ОНДЖЕНТИС 25 мг Капсулы

Содержание инструкции

1. Ongentys 25 mg hard capsules
   1. What is Ongentys and what is it 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. Package contents and other information
2. Ongentys 50 mg hard capsules
   1. What is Ongentys and what is it used for
   2. What you need to know before you take Ongentys
   3. How to take Ongentys
   4. Possible side effects
   5. How to store Ongentys
   6. Package contents and other information

Ongentys 25 mg hard capsules

opicapone

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Ongentys and what is it used for

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

2. What you need to know before taking 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 tumor of the adrenal gland (called pheochromocytoma) or of the nervous system (called paraganglioma), or any other type of tumor 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 disease called rhabdomyolysis, not due to trauma;
• 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 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 suffered from loss of appetite, weight loss, weakness or exhaustion in a short period of time. Your doctor may need to reassess the treatment you are receiving.

Talk to your doctor or pharmacist if you, a family member or the person who cares for you, notices that you are
developing the urge or desire to behave in a way that is unusual for you or are unable to resist
the urge, desire or temptation to carry out activities that may be harmful to you or to others.
These types of behavior are called “impulse control disorders” and may include gambling addiction, an
increased sexual desire or increased thoughts or feelings of a sexual nature. Behaviors of this type have
been observed in patients treated with other medicines for Parkinson’s disease.
Your doctor may need to check the treatment you are receiving.

Children and adolescents
Children and adolescents under 18 years of age should 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 therapy;
• safinamide, a medicine used for Parkinson’s disease. There is no experience regarding the concomitant use of Ongentys and safinamide. Your doctor may need to adjust your therapy;
• 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 have effects on the immune system, such as methotrexate. Ongentys may increase their effects;
• medicines containing quinidine, a medicine used to treat heart arrhythmias or malaria. Taking Ongentys and quinidine at the same time may decrease the effect of Ongentys.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Ongentys is not recommended if you are pregnant. Use effective contraception if there is a possibility that
you may become pregnant.
It is not known whether Ongentys passes into breast milk. As the risk to the baby cannot be excluded, 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 use machines 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 an intolerance to some 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is 50 mg/ once a day.
Ongentys should preferably be taken before going to sleep.
Take Ongentys at least one hour before or one hour after taking the medicine containing levodopa.

Dose 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
a doctor to understand what you have taken.

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

If you stop taking Ongentys
Do not stop treatment with Ongentys unless your doctor tells you to, as otherwise your
symptoms may worsen.
If you stop treatment with Ongentys, your doctor may need to adjust the dose of other
medicines you are taking to treat Parkinson's disease.
If you have any doubts about 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
during the first few weeks of treatment. Some side effects may be due to an increase
in the effect caused by the use of Ongentys together with levodopa.
Consult your doctor immediately if you experience any side effect at the beginning of treatment.
Most side effects can be managed by the doctor by adjusting the dose of 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, or 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
• sleepiness
• difficulty falling asleep or staying asleep
• strange dreams
• experiencing things or seeing things that are not there (hallucinations)
• low blood pressure when standing up, leading to dizziness, mild confusion or fainting

Uncommon: may affect up to 1 in 100 people

• palpitations or irregular heartbeat
• ears feeling blocked
• dry eye
• pain or swelling in the abdomen
• indigestion
• weight loss
• loss of appetite
• increased levels of triglycerides (fats) in the blood
• contractions, stiffness or muscle pain
• pain in the arms or legs
• changes in taste
• excessive body movements
• fainting
• anxiety
• depression
• hearing sounds that are not there
• feeling confused
• nightmares
• sleep disorders
• abnormal urine color
• 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, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the national reporting system
mentioned 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/box after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Blisters: 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 any medicine in 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 ingredient is opicapone. Each hard capsule contains 25 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, indigotine, carmine indigo (E 132), erythrosine (E 127) and titanium dioxide (E 171), printing ink: shellac, propylene glycol, concentrated ammonia solution, indigotine, carmine indigo (E 132)

Description of Ongentys and package contents
Ongentys 25 mg hard capsules are azure, approximately 19 mm long, with the inscriptions “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 further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien/
Deutschland/ Ελλάδα/France/
Ireland/ Italia/Κύπρος/
Luxembourg/Luxemburg/
Malta/Nederland/ Österreich/Polska/Portugal/
România
BIAL - Portela & Cª, S.A.
Tél/Tel/ Tlf/Τηλ: + 351 22 986 61 00

España
Laboratorios BIAL, S.A.
Tel: + 34 91 562 41 96

България
Medis Pharma Bulgaria EOOD
Teл.: +359(0)24274958

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 European Medicines Agency website,
http://www.ema.europa.eu.

