Prescribing Information

Summary of Product Characteristics – Portugal
Summary of Product Characteristics - Spain
Summary of Product Characteristics - Germany
Summary of Product Characteristics – EN

Ongentys® Opicapone Please refer to the SPC before prescribing. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Presentation: OngentysP P50 mg hard capsules. Indication: Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. Posology and method of administration:  The recommended dose of opicapone is 50 mg.  Ongentys should be taken once-daily at bedtime at least one hour before or after levodopa combinations. Dose adjustments of antiparkinsonian therapy: Opicapone enhances the effects of levodopa. Hence, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating the treatment with opicapone.  Missed dose: If one dose is missed, the next dose should be taken as scheduled. The patient should not take an extra dose to make up for the missed dose. Elderly: No dose adjustment is needed for elderly patients. Caution must be exercised in patients ≥ 85 years of age as there is limited experience in this age group. Renal impairment: No dose adjustment is necessary in patients with renal impairment, as opicapone is not excreted by the kidney. Hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh Class B). Caution must be exercised in these patients and dose adjustment may be necessary. There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C), therefore, Ongentys is not recommended in these patients. Paediatric population: There is no relevant use of Ongentys in the paediatric population with Parkinson’s disease and motor fluctuations. Method of administration: Oral use. The capsules should be swallowed whole with water. Contraindications:  Hypersensitivity to the active substance or to any of the excipients. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms. History of neuroleptic malignant syndrome and/or non-traumatic rhabdomyolysis. Concomitant use with monoamine oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson’s disease. Special warnings and precautions for use: Dose adjustments of antiparkinsonian therapy: Ongentys is to be administered as an adjunct to levodopa treatment. Hence, the precautions valid for levodopa treatment should also be taken into account for Ongentys. Opicapone enhances the effects of levodopa. To reduce levodopa-related dopaminergic adverse reactions (e.g. dyskinesia, hallucinations, nausea, vomiting and orthostatic hypotension), it is often necessary to adjust the daily dose of levodopa by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after initiating treatment with Ongentys, according to the clinical condition of the patient.  If Ongentys is discontinued it is necessary to adjust the dosing of the other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the symptoms. Psychiatric disorders: Patients and care-givers should be made aware that impulse control disorders including 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. Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop. Others: Increases in liver enzymes were reported in studies with nitrocatechol inhibitors of catechol-O-methyltransferase (COMT). For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered. Intolerance to excipients: Ongentys contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ongentys. Interaction with other medicinal products and other forms of interaction: Monoamino oxidase (MAO) inhibitors: Combination of opicapone and MAO inhibitors could result in inhibition of the majority of the pathways responsible for the metabolism of catecholamines. Because of this, concomitant use of opicapone with MAO inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson’s disease is contraindicated. Concomitant use of opicapone and MAO inhibitors for the treatment of Parkinson’s disease, e.g. rasagiline (up to 1 mg/day) and selegiline (up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation), is permissible. There is no experience with opicaponeR Rwhen used concomitantly with the MAO-B inhibitor safinamide. Therefore, their concomitant use should be considered with appropriate caution. Medicinal products metabolised by COMT: Opicapone may interfere with the metabolism of medicinal products containing a catechol group that are metabolised by COMT, e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dopexamine or dobutamine, leading to potentiated effects of these medicinal products. Careful monitoring of patients being treated with these medicinal products is advised when opicapone is used. Tricyclic antidepressants and noradrenaline re-uptake inhibitors: There is limited experience with opicapone when used concomitantly with tricyclic antidepressants and noradrenaline re-uptake inhibitors (e.g. venlafaxine, maprotiline and desipramine). Thus, their concomitant use should be considered with appropriate caution. CYP2C8 and OATP1B1 substrates: Opicapone is a weak in vitro inhibitor of CYP2C8 and OATP1B1, whereas repaglinide is a sensitive CYP2C8 and OATP1B1 substrate. A study conducted in healthy subjects showed that there were no changes in repaglinide’s exposure when repaglinide was administered following multiple once-daily administration of opicapone 50 mg. Quinidine: A study conducted in healthy volunteers showed that when a single dose of 50 mg opicapone was co-administered (within 1 hour) with a single dose of quinidine (600 mg), systemic exposure of opicapone decreased by 37% (AUCR0-tlastR). Thus, particular consideration should be given to cases where quinidine needs to be administered together with opicapone as their co-administration should be avoided. Fertility, pregnancy and lactation: Pregnancy: There are no or limited amount of data from the use of opicapone in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Ongentys is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding: It is unknown whether opicapone or its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Ongentys. Fertility: The effects of opicapone on fertility in humans have not been studied. Animal studies with opicapone do not indicate harmful effects with respect to fertility. Effects on ability to drive and use machines: Opicapone in association with levodopa may have major influence on the ability to drive and use machines. Opicapone may, together with levodopa, cause dizziness, symptomatic orthostatism and somnolence. Therefore, caution should be exercised when driving or using machines. Undesirable effects: Summary of the safety profile:  The most common adverse reactions reported were nervous system disorders. Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%). List of adverse reactions: Very common  (≥ 1/10): Dyskinesia. Common (≥ 1/100 to < 1/10): Abnormal dreams, Hallucination, Hallucination visual, Insomnia, Dizziness, Headache, Somnolence, Orthostatic Hypotension, Constipation, Dry mouth, Vomiting, Muscle spasms, Blood creatine phosphokinase increased; Uncommon (≥ 1/1,000 to < 1/100) Decreased appetite, Hypertriglyceridaemia, Anxiety, Depression, Hallucination auditory, Nightmare, Sleep disorder., Dysgeusia, Hyperkinesia, Syncope,  Dry eye, Ear congestion, Palpitations, Hypertension, Hypotension, Dyspnoea, Abdominal distention, Abdominal pain, Abdominal pain upper, Dyspepsia, Muscle twitching, Musculoskeletal stiffness, Myalgia, Pain in extremity, Chromaturia, Nocturia, Weight decreased. 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 local regulations. Overdose: There is no known specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Removal of opicapone by gastric lavage and/or inactivation by administering activated charcoal should be considered. List of excipients: Capsule content: Lactose monohydrate; Sodium starch glycolate, Type A; Maize starch, pregelatinized; Magnesium stearate. Capsule shell: Gelatin; Indigo carmine aluminium lake (E132); Erythrosine (E127); Titanium dioxide (E171). Printing ink: Shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone. Special precautions for storage: This medicinal product does not require any special temperature storage conditions. Blisters:

Store in the original blister in order to protect from moisture. Nature and contents of container: OPA/Al/PVC//Al blisters containing 10, 30 or 90 capsules. Marketing Authorisation Holder: Bial - Portela & Cª, S.A. À Av. da Siderurgia Nacional. 4745-457 S. Mamede do Coronado. Portugal. Tel:+351 22 986 61 00. Fax: +351 22 986 61 90. e-mail: Uinfo@bial.comU. Marketing Authorisation number(s): EU/1/15/1066/002-004. Date of first Authorisation /Date of text Revision:

24PthP June 2016/13PthP December 2019. Currently it´s not available in all European Union countries. Adverse events must be reported to country Health Authorities following country procedures. ON/DEC19/G/276


date of preparation February 2020