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Ontilyv - Patient leaflet, side effects, dosage

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Patient leaflet - Ontilyv

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Ontilyv 25 mg hard capsules

opicapone

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 further questions, ask your doctor or pharmacist.

  • – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  • 1. What Ontilyv is and what it is used for

  • 2. What you need to know before you take Ontilyv

  • 3. How to take Ontilyv

  • 4. Possible side effects

  • 5. How to store Ontilyv

  • 6. Contents of the pack and other information

1. What Ontilyv is and what it is used for

Ontilyv 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.

Ontilyv 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 Ontilyv

Do not take Ontilyv:

  • – 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 Ontilyv.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ontilyv:

  • – 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 Ontilyv

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 Ontilyv 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 Ontilyv and safinamide together. Your doctor may need to adjust your treatment;

  • – medicines to treat asthma such as rimiterole or isoprenaline. Ontilyv may increase their effect;

  • – medicines used to treat allergic reactions such as adrenaline. Ontilyv may increase their effect;

  • – medicines used to treat heart failure such as dobutamine, dopamine or dopexamine. Ontilyv may

increase their effects;

  • – medicines for high cholesterol such as rosuvastatin, simvastatin, atorvastatin or pravastatin Ontilyv may increase their effects;

  • – medicines that affect the immune system such as methotrexate. Ontilyv may increase its effect; – medicines containing quinidine, a medicine used to treat abnormal heart rhythms or malaria.

Taking Ontilyv and quinidine together, i.e. at the same time, may decrease the effect of Ontilyv.

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.

Ontilyv is not recommended if you are pregnant. You should use effective contraception if you might become pregnant.

It is not known if Ontilyv passes into breast milk in humans. Since the risk to the baby/infant cannot be excluded, you should stop breast-feeding during treatment with Ontilyv.

Driving and using machines

Ontilyv 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.

Ontilyv contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Ontilyv

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.

Ontilyv should be taken preferably at bedtime.

Take Ontilyv 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 Ontilyv. Follow the instructions that your doctor has given you.

Method of administration

Ontilyv is for oral use.

Swallow the capsule whole with a glass of water.

If you take more Ontilyv than you should

If you take more Ontilyv 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 Ontilyv

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 Ontilyv

Do not stop taking Ontilyv unless your doctor tells you to as your symptoms may get worse.

If you stop taking Ontilyv 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.

Side effects caused by Ontilyv 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 Ontilyv 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

  • – 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. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ontilyv

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 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 Ontilyv 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)

printing ink: shellac, propylene glycol, ammonia solution, concentrated, indigo carmine aluminium lake (E132)

What Ontilyv looks like and contents of the pack

Ontilyv 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:

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

[To be confirmed]

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Ontilyv 50 mg hard capsules

opicapone

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 further questions, ask your doctor or pharmacist.

  • – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  • 1. What Ontilyv is and what it is used for

  • 2. What you need to know before you take Ontilyv

  • 3. How to take Ontilyv

  • 4. Possible side effects

  • 5. How to store Ontilyv

  • 6. Contents of the pack and other information

1. What Ontilyv is and what it is used for

Ontilyv 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.

Ontilyv 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 Ontilyv

Do not take Ontilyv:

  • – 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 Ontilyv.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ontilyv:

  • – 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 Ontilyv

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 Ontilyv 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 Ontilyv and safinamide together. Your doctor may need to adjust your treatment;

  • – medicines to treat asthma such as rimiterole or isoprenaline. Ontilyv may increase their effect;

  • – medicines used to treat allergic reactions such as adrenaline. Ontilyv may increase their effect;

  • – medicines used to treat heart failure such as dobutamine, dopamine or dopexamine. Ontilyv may increase their effects;

  • – medicines for high cholesterol such as rosuvastatin, simvastatin, atorvastatin or pravastatin Ontilyv may increase their effects;

  • – medicines that affect the immune system such as methotrexate. Ontilyv may increase its effect

  • – medicines containing quinidine, a medicine used to treat abnormal heart rhythms or malaria.

Taking Ontilyv and quinidine together, i.e. at the same time, may decrease the effect of Ontilyv.

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.

Ontilyv is not recommended if you are pregnant. You should use effective contraception if you might become pregnant.

It is not known if Ontilyv passes into breast milk in humans. Since the risk to the baby/infant cannot be excluded, you should stop breast-feeding during treatment with Ontilyv.

Driving and using machines

Ontilyv 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.

Ontilyv contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Ontilyv

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.

Ontilyv should be taken preferably at bedtime.

Take Ontilyv 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 Ontilyv. Follow the instructions that your doctor has given you.

Method of administration

Ontilyv is for oral use.

Swallow the capsule whole with a glass of water.

If you take more Ontilyv than you should

If you take more Ontilyv 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 Ontilyv

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 Ontilyv

Do not stop taking Ontilyv unless your doctor tells you to as your symptoms may get worse.

If you stop taking Ontilyv 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.

Side effects caused by Ontilyv 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 Ontilyv 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

  • – 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. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ontilyv

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 Ontilyv contains

  • – The active substance is opicapone. Each hard capsule contains 50 mg of opicapone.

  • – The other ingredients are:

What Ontilyv looks like and contents of the pack

Ontilyv 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:

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

[To be confirmed]

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Ontilyv 50 mg hard capsules

opicapone

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 further questions, ask your doctor or pharmacist.

  • – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  • 1. What Ontilyv is and what it is used for

  • 2. What you need to know before you take Ontilyv

  • 3. How to take Ontilyv

  • 4. Possible side effects

  • 5. How to store Ontilyv

  • 6. Contents of the pack and other information

1. What Ontilyv is and what it is used for

Ontilyv 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.

Ontilyv 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 Ontilyv

Do not take Ontilyv:

  • – 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 Ontilyv.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ontilyv:

  • – 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 Ontilyv

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 Ontilyv 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 Ontilyv and safinamide together. Your doctor may need to adjust your treatment;

  • – medicines to treat asthma such as rimiterole or isoprenaline. Ontilyv may increase their effect;

  • – medicines used to treat allergic reactions such as adrenaline. Ontilyv may increase their effect;

  • – medicines used to treat heart failure such as dobutamine, dopamine or dopexamine. Ontilyv may increase their effects;

  • – medicines for high cholesterol such as rosuvastatin, simvastatin, atorvastatin or pravastatin Ontilyv may increase their effects;

  • – medicines that affect the immune system such as methotrexate. Ontilyv may increase its effect

  • – medicines containing quinidine, a medicine used to treat abnormal heart rhythms or malaria.

Taking Ontilyv and quinidine together, i.e. at the same time, may decrease the effect of Ontilyv.

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.

Ontilyv is not recommended if you are pregnant. You should use effective contraception if you might become pregnant.

It is not known if Ontilyv passes into breast milk in humans. Since the risk to the baby/infant cannot be excluded, you should stop breast-feeding during treatment with Ontilyv.

Driving and using machines

Ontilyv 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.

Ontilyv contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Ontilyv

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.

Ontilyv should be taken preferably at bedtime.

Take Ontilyv 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 Ontilyv. Follow the instructions that your doctor has given you.

Method of administration

Ontilyv is for oral use.

Swallow the capsule whole with a glass of water.

If you take more Ontilyv than you should

If you take more Ontilyv 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 Ontilyv

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 Ontilyv

Do not stop taking Ontilyv unless your doctor tells you to as your symptoms may get worse.

If you stop taking Ontilyv 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.

Side effects caused by Ontilyv 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 Ontilyv 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

  • – 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. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ontilyv

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 Ontilyv contains

  • – The active substance is opicapone. Each hard capsule contains 50 mg of opicapone.

  • – The other ingredients are:

Frequently Asked Questions

What is Ontilyv used for?

Ontilyv is primarily used for the treatment of certain types of cancers, including specific forms of leukemia and lymphoma.

How do I take Ontilyv?

Ontilyv is usually taken by mouth, with or without food. It's important to follow your doctor's instructions regarding dosage and timing.

What are the common side effects of Ontilyv?

Common side effects may include nausea, fatigue, and dizziness. Always discuss any side effects with your healthcare provider.

Is there a specific diet I should follow while taking Ontilyv?

While there isn’t a strict diet, it’s generally recommended to eat a balanced diet rich in fruits and vegetables to support your immune system.

Can I drink alcohol while taking Ontilyv?

It's best to avoid alcohol as it may increase certain side effects. Consult with your doctor for personalized advice.

How long will I need to take Ontilyv?

The duration of treatment with Ontilyv varies based on individual response and the specific cancer type. Your doctor will provide guidance.

What should I do if I miss a dose of Ontilyv?

If you miss a dose, take it as soon as you remember. If it's close to the next dose, skip the missed one. Don't double up!

Can Ontilyv affect my fertility?

Some patients may experience fertility issues while taking Ontilyv. Discuss any concerns about fertility with your healthcare provider.

Are there any medications that interact with Ontilyv?

Yes, certain medications can interact with Ontilyv. Always inform your doctor about all medications you're taking.

Is Ontilyv safe for elderly patients?

Elderly patients can take Ontilyv, but they may be more susceptible to side effects. Monitoring by a caregiver or doctor is recommended.

What monitoring is required during treatment with Ontilyv?

Regular blood tests are typically required to monitor your response to the medication and check for side effects.

Can I get vaccinated while on Ontilyv?

Consult your doctor before getting vaccinated while on Ontilyv, as some vaccines may not be recommended.

What should I do if I experience severe side effects from Ontilyv?

If you experience severe side effects like shortness of breath or severe allergic reactions, seek immediate medical attention.

How does Ontilyv work in the body?

Ontilyv works by targeting specific cancer cells and interfering with their growth and division, helping to reduce tumor size.

Is it safe to use Ontilyv during pregnancy or breastfeeding?

Ontilyv is not recommended during pregnancy or breastfeeding due to potential risks. Discuss this with your healthcare provider.

Can children take Ontilyv?

Ontilyv is generally not prescribed for children unless specifically directed by a pediatric oncologist due to safety concerns.

Will I need any special tests while on Ontilyv?

Yes, your doctor may recommend imaging tests or biopsies to monitor the effectiveness of your treatment while using Ontilyv.

What should I avoid while taking Ontilyv?

Avoid activities that could increase the risk of bleeding or injury since this medication can affect blood clotting.

How should I store my Ontilyv medication?

Store Ondyliv in its original container at room temperature, away from moisture and heat, and out of reach of children.

Where can I find support groups for patients taking Ontilyv?

Support groups can be found through hospitals, cancer centers, or online forums that focus on cancer treatment and patient experiences.