Ongentys

Package leaflet: Information for the patient

Ongentys 25 mg hard capsules

opicapone
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Ongentys is and what it is used for
2. What you need to know before taking Ongentys
3. How to take Ongentys
4. Possible side effects
5. How to store Ongentys
6. Contents of the pack and other information

1. What Ongentys is and what it is used for

Ongentys contains the active substance opicapone and is used to treat Parkinson’s disease and
the associated movement disorders. Parkinson’s disease is a progressive disorder of the nervous
system that causes tremors and impairs movement.
Ongentys is intended for use in adults who are already taking medications containing levodopa and
DOPA decarboxylase inhibitors. This medicine enhances the effects of levodopa and helps improve the
symptoms of Parkinson’s disease and associated movement disorders.

2. What you should know before taking Ongentys

Do not take Ongentys

• if you are allergic to opicapone or to any of the other ingredients of this medicine (listed in section 6);
• if you have a tumour of the adrenal gland (called phaeochromocytoma) or of the nervous system (called paraganglioma), or any other type of tumour that increases the risk of very high blood pressure;
• if you have previously suffered from neuroleptic malignant syndrome, a rare reaction to antipsychotic medicines;
• if you have previously suffered from a rare muscle disorder called rhabdomyolysis not due to trauma;
• if you are taking certain antidepressants called monoamine oxidase inhibitors (MAO inhibitors) (e.g. phenelzine, tranylcypromine or moclobemide). Ask your doctor or pharmacist whether you can take the antidepressant together with Ongentys.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ongentys:

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

Talk to your doctor or pharmacist if you, a family member or your caregiver notice that you are
developing an urge or desire to behave in an unusual way or are unable to resist
the urge, desire or temptation to carry out activities that could be dangerous for you or for others.
These types of behaviour are known as “impulse control disorders” and may
include gambling addiction, abnormally increased sexual desire or increased
sexual thoughts or feelings. Such behaviours have been observed in
patients treated with other medicines for Parkinson’s disease.
Your doctor may need to review your treatment.

Children and adolescents
Children and adolescents under 18 years of age must not take this medicine. The medicine has not been
studied in this age group because 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 together with these medicines may increase the risk of side effects. Your doctor may need to adjust your treatment;
• safinamide, a medicine used for Parkinson’s disease. There is no experience with taking Ongentys and safinamide together. Your doctor may need to adjust your treatment;
• medicines used for asthma, such as rimiterol or isoprenaline. Ongentys may increase their effects;
• medicines used for allergic reactions, such as adrenaline. Ongentys may increase their effects;
• medicines used for 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 containing quinidine, a medicine used to treat heart rhythm disorders or malaria. Taking Ongentys and quinidine together (concomitantly) may reduce the effect of Ongentys.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Ongentys is not recommended during pregnancy. Use an effective contraceptive method if there is any possibility of becoming pregnant.
It is not known whether Ongentys passes into breast milk. Since a risk to the infant cannot be excluded, you must
discontinue breastfeeding during treatment with Ongentys.

Driving and using machines
Ongentys taken together with levodopa may cause dizziness, make you feel faint or sleepy.
Do not drive and do not operate machinery if you experience any of these side effects.

Ongentys contains lactose and sodium

• Lactose: if your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Ongentys

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
The recommended dose is 50 mg once daily.
Ongentys should preferably be taken before going to sleep.
Take Ongentys at least one hour before or one hour after taking your levodopa-containing medicine.

Dosing of other medicines used to treat Parkinson's disease
When you start taking Ongentys, it may be necessary to adjust the dose of other medicines used
to treat Parkinson's disease. Follow your doctor's instructions.

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, inform your doctor or pharmacist or go to hospital immediately.
Take the medicine pack and this leaflet with you. This will help the doctor understand what you have taken.

If you forget to take Ongentys
If you forget to take a dose, continue your treatment and take the next dose as scheduled.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Ongentys
Do not stop taking Ongentys unless your doctor tells you to, as otherwise your
symptoms may worsen.
If you stop taking Ongentys, your doctor may need to adjust the dose of other medicines you are taking for Parkinson's disease.

