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

HOS-288059 · has-adverse-reaction-information · PDF-Seite 12

Summary of the safety profile The most frequently reported adverse drug reactions (ADRs) that were reported in a phase 3 clinical trial are: blood prolactin increased (11.7%), hyperprolactinaemia (7.2%), akathisia (5.5%), headache (4.8%), somnolence (4.1%), weight increased (3.8%), injection site pain (3.1%) and dizziness (3.1%). Tabulated list of adverse reactions The following are all the ADRs that were reported in clinical trials and post-marketing experience with risperidone by frequency category estimated from risperidone clinical trials. The following terms and frequencies are applied: 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) and very rare (< 1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse Drug Reaction System Frequency Organ Class Very Very Not Common Uncommon Rare Common Rare known Infections pneumonia, respiratory tract infection and bronchitis, upper infection, cystitis, infestations respiratory tract eye infection, infection, tonsillitis, 12  Adverse Drug Reaction System Frequency Organ Class Very Very Not Common Uncommon Rare Common Rare known sinusitis, urinary onychomycosis, tract infection, ear cellulitis localised infection, infection, viral influenza infection, acarodermatitis Blood and neutropenia, white agranulocytosis lymphatic

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HOS-288055 · has-contraindication-information · PDF-Seite 4

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

HOS-288054 · has-indication-information · PDF-Seite 2

OKEDI is indicated for the treatment of schizophrenia in adults for whom tolerability and effectiveness have been established with oral risperidone.

HOS-288057 · has-interaction-information · PDF-Seite 8

The interactions of OKEDI with co-administration of other medicinal products have not been systematically evaluated. The interaction data provided in this section are based on studies with oral risperidone. 8 Pharmacodynamic-related interactions Medicinal products known to prolong the QT interval Caution is advised when prescribing OKEDI with medicinal products known to prolong the QT interval, such as antiarrhythmics (e.g., quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), tricyclic antidepressants (i.e., amitriptyline), tetracyclic antidepressants (i.e., maprotiline), some antihistamines, other antipsychotics, some antimalarials (i.e., quinine and mefloquine), and with medicines causing electrolyte imbalance (hypokalaemia, hypomagnesaemia), bradycardia, or those which inhibit the hepatic metabolism of risperidone. This list is indicative and not exhaustive. Centrally-acting medicinal products and alcohol OKEDI should be used with caution in combination with other centrally-acting substances, notably including alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation. Levodopa and dopamine agonists OKEDI may antagonise the effect of levodopa and other dopamine agonists. If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed. Medicinal products with hypotensive effect Clinically significant hypotension has been observed post-marketing with concomitant use of risperidone and antihypertensive treatment. Psychostimulants The combined use of psychostimulants (e.g. methylphenidate) with OKEDI can lead to extrapyramidal symptoms upon change of either or both treatments (see section 4.4). Paliperidone Concomitant use of OKEDI with paliperidone is not recommended as paliperidone is the active metabolite of risperidone and the combination of the two may lead to additive active moiety exposure. Pharmacokinetic-related interactions OKEDI is mainly metabolised through Cytochrome P (CYP) 2D6, and to a lesser extent through CYP3A4. Both risperidone and its active metabolite 9-hydroxy-risperidone are substrates of P- glycoprotein (P-gp). Substances that modify CYP2D6 activity, or substances strongly inhibiting or inducing CYP3A4 and/or P-gp activity, may influence the pharmacokinetics of the risperidone active moiety. Strong CYP2D6 inhibitors Co-administrati

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HOS-288058 · has-pregnancy-information · PDF-Seite 11

Pregnancy There are no or limited amount of data from the use of risperidone in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Neonates exposed to antipsychotics (including risperidone) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of 11 agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully. OKEDI should not be used during pregnancy unless clearly necessary. Breast-feeding Physico-chemical data suggest excretion of risperidone/metabolites in breast milk. A risk to the breastfed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from OKEDI therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility Risperidone elevates prolactin level. Hyperprolactinaemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. There were no relevant effects observed in the non-clinical studies.

HOS-288056 · has-warning-information · PDF-Seite 4

For risperidone-naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with OKEDI (see section 4.2). Consideration should be given to the prolonged release nature of the medicinal product and the long elimination half-life of risperidone when assessing treatment needs and the potential need to be able to discontinue treatment. 4 Elderly patients with dementia Increased mortality in elderly people with dementia OKEDI has not been studied in elderly patients with dementia, hence it should not be used in this group of patients. In a meta-analysis of 17 controlled trials of atypical antipsychotics, including risperidone, elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo. In placebo-controlled trials with oral risperidone in this population, the incidence of mortality was 4% for risperidone-treated patients compared to 3.1% for placebo-treated patients. The odds ratio (95% exact confidence interval) was 1.21 (0.7; 2.1). The mean age (range) of patients who died was 86 years (range 67-100). Data from two large observational studies showed that elderly people with dementia who are treated with conventional antipsychotics are also at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic active substance as opposed to some characteristic(s) of the patients is not clear. Concomitant use with furosemide In the risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90). The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials. Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings. No pathophysiological mechanism has been identified to explain this finding, and no cons

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