Onerji · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-100882 · has-adverse-reaction-information · PDF-Seite 9

Summary of safety profile The most frequent adverse reactions reported with Onerji were infusion site reactions including nodule (70.4%), haematoma (64.9%), pain (23.2%), infection (19.3%), erythema (18.4%), eschar (12.9%) and dyskinesia (11.5%). Refer to section 4.4 for mitigation measures. Tabulated list of adverse reactions In table 3 below, adverse reactions expected from Onerji are presented by System Organ Class (SOC) and frequency. Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), and not known (cannot be estimated from the available data). Table 3 Tabulated list of adverse reactions System Organ Very common Common Uncommon Not known3 Class Infections and Infusion site Urinary tract infestations infection1, 2 infection Neoplasm Malignant benign, melanoma malignant and unspecified (incl. cysts and polyps) Blood and Anaemia, lymphatic Agranulocytosis, system disorders Thrombocytopenia, Leukopenia Immune system Hypersensitivity1 disorders Metabolism and Vitamin B6 Hyperhomocystein Decreased appetite nutrition deficiency1 aemia, Folate disorders deficiency1, Vitamin B12 deficiency1 Psychiatric Anxiety, Abnormal dreams, Suicidal ideation, disorders Hallucinations1, Confusional state, Psychotic disorder, Insomnia Delusion, Agitation, Depression1, Disorientation, Impulse-control Dopamine

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HOS-100878 · has-contraindication-information · PDF-Seite 4

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Narrow-angle glaucoma. 4 • Concomitant administration of non-selective monoamine oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine). • Patients with significant cognitive impairment. • Conditions in which adrenergics are contraindicated, e.g. phaeochromocytoma, hyperthyroidism and Cushing's syndrome.

HOS-100877 · has-indication-information · PDF-Seite 2

Onerji is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease which are not sufficiently controlled by oral anti-Parkinson medicinal products.

HOS-100880 · has-interaction-information · PDF-Seite 7

No interaction studies have been performed with Onerji. The following interactions are known from the generic combination of levodopa/carbidopa. Non-selective monoamine oxidase (MAO) inhibitors Levodopa is contraindicated in patients treated with non-selective monoamine oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine, see section 4.3), as coadministration of levodopa with non-selective MAO inhibitors could result in hypertensive crisis. These inhibitors must be discontinued at least 14 days prior to initiating therapy with Onerji. Caution is needed in concomitant administration of Onerji with the following medicinal products: Selective monoamine oxidase (MAO) inhibitors The use of selective MAO-B inhibitors (e.g. rasagiline and selegiline) with levodopa may be associated with orthostatic hypotension. Patients who are taking these medicinal products should be monitored. COMT inhibitors (tolcapone, entacapone, opicapone) COMT inhibitors increase the bioavailability of levodopa. An adjustment of the dose of Onerji may be needed. Amantadine Amantadine has synergic effect with levodopa and may increase levodopa related renal and hepatic impairment events. An adjustment of the dose of Onerji may be needed. 7 Tricyclic antidepressants There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant administration of tricyclic antidepressants and levodopa. Antihypertensives The concurrent use of levodopa/carbidopa with antihypertensive medicinal products can cause symptomatic postural hypotension. A dose reduction of the antihypertensive medicinal products may be needed after initiating treatment or increasing the dose of Onerji. Dopamine D2 receptor antagonists and isoniazid Dopamine D2 receptor antagonists (e.g. phenothiazines, butyrophenones, risperidone and metoclopramide), and isoniazid, may reduce the therapeutic effect of levodopa. Monitor patients for worsening of Parkinson’s disease symptoms.

HOS-100881 · has-pregnancy-information · PDF-Seite 8

Pregnancy There are no adequate data from the use of levodopa/carbidopa in pregnant women. Studies of levodopa and carbidopa in animals have shown reproduction toxicity (see section 5.3). Onerji is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding Levodopa and possibly levodopa metabolites are excreted in human milk. There is evidence that lactation is suppressed during treatment with levodopa. It is unknown whether carbidopa or its metabolites are excreted in human milk. Animal studies have shown excretion of carbidopa in breast milk. There is insufficient information on the effects of levodopa/carbidopa or their metabolites in newborns/infants. Breast-feeding should be discontinued during treatment with Onerji. Fertility In reproduction studies, no effects on fertility were observed in rats receiving levodopa/carbidopa.

HOS-100879 · has-warning-information · PDF-Seite 5

Somnolence and episodes of sudden sleep onset Levodopa has been associated with somnolence and episodes of sudden sleep onset (see section 4.7). 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 (see section 4.7). Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore, a reduction of dose or termination of therapy may be considered. Withdrawal-induced hyperpyrexia and confusion A symptom complex that resembles neuroleptic malignant syndrome (characterised by elevated temperature, muscular rigidity, altered consciousness and autonomic instability) with no other obvious aetiology, has been reported in association with rapid dose reduction, withdrawal of, or change in dopaminergic therapy (see section 4.2). Cardiovascular ischaemic events Levodopa should be administered with caution in patients with severe cardiovascular disease. In patients with a history of myocardial infarction who have residual atrial, nodal or ventricular arrhythmias, cardiac function should be monitored with particular care during the period of initial Onerji dose adjustments. Hallucinations, psychosis, confusion There is an increased risk of hallucinations and psychosis in patients taking levodopa. Hallucinations may present shortly after the initiation of levodopa therapy and be responsive to levodopa dose reduction. Hallucinations may be accompanied by confusion, insomnia, and excessive dreaming. Abnormal thinking and behaviour may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation and delirium. Patients with a major psychotic disorder or a history of psychotic disorder must be treated cautiously with Onerji because of the risk of exacerbating psychosis. In addition, medicinal products that antagonise the effects of dopamine used to treat psychosis may exacerbate the symptoms of Parkinson’s disease and may decrease the effectiveness of Onerji. Impulse control, compulsive behaviours Patients may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, as well as the inability to cont

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