If you have any doubts about how to use this medicine, consult 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 during the first weeks of treatment. Some side effects may be due to an increased effect resulting from the use of Ongentys together with levodopa.
Contact your doctor immediately if you experience any side effects at the beginning of treatment.
Most side effects can be managed by your doctor adjusting the dose of levodopa.
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, difficult or painful body movements

Common: may affect up to 1 in 10 people

• constipation
• dry mouth
• feeling unwell (nausea)
• vomiting
• increased levels of an enzyme (creatine kinase) in the blood
• muscle spasms
• dizziness
• headache
• drowsiness
• difficulty falling asleep or staying asleep
• unusual dreams
• experiencing events or seeing things that are not real (hallucinations)
• drop in blood pressure upon standing, leading to dizziness, mild confusion or fainting

Uncommon: may affect up to 1 in 100 people

• palpitations or irregular heartbeat
• blocked ears
• dry eyes
• abdominal pain or swelling
• indigestion
• weight loss
• loss of appetite
• increased levels of triglycerides (fats) in the blood
• muscle cramps, stiffness or pain
• pain in arms or legs
• changes in taste sensation
• excessive body movements
• fainting
• anxiety
• depression
• hearing sounds that are not real
• feeling confused
• nightmares
• sleep disorders
• abnormal urine colour
• need to wake up at night to urinate
• shortness of breath
• high or low blood pressure
• falls
• feeling of low energy or tiredness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 pack/carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Blister packs: store in the original blister pack to protect the medicine from moisture.
Bottles: keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ongentys contains

• The active substance is opicapone. Each hard capsule contains 25 mg of opicapone.
• The other components are:
  – capsule contents: monohydrate lactose, sodium starch glycolate (type A), pregelatinized corn starch, and magnesium stearate
  – capsule shell: gelatin, indigotine, indigo carmine (E 132), erythrosine (E 127), and titanium dioxide (E 171)
  – printing ink: shellac, propylene glycol, concentrated ammonia solution, indigotine, indigo carmine (E 132)

Description of the appearance of Ongentys and contents of the pack
Ongentys 25 mg hard capsules are blue, approximately 19 mm long, with the inscriptions "OPC 25" and "Bial" printed on the capsules.
The capsules are packaged in bottles or in blister packs.
Bottles: 10 or 30 capsules.
Blister packs: 10 or 30 capsules.
Not all pack sizes may be marketed.

Marketing Authorization 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
Email: [email protected]

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien/ España
Deutschland/ Ελλάδα/France/ Laboratorios BIAL, S.A.
Ireland/ Italia/Κύπρος/ Tel: +34 91 562 41 96
Luxembourg/Luxemburg/
Malta/Nederland/ Österreich/Polska/Portugal/ България
România Medis Pharma Bulgaria EOOD
BIAL - Portela & Cª, S.A. Tel: +359(0)24274958
Tél/Tel/ Tlf/Τηλ: +351 22 986 61 00

Česká republika
Medis Pharma s.r.o.
Tel: +386(0)15896900

Danmark
Nordicinfu Care AB
Tlf: +45 (0) 70 28 10 24

Eesti / Latvija/ Lietuva
Medis Pharma Lithuania UAB
Tel: +386(0)15896900

Hrvatska
Medis Adria d.o.o.
Tel.: +385(0)12303446

Suomi/Finland
Nordicinfu Care AB
Puh/Tel: +358 (0) 207 348 760

Magyarország
Medis Hungary Kft
Tel: +36(0)23801028

Ísland / Sverige
Nordicinfu Care AB
Tel / Sími: +46 (0) 8 601 24 40

Norge
Nordicinfu Care AB
Tlf: +47 (0) 22 20 60 00

Slovenija
Medis d.o.o.
Tel: +386(0)15896900

Slovenská republika
Medis Pharma Slovakia s.r.o.
Tel: +42(1)232393403

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Patient information leaflet

Ongentys 50 mg hard capsules

opicapone
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Ongentys is and what it is used for
2. What you need to know before taking Ongentys
3. How to take Ongentys
4. Possible side effects
5. How to store Ongentys
6. Contents of the pack and other information

1. What Ongentys is and what it is used for

Ongentys contains the active substance opicapone and is used to treat Parkinson's disease and
associated movement disorders. Parkinson's disease is a progressive disorder of the nervous
system that causes tremors and impairs movement.
Ongentys is intended for use in adults who are already taking medications containing levodopa and DOPA decarboxylase inhibitors. This medicine enhances the effects of levodopa and helps improve the symptoms
of Parkinson's disease and associated movement disorders.

