Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Pramipexole Teva

Pramipexole Teva 0.088 mg tablets Pramipexole Teva 0.18 mg tablets Pramipexole Teva 0.35 mg tablets Pramipexole Teva 0.7 mg tablets · Abschnitt 4.8 · PDF-Seite 9–11

HOS-119871 · Präparat HOS-095037

9 Table 2: Restless Legs Syndrome Body System Very Common Uncommon Rare Not known common (≥ 1/100 to (≥ 1/1 000 to (≥ 1/10 000 (≥ 1/10) < 1/10) < 1/100) to < 1/1 000) Infections and pneumonia1 infestations Endocrine inappropriate disorders antidiuretic hormone secretion1 Psychiatric insomnia restlessness disorders abnormal confusion dreams hallucinations libido disorder delusion1 hyperphagia1 paranoia1 mania1 delirium1 behavioural symptoms of impulse control disorders and compulsions1 (such as: compulsive shopping, pathological gambling, hypersexuality, binge eating) Nervous Restless legs headache sudden onset of system augmentation dizziness sleep disorders syndrome somnolence syncope dyskinesia amnesia1 hyperkinesia1 Eye disorders visual impairment including visual acuity reduced diplopia vision blurred Cardiac cardiac failure1 disorders Vascular hypotension disorders Respiratory, dyspnoea thoracic, and hiccups mediastinal disorders Gastrointestinal nausea constipation disorders vomiting Skin and hypersensitivity subcutaneous pruritus tissue disorders rash Reproductive spontaneous system and penile 10  breast disorders erection General fatigue peripheral oedema dopamine disorders and agonist administration withdrawal site conditions syndrome including apathy, anxiety, depression, fatigue, sweating and pain Investigations weight decrease including decreased appetite weight increase 1 This side effect has been observed in post-marketing experience. With 95 % certainty, the frequency category is not greater than uncommon, but might be lower. A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 1 395 patients with Restless Legs Syndrome treated with pramipexole.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.