg salt (0.088 mg
absorbed active substance is excreted through
base) daily.
the kidneys. However, the potential influence of
If renal function declines during
hepatic insufficiency on SIFROL
maintenance therapy reduce
pharmacokinetics has not been investigated.
SIFROL daily dose by the same
Paediatric population
percentage as the decline in
The safety and efficacy of SIFROL in children
creatinine clearance, i.e. if creatinine
3 of 21
below 18 years has not been established. There
clearance declines by 30%, then
is no relevant use of SIFROL in the paediatric
reduce the SIFROL daily dose by
population in Parkinson’s Disease.
30%. The daily dose can be
Restless Legs Syndrome:
administered in two divided doses if
The tablets should be taken orally, swallowed
creatinine clearance is between 20
with water, and can be taken either with or
and 50 ml/min and as a single daily
without food.
dose if creatinine clearance is less
The recommended starting dose of SIFROL is
than 20 ml/min.
0.125 mg salt (0.088 mg base) taken once daily
Dosing in patients with hepatic
2-3 hours before bedtime. For patients requiring
impairment
additional symptomatic relief, the dose may be
Dose adjustment in patients with
increased every 4-7 days to a maximum of 0.75
hepatic failure is probably not
mg salt (0.54 mg base) per day (as shown in the
necessary, as approx. 90% of
table below).
absorbed active substance is
Dose Schedule of SIFROL table - no significant
excreted through the kidneys.
changes
However, the potential influence of
As long-term efficacy of SIFROL in the treatment
hepatic insufficiency on SIFROL
of RLS has not been sufficiently tested,
pharmacokinetics has not been
pPatient´s response should be evaluated after 3
investigated.
months treatment and the need for treatment
Restless Legs Syndrome:
continuation should be reconsidered. If
The tablets should be taken orally,
treatment is interrupted for more than a few days
swallowed with water, and can be
it should be re-initiated by dose titration carried
taken either with or without food.
out as above.
The recommended starting dose of
Treatment discontinuation
SIFROL is 0.125 mg salt (0.088 mg
Since the daily dose for the treatment of
base) taken once daily 2-3 hours
Restless Legs Syndrome will not exceed 0.75
before bedtime. For patients
mg salt (0.54 mg base) SIFROL can be
requiring additional symptomatic
discontinued without tapering off. Rebound
relief, the dose may be increased
(worsening of symptoms after abrupt
every 4-7 days to a maximum of
discontinuation of treatment) cannot be
0.75 mg salt (0.54 mg base) per day
excluded. In a 26 week placebo controlled trial,
(as shown in the table below).
rebound of RLS symptoms (worsening of
Dose Schedule of SIFROL table
symptom severity as compared to baseline) was
As long-term efficacy of SIFROL in
observed in 10% of patients (14 out of 135) after
the treatment of RLS has not been
abrupt discontinuation of treatment. This effect
sufficiently tested, patient´s
was found to be similar across all doses.
response should be evaluated after
Dosing in patients with renal impairment
3 months treatment and the need for
The elimination of pramipexole is dependent on
treatment continuation should be
renal function. Patients with a creatinine
reconsidered. If treatment is
clearance above 20 ml/min require no reduction
interrupted for more than a few days
4 of 21
in daily dose.
it should be re-initiated by dose
The use of SIFROL has not been studied in
titration carried out as above.
haemodialysis patients, or in patients with
Treatment discontinuation
severe renal impairment.
Since daily dose for the treatment of
Dosing in patients with hepatic impairment
Restless Legs Syndrome will not
Dose adjustment in patients with hepatic failure
exceed 0.75 mg salt (0.54 mg base)
is not required, as approx. 90% of absorbed
SIFROL can be discontinued without
active substance is excreted through the
tapering off. Rebound (worsening of
kidneys.
symptoms after abrupt
Dosing in children and adolescents Paediatric
discontinuation of treatment) cannot
population
be excluded.
SIFROL is not recommended for use in children
Dosing in patients with renal
and adolescents below 18 years due to a lack of
impairment
data on safety and efficacy.
The elimination of pramipexole is
Tourette Disorder
dependent on renal function.
Paediatric population
Patients with a creatinine clearance
SIFROL is not recommended for use in children
above 20 ml/min require no
and adolescents below 18 years since the
reduction in daily dose.
efficacy and safety has not been established in
The use of SIFROL has not been
this population. SIFROL should not be used in
studied in haemodialysis patients, or
children or adolescents with Tourette Disorder
in patients with severe renal
because of a negative benefit-risk balance for
impairment.
this disorder (see section 5.1).
Dosing in patients with hepatic
impairment
Dose adjustment in patients with
Method of administration
hepatic failure is not required, as
approx. 90% of absorbed active
The tablets should be taken orally, swallowed
substance is excreted through the
with water, and can be taken either with or
kidneys.
without food.
Dosing in children and adolescents
SIFROL is not recommended for use
in children and adolescents below 18
years due to a lack of data on safety
and efficacy.
When prescribing SIFROL tablets in a patient
When prescribing SIFROL tablets in
Special Warning
with Parkinson's disease with renal impairment a
a patient with Parkinson's disease
and Precautions
reduced dose is suggested in line with section
with renal impairment a reduced
for Use
4.2.
dose is suggested in line with
5 of 21
Hallucinations
section 4.2.
Hallucinations are known as a side effect of
treatment with dopamine agonists and levodopa.
Hallucinations are known as a side
Patients should be informed that (mostly visual)
effect of treatment with dopamine
hallucinations can occur.
agonists and levodopa. Patients
Dyskinesia
should be informed that (mostly
In advanced Parkinson's disease, in combination
visual) hallucinations can occur.
treatment with levodopa, dyskinesias can occur
during the initial titration of SIFROL. If they
In advanced Parkinson's disease, in
occur, the dose of levodopa should be
combination treatment with
decreased.
levodopa, dyskinesias can occur
Sudden onset of sleep and somnolence
during the initial titration of SIFROL.