2. What you need to know before taking Ongentys

Do not take Ongentys

• if you are allergic to opicapone or to any of the other ingredients of this medicine (listed in section 6);
• if you have a tumour of the adrenal gland (called phaeochromocytoma) or of the nervous system (called paraganglioma), or any other type of tumour that increases the risk of very high blood pressure;
• if you have previously suffered from neuroleptic malignant syndrome, a rare reaction to antipsychotic medicines;
• if you have previously suffered from a rare muscle disorder called rhabdomyolysis not caused by trauma;
• if you are taking certain antidepressants called monoamine oxidase inhibitors (MAO inhibitors) (e.g. phenelzine, tranylcypromine or moclobemide). Ask your doctor or pharmacist whether 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 have experienced loss of appetite, weight loss, weakness or exhaustion within a short period of time. Your doctor may need to reassess your treatment.

Talk to your doctor or pharmacist if you, a family member or the person caring for you notice that you are
developing an impulse or desire to behave in an unusual way or are unable to resist the impulse, desire or
temptation to carry out activities that could be dangerous for you or others. These types of behaviour are
called “impulse control disorders” and may include gambling addiction, abnormally increased sexual desire or
increased sexual thoughts or feelings. Such behaviours have been observed in patients treated with other
medicines for Parkinson’s disease.
Your doctor may need to review your treatment.

Children and adolescents
Ongentys must not be used in children and adolescents under 18 years of age. The medicine has not been
studied in this age group because 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 together with these medicines may increase the risk of side effects. Your doctor may need to adjust your treatment;
• safinamide, a medicine used for Parkinson’s disease. There is no experience with taking Ongentys and safinamide together. Your doctor may need to adjust your treatment;
• medicines used for asthma, such as rimiterol or isoprenaline. Ongentys may increase their effects;
• medicines used for allergic reactions, such as adrenaline. Ongentys may increase their effects;
• medicines used for 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 containing quinidine, a medicine used to treat abnormal heart rhythms or malaria. Taking Ongentys together with quinidine may reduce the effect of Ongentys.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Ongentys is not recommended during pregnancy. Use an effective method of contraception if there is any
possibility of becoming pregnant.
It is not known whether Ongentys passes into breast milk. Since the risk to the infant cannot be ruled out,
you must stop breastfeeding during treatment with Ongentys.

Driving and using machines
Ongentys taken together with levodopa may cause dizziness, make you feel faint or sleepy.
Do not drive or operate machinery if you experience any of these side effects.

Ongentys contains lactose and sodium

• Lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Ongentys

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 50 mg once daily.
Ongentys should preferably be taken before going to sleep.
Take Ongentys at least one hour before or one hour after taking your levodopa-containing medicine.

Dosing of other medicines used to treat Parkinson's disease
When you start taking Ongentys, it may be necessary to adjust the dose of other medicines used to treat Parkinson's disease. Follow your doctor's instructions.

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, inform your doctor or pharmacist or go immediately to hospital. Take the medicine pack and this leaflet with you. This will help your doctor understand what you have taken.

If you forget to take Ongentys
If you forget to take a dose, continue your treatment and take the next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Ongentys
Do not stop taking Ongentys unless your doctor tells you to, because otherwise your symptoms may worsen.
If you stop taking Ongentys, your doctor may need to adjust the dose of other medicines you are taking for Parkinson's disease.

If you have any questions about how to use 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 during the first weeks of treatment. Some side effects may be due to an increased effect resulting from the use of Ongentys together with levodopa.
Contact your doctor immediately if you experience any side effects at the beginning of treatment.
Most side effects can be managed by your doctor adjusting the dose of levodopa.
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, difficult, or painful body movements

Common: may affect up to 1 in 10 people

• constipation
• dry mouth
• feeling unwell (nausea)
• vomiting
• increased levels of an enzyme (creatine kinase) in the blood
• muscle spasms
• dizziness
• headache
• drowsiness
• difficulty falling asleep or staying asleep
• unusual dreams
• experiencing events or seeing things that are not real (hallucinations)
• drop in blood pressure upon standing, causing dizziness, mild confusion, or fainting

