Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Tasmar

Tasmar 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 4

HOS-086557 · Präparat HOS-083306

• Hypersensitivity to tolcapone or any of its other ingredients listed in section 6.1. • Evidence of liver disease or increased liver enzymes. • Severe dyskinesia. • A previous history of Neuroleptic Malignant Syndrome (NMS) Symptom Complex and/or nontraumatic rhabdomyolysis or hyperthermia. • Phaeochromocytoma. • Treatment with non-selective mono amino oxidase (MAO) inhibitors.

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

Gegenanzeigen · Tasmar

Tasmar 200 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 16

HOS-086589 · Präparat HOS-083306

• Hypersensitivity to tolcapone or any of its other ingredients listed in section 6.1. • Evidence of liver disease or increased liver enzymes. • Severe dyskinesia. • A previous history of Neuroleptic Malignant Syndrome (NMS) Symptom Complex and/or nontraumatic rhabdomyolysis or hyperthermia. • Phaeochromocytoma. • Treatment with non-selective mono amino oxidase (MAO) inhibitors.

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

Wechselwirkungen · Tasmar

Tasmar 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-086558 · Präparat HOS-083306

Tasmar, as a COMT inhibitor, is known to increase the bioavailability of the co-administered levodopa. The consequent increase in dopaminergic stimulation can lead to the dopaminergic adverse reactions observed after treatment with COMT inhibitors. The most common of these are increased dyskinesia, nausea, vomiting, abdominal pain, syncope, orthostatic complains, constipation, sleep disorders, somnolence, hallucination.

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) lead (HOS-085592)

Wechselwirkungen · Tasmar

Tasmar 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-086560 · Präparat HOS-083306

Levodopa has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines (see section 4.7). Furthermore a reduction of levodopa dose or termination of therapy may be considered.

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 · Tasmar

Tasmar 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-086561 · Präparat HOS-083306

Catechols and other drugs metabolised by catechol-O-methyltransferase (COMT) Tolcapone may influence the pharmacokinetics of drugs metabolised by COMT. No effects were seen on the pharmacokinetics of the COMT substrate carbidopa. An interaction was observed with benserazide, which may lead to increased levels of benserazide and its active metabolite. The magnitude of the effect was dependent on the dose of benserazide. The plasma concentrations of benserazide observed after co-administration of tolcapone and benserazide-25 mg/levodopa were still within the range of values observed with levodopa/benserazide alone. On the other hand, after coadministration of tolcapone and benserazide-50 mg/levodopa the benserazide plasma concentrations could be increased above the levels usually observed with levodopa/benserazide alone. The effect of tolcapone on the pharmacokinetics of other drugs metabolised by COMT such as -methyldopa, dobutamine, apomorphine, adrenaline and isoprenaline have not been evaluated. The prescriber should be observant of adverse reactions caused by putative increased plasma levels of these drugs when combined with Tasmar.

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) methyldopa (HOS-086564) dobutamine (HOS-086565) apomorphine (HOS-086566) carbidopa (HOS-086562) benserazide (HOS-086563) lead (HOS-085592)

Wechselwirkungen · Tasmar

Tasmar 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-086567 · Präparat HOS-083306

Effect of tolcapone on the metabolism of other drugs Due to its affinity for cytochrome CYP2C9 in vitro, tolcapone may interfere with drugs whose clearance is dependent on this metabolic pathway, such as tolbutamide and warfarin. In an interaction study, tolcapone did not change the pharmacokinetics of tolbutamide. Therefore, clinically relevant interactions involving cytochrome CYP2C9 appear unlikely.

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): tolbutamide (HOS-086568) warfarin (HOS-085950)

Wechselwirkungen · Tasmar

Tasmar 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-086569 · Präparat HOS-083306

Since clinical information is limited regarding the combination of warfarin and tolcapone, coagulation parameters should be monitored when these drugs are co-administered.

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 · Tasmar

Tasmar 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-086570 · Präparat HOS-083306

Drugs that increase catecholamines Since tolcapone interferes with the metabolism of catecholamines, interactions with other drugs affecting catecholamine levels are theoretically possible.

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

Wechselwirkungen · Tasmar

Tasmar 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6–7

HOS-086571 · Präparat HOS-083306

6 When Tasmar was given together with levodopa/carbidopa and desipramine, there was no significant change in blood pressure, pulse rate and plasma concentrations of desipramine. Overall, the frequency of adverse reactions increased slightly. These adverse reactions were predictable based on the known adverse reactions to each of the three drugs individually. Therefore, caution should be exercised when potent noradrenaline uptake inhibitors such as desipramine, maprotiline, or venlafaxine are administered to Parkinson’s disease patients being treated with Tasmar and levodopa preparations.

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): desipramine (HOS-086249) maprotiline (HOS-086572) venlafaxine (HOS-086573) levodopa (HOS-086559) carbidopa (HOS-086562)

Wechselwirkungen · Tasmar

Tasmar 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-086574 · Präparat HOS-083306

In clinical trials, patients receiving Tasmar/levodopa preparations reported a similar adverse reaction profile independent of whether or not they were also concomitantly administered selegiline (a MAO-B inhibitor).

