ONTILYV 25 mg Капсулы Твердые

Содержание инструкции

1. Ontilyv 25 mg hard capsules
   1. What is Ontilyv and what is it used for
   2. What you need to know before taking Ontilyv
   3. How to take Ontilyv
   4. Possible side effects
   5. How to store Ontilyv
   6. Package Contents and Other Information
2. Ontilyv 50 mg hard capsules
   1. What is Ontilyv and what is it used for
   2. What you need to know before taking Ontilyv
   3. How to take Ontilyv
   4. Possible side effects
   5. How to store Ontilyv
   6. Package Contents and Other Information

Ontilyv 25 mg hard capsules

opicapone

Read this leaflet carefully before 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 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 is Ontilyv and what is it used for

Ontilyv 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 Ontilyv is intended for adults who are already taking medications containing levodopa and DOPA decarboxylase inhibitors. 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 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 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 Ontilyv.

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

• 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 an 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 others.
These types of behaviours 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 your treatment.

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 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 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 Ontilyv and safinamide. Your doctor may need to adjust your therapy;
• medicines used for asthma, such as rimiterol or isoprenaline. Ontilyv may increase their effects;
• medicines used for allergic reactions, such as adrenaline. Ontilyv may increase their effects;
• medicines used for 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 have effects on the immune system, such as methotrexate. Ontilyv may increase their effects;
• medicines containing quinidine, a medicine used for the treatment of heart arrhythmias or malaria. Taking Ontilyv and quinidine at the same time may decrease the effect of Ontilyv.

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.
Ontilyv is not recommended if you are pregnant. Use effective contraception if there is a possibility of
becoming pregnant.
It is not known whether Ontilyv passes into breast milk. As the risk to the baby cannot be excluded, you should
stop breastfeeding during treatment with Ontilyv.

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

Ontilyv contains lactose and sodium

• Lactose: if you have been diagnosed with 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. it is essentially ‘sodium-free’.

3. How to take Ontilyv

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.
Ontilyv should preferably be taken before going to sleep.
Take Ontilyv 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 Ontilyv, 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
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, inform your doctor or pharmacist or go immediately to
a doctor to understand what you have taken.

If you forget to take Ontilyv
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 Ontilyv
Do not stop treatment with Ontilyv unless your doctor tells you to, as otherwise your
symptoms may worsen.
If you stop treatment with Ontilyv, 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.
Side effects caused by Ontilyv are generally mild to moderate and occur mainly during the first weeks of
treatment. Some side effects may be due to an increase in the effect caused by the use of Ontilyv 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
• drowsiness
• difficulty falling asleep or staying asleep
• strange dreams
• having experiences 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
• convulsions, 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
• nightmares
• sleep disorders
• abnormal urine color
• need to get up at night to urinate
• 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. You can also report side effects directly through the national reporting system listed in
Appendix V. 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/pack 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 Ontilyv contains

• The active ingredient 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 corn starch and magnesium stearate o capsule shell: gelatin, indigotine, carmine (E 132), erythrosine (E 127) and titanium dioxide (E 171) o printing ink: shellac, propylene glycol, concentrated ammonia solution, indigotine, carmine (E 132)

Description of the appearance of Ontilyv and package contents
Ontilyv 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 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]

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.

Ontilyv 50 mg hard capsules

opicapone

Read this leaflet carefully before 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 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 is Ontilyv and what is it used for

Ontilyv 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 Ontilyv is intended for adults who are already taking medications containing levodopa and DOPA decarboxylase inhibitors. 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 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 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 (MAO) (e.g. phenelzine, tranylcypromine or moclobemide). Ask your doctor or pharmacist if you can take the antidepressant together with Ontilyv.

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

• 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 the person caring for you, notices that you are
developing an impulse or desire to behave in a way that is unusual for you or are unable to resist
the impulse, desire or temptation to carry out activities that may be harmful to you or to others.
These types of behaviors are called “impulse control disorders” and may
include gambling addiction, an increased sexual desire or increased
thoughts or sensations 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 Ontilyv
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Tell your doctor if you are taking:

• medicines for depression or anxiety, such as venlafaxine, maprotiline and desipramine. Taking Ontilyv 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 Ontilyv and safinamide. Your doctor may need to adjust your therapy;
• medicines used for asthma, such as rimiterol or isoprenaline. Ontilyv may increase their effects;
• medicines used for allergic reactions, such as adrenaline. Ontilyv may increase their effects;
• medicines used for 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 have effects on the immune system, such as methotrexate. Ontilyv may increase their effects;
• medicines containing quinidine, a medicine used for the treatment of abnormal heart rhythms or malaria. Taking Ontilyv and quinidine at the same time may decrease the effect of Ontilyv.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Ontilyv 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 Ontilyv passes into breast milk. As the risk to the baby cannot be excluded, you should
stop breastfeeding during treatment with Ontilyv.