Uncommon: may affect up to 1 in 100 people

• palpitations or irregular heartbeat
• blocked ears
• dry eyes
• abdominal pain or swelling
• indigestion
• weight loss
• loss of appetite
• increased levels of triglycerides (fats) in the blood
• muscle cramps, stiffness, or pain
• pain in arms or legs
• changes in taste sensation
• excessive body movements
• fainting
• anxiety
• depression
• hearing sounds that are not real
• feeling confused
• nightmares
• sleep disorders
• abnormal urine colour
• need to wake up at night to urinate
• shortness of breath
• high or low blood pressure
• falls
• feeling of low energy or fatigue

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ongentys

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle/blister pack/box after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Blister packs: keep in the original blister pack to protect the medicine from moisture.
Bottles: keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ongentys contains

• The active substance is opicapone. Each hard capsule contains 50 mg of opicapone.
• The other components are:
  o capsule contents: lactose monohydrate, sodium starch glycolate (type A), pregelatinized corn starch, and magnesium stearate
  o capsule shell: gelatin, indigotine, indigo carmine (E 132), erythrosine (E 127), and titanium dioxide (E 171)
  o printing ink: shellac, titanium dioxide (E 171), propylene glycol, concentrated ammonia solution, simethicone

Description of the appearance of Ongentys and pack contents
Ongentys 50 mg hard capsules are dark blue, approximately 19 mm long, with the inscriptions “OPC 50” and “Bial” printed on the capsules.
The capsules are packaged in bottles or in blisters.
Bottles: 10, 30, or 90 capsules.
Blister packs: 10, 30, or 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Bial - Portela & Cª, S.A.
Av. da Siderurgia Nacional
4745-457 S. Mamede do Coronado
Portugal
Tel: +351 22 986 61 00
Fax: +351 22 986 61 90
Email: [email protected]

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien/ España
Deutschland/ Ελλάδα/France/ Laboratorios BIAL, S.A.
Ireland/ Italia/Κύπρος/ Tel: + 34 91 562 41 96
Luxembourg/Luxemburg/
Malta/Nederland/ Österreich/Polska/Portugal/ България
România Medis Pharma Bulgaria EOOD
BIAL - Portela & Cª, S.A. Tel: +359(0)24274958
Tél/Tel/ Tlf/Τηλ: + 351 22 986 61 00

Česká republika
Medis Pharma s.r.o.
Tel: +386(0)15896900

Danmark
Nordicinfu Care AB
Tlf: +45 (0) 70 28 10 24

Eesti / Latvija/ Lietuva
Medis Pharma Lithuania UAB
Tel: +386(0)15896900

Hrvatska
Medis Adria d.o.o.
Tel.: +385(0)12303446

Suomi/Finland
Nordicinfu Care AB
Puh/Tel: +358 (0) 207 348 760

Magyarország
Medis Hungary Kft
Tel: +36(0)23801028

Ísland / Sverige
Nordicinfu Care AB
Tel / Sími: +46 (0) 8 601 24 40

Norge
Nordicinfu Care AB
Tlf: +47 (0) 22 20 60 00

Slovenija
Medis d.o.o.
Tel: +386(0)15896900

Slovenská republika
Medis Pharma Slovakia s.r.o.
Tel: +42(1)232393403

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION OF THE TERMS OF THE
MARKETING AUTHORISATION(S)

Scientific conclusions
Taking into account the assessment by the Pharmacovigilance Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for opicapone, the PRAC's scientific conclusions are as follows:
Based on available data regarding confusion, derived from clinical trials and spontaneous reports, including several cases with a close temporal association and a positive de-challenge (cessation of treatment), and considering a plausible mechanism of action, the PRAC considers that a causal relationship between opicapone and confusion may at least represent a reasonable possibility. The PRAC concludes that, therefore, the product information for medicinal products containing opicapone should be updated accordingly.

Having reviewed the PRAC's recommendation, the Committee for Human Medicinal Products (CHMP) agrees with its overall conclusions and the rationale behind the recommendation.

Grounds for the variation of the terms of the marketing authorisations
Based on the scientific conclusions on opicapone, the CHMP considers that the benefit-risk balance of medicinal products containing opicapone remains unchanged, subject to the proposed amendments to the product information.
The CHMP recommends a variation to the terms of the marketing authorisations.