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) selegiline (HOS-086575)

Wechselwirkungen · Tasmar

Tasmar 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 18

HOS-086590 · Präparat HOS-083306

Tasmar, as a COMT inhibitor, is known to increase the bioavailability of the co-administered levodopa. The consequent increase in dopaminergic stimulation can lead to the dopaminergic adverse reactions observed after treatment with COMT inhibitors. The most common of these are increased dyskinesia, nausea, vomiting, abdominal pain, syncope, orthostatic complains, constipation, sleep disorders, somnolence, hallucination.

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) lead (HOS-085592)

Wechselwirkungen · Tasmar

Tasmar 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 18

HOS-086591 · Präparat HOS-083306

Levodopa has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines (see section 4.7). Furthermore a reduction of levodopa dose or termination of therapy may be considered.

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 · Tasmar

Tasmar 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 18

HOS-086592 · Präparat HOS-083306

Catechols and other drugs metabolised by catechol-O-methyltransferase (COMT) Tolcapone may influence the pharmacokinetics of drugs metabolised by COMT. No effects were seen on the pharmacokinetics of the COMT substrate carbidopa. An interaction was observed with benserazide, which may lead to increased levels of benserazide and its active metabolite. The magnitude of the effect was dependent on the dose of benserazide. The plasma concentrations of benserazide observed after co-administration of tolcapone and benserazide-25 mg/levodopa were still within the range of values observed with levodopa/benserazide alone. On the other hand, after coadministration of tolcapone and benserazide-50 mg/levodopa the benserazide plasma concentrations could be increased above the levels usually observed with levodopa/benserazide alone. The effect of tolcapone on the pharmacokinetics of other drugs metabolised by COMT such as -methyldopa, dobutamine, apomorphine, adrenaline and isoprenaline have not been evaluated. The prescriber should be observant of adverse reactions caused by putative increased plasma levels of these drugs when combined with Tasmar.

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) methyldopa (HOS-086564) dobutamine (HOS-086565) apomorphine (HOS-086566) carbidopa (HOS-086562) benserazide (HOS-086563) lead (HOS-085592)

Wechselwirkungen · Tasmar

Tasmar 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 18

HOS-086593 · Präparat HOS-083306

Effect of tolcapone on the metabolism of other drugs Due to its affinity for cytochrome CYP2C9 in vitro, tolcapone may interfere with drugs whose clearance is dependent on this metabolic pathway, such as tolbutamide and warfarin. In an interaction study, tolcapone did not change the pharmacokinetics of tolbutamide. Therefore, clinically relevant interactions involving cytochrome CYP2C9 appear unlikely.

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): tolbutamide (HOS-086568) warfarin (HOS-085950)

Wechselwirkungen · Tasmar

Tasmar 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 18

HOS-086594 · Präparat HOS-083306

Since clinical information is limited regarding the combination of warfarin and tolcapone, coagulation parameters should be monitored when these drugs are co-administered.

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 · Tasmar

Tasmar 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 18

HOS-086595 · Präparat HOS-083306

Drugs that increase catecholamines Since tolcapone interferes with the metabolism of catecholamines, interactions with other drugs affecting catecholamine levels are theoretically possible.

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

Wechselwirkungen · Tasmar

Tasmar 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 18–19

HOS-086596 · Präparat HOS-083306

18 When Tasmar was given together with levodopa/carbidopa and desipramine, there was no significant change in blood pressure, pulse rate and plasma concentrations of desipramine. Overall, the frequency of adverse reactions increased slightly. These adverse reactions were predictable based on the known adverse reactions to each of the three drugs individually. Therefore, caution should be exercised when potent noradrenaline uptake inhibitors such as desipramine, maprotiline, or venlafaxine are administered to Parkinson’s disease patients being treated with Tasmar and levodopa preparations.

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): desipramine (HOS-086249) maprotiline (HOS-086572) venlafaxine (HOS-086573) levodopa (HOS-086559) carbidopa (HOS-086562)

Wechselwirkungen · Tasmar

Tasmar 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 19

HOS-086597 · Präparat HOS-083306

In clinical trials, patients receiving Tasmar/levodopa preparations reported a similar adverse reaction profile independent of whether or not they were also concomitantly administered selegiline (a MAO-B inhibitor).

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) selegiline (HOS-086575)

Nebenwirkungen · Tasmar

Tasmar 100 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-086576 · Präparat HOS-083306

The most commonly observed adverse reactions associated with the use of Tasmar, occurring more frequently than in placebo-treated patients are listed in the table below. However, Tasmar, as a COMT inhibitor, is known to increase the bioavailability of the co-administered levodopa. The consequent increase in dopaminergic stimulation can lead to the dopaminergic side effects observed after treatment with COMT inhibitors. The most common of these are increased dyskinesia, nausea, vomiting, abdominal pain, syncope, orthostatic complains, constipation, sleep disorders, somnolence, hallucination.

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

Nebenwirkungen · Tasmar

Tasmar 100 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-086577 · Präparat HOS-083306

The only adverse reaction commonly leading to discontinuation of Tasmar in clinical trials was diarrhoea (see section 4.4).

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