Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-086611 · Präparat HOS-083320

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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

Gegenanzeigen · Sifrol

SIFROL 0.26 mg prolonged-release tablets SIFROL 0.52 mg prolonged-release tablets SIFROL 1.05 mg prolonged-release tablets SIFROL 1.57 mg prolonged-release tablets SIFROL 2.1 mg prolonged-release tablets SIFROL 2.62 mg prolonged-release tablets SIFROL 3.15 mg prolonged-release tablets · Abschnitt 4.3 · PDF-Seite 20

HOS-086637 · Präparat HOS-083320

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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

Wechselwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-086612 · Präparat HOS-083320

Plasma protein binding Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man. Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely. As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated. There is no pharmacokinetic interaction with selegiline and levodopa.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): pramipexole (HOS-086613) selegiline (HOS-086575) levodopa (HOS-086559)

Wechselwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-086614 · Präparat HOS-083320

Inhibitors/competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules. Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, and procainamide, may interact with pramipexole resulting in reduced clearance of pramipexole. Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with SIFROL.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): pramipexole (HOS-086613) cimetidine (HOS-085835) mexiletine (HOS-086341) cisplatin (HOS-086022) quinine (HOS-086616) amantadine (HOS-086615) procainamide (HOS-086617) zidovudine (HOS-085837)

Wechselwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-086618 · Präparat HOS-083320

Combination with levodopa When SIFROL is given in combination with levodopa, it is recommended that the dose of levodopa is reduced and the dose of other anti-parkinsonian medicinal products is kept constant while increasing the dose of SIFROL.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): levodopa (HOS-086559)

Wechselwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-086619 · Präparat HOS-083320

Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see sections 4.4, 4.7 and 4.8).

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): pramipexole (HOS-086613)

Wechselwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-086620 · Präparat HOS-083320

Antipsychotic medicinal products Co-administration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e.g. if antagonistic effects can be expected.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): pramipexole (HOS-086613)

Wechselwirkungen · Sifrol

SIFROL 0.26 mg prolonged-release tablets SIFROL 0.52 mg prolonged-release tablets SIFROL 1.05 mg prolonged-release tablets SIFROL 1.57 mg prolonged-release tablets SIFROL 2.1 mg prolonged-release tablets SIFROL 2.62 mg prolonged-release tablets SIFROL 3.15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 21

HOS-086638 · Präparat HOS-083320

Plasma protein binding Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man. Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely. As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated. There is no pharmacokinetic interaction with selegiline and levodopa.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): pramipexole (HOS-086613) selegiline (HOS-086575) levodopa (HOS-086559)

Wechselwirkungen · Sifrol

SIFROL 0.26 mg prolonged-release tablets SIFROL 0.52 mg prolonged-release tablets SIFROL 1.05 mg prolonged-release tablets SIFROL 1.57 mg prolonged-release tablets SIFROL 2.1 mg prolonged-release tablets SIFROL 2.62 mg prolonged-release tablets SIFROL 3.15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 21

HOS-086639 · Präparat HOS-083320

Inhibitors/competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules. Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, and procainamide, may interact with pramipexole resulting in reduced clearance of pramipexole. Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with SIFROL.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): pramipexole (HOS-086613) cimetidine (HOS-085835) mexiletine (HOS-086341) cisplatin (HOS-086022) quinine (HOS-086616) amantadine (HOS-086615) procainamide (HOS-086617) zidovudine (HOS-085837)

Wechselwirkungen · Sifrol

SIFROL 0.26 mg prolonged-release tablets SIFROL 0.52 mg prolonged-release tablets SIFROL 1.05 mg prolonged-release tablets SIFROL 1.57 mg prolonged-release tablets SIFROL 2.1 mg prolonged-release tablets SIFROL 2.62 mg prolonged-release tablets SIFROL 3.15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 21