SIFROL Pramipexole has been associated with
If they occur, the dose of levodopa
somnolence and episodes of sudden sleep
should be decreased.
onset, particularly in patients with Parkinson's
disease. Sudden onset of sleep during daily
SIFROL has been associated with
activities, in some cases without awareness or
somnolence and episodes of sudden
warning signs, has been reported uncommonly.
sleep onset, particularly in patients
Patients must be informed of this and advised to
with Parkinson's disease. Sudden
exercise caution while driving or operating
onset of sleep during daily activities,
machines during treatment with SIFROL.
in some cases without awareness or
Patients who have experienced somnolence
warning signs, has been reported
and/or an episode of sudden sleep onset must
uncommonly. Patients must be
refrain from driving or operating machines.
informed of this and advised to
Furthermore a reduction of the dosage or
exercise caution while driving or
termination of therapy may be considered.
operating machines during treatment
Because of possible additive effects, caution
with SIFROL. Patients who have
should be advised when patients are taking
experienced somnolence and/or an
other sedating medicinal products or alcohol in
episode of sudden sleep onset must
combination with pramipexole (see sections 4.5,
refrain from driving or operating
4.7 and section 4.8).
machines. Furthermore a reduction
Impulse control disorders and compulsive
of dosage or termination of therapy
behaviours
may be considered. Because of
Pathological gambling, increased libido and
possible additive effects, caution
hypersexuality have been reported in patients
should be advised when patients are
treated with dopamine agonists for Parkinson's
taking other sedating medicinal
disease, including SIFROL. Furthermore,
products or alcohol in combination
patients and caregivers should be aware of the
with pramipexole (see sections 4.7
fact that other behavioural changes symptoms of
and section 4.8).
impulse control disorders and compulsions such
as binge eating and compulsive shopping can
Pathological gambling, increased
6 of 21
occur. Dose reduction/tapered discontinuation
libido and hypersexuality have been
should be considered.
reported in patients treated with
Patients with psychotic disorders
dopamine agonists for Parkinson's
Patients with psychotic disorders should only be
disease, including SIFROL.
treated with dopamine agonists if the potential
Furthermore, patients and caregivers
benefits outweigh the risks.
should be aware of the fact that
Co-administration of antipsychotic medicinal
behavioural changes can occur.
products with pramipexole should be avoided
Dose reduction/taper discontinuation
(see section 4.5).
should be considered.
Ophthalmologic monitoring
Ophthalmologic monitoring is recommended at
Patients with psychotic disorders
regular intervals or if vision abnormalities occur.
should only be treated with
Severe cardiovascular disease
dopamine agonists if the potential
In case of severe cardiovascular disease, care
benefits outweigh the risks.
should be taken. It is recommended to monitor
Co-administration of antipsychotic
blood pressure, especially at the beginning of
medicinal products with pramipexole
treatment, due to the general risk of postural
should be avoided (see section 4.5).
hypotension associated with dopaminergic
therapy.
Ophthalmologic monitoring is
Neuroleptic malignant syndrome
recommended at regular intervals or
Symptoms suggestive of neuroleptic malignant
if vision abnormalities occur.
syndrome have been reported with abrupt
withdrawal of dopaminergic therapy (see section
In case of severe cardiovascular
4.2).
disease, care should be taken. It is
Augmentation
recommended to monitor blood
Reports in the literature indicate that treatment
pressure, especially at the beginning
of Restless Legs Syndrome with dopaminergic
of treatment, due to the general risk
medicinalations products can result in
of postural hypotension associated
augmentation. Augmentation refers to the earlier
with dopaminergic therapy.
onset of symptoms in the evening (or even the
afternoon), increase in symptoms, and spread of
Symptoms suggestive of neuroleptic
symptoms to involve other extremities. The
malignant syndrome have been
controlled trials of SIFROL in patients with
reported with abrupt withdrawal of
Restless Legs Syndrome were generally not of
dopaminergic therapy (see section
sufficient duration to adequately capture
4.2).
augmentation phenomena. The frequency of
augmentation after longer use of SIFROL and
Reports in the literature indicate
the appropriate management of these events
treatment of Restless Legs
have not been evaluated in controlled clinical
Syndrome with dopaminergic
trials. Augmentation was specifically
mediations can result in
investigated in a controlled clinical trial over 26
augmentation. Augmentation refers
7 of 21
weeks. Augmentation was observed in 11.8% of
to the earlier onset of symptoms in
patients in the pramipexole group (N = 152) and
the evening (or even the afternoon),
9.4% of patients in the placebo group (N = 149).
increase in symptoms, and spread of
Kaplan-Meier analysis of time to augmentation
symptoms to involve other
showed no significant difference between
extremities. The controlled trials of
pramipexole and placebo groups.
SIFROL in patients with Restless
Legs Syndrome were generally not
of sufficient duration to adequately
capture augmentation phenomena.
The frequency of augmentation after
longer use of SIFROL and the
appropriate management of these
events have not been evaluated in
controlled clinical trials.
Plasma protein binding
Pramipexole is bound to plasma
Interaction with
Pramipexole is bound to plasma proteins to a
proteins to a very low (< 20%)
other medicinal
very low (< 20%) extent, and little
extent, and little biotransformation is
products and
biotransformation is seen in man. Therefore,
seen in man. Therefore, interactions
other forms of
interactions with other medicinal products
with other medicinal products
interaction
affecting plasma protein binding or elimination
affecting plasma protein binding or
by biotransformation are unlikely. As
elimination by biotransformation are
anticholinergics are mainly eliminated by
unlikely. As anticholinergics are
biotransformation, the potential for an interaction
mainly eliminated by
is limited, although an interaction with
biotransformation, the potential for
anticholinergics has not been investigated.
an interaction is limited, although an
There is no pharmacokinetic interaction with
interaction with anticholinergics has
selegiline and levodopa.
not been investigated. There is no
Inhibitors/competitors of active renal elimination
pharmacokinetic interaction with
pathway
selegiline and levodopa.