Ongentys 50 mg hard capsules

opicapone

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Ongentys and what is it used for

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

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 a tumor of the adrenal gland (called pheochromocytoma) or of the nervous system (called paraganglioma), or any other type of tumor 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 disease called rhabdomyolysis, not due to trauma;
• 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 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 suffered from loss of appetite, weight loss, weakness or exhaustion in a short period of time. Your doctor may need to re-evaluate the treatment you are receiving.

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

Children and adolescents
Children and adolescents under 18 years of age should 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 therapy;
• safinamide, a medicine used for Parkinson’s disease. There is no experience regarding the concomitant use of Ongentys and safinamide. Your doctor may need to adjust your therapy;
• 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 have effects on the immune system, such as methotrexate. Ongentys may increase their effects;
• medicines containing quinidine, a medicine used for the treatment of abnormal heart rhythms or malaria. Taking Ongentys and quinidine at the same time may decrease the effect of Ongentys.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Ongentys is not recommended if you are pregnant. Use effective contraception if there is a possibility of
becoming pregnant.
It is not known whether Ongentys passes into breast milk. As the risk to the baby cannot be excluded, you should
stop breastfeeding during treatment with Ongentys.

Driving and using machines
Ongentys taken together with levodopa can cause dizziness, make you feel faint or drowsy.
Do not drive and do not use machines 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 an intolerance to some sugars, contact your doctor before taking this medicine.
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially ‘sodium-free’.

3. How to take Ongentys

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is 50 mg/ once a day.
Ongentys should preferably be taken before going to sleep.
Take Ongentys at least one hour before or one hour after taking the medicine based on levodopa.

Dose 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
a doctor to understand what you have taken.

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

If you stop taking Ongentys
Do not stop treatment with Ongentys unless your doctor tells you to, as otherwise your
symptoms may worsen.
If you stop treatment with Ongentys, your doctor may need to adjust the dose of other
medicines you are taking to treat Parkinson's disease.
If you have any doubts about 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
during the first few weeks of treatment. Some side effects may be due to an increase
in the effect caused by the use of Ongentys together with levodopa.
Consult your doctor immediately if you experience any side effect at the start of treatment.
Most side effects can be managed by the doctor by adjusting the dose of 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, or 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
• sleepiness
• difficulty falling asleep or staying asleep
• strange dreams
• experiencing things or seeing things that are not there (hallucinations)
• low blood pressure when standing up, leading to dizziness, mild confusion or fainting

Uncommon: may affect up to 1 in 100 people

• palpitations or irregular heartbeat
• ears feeling blocked
• dry eye
• pain or swelling in the abdomen
• indigestion
• weight loss
• loss of appetite
• increased levels of triglycerides (fats) in the blood
• contractions, stiffness or muscle pain
• pain in the arms or legs
• changes in taste
• excessive body movements
• fainting
• anxiety
• depression
• hearing sounds that are not there
• feeling confused
• nightmares
• sleep disorders
• abnormal urine color
• need to get 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, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system
described 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/box after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Blisters: 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 any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that 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 ingredients are: capsule contents: lactose monohydrate, sodium starch glycolate (type A), pregelatinized corn starch and magnesium stearate, capsule shell: gelatin, indigotine, carmine indigo (E 132), erythrosine (E 127) and titanium dioxide (E 171), printing ink: shellac, titanium dioxide (E 171), propylene glycol, concentrated ammonia solution, simethicone

Description of the appearance of Ongentys and package 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 blisters.
Bottles: 10, 30 or 90 capsules.
Blisters: 10, 30 or 90 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
e-mail: [email protected]
For further information on this medicinal product, contact the local representative of the marketing authorization holder:

België/Belgique/Belgien/
Deutschland/ Ελλάδα/France/
Ireland/ Italia/Κύπρος/
Luxembourg/Luxemburg/
Malta/Nederland/ Österreich/Polska/Portugal/
România
BIAL - Portela & Cª, S.A.
Tél/Tel/ Tlf/Τηλ: + 351 22 986 61 00

España
Laboratorios BIAL, S.A.
Tel: + 34 91 562 41 96

България
Medis Pharma Bulgaria EOOD
Teл.: +359(0)24274958

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 JUSTIFICATION FOR VARIATION(S) TO THE
MARKETING AUTHORISATION(S)
Scientific conclusions
Taking into account the evaluation of the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for opicapone, the PRAC’s scientific conclusions are as follows:
Based on the available data regarding confusional state, obtained from clinical trials and spontaneous reports, including some cases with a close temporal association, a positive de-challenge and considering a plausible mechanism of action, the PRAC considers that a causal relationship between opicapone and confusional state can constitute at least a reasonable possibility. The PRAC concludes that the medicinal product information for medicinal products containing opicapone will consequently need to be amended.
Having examined the PRAC recommendation, the Committee for Medicinal Products for Human Use (CHMP) agrees with the overall conclusions and with the justification for the recommendation.

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