HOS-086640 · Präparat HOS-083320

Combination with levodopa When SIFROL is given in combination with levodopa, it is recommended that the dose of levodopa is reduced and the dose of other anti-parkinsonian medicinal products is kept constant while increasing the dose of SIFROL.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): levodopa (HOS-086559)

Wechselwirkungen · Sifrol

SIFROL 0.26 mg prolonged-release tablets SIFROL 0.52 mg prolonged-release tablets SIFROL 1.05 mg prolonged-release tablets SIFROL 1.57 mg prolonged-release tablets SIFROL 2.1 mg prolonged-release tablets SIFROL 2.62 mg prolonged-release tablets SIFROL 3.15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 21

HOS-086641 · Präparat HOS-083320

Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see sections 4.4, 4.7 and 4.8).

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): pramipexole (HOS-086613)

Wechselwirkungen · Sifrol

SIFROL 0.26 mg prolonged-release tablets SIFROL 0.52 mg prolonged-release tablets SIFROL 1.05 mg prolonged-release tablets SIFROL 1.57 mg prolonged-release tablets SIFROL 2.1 mg prolonged-release tablets SIFROL 2.62 mg prolonged-release tablets SIFROL 3.15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 21–22

HOS-086642 · Präparat HOS-083320

21 Antipsychotic medicinal products Co-administration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e.g. if antagonistic effects can be expected.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): pramipexole (HOS-086613)

Nebenwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-086621 · Präparat HOS-083320

Based on the analysis of pooled placebo-controlled trials, comprising a total of 1 923 patients on pramipexole and 1 354 patients on placebo, adverse drug reactions were frequently reported for both groups. 63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.

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

Nebenwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-086622 · Präparat HOS-083320

The majority of adverse drug reactions usually start early in therapy and most tend to disappear even as therapy is continued.

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

Nebenwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-086623 · Präparat HOS-083320

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).

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

Nebenwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-086624 · Präparat HOS-083320

Parkinson’s disease, most common adverse reactions The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’s disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue. The incidence of somnolence is increased at doses higher than 1.5 mg pramipexole salt per day (see section 4.2). A more frequent adverse drug reaction in combination with levodopa was dyskinesia. Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.

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

Nebenwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.8 · PDF-Seite 8–10

HOS-086625 · Präparat HOS-083320

8 Table 1: Parkinson’s disease 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 pneumonia infestations Endocrine inappropriate disorders antidiuretic hormone secretion1 Psychiatric insomnia compulsive mania disorders hallucinations shopping abnormal dreams pathological confusion gambling restlessness behavioural hypersexuality symptoms of delusion impulse control libido disorder disorders and paranoia compulsions delirium binge eating1 hyperphagia1 Nervous somnolence headache sudden onset of system dizziness sleep disorders dyskinesia amnesia hyperkinesia syncope Eye disorders visual impairment including diplopia vision blurred visual acuity reduced 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 breast disorders erection General fatigue dopamine disorders and peripheral agonist administration oedema withdrawal site conditions syndrome including apathy, anxiety, 9  depression, fatigue, sweating and pain. Investigations weight decrease weight increase including decreased appetite 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 2 762 patients with Parkinson’s Disease treated with pramipexole.

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

Nebenwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-086626 · Präparat HOS-083320

Restless Legs Syndrome, most common adverse reactions The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with pramipexole were nausea, headache, 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).

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

Nebenwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-086627 · Präparat HOS-083320

Table 2: Restless Legs Syndrome Body System Very Common Uncommon Rare Not known common (≥ 1/100 to (≥ 1/1 000 to < 1/100) (≥ 1/10 000 (≥ 1/10) < 1/10) 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 sleep system augmentation dizziness syncope disorders syndrome somnolance dyskinesia amnesia1 hyperkinesia1 Eye disorders visual impairment including visual acuity reduced diplopia vision blurred Cardiac cardiac failure1

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

Nebenwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.8 · PDF-Seite 10–11

HOS-086628 · Präparat HOS-083320

10 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 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.