Cimetidine reduced the renal clearance of
pramipexole by approximately 34%, presumably
Cimetidine reduced the renal
by inhibition of the cationic secretory transport
clearance of pramipexole by
system of the renal tubules. Therefore,
approximately 34%, presumably by
medicinal products that are inhibitors of this
inhibition of the cationic secretory
active renal elimination pathway or are
transport system of the renal
eliminated by this pathway, such as cimetidine,
tubules. Therefore, medicinal
and amantadine, mexiletine, zidovudine,
products that are inhibitors of this
cisplatin, quinine, and procainamide, may
active renal elimination pathway or
interact with pramipexole resulting in reduced
are eliminated by this pathway, such
clearance of pramipexole either or both
as cimetidine, and amantadine may
8 of 21
medicinal products. Reduction of the
interact with pramipexole resulting in
pramipexole dose should be considered when
reduced clearance of either or both
these medicinal products are administered
medicinal products. Reduction of the
concomitantly with SIFROL.
pramipexole dose should be
Combination with levodopa
considered when these medicinal
When SIFROL is given in combination with
products are administered
levodopa, it is recommended that the dosage of
concomitantly with SIFROL.
levodopa is reduced and the dosage of other
anti-parkinsonian medicationinal products is kept
When SIFROL is given in
constant while increasing the dose of SIFROL.
combination with levodopa, it is
Because of possible additive effects, caution
recommended that the dosage of
should be advised when patients are taking
levodopa is reduced and the dosage
other sedating medicinal products or alcohol in
of other anti-parkinsonian
combination with pramipexole (see section 4.4,
medication is kept constant while
4.7 and 4.8).
increasing the dose of SIFROL.
Antipsychotic medicinal products
Because of possible additive effects,
Co-administration of antipsychotic medicinal
caution should be advised when
products with pramipexole should be avoided
patients are taking other sedating
(see section 4.4), e.g. if antagonistic effects can
medicinal products or alcohol in
be expected.
combination with pramipexole.
Co-administration of antipsychotic
medicinal products with pramipexole
should be avoided (see section 4.4),
e.g. if antagonistic effects can be
expected.
Pregnancy
The effect on pregnancy and
Fertility,
The effect on pregnancy and lactation has not
lactation has not been investigated
Ppregnancy and
been investigated in humans. Pramipexole was
in humans. Pramipexole was not
lactation
not teratogenic in rats and rabbits, but was
teratogenic in rats and rabbits, but
embryotoxic in the rat at maternotoxic doses
was embryotoxic in the rat at
(see section 5.3). SIFROL should not be used
maternotoxic doses (see section
during pregnancy unless clearly necessary, i.e. if
5.3). SIFROL should not be used
the potential benefit justifies the potential risk to
during pregnancy unless clearly
the foetus.
necessary, i.e. if the potential benefit
Breast-feeding
justifies the potential risk to the
As SIFROL pramipexole treatment inhibits
foetus.
secretion of prolactin in humans, inhibition of
9 of 21
lactation is expected. The excretion of SIFROL
As SIFROL treatment inhibits
pramipexole into breast milk has not been
secretion of prolactin in humans,
studied in women. In rats, the concentration of
inhibition of lactation is expected.
active substance-related radioactivity was higher
The excretion of SIFROL into breast
in breast milk than in plasma.
milk has not been studied in women.
In the absence of human data, SIFROL should
In rats, the concentration of active
not be used during breast-feeding. However, if
substance-related radioactivity was
its use is unavoidable, breast-feeding should be
higher in breast milk than in plasma.
discontinued.
In the absence of human data,
Fertility
SIFROL should not be used during
No studies on the effect on human fertility have
breast-feeding. However, if its use is
been conducted. In animal studies, pramipexole
unavoidable, breast-feeding should
affected oestrous cycles and reduced female
be discontinued.
fertility as expected for a dopamine agonist.
However, these studies did not indicate direct or
indirect harmful effects with respect to male
fertility
Patients treated with pramipexole tablets
Patients treated with
Undesirable
have reported falling asleep during activities
pramipexole tablets have
effects
of daily living, including the operation of
reported falling asleep during
motor vehicles, which sometimes resulted in
activities of daily living, including
accidents. Some of them did not report a
the operation of motor vehicles,
warning sign such as somnolence, which is
which sometimes resulted in
a common occurrence in patients receiving
accidents. Some of them did not
pramipexole tablets at doses above 1.5
report a warning sign such as
mg/day, and which, according to the current
somnolence, which is a common
knowledge of sleep physiology, always
occurrence in patients receiving
proceeds falling asleep. There was no clear
pramipexole tablets at doses
relation to the duration of treatment. Some
above 1.5 mg/day, and which,
patients were taking other medication with
according to the current
potentially sedative properties. In most
knowledge of sleep physiology,
cases where information was available,
always proceeds falling asleep.
there were no further episodes following
There was no clear relation to
reduction of dosage or termination of
the duration of treatment. Some
therapy.
patients were taking other
Expected adverse reactions
medication with potentially
The following adverse reactions are expected
sedative properties. In most
under the use of SIFROL: abnormal dreams,
cases where information was
amnesia, behavioural symptoms of impulse
available, there were no further
control disorders and compulsions such as
episodes following reduction of
10 of 21
binge eating, compulsive shopping,
dosage or termination of
hypersexuality and pathological gambling;
therapy.
cardiac failure, confusion, constipation, delusion,
dizziness, dyskinesia, dyspnoea, fatigue,
The following adverse reactions are
hallucinations, headache, hiccups,
expected under the use of SIFROL:
hyperkinesia, hyperphagia, hypotension,
abnormal dreams, confusion,
increased eating (binge eating, hyperphagia),
constipation, delusion, dizziness,
insomnia, libido disorders, nausea, paranoia,
dyskinesia, fatigue, hallucinations,
peripheral oedema, paranoia, pneumonia,
headache, hyperkinesia,
pruritus rash and other hypersensitivity;
hypotension, increased eating (binge
pathological gambling, hypersexuality and other
eating, hyperphagia), insomnia,
abnormal behaviour, restlessness, somnolence,
libido disorders, nausea, peripheral
sudden onset of sleep, syncope, visual
oedema, paranoia, pathological
impairment including diplopia, vision blurred and
gambling, hypersexuality and other
visual acuity reduced, vomiting, weight decrease
abnormal behaviour, somnolence,
including decreased appetite, weight increase,
weight increase, sudden onset of
sudden onset of sleep, pruritis and rash and
sleep, pruritis rash and other
other hypersensitivity.
hypersensitivity.
