Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Stalevo

Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Stalevo 100 mg/25 mg/200 mg film-coated tablets Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Stalevo 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-112350 · Präparat HOS-093651

Convulsions have occurred rarely with levodopa/carbidopa; however a causal relationship to levodopa/carbidopa therapy has not been established.

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

Nebenwirkungen · Stalevo

Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Stalevo 100 mg/25 mg/200 mg film-coated tablets Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Stalevo 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-112351 · Präparat HOS-093651

Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Stalevo (see section 4.4).

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

Nebenwirkungen · Stalevo

Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Stalevo 100 mg/25 mg/200 mg film-coated tablets Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Stalevo 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-112352 · Präparat HOS-093651

Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with carbidopa/levodopa. Affected patients show a compulsive pattern of dopaminergic drug misuse above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias (see also section 4.4).

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

Nebenwirkungen · Stalevo

Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Stalevo 100 mg/25 mg/200 mg film-coated tablets Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Stalevo 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-112353 · Präparat HOS-093651

Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.

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

Nebenwirkungen · Stalevo

Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Stalevo 100 mg/25 mg/200 mg film-coated tablets Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Stalevo 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-112354 · Präparat HOS-093651

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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

Wechselwirkungen · Neupro

Neupro 1 mg/24 h transdermal patch Neupro 3 mg/24 h transdermal patch · Abschnitt 4.5 · PDF-Seite 5–6

HOS-114654 · Präparat HOS-094135

5 Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa.

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): carbidopa (HOS-086562)

Wechselwirkungen · Neupro

Neupro 2 mg/24 h transdermal patch · Abschnitt 4.5 · PDF-Seite 19

HOS-114681 · Präparat HOS-094135

Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa.

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): carbidopa (HOS-086562)

Wechselwirkungen · Neupro

Neupro 4 mg/24 h transdermal patch Neupro 6 mg/24 h transdermal patch Neupro 8 mg/24 h transdermal patch · Abschnitt 4.5 · PDF-Seite 38

HOS-114717 · Präparat HOS-094135

Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa.

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): carbidopa (HOS-086562)

Wechselwirkungen · Neupro

Neupro 2 mg/24 h 4 mg/24 h 6 mg/24 h 8 mg/24 h Transdermal patch · Abschnitt 4.5 · PDF-Seite 53

HOS-114741 · Präparat HOS-094135

Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa.

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): carbidopa (HOS-086562)

Wechselwirkungen · Entacapone Teva

Entacapone Teva 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 4

HOS-213531 · Präparat HOS-155128

No interaction of entacapone with carbidopa has been observed with the recommended treatment schedule. Pharmacokinetic interaction with benserazide has not been studied.

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): carbidopa (HOS-086562) benserazide (HOS-086563)

Wechselwirkungen · Entacapone Orion

Entacapone Orion 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 4

HOS-215634 · Präparat HOS-155488

No interaction of entacapone with carbidopa has been observed with the recommended treatment schedule. Pharmacokinetic interaction with benserazide has not been studied.

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): carbidopa (HOS-086562) benserazide (HOS-086563)

Gegenanzeigen · Levodopa/Carbidopa/Entacapone Orion

Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-125963 · Präparat HOS-096201

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Severe hepatic impairment. - Narrow-angle glaucoma. - Pheochromocytoma. - Coadministration of Levodopa/Carbidopa/Entacapone Orion with non-selective monoamine oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine, tranylcypromine). - Coadministration with a selective MAO-A inhibitor and a selective MAO-B inhibitor (see section 4.5). - A previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.

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): phenelzine (HOS-087875) tranylcypromine (HOS-087876)

Wechselwirkungen · Levodopa/Carbidopa/Entacapone Orion

Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-125966 · Präparat HOS-096201

Other antiparkinsonian medicinal products: To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Levodopa/Carbidopa/Entacapone Orion therapy. Entacapone in high doses may affect the absorption of carbidopa. However, no interaction with carbidopa has been observed with the recommended treatment schedule (200 mg of entacapone up to 10 times daily). Interactions between entacapone and selegiline have been investigated in repeated dose studies in Parkinson's disease patients treated with levodopa/DDC inhibitor and no interaction was observed. When used with Levodopa/Carbidopa/Entacapone Orion, the daily dose of selegiline should not exceed 10 mg.

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): selegiline (HOS-086575)

Wechselwirkungen · Levodopa/Carbidopa/Entacapone Orion

Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-125968 · Präparat HOS-096201

Caution should be exercised when the following active substances are administered concomitantly with levodopa therapy.

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

Wechselwirkungen · Levodopa/Carbidopa/Entacapone Orion

Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-125969 · Präparat HOS-096201

Antihypertensives: Symptomatic postural hypotension may occur when levodopa is added to the treatment of patients already receiving antihypertensives. Dose adjustment of the antihypertensive agent may be required.

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

Wechselwirkungen · Levodopa/Carbidopa/Entacapone Orion

Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-125970 · Präparat HOS-096201

Antidepressants: Rarely, reactions including hypertension and dyskinesia have been reported with the concomitant use of tricyclic antidepressants and levodopa/carbidopa. Interactions between entacapone and imipramine and between entacapone and moclobemide have been investigated in single dose studies in healthy volunteers. No pharmacodynamic interactions were observed. A significant number of Parkinson's disease patients have been treated with the combination of levodopa, carbidopa and entacapone with several active substances including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine and medicinal products that are metabolised by COMT (e.g. catechol-structured compounds, paroxetine). No pharmacodynamic interactions have been observed. However, caution should be exercised when these medicinal products are used concomitantly with Levodopa/Carbidopa/Entacapone Orion (see sections 4.3 and 4.4).

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): maprotiline (HOS-086572) paroxetine (HOS-086246) desipramine (HOS-086249) imipramine (HOS-085907) moclobemide (HOS-087879) venlafaxine (HOS-086573)

Wechselwirkungen · Levodopa/Carbidopa/Entacapone Orion

Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-125972 · Präparat HOS-096201

Other active substances: Dopamine receptor antagonists (e.g. some antipsychotics and antiemetics), phenytoin and papaverine may reduce the therapeutic effect of levodopa. Patients taking these medicinal products with Levodopa/Carbidopa/Entacapone Orion should be carefully observed for loss of therapeutic response.

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): dopamine (HOS-085948) papaverine (HOS-112321) phenytoin (HOS-084531)

Wechselwirkungen · Levodopa/Carbidopa/Entacapone Orion

Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-125974 · Präparat HOS-096201

Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Levodopa/Carbidopa/Entacapone Orion may potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as S-warfarin. However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R- warfarin increased on average by 18% [CI90 11–26%]. The INR values increased on average by 13%

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): warfarin (HOS-085950)

Wechselwirkungen · Levodopa/Carbidopa/Entacapone Orion

Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7–8

HOS-125975 · Präparat HOS-096201

7 [CI90 6–19%]. Thus, a control of INR is recommended when Levodopa/Carbidopa/Entacapone Orion is initiated for patients receiving warfarin.

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): warfarin (HOS-085950)

Wechselwirkungen · Levodopa/Carbidopa/Entacapone Orion

Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-125976 · Präparat HOS-096201

Other forms of interactions: Since levodopa competes with certain amino acids, the absorption of Levodopa/Carbidopa/Entacapone Orion may be impaired in some patients on high protein diet.

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