Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ongentys 25 mg hard capsules
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Opicapone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Ongentys contains the active substance opicapone. It is used to treat Parkinson's disease and associated movement problems. Parkinson's disease is a progressive disease of the nervous system that causes shaking and affects your movement. Ongentys is for use in adults who are already taking medicines containing levodopa and DOPA decarboxylase inhibitors. It increases the effects of levodopa and helps to relieve the symptoms of Parkinson's disease and movement problems.
2.
What you need to know before you take it
e Ongentys
Do not take Ongentys: if you are allergic to opicapone or any of the other ingredients of this medicine (listed in section 6); if you have a tumour of the adrenal gland (known as phaeochromocytoma), or of the nervous system (known as paraganglioma), or any other tumour which increase the risk of severe high blood pressure; if you have ever suffered from neuroleptic malignant syndrome which is a rare reaction to antipsychotic medicines; if you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury; if you are taking certain antidepressants called monoamine-oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine or moclobemide). Ask your doctor or pharmacist if you can take your antidepressant together with Ongentys. Warnings and precautions Talk to your doctor or pharmacist before taking Ongentys: if you have severe liver problems and suffered from loss of appetite, weight loss, weakness, or exhaustion within a short period of time. Your doctor may need to reconsider your treatment.
Talk to your doctor or pharmacist if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm you or others. These behaviours are called 'impulse control disorders' and can include: addictive gambling, an abnormally high sex drive or an increased preoccupation with sexual thoughts or feelings. Behaviours such as these have been reported in patients using other medicines for Parkinsons ́s disease. Your doctor may need to review your treatments. Children and adolescents Children and adolescents under the age of 18 years must not take this medicine. It has not been studied in these age groups since treatment of Parkinson's disease is not relevant in children and adolescents. Other medicines and Ongentys Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you are taking: medicines for depression or anxiety such as venlafaxine, maprotiline and desipramine. Taking Ongentys with these medicines may increase the risk of side effects. Your doctor may need to adjust your treatment; safinamide used for Parkinson's disease. There is no experience taking Ongentys and safinamide together. Your doctor may need to adjust your treatment; medicines to treat asthma such as rimiterole or isoprenaline. Ongentys may increase their effect; medicines used to treat allergic reactions such as adrenaline. Ongentys may increase their effect; medicines used to treat heart failure such as dobutamine, dopamine or dopexamine. Ongentys may increase their effects; medicines for high cholesterol such as rosuvastatin, simvastatin, atorvastatin or pravastatin Ongentys may increase their effects; medicines that affect the immune system such as methotrexate. Ongentys may increase its effect; medicines containing quinidine, a medicine used to treat abnormal heart rhythms or malaria. Taking Ongentys and quinidine together, i.e. at the same time, may decrease the effect of Ongentys. Pregnancy and breast-feeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Ongentys is not recommended if you are pregnant. You should use effective contraception if you might become pregnant. It is not known if Ongentys passes into breast milk in humans. Since the risk to the baby/infant cannot be excluded, you should stop breast-feeding during treatment with Ongentys. Driving and using machines Ongentys taken with levodopa may make you feel light-headed, dizzy, or sleepy. Do not drive or operate machinery if you experience any of these side effects.
Ongentys contains lactose and sodium
- Lactose: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
- Sodium: This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'. 3.
How to take it
Ongentys
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 50 mg once daily. Ongentys should be taken preferably at bedtime. Take Ongentys at least one hour before or after taking your levodopa medicine. Doses of other medicines to treat Parkinson's disease The dose of other medicines to treat Parkinson's disease may need to be adjusted when you start taking Ongentys. Follow the instructions that your doctor has given you. Method of administration Ongentys is for oral use. Swallow the capsule whole with a glass of water. If you take more Ongentys than you should If you take more Ongentys than you should, tell your doctor or pharmacist, or go to a hospital immediately. Take the medicine package and this leaflet with you. This will help the doctor identify what you have taken. If you forget to take Ongentys If you forget to take one dose, you should continue the treatment and take the next dose as scheduled. Do not take a double dose to make up for a forgotten dose. If you stop taking Ongentys Do not stop taking Ongentys unless your doctor tells you to as your symptoms may get worse. If you stop taking Ongentys your doctor may need to adjust the dose of other medicines that you are taking to treat Parkinson's disease. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects
caused by Ongentys are usually mild to moderate and occur mostly within the first weeks of treatment. Some side effects may be caused by the increased effects of using Ongentys together with levodopa. Contact your doctor straight away if you experience any side effects at the start of treatment. Many of the side effects can be managed by your doctor adjusting your levodopa medicine. Tell your doctor as soon as possible if you notice any of the following side effects:
Very common: may affect more than 1 in 10 people involuntary and uncontrollable, or difficult or painful body movements Common: may affect up to 1 in 10 people constipation dry mouth feeling sick (nausea) vomiting (being sick) increased levels of the enzyme (creatine kinase) in your blood muscle spasm dizziness headache sleepiness difficulty falling or staying asleep strange dreams experiencing or seeing things which do not exist (hallucinations) a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting Uncommon: may affect up to 1 in 100 people palpitations or irregular heartbeat blocked ear dry eye pain or swelling of the abdomen indigestion weight loss loss of appetite increased levels of triglycerides (fats) in your blood muscle twitching, stiffness or pain pain in arms or legs altered sense of taste excessive body movements fainting anxiety depression hearing things which do not exist nightmares sleep disorder abnormal colour of urine need to wake and pass urine at night shortness of breath high or low blood pressure Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