Based on the analysis of pooled placebo-
Based on the analysis of pooled
controlled trials, comprising a total of 1,923
placebo-controlled trials, comprising
patients on SIFROL pramipexole and 1,354
a total of 1923 patients on SIFROL
patients on placebo, adverse drug reactions
and 1354 patients on placebo,
were frequently reported for both groups. 63% of
adverse drug reactions were
patients on SIFROL pramipexole and 52% of
frequently reported for both groups.
patients on placebo reported at least one
63% of patients on SIFROL and 52%
adverse drug reaction.
of patients on placebo reported at
Tables 1 and 2 below display the frequency of
least one adverse drug reaction.
adverse drug reactions from placebo-controlled
clinical trials in Parkinson's disease and
The most commonly (
Restless Legs Syndrome. The adverse drug
reported adverse drug reactions in
reactions reported in these tables are those
patients with Parkinson's disease
events that occurred in 0.1% or more of patients
more frequent with SIFROL
treated with SIFROL pramipexole and were
treatment than with Placebo were
reported significantly more often in patients
nausea, dyskinesia, orthostatic
taking SIFROL pramipexole than placebo, or
hypotension, dizziness, somnolence,
where the event was considered clinically
insomnia, constipation, hallucination
relevant. However, tThe majority of adverse
visual, headache and fatigue. The
drug reactions were mild to moderate;, they
incidence of somnolence is
usually start early in therapy, and most tended to
increased at doses higher than 1.5
disappear even as therapy was continued.
mg/ day (see section 4.2.). A More
11 of 21
5%)
Within the system organ classes, adverse
frequent adverse drug reactions in
reactions are listed under headings of frequency
combination with levodopa were
(number of patients expected to experience the
dyskinesias. Hypotension may occur
reaction), using the following categories: very
at the beginning of treatment,
common (≥ 1/10); common (≥ 1/100 to < 1/10);
especially if SIFROL is titrated too
uncommon (≥ 1/1,000 to < 1/100); rare
fast.
(≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
(on form, see Table 1 at end of
Parkinson's disease, most common adverse
doctors' leaflet)
reactions
The most commonly (
5%) reported adverse
The most commonly (
5%)
drug reactions in patients with Parkinson's
reported adverse drug reactions in
disease more frequent with SIFROL
patients with Restless Legs
pramipexole treatment than with Placebo were
Syndrome treated with SIFROL were
nausea, dyskinesia, orthostatic hypotension,
nausea, headache, and fatigue.
dizziness, somnolence, insomnia, constipation,
Nausea and fatigue were more often
hallucination visual, headache and fatigue. The
reported in female patients treated
incidence of somnolence is increased at doses
with SIFROL (20.8% and 10.5%,
higher than 1.5 mg/ pramipexole salt per day
respectively) compared to males
(see section 4.2.). A Mmore frequent adverse
(6.7% and 7.3%, respectively).
drug reactions in combination with levodopa
were was dyskinesias. Hypotension may occur
(on form, see table 2 at end of
at the beginning of treatment, especially if
doctors' leaflet)
SIFROL pramipexole is titrated too fast.
Table 1: Parkinson’s disease (ON FORM, SEE AT
Tables 1 and 2 below display the
END OF DOCTORS' LEAFLET)
frequency of adverse drug reactions
1
This side effect has been observed in post-
from placebo-controlled clinical trials
marketing experience. With 95 % certainty,
in Parkinson's disease and Restless
the frequency category is not greater than
Legs Syndrome. The adverse drug-
uncommon, but might be lower. A precise
reactions reported in these tables
frequency estimation is not possible as the
are those events that occurred in 1%
side effect did not occur in a clinical trial
or more of patients treated with
database of 2,762 patients with Parkinson’s
SIFROL and were reported
Disease treated with pramipexole.
Restless Legs Syndrome, most common
significantly more often in patients
adverse reactions
taking SIFROL than placebo, or
The most commonly (
where the event was considered
5%) reported adverse
drug reactions in patients with Restless Legs
clinically relevant. However, the
Syndrome treated with SIFROL Pramipexole
majority of common drug adverse
were nausea, headache, dizziness and fatigue.
reactions were mild to moderate;
Nausea and fatigue were more often reported in
they usually start early in therapy,
female patients treated with SIFROL (20.8% and
and most tended to disappear even
as therapy was continued.
12 of 21
10.5%, respectively) compared to males (6.7%
and 7.3%, respectively).
Table 1: Very common Adverse
Table 2: Restless Legs Syndrome (ON FORM, SEE
Drug Reactions ( 1/10) (on form,
AT END OF DOCTORS' LEAFLET)
see at end of doctors' leaflet)
1
This side effect has been observed in postmarketing experience. With 95 % certainty,
Table 2: Common Adverse Drug
the frequency category is not greater than
Reactions ( 1/100 to <1/10) (on
uncommon, but might be lower. A precise
form, see at end of doctors' leaflet)
frequency estimation is not possible as the
side effect did not occur in a clinical trial
SIFROL is associated with
database of 1,395 patients with Restless
somnolence (8.6%) and has been
Legs Syndrome treated with pramipexole.
associated uncommonly with
Tables 1 and 2 below display the frequency of
excessive daytime somnolence and
adverse drug reactions from placebo-controlled
sudden sleep onset episodes
clinical trials in Parkinson's disease and
(0.1%). See also section 4.4.
Restless Legs Syndrome. The adverse drugreactions reported in these tables are those
SIFROL may be associated with
events that occurred in 1% or more of patients
libido disorders [(increased (0.1%) or
treated with SIFROL and were reported
decreased (0.4%)].
significantly more often in patients taking
SIFROL than placebo, or where the event was
Patients treated with dopamine
considered clinically relevant. However, the
agonists for Parkinson's disease,
majority of common drug adverse reactions
including Sifrol, especially at high
were mild to moderate; they usually start early in
doses, have been reported as
therapy, and most tended to disappear even as
exhibiting signs of pathological
therapy was continued.
gambling, increased libido and
Table 1: Very common Adverse Drug Reactions
hypersexuality, generally reversible
( 1/10) (ON FORM, SEE AT END OF DOCTORS'
upon reduction of the dose or
LEAFLET)
treatment discontinuation
Table 2: Common Adverse Drug Reactions (
1/100 to <1/10) (ON FORM, SEE AT END OF
DOCTORS' LEAFLET)
Somnolence
SIFROL Pramipexole is commonly associated
with somnolence (8.6%) and has been
associated uncommonly with excessive daytime
somnolence and sudden sleep onset episodes
(0.1%). S(see also section 4.4).
Libido disorders
SIFROL Pramipexole may be uncommonly be
13 of 21
associated with libido disorders [(increased
(0.1%) or decreased (0.4%)].
