ONGENTYS 50 mg HARD CAPSULES

2. What you need to know before you take 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 an adrenal gland tumor (known as pheochromocytoma), or a nervous system tumor (known as paraganglioma), or any other tumor that increases the risk of severe high blood pressure;
• if you have ever suffered from malignant neuroleptic 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) (e.g. phenelzine, tranylcypromine or moclobemide). Ask your doctor or pharmacist if you can take your antidepressant with Ongentys.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Ongentys:

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

Tell your doctor or pharmacist if you or your family/caregiver notice that you are developing desires or impulses to behave in an unusual way for 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: gambling addiction, abnormally increased sexual impulse or an increased concern with thoughts or feelings about sex. Such behaviors 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 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

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 of taking Ongentys and safinamide together. Your doctor may need to adjust your treatment;
• medicines for 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 rosuvastatin, simvastatin, atorvastatin or pravastatin. Ongentys may increase their effects;
• medicines that affect the immune system, such as methotrexate. Ongentys may increase their effects.
• medicines that contain 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 breastfeeding

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 an effective method of contraception if you can become pregnant.

It is not known whether Ongentys passes into breast milk. Because it cannot be excluded that there is a risk to the newborn/baby, you should interrupt breastfeeding during treatment with Ongentys.

Driving and using machines

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

Do not drive or use machines if you feel any of these side effects.

Ongentys contains lactose and sodium

Lactose: If your doctor has told you that you have an intolerance to some sugars, consult them 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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3. How to take Ongentys

Follow exactly the administration instructions of this medicine given by your doctor. In case of 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 you have taken levodopa.

Dose of other medicines for treating Parkinson's disease

It may be necessary to adjust the dose of other medicines for treating Parkinson's disease when you start taking Ongentys. Follow the instructions given by your doctor.

Method of administration

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 a hospital. 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 a dose, you should continue the treatment and take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Ongentys

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

If you stop taking Ongentys, your doctor may need to adjust the dose of the other medicines you are taking for 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.

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

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

Tell 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 movements

Common: may affect up to 1 in 10 people

• constipation
• dry mouth
• feeling sick (nausea)
• vomiting (feeling sick)
• increased levels of an enzyme in your blood (creatine kinase)
• muscle spasms
• dizziness
• headache
• sleepiness
• difficulty falling or staying asleep
• strange dreams
• experiencing or seeing things that do not exist (hallucinations)
• drop in blood pressure when standing up that causes dizziness, mild vertigo or fainting

Uncommon: may affect up to 1 in 100 people

• palpitations and irregular heartbeats
• blocked ear
• 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 of side effects

If you experience 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 to the Spanish Medicines Vigilance System for Human Use www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 carton/blister/label after EXP. The expiry date refers to the last day of the month shown.

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

Bottles: Keep the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What is in Ongentys

• The active substance is opicapone. Each hard capsule contains 50 mg of opicapone.
• The other ingredients are:
  • capsule content: lactose monohydrate, sodium starch glycolate (Type A), pregelatinized corn starch and magnesium stearate.
  • capsule shell: gelatin, indigo carmine (E132), erythrosine (E127) and titanium dioxide (E171).
  • printing ink: shellac, titanium dioxide (E171), propylene glycol, concentrated ammonia solution, simethicone

Appearance and packaging

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

The capsules are packaged in bottles or blister packs.

Bottles: 10, 30 or 90 capsules.

Blister packs: 10, 30 or 90 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]

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: 03/2022}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.