Expected Adverse Reactions: The following side effects are listed
under the use of Sifrol: Abnormal dreams, amnesia, cardiac failure, behavioural
symptoms of impulse control disorders and compulsions e.g., binge eating,
compulsive shopping, hypersexuality and pathological gambling; confusion,
constipation, delirium, delusion, dizziness, dyskinesia, dyspnoea, fatigue, hallucinations,
headache, hiccups, hyperkinesia, hyperphagia, hypotension, inappropriate
antidiuretic hormone secretion, insomnia, libido disorders, mania, nausea,
paranoia, peripheral oedema, pneumonia, pruritus, rash and other
hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope,
visual impairment including diplopia, blurred vision and reduced visual acuity,
vomiting, decreased weight including decreased appetite, weight increase.
The
most commonly (≥5%) reported adverse drug reactions in patients with
Parkinson's disease more frequent with Sifrol treatment than with placebo were
nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation,
hallucination, headache and fatigue. The incidence of somnolence is increased
at doses >1.5 mg/day (see Dosage & Administration). A more frequent
adverse drug reaction in combination with levodopa was dyskinesia. Hypotension
may occur at the beginning of treatment, especially if Sifrol is titrated too
fast.
Sifrol Immediate-Release Tablet: Based on the analysis of pooled placebo-controlled trials, comprising a total of 1923 patients on SIFROL and 1354 patients on placebo. adverse drug reactions were frequently reported for both groups. 63% of patients on SIFROL and 52% of patients on placebo reported at least one adverse drug reaction.
The majority of adverse reactions usually start early in therapy and most tend to disappear even as therapy is continued.
The most commonly (≥5%) reported adverse drug reactions in patients with Parkinson's disease more frequent with SIFROL treatment than with Placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucinatin, headache and fatigue. The incidence of somnolence is increased at doses higher than 1.5 mg/day (see Dosage & Administration). More frequent adverse drug reactions in combination with levodopa were dyskinesia. Hypotension may occur at the beginning of treatment, especially if SIFROL is titrated too fast. (See Table 3.)
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The most commonly (≥5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with SIFROL were nausea, headahe, dizziness, and fatigue. Nausea and fatigue were more often reported in female patients treated with SIFROL (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively). (See Table 4.)
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SIFROL is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%). (See Precautions.)
SIFROL may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
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.
Dopamine agonist withdrawal syndrome: Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including pramipexole. Symptoms include apathy, anxiety, depression, fatigue, sweating and pain (see Precautions).
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. A causal relationship between pramipexole and cardiac failure has not been demonstrated.
Inform the doctor or pharmacist immediately about side effects that occur while taking the drug.
Sifrol
Prolonged-Release Tablet: Based on the analysis of
pooled placebo-controlled trials, comprising a total of 1778 Parkinson's
disease patients on pramipexole and 1297 patients on placebo, adverse drug
reactions were frequently reported for both groups. Sixty-seven percent of
patients on pramipexole and 54% of patients on placebo reported at least 1
adverse drug reaction.
The adverse drug reactions reported as follows are
those events that occurred in ≥0.1% of patients treated with pramipexole and
were reported significantly more often in patients taking pramipexole than
placebo, or where the event was considered clinically relevant. The majority of
adverse drug reactions were mild to moderate; they usually start early in
therapy and most tended to disappear even as therapy was continued.
Within the system organ classes, adverse reactions
are listed under headings of frequency (number of patients expected to
experience the reaction), using the following categories: 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); not known (cannot be estimated from
the available data).
Infections and
Infestations: Uncommon: Pneumonia.
Psychiatric
Disorders: Common: Abnormal dreams, behavioural
symptoms of impulse control disorders and compulsions, confusion,
hallucinations, insomnia, restlessness, delirium.
Uncommon: Compulsive shopping, delusion,
hypersexuality, libido disorder, paranoia, pathological gambling.
Rare: Mania.
Not Known: Binge eating, hyperphagia.
Nervous System
Disorders: Very Common: Dizziness, dyskinesia,
somnolence.
Common: Amnesia, headache.
Uncommon: Hyperkinesia, sudden onset of sleep,
syncope.
Eye Disorders: Common: Visual disturbance including vision blurred and visual
acuity reduced.
Vascular
Disorders: Very Common: Hypotension.
Respiratory,
Thoracic and Mediastinal Disorders: Uncommon:
Dyspnoea.
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.
Uncommon: Weight increase.
Somnolence: Pramipexole is commonly associated with somnolence (8.6%) and has
been associated uncommonly with excessive daytime somnolence and sudden sleep
onset episodes (0.1%) (see Precautions).
Libido
Disorders: Pramipexole may uncommonly be associated
with libido disorders [increased or decreased].
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 Precautions).
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. A causal
relationship between pramipexole and cardiac failure has not been demonstrated.
In a cross-sectional, retrospective screening and case-control study including
3090 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 6 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.