Impulse control disorders and compulsive
behaviours
Patients treated with dopamine agonists for
Parkinson's disease, including Sifrol, especially
at high doses, have been reported as exhibiting
signs of pathological gambling, increased libido
and hypersexuality, generally reversible upon
reduction of the dose or treatment
discontinuation (see also section 4.4).
In a cross-sectional, retrospective screening and
case-control study including 3,090 Parkinson’s
disease patients, 13.6% of all patients receiving
dopaminergic or non-dopaminergic treatment
had symptoms of an impulse control disorder
during the past six months. Manifestations
observed include pathological gambling,
compulsive shopping, binge eating, and
compulsive sexual behaviour (hypersexuality).
Possible independent risk factors for impulse
control disorders included dopaminergic
treatments and higher doses of dopaminergic
treatment, younger age ( ≤ 65 years), not being
married and self-reported family history of
gambling behaviours.
Cardiac failure
In clinical studies and post-marketing experience
cardiac failure has been reported in patients with
pramipexole. In a pharmacoepidemiological
study pramipexole use was associated with an
increased risk of cardiac failure compared with
non-use of pramipexole (observed risk ratio
1.86; 95% CI, 1.21-2.85).
14 of 21
‫טקסט חדש‬
Table 1: Parkinson’s disease
System Organ Class
Adverse Drug Reaction
Infections and infestations
Uncommon
pneumonia
Psychiatric disorders
Common
abnormal dreams, behavioural symptoms of impulse control disorders and
compulsions, confusion, hallucinations, insomnia
Uncommon
binge eating1, compulsive shopping, delusion, hyperphagia1, hypersexuality,
libido disorder, paranoia, pathological gambling, restlessness
Nervous system disorders
Very common
dizziness, dyskinesia, somnolence
Common
headache
Uncommon
amnesia, hyperkinesia, sudden onset of sleep, syncope
Eye disorders
Common
visual impairment including diplopia,vision blurred and visual acuity reduced
Cardiac disorders
Uncommon
cardiac failure1
Vascular disorders
Common
hypotension
Respiratory, thoracic, and mediastinal disorders
Uncommon
dyspnoea, hiccups
Gastrointestinal disorders
Very common
nausea
Common
constipation, vomiting
Skin and subcutaneous tissue disorders
Uncommon
hypersensitivity, pruritus, rash
General disorders and administration site conditions
Common
fatigue, peripheral oedema
Investigations
Common
weight decrease including decreased appetite
Uncommon
weight increase
Table 2: Restless Legs Syndrome
System Organ Class
Adverse Drug Reaction
Infections and infestations
Uncommon
pneumonia1
Psychiatric disorders
Common
abnormal dreams, insomnia
Uncommon
behavioural symptoms of impulse control disorders and compulsions such as
15 of 21
binge eating, compulsive shopping, hypersexuality, and pathological gambling1;
confusion, delusion1, hallucinations, hyperphagia1, libido disorder, paranoia1,
restlessness
Nervous system disorders
Common
dizziness, headache, somnolence
Uncommon
amnesia1, dyskinesia, hyperkinesia1, sudden onset of sleep, syncope
Eye disorders
Uncommon
visual impairment including diplopia,vision blurred and visual acuity reduced
Cardiac disorders
Uncommon
cardiac failure1
Vascular disorders
Uncommon
hypotension
Respiratory, thoracic, and mediastinal disorders
Uncommon
dyspnoea, hiccups
Gastrointestinal disorders
Very common
nausea
Common
constipation, vomiting
Skin and subcutaneous tissue disorders
Uncommon
hypersensitivity, pruritus, rash
General disorders and administration site conditions
Common
fatigue
Uncommon
peripheral oedema
Investigations
Uncommon
weight decrease including decreased appetite, weight increase
16 of 21
‫טקסט נוכחי‬
Table 1: Very common Adverse Drug Reactions ( 1/10)
System organ class
Adverse reaction
Pramipexole
N = 1923 (%)
Nervous system disorders
Dizziness
15.5
Dyskinesia
12.9
Gastrointestinal disorders
Nausea
17.2
Vascular disorders
Hypotension
12.6
Table 2: Common Adverse Drug Reactions ( 1/100 to <1/10)
System organ class
Adverse reaction
Pramipexole
N = 1923 (%)
Psychiatric disorders
Abnormal dreams
3.5
Confusional state
3.0
Hallucinations
6.6
Insomnia
8.2
Somnolence
8.6
Nervous system disorders
Headache
6.5
Gastrointestinal
Constipation
5.5
General disorders and
Fatigue
6.1
administration site conditions
Peripheral oedema
1.9
Disorders
17 of 21
‫לצרכן‬
‫בעלון לצרכן‬
‫בעלון‬
‫פרק בעלון‬
‫מתי אין להשתמש‬
‫בתכשיר‬
‫טקסט נוכחי‬
‫אל תשתמשי בתכשיר כאשר הינך מניקה‪.‬‬
‫אין להשתמש בתכשיר אם ידועה רגישות‬
‫לאחד ממרכיביו‪.‬‬
‫אין להשתמש בתכשיר זה אם הינך נוטל‪/‬ת‬
‫במקביל תרופה אנטי פסיכוטית‪[ .‬הועבר‬
‫לסעיף "תגובות בין תרופתיות" ע"פ דרישת‬
‫משרד הבריאות באישור של עלון סיפרול‬
‫‪ ER‬מנובמבר ‪]6022‬‬
‫טקסט חדש‬
‫אין להשתמש בתכשיר אם ידועה רגישות לאחד‬
‫ממרכיביו‪.‬‬
‫אל אין להתשתמשי בתכשיר כאשר אם הינך‬
‫מניקה‪.‬‬
‫אין להשתמש בתכשיר אם ידועה רגישות לאחד‬
‫ממרכיביו‪.‬‬
‫אין להשתמש בתכשיר זה אם הינך נוטל‪/‬ת‬
‫במקביל תרופה אנטי פסיכוטית‪[ .‬הועבר לסעיף‬
‫"תגובות בין תרופתיות" ע"פ דרישת משרד‬
‫הבריאות באישור של עלון סיפרול ‪ ER‬מנובמבר‬
‫‪]6022‬‬
‫אין להשתמש‬
‫בתכשיר מבלי‬
‫להיוועץ ברופא‬
‫לפני התחלת‬
‫הטיפול‬
‫אם הינך בהריון; אם הינך סובל‪/‬ת או סבלת‬
‫אם הינך בהריון; או מתכננת הריון‪.‬‬
‫בעבר מליקוי בתפקוד‪ :‬הלב ו‪/‬או כלי הדם‪,‬‬
‫העיניים‪ ,‬הכליה‪/‬מערכת השתן‪ ,‬מערכת‬
‫אם הינך סובל‪/‬ת או סבלת בעבר מליקוי‬
‫בתפקוד‪ :‬הלב ו‪/‬או כלי הדם‪ ,‬העיניים‪,‬‬
‫אם הינך סובל‪/‬ת מבעיות‬
‫הכליה‪/‬מערכת השתן‪ ,‬מערכת העצבים‪ ;,‬או אם‬
‫פסיכוטיות‪ ,‬הזיות‪ ,‬שינויים התנהגותיים‬
‫ו‪/‬או אם הינך סובל מעייפות יתרה או‬
‫הירדמויות פתאומיות‪.‬‬
‫הינך סובל‪/‬ת מבעיות פסיכוטיות‪ ,‬הזיות‪,‬‬
‫שינויים התנהגותיים (הימורים פתולוגיים‪,‬‬
‫עריכת קניות באופן כפייתי‪ ,‬התנהגות מינית‬
‫העצבים;‬
‫חריגה‪ ,‬התקפי אכילה מופרזת); ו‪/‬או אם הינך‬
‫איך תשפיע‬
‫התרופה על חיי‬
‫היום יום שלך?‬
‫השימוש בתרופה זו עלול לפגום בערנות‬
‫ועל כן מחייב זהירות בנהיגה ברכב‪,‬‬
‫בהפעלת מכונות מסוכנות בכל פעילות‬
‫המחייבת ערנות‪ .‬באשר לילדים יש להזהירם‬
‫מרכיבה על אופניים או ממשחקים בקרבת‬
‫הכביש וכדומה‪.‬‬
‫אין לשתות יינות או משקאות חריפים‬
‫בתקופת הטיפול עם התרופה‪.‬‬
‫אזהרות‬
‫השימוש בתרופה זו עלול לגרום לטשטוש‬
‫הראייה‪.‬‬
‫יש לנטר את לחץ הדם‪ ,‬בעיקר בתחילת‬
‫הטיפול בתרופה‪.‬‬
‫במהלך הטיפול בתכשיר יש לבצע בדיקות‬
‫עיניים במרווחים קבועים‪.‬‬
‫מנוחה" יש‬
‫בטיפול ב"רגליים חסרות‬
‫להיבדק אצל הרופא לאחר ‪ 3‬חודשים‪ ,‬על‬
‫מנת להעריך את יעילות הטיפול‪.‬‬
‫אם הינך רגיש‪/‬ה למזון כלשהו או לתרופה‬
‫כלשהי‪ ,‬עליך להודיע על כך לרופא לפי‬
‫נטילת התרופה‪.‬‬
‫סובל מעייפות יתרה ליקוי בתנועה (דיסקינזיה)‪,‬‬
‫ישנוניות או הירדמויות פתאומיות‪.‬‬
‫אם הנך נוטל לבודופה בנוסף לסיפרול‪ -‬היוועץ‬
‫ברופא בנוגע להורדת מינון הלבודופה לפני‬
‫תחילת השימוש בסיפרול (ראה גם בסעיף‬
‫"תגובות בין תרופתיות")‪.‬‬
‫השימוש בתרופה זו עלול לפגום בערנות ולגרום‬
‫לישנוניות או לגרום להופעת הזיות‪.‬‬
‫אם התכשיר השפיע עליך באופן זה‪ ,‬אין לנהוג‬
‫או להפעיל ועל כן מחייב זהירות בנהיגה ברכב‪,‬‬
