Package Insert: Information for the Patient

Ongentys 50 mg Hard Capsules

opicapona

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

- Keep this package insert, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Ongentys and how is it used

2. What you need to know before starting to take Ongentys

3. How to take Ongentys

4. Possible side effects

5. Storage of Ongentys

6. Contents of the pack and additional information

Ongentys contains the active ingredient opicapone. It is used to treat Parkinson's disease and associated movement problems. Parkinson's disease is a progressive nervous system disorder that causes tremor and affects movement.

Ongentys is used in adults who are already taking medications that contain levodopa and DOPA decarboxylase inhibitors. It increases the effects of levodopa and helps to alleviate the symptoms of Parkinson's disease and movement problems.

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 tumor of the adrenal gland (known as pheochromocytoma), or of the nervous system (known as paraganglioma), or any other tumor that increases the risk of severe high blood pressure;
• if you have ever suffered from a rare condition called neuroleptic malignant syndrome, which is a rare reaction to antipsychotic medicines;
• if you have ever suffered from a rare muscle disorder called rhabdomyolysis that was not caused by an injury;
• if you are taking certain antidepressants called monoamine oxidase inhibitors (MAOIs) (such as phenelzine, tranylcypromine or moclobemide). Ask your doctor or pharmacist if you can take your antidepressant with Ongentys.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ongentys:

-if you have severe liver problems and experience loss of appetite, weight loss, weakness or fatigue over a short period of time. Your doctor may need to reconsider your treatment.

Inform your doctor or pharmacist if you or your family/carer notice that you are developing unusual desires or impulses to behave in an unusual way in you or that you cannot resist the impulse, determination or temptation to perform certain activities that may harm you or others. These behaviors are called ‘impulse control disorders’ and may include: compulsive gambling, abnormally elevated sexual drive or an increased concern about sexual thoughts or feelings. Behaviors like these have been reported in patients using other medicines for Parkinson's disease.

Your doctor may need to review your treatments.

Children and adolescents

Children and adolescents under 18 years old should not take this medicine. It has not been studied in these age groups as the treatment of Parkinson's disease is not relevant in children and adolescents.

Other medicines and Ongentys

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Inform 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;
• safinamida used for Parkinson's disease. There is no experience of taking Ongentys and safinamida together. Your doctor may need to adjust your treatment;
• medicines to treat asthma, such as rimiterol or isoprenaline. Ongentys may increase their effects;
• medicines used to treat allergic reactions, such as adrenaline. Ongentys may increase their effects;
• medicines used to treat heart failure, such as dobutamine, dopamine or dopexamine. Ongentys may increase their effects;
• medicines for high cholesterol, such as rosuvastatina, simvastatina, atorvastatina or pravastatina. Ongentys may increase their effects;
• medicines that affect the immune system, such as methotrexate. Ongentys may increase their effects.
• medicines that contain quinidina, a medicine used to treat abnormal heart rhythms or malaria. Taking Ongentys and quinidina together, that is, at the same time, may decrease the effect of Ongentys.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Ongentys is not recommended if you are pregnant. You should use an effective contraceptive if you can become pregnant.

It is unknown whether Ongentys passes into breast milk. As the risk to the newborn/baby cannot be ruled out, you should stop breastfeeding during treatment with Ongentys.

Driving and operating machines

Taking Ongentys with levodopa may make you feel dizzy, with vertigo or drowsy.

Do not drive or operate machines if you experience any of these side effects.

Ongentys contains lactose and sodium

Lactose: If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine

Sodium: This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is, essentially “sodium-free”.

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Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 50 mg once a day.

Ongentys should be taken preferably at bedtime.

Take Ongentys at least one hour before or after taking levodopa.

Dose of other medications for Parkinson's disease

You may need to adjust the dose of other medications for Parkinson's disease when starting Ongentys. Follow the instructions given by your doctor.

Administration form

Ongentys is taken orally.

Swallow the capsule whole with a glass of water.

If you take more Ongentys than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to the hospital. Bring the medication packaging and this leaflet with you. This will help the doctor to identify what you have taken.

If you forget to take Ongentys

If you forget to take a dose, continue treatment and take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ongentys

Do not stop taking Ongentys unless your doctor tells you to, as this may worsen your symptoms.

If you stop taking Ongentys, your doctor may need to adjust the dose of other medications you are taking for Parkinson's disease.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects caused by Ongentys are generally mild to moderate and occur mainly in the first weeks of treatment. Some side effects may be caused by the increased effects of using Ongentys together with levodopa.

Immediately contact your doctor if you experience any side effect at the start of treatment. Many of the side effects can be controlled by your doctor adjusting the levodopa medication.

Inform your doctor as soon as possibleif you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

- involuntary and uncontrollable body movements, or difficult or painful

Common: may affect up to 1 in 10 people

- constipation

- dry mouth

- feeling unwell (nausea)

- vomiting (feeling nauseous)

- increased levels of an enzyme in your blood (creatinine kinase)

- muscle spasms

- dizziness

- headache

- drowsiness

- difficulty falling or staying asleep

- strange dreams

- experiencing or seeing things that do not exist (hallucinations)

- low blood pressure when standing that causes dizziness, light-headedness or fainting

Uncommon: may affect up to 1 in 100 people

- palpitations and irregular heartbeats

- ear plugged

- dry eye

- abdominal pain or swelling

- indigestion

- weight loss

- loss of appetite

- increased levels of triglycerides (fats) in the blood

- muscle fasciculations, stiffness or pain

- pain in arms and legs

- altered sense of taste

- excessive body movements

- fainting

- anxiety

- depression

- hearing things that do not exist

- nightmares

- sleep disorder

- abnormal urine color

- need to wake up and urinate at night

- shortness of breath

- high or low blood pressure

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle/ blister/ box after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Blister packs: Store in the original blister pack to protect it from moisture.

Bottles: Keep the bottle perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Ongentys

- The active ingredient is opicapone. Each hard capsule contains 50 mg of opicapone.

- The other components are:

• capsule content: lactose monohydrate, sodium glycolate starch (Type A), pregelatinized cornstarch, and magnesium stearate.
• capsule coating: gelatin, indigotin (E132), erythrosine (E127), and titanium dioxide (E171).
• printing ink: shellac, titanium dioxide (E171), propylene glycol, concentrated ammonia solution, and simethicone

Appearance of the product and contents of the package

- Ongentys 50 mg hard capsules are dark blue capsules, approximately 19 mm in length, with the imprint “OPC 50” and “Bial”.

The capsules are packaged in bottles or blisters.

Bottles: 10, 30, or 90 capsules.

Blister packs: 10, 30, or 90 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible 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]

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet: 03/2022}

Other sources of information

The detailed information about this medication is available on the European Medicines Agency website:http://www.ema.europa.eu.