Ongentys
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle/blister/carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special temperature storage conditions. Blisters: Store in the original blister in order to protect from moisture. Bottles: Keep the bottle tightly closed in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Ongentys contains The active substance is opicapone. Each hard capsule contains 25 mg of opicapone. The other ingredients are: o capsule content: lactose monohydrate, sodium starch glycolate (Type A), pregelatinized maize starch and magnesium stearate o capsule shell: gelatine, indigo carmine aluminium lake (E 132), erythrosine (E 127) and titanium dioxide (E 171) o printing ink: shellac, propylene glycol, ammonia solution, concentrated, indigo carmine aluminium lake (E132) What Ongentys looks like and contents of the pack Ongentys 25 mg hard capsules are light blue, approximately 19 mm length, with "OPC 25" and "Bial" printed on the capsules. The capsules are packaged in bottles or blisters. Bottles: 10 or 30 capsules. Blisters: 10 or 30 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer 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: [email protected] For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: België/Belgique/Belgien/България/Česká republika/ Deutschland/Eesti/Ελλάδα/France/ Hrvatska/Ireland/ Italia/Κύπρος/Latvija/ Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/Nederland/ Österreich/Polska/Portugal/
España Laboratorios BIAL, S.A. Tel: + 34 91 562 41 96
Danmark
România/Slovenija/Slovenská republika/ United Kingdom (Northern Ireland) BIAL – Portela & Ca, S.A. Tél/Tel/Teл./Tlf/Τηλ: + 351 22 986 61 00
Nordicinfu Care AB Tlf: +45 (0) 70 28 10 24 Suomi/Finland Nordicinfu Care AB Puh/Tel: +358 (0) 207 348 760
Ísland / Sverige Nordicinfu Care AB Tel / Sími: +46 (0) 8 601 24 40 Norge Nordicinfu Care AB Tlf: +47 (0) 22 20 60 00
This leaflet was last revised in 01/2023.
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Frequently asked questions about Ongentys 25 mg hard capsules
How do I take Ongentys 25 mg hard capsules?
Ongentys 25 mg hard capsules comes as capsule containing 25mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ongentys 25 mg hard capsules?
The active substance in Ongentys 25 mg hard capsules is opicapone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ongentys 25 mg hard capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ongentys 25 mg hard capsules without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: opicapone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
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.
4.2. Posology and method of administration
Posology
The recommended dose is 50 mg of opicapone.
Ongentys should be taken once-daily at bedtime at least one hour before or after levodopa combinations.
Dose adjustments of antiparkinsonian therapy
Ongentys is to be administered as an adjunct to levodopa treatment and enhances the effects of levodopa. Hence, it is often necessary to adjust levodopa dose by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after initiating the treatment with opicapone according to the clinical condition of the patient (see section 4.4).
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.
Special populations
Elderly
No dose adjustment is needed for elderly patients (see section 5.2).
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 (see section 5.2).
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 (see section 5.2).
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C), therefore, opicapone is not recommended in these patients (see section 5.2).
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.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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 (see section 4.5).
4.4. 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 (see section 4.2).
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.
Excipients
Ongentys contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Ongentys contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
4.5. 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 (see section 4.3).
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 opicapone when 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.
Quinidine
A study conducted in healthy volunteers showed that when a single dose of 50 mg opicapone was coadministered (within 1 hour) with a single dose of quinidine (600 mg), systemic exposure of opicapone decreased by 37% (AUC0-tlast). Thus, particular consideration should be given to cases where quinidine needs to be administered together with opicapone as their co-administration should be avoided.
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.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of opicapone in pregnant women. Opicapone crossed the placenta in rats. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Ongentys is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding
Opicapone levels in the milk of lactating rats were equivalent to those in plasma. It is unknown whether opicapone or its metabolites are excreted into 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 (see section 5.3).
4.7. 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.
4.8. 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%).
Tabulated list of adverse reactions
In the table below (Table 1) all adverse reactions are presented by System Organ Class 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), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Table 1 – Frequency of adverse reactions (MedDRA) in placebo-controlled Phase 3 studies
System Organ Class
Very common
Common
Uncommon
Metabolism and nutrition disorders
Decreased appetite, Hypertriglyceridaemia
Psychiatric disorders
Abnormal dreams, Hallucination, Hallucination visual, Insomnia
Anxiety, Depression, Hallucination auditory, Nightmare, Sleep disorder
Nervous system disorders
Dyskinesia
Dizziness, Headache, Somnolence
Dysgeusia, Hyperkinesia, Syncope
Eye disorders
Dry eye
Ear and labyrinth disorders
Ear congestion
Cardiac disorders
Palpitations
Vascular disorders
Orthostatic Hypotension
Hypertension, Hypotension
Respiratory, thoracic and mediastinal disorders
Dyspnoea
Gastrointestinal disorders
Constipation, Dry mouth, Nausea, Vomiting
Abdominal distention, Abdominal pain, Abdominal pain upper, Dyspepsia
Musculoskeletal and connective tissue disorders
Muscle spasms
Muscle twitching, Musculoskeletal stiffness, Myalgia, Pain in extremity
Renal and urinary disorders
Chromaturia, Nocturia
Investigations
Blood creatine phosphokinase increased
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. 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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- ONGENTYS 50 mg prescriptionOPICAPONUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- OngentysOpicaponum
- OntilyvOpicaponum
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Ongentys 25 mg hard capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.