‫בהפעלת מכונות מסוכנות או לעסוק בכל‬
‫פעילות המחייבת ערנות‪ .‬באשר לילדים יש‬
‫להזהירם מרכיבה על אופניים או ממשחקים‬
‫בקרבת הכביש וכדומה‪.‬‬
‫אין לשתות יינות או משקאות חריפים בתקופת‬
‫הטיפול עם הבתרופה זו‪.‬‬
‫אם הינך רגיש למזון כלשהו או לתרופה כלשהי‪,‬‬
‫עליך להודיע על כך לרופא לפי נטילת התרופה‪.‬‬
‫השימוש בתרופה זו עלול לגרום לטשטוש‬
‫הראייה‪.‬‬
‫במהלך הטיפול בתכשיר‪ ,‬ובמיוחד בתחילת‬
‫הטיפול‪ ,‬יש לנטר באופן קבוע את לחץ הדם‪,‬‬
‫בעיקר בתחילת הטיפול בתרופה‪.‬‬
‫במהלך הטיפול בתכשיר יש לבצע בדיקות‬
‫עיניים במרווחים קבועים‪.‬‬
‫בטיפול ב"רגליים חסרות מנוחה" יש להיבדק‬
‫אצל הרופא לאחר ‪ 3‬חודשים‪ ,‬על מנת להעריך‬
‫את יעילות הטיפול‪.‬‬
‫אם הינך רגיש‪/‬ה למזון כלשהו או לתרופה‬
‫‪18 of 21‬‬
‫תגובות בין‬
‫תרופתיות‬
‫אם הינך נוטל‪/‬ת תרופה נוספת‪ ,‬או אם גמרת‬
‫זה עתה טיפול בתרופה אחרת‪ ,‬עליך לדווח‬
‫לרופא המטפל כדי למנוע סיכונים או אי‪-‬‬
‫יעילות הנובעים מתגובות בין תרופתיות‪.‬‬
‫במיוחד‪ ,‬לגבי תרופות מהקבוצות הבאות‪:‬‬
‫העצבים‬
‫מערכת‬
‫על‬
‫המשפיעות‬
‫המרכזית(כגון‪ :‬תרופות להרגעה‪ ,‬לשינה‬
‫פרקינסון‪ ,‬אפילפסיה‪ ,‬תרופות אנטי‬
‫תרופות‬
‫סכיזופרניה)‪,‬‬
‫פסיכוטיות‪,‬‬
‫המשפיעות על התפקוד‪/‬הפינוי הכליתי‬
‫(כגון סימטידין ו אמאנטאדין)‬
‫תופעות לוואי‬
‫בנוסף לפעילות הרצויה של התרופה‪ ,‬בזמן‬
‫השימוש בה עלולות להופיע השפעות לוואי‪,‬‬
‫כגון‪ :‬עצירות‪ ,‬טשטוש הראיה‪ ,‬בחילה‪,‬‬
‫הקאה‪ ,‬בצקות‪ ,‬כאב ראש‪ ,‬בלבול‪,‬הזיות‬
‫(בעיקר חזותיות)‪ ,‬ליקוי תנועה‪ ,‬תת לחץ‬
‫דם‪ ,‬הפרעות שינה‪ ,‬ישנוניות‪ ,‬עייפות‪,‬‬
‫סחרחורת‪ ,‬חלומות מוזרים‪ ,‬ירידה במשקל‬
‫תופעות אלו חולפות בדרך כלל תוך זמן‬
‫קצר לאחר תקופת ההסתגלות לתכשיר‪ .‬אם‬
‫התופעות הנ"ל מתמשכות ו‪/‬או מטרידות יש‬
‫לפנות לרופא‪.‬‬
‫השימוש בתרופה עלול לגרום לשינוי‬
‫בהתנהגות (נטייה להימורים‪ ,‬הפרעות‬
‫בחשק המיני‪ ,‬אכילה מופרזת)‪ .‬במקרה כזה‬
‫יש לפנות לרופא המטפל‪.‬‬
‫תופעות לוואי‬
‫הדורשות‬
‫הירדמויות פתאומיות עם או בלי תחושת‬
‫עייפות‪ ,‬קשיי נשימה או דלקת ריאות (לא‬
‫כלשהי‪ ,‬עליך להודיע על כך לרופא לפי נטילת‬
‫התרופה‪.‬‬
‫אין להפסיק ליטול תרופה זו בצורה פתאומית‬
‫מבלי להיוועץ ברופא‪ ,‬היות ויתכן כי קיים צורך‬
‫להפסיק את המינון בצורה הדרגתית‪,‬על מנת‬
‫להימנע מתופעות לוואי‪.‬‬
‫אם הינך נוטל‪/‬ת תרופותה נוספות‪ ,‬כולל תרופות‬
‫הנמכרות ללא מרשם ותוספי תזונה או אם‬
‫סיימת גמרת זה עתה טיפול בתרופה אחרת‪,‬‬
‫עליך לדווח לרופא המטפל כדי למנוע סיכונים‬
‫או אי‪-‬יעילות הנובעים מתגובות בין תרופתיות‪.‬‬
‫במיוחד‪ ,‬לגבי תרופות מהקבוצות הבאות‪:‬‬
‫תרופות הפועלות להרגעת המשפיעות על‬
‫מערכת העצבים המרכזית‪( ,‬כגון‪ :‬תרופות‬
‫להרגעה‪ ,‬או לשינה (זהירות יתרה נדרשת‬
‫בנהיגה או בהפעלת מכונות מסוכנות‪ ,‬ראה גם‬
‫סעיף "איך תשפיע התרופה על חיי היום יום‬
‫שלך?")‪ ,‬פרקינסון‪ ,‬אפילפסיה‪ ,‬תרופות אנטי‬
‫פסיכוטיות‪ ,‬סכיזופרניה)‪ ,‬תרופות המשפיעות‬
‫על התפקוד‪/‬הפינוי הכליתי (כגון סימטידין‬
‫(לטיפול בצרבת וכיב קיבה או)‪ ,‬אמאנטאדין)‬
‫(לטיפול במחלת הפרקינסון)‪ ,‬פרוקאינאמיד‬
‫(לטיפול בקצב לב לא סדיר)‪ ,‬זידובודין (לטיפול‬
‫באיידס‪ ,)HIV /‬ציספלטין (לטיפול בסרטן)‪,‬‬
‫קווינין‪.‬‬
‫אם הנך מטופל בלבודופה‪ -‬היועץ ברופא בנוגע‬
‫להורדת מינון הלבודופה עם תחילת הטיפול‬
‫בסיפרול‪( .‬ראה גם בסעיף‪":‬אין להשתמש‬
‫בתכשיר מבלי להיוועץ ברופא לפני התחלת‬
‫הטיפול")‪.‬‬
‫יש להימנע משימוש בתכשיר זה‪ ,‬אם הינך נוטל‬
‫תרופות אנטי פסיכוטיות‪.‬‬
‫בנוסף לפעילות הרצויה של התרופה‪ ,‬בזמן‬
‫השימוש בה עלולות להופיע תופעות השפעות‬
‫לוואי‪ ,‬כגון‪ :‬דחף להתנהגות בלתי רגילה‪,‬‬
‫עצירות‪ ,‬טשטוש הפרעות הבראיה‪ ,‬בחילה‪,‬‬
‫הקאה‪ ,‬בצקות (בעיקר ברגליים)‪ ,‬כאב ראש‪ ,‬אי‬
‫שקט‪ ,‬בלבול‪ ,‬הפרעות בזיכרון‪ ,‬הזיות (בעיקר‬
‫חזותיות)‪ ,‬ליקוי תנועה‪ ,‬תת ירידה בלחץ דם‪,‬‬
‫הפרעות שינה‪ ,‬ישנוניות‪ ,‬עייפות‪ ,‬סחרחורת‪,‬‬
‫חלומות מוזרים‪ ,‬ירידה במשקל כולל ירידה‬
‫בתאבון‪.‬‬
‫תופעות אלו חולפות בדרך כלל תוך זמן קצר‬
‫לאחר תקופת ההסתגלות לתכשיר‪ .‬אם‬
‫התופעות הלוואי אינן חולפות או שהן הנ"ל‬
‫מתמשכות ו‪/‬או מטרידות‪ ,‬יש להתייעץ עם‬
‫לפנות להרופא‪.‬‬
‫השימוש בתרופה עלול לגרום לשינוי בהתנהגות‬
‫(נטייה להימורים‪ ,‬הפרעות בחשק המיני‪ ,‬אכילה‬
‫מופרזת)‪ .‬במקרה כזה יש לפנות לרופא המטפל‪.‬‬
‫אי ספיקה לבבית (יכולה לגרום לבצקות‬
‫ברגליים או קוצר נשימה); הירדמויות פתאומיות‬
‫‪19 of 21‬‬
‫התייחסות מיוחדת‬
‫שכיח)‪ ,‬המשך טיפול ופנה לרופא מיד!‬
‫לעיתים טיפול התחלתי בתסמונת "הרגליים‬
‫חסרות המנוח" עלול לגרום להגברה‪/‬שינוי‬
‫של התסמינים הראשוניים (נדיר)‪ :‬המשך‬
‫בטיפול ופנה לרופא מיד!‬
‫בכל מקרה שבו הינך מרגיש‪/‬ה תופעות‬
‫לוואי שלא צוינו בעלון זה‪ ,‬או אם חל שינוי‬
‫בהרגשתך הכללית עליך להתייעץ עם‬
‫הרופא מיד‬
‫מינון‬
‫מינון לפי הוראות הרופא בלבד‪ .‬אין לעבור‬
‫על המנה המומלצת‪.‬‬
‫תרופה זו אינה מיועדת לילדים תחת גיל‬
‫‪.21‬‬
‫יש להשתמש בתרופה זו בזמנים קצובים‬
‫כפי שנקבע על‪-‬ידי הרופא המטפל‪.‬‬
‫אם שכחת ליטול תרופה זו בזמן קצוב‪ ,‬יש‬
‫ליטול מנה מיד כשנזכרת‪ ,‬אך בשום אופן‬
‫אין ליטול שתי מנות ביחד!‬
‫אם לא חל שיפור במצבך‪ ,‬יש לפנות לרופא‪.‬‬
‫כאשר מפסיקים את הטיפול בתרופה יש‬
‫לעשות זאת באופן הדרגתי במשך מספר‬
‫ימים‪.‬‬
‫אופן השימוש‬
‫אין ללעוס!‬
‫יש לבלוע את התרופה עם כוס מים‪.‬‬
‫ניתן ליטול את התרופה ללא קשר לזמני‬
‫הארוחות‪.‬‬
‫כיצד תוכל לסייע‬
‫להצלחת הטיפול?‬
‫עליך להשלים את הטיפול שהומלץ על‪-‬ידי‬
‫הרופא‪.‬‬
‫גם אם חל שיפור במצב בריאותך אין‬
‫להפסיק הטיפול בתרופה ללא התייעצות‬
‫עם הרופא‪ ,‬וגם אז רק באופן הדרגתי‪.‬‬
‫עם או בלי תחושת עייפות‪ ,‬קשיי נשימה או‬
‫דלקת ריאות (לא שכיח)‪ ,‬הזיות‪ ,‬פרנויה‪ ,‬עילפון‪:‬‬
‫– המשך טיפול ופנה לרופא מיד!‬
‫בהופיעה תגובה אלרגית המתבטאת בפריחה‪,‬‬
‫גירוי‪ ,‬רגישות יתר בעור‪ ,‬או קשיי נשימה ‪ -‬פנה‬
‫לרופא מיד!‬
‫לעיתים טיפול התחלתי בתסמונת "הרגליים‬
‫חסרות המנוח" עלול לגרום להגברה‪/‬שינוי של‬
‫התסמינים הראשוניים (נדיר)‪ :‬המשך בטיפול‬
‫ופנה לרופא מיד!‬
‫השימוש בתרופה עלול לגרום להתנהגות חריגה‬
‫(לא שכיח)‪ ,‬כגון‪ :‬אכילה מופרזת‪ ,‬קניה‬
‫כפייתית‪ ,‬שינויים בהתנהגות מינית ונטייה‬
‫להימורים‪ ,‬אשר דווחו בחולים הנוטלים תרופות‬
‫מקבוצה זו‪ .‬במקרה כזה יש לפנות לרופא‬
‫המטפל‪.‬‬
‫בכל מקרה שבו הינך מרגיש‪/‬ה תופעות לוואי‬
‫שלא צוינו בעלון זה‪ ,‬או אם חל שינוי בהרגשתך‬
‫הכללית עליך להתייעץ עם הרופא מיד‬
‫תרופה זו אינה מיועדת לילדים ומתבגרים‬
‫מתחת לגיל ‪.21‬‬
‫מינון לפי הוראות הרופא בלבד‪ .‬אין לעבור על‬
‫המנה המומלצת‪.‬‬
‫תרופה זו אינה מיועדת לילדים תחת גיל ‪.21‬‬
‫יש להשתמש בתרופה זו בזמנים קצובים כפי‬
‫שנקבע על‪-‬ידי הרופא המטפל‪.‬‬
‫אם שכחת ליטול תרופה זו בזמן קצוב‪ ,‬יש לדלג‬
‫על המנה ששכחת ולקחת את המנה הבאה‬
‫במועדה‪ .‬ליטול מנה מיד כשנזכרת‪ ,‬אך בכל‬
‫מקרה בשום אופן אין ליטול שתי מנות ביחד!‬
‫אם לא חל שיפור במצבך‪ ,‬יש לפנות לרופא‪.‬‬
‫כאשר מפסיקים את הטיפול בתרופה יש לעשות‬
‫זאת באופן הדרגתי במשך מספר ימים‪.‬‬
‫אין לכתוש או ללעוס את הטבליה!‬
‫יש לבלוע את התרופה עם כוס מים‪.‬‬
‫ניתן ליטול את התרופה ללא קשר לזמני‬
‫הארוחות‪.‬‬
‫אין להחזיק את התרופה בפה מעבר לזמן הדרוש‬
‫לבליעתה‪.‬‬
‫ניתן לחצות את הטבליה על פי קו החציה‬
‫המסומן‪.‬‬
‫עליך להשלים את הטיפול שהומלץ על‪-‬ידי‬
‫הרופא‪.‬‬
‫גם אם חל שיפור במצב בריאותך אין להפסיק‬
‫הטיפול בתרופה ללא התייעצות עם הרופא‪ ,‬וגם‬
‫אז רק באופן הדרגתי‪.‬‬
‫הפסקה פתאומית של השימוש בתרופה עלולה‬
‫להוביל למצב רפואי חמור‪ ,‬הקרוי סינדרום‬
‫סרוטונין‪ ,‬הכולל‪ :‬אקינזיה (אובדן כושר התנועה‬
‫בשרירים)‪ ,‬נוקשות של השרירים‪ ,‬חום‪ ,‬לחץ דם‬
‫לא יציב‪ ,‬קצב לב מואץ‪ ,‬בלבול‪ ,‬ירידה במצב‬
‫‪20 of 21‬‬
‫ההכרה‪.‬‬
‫‪21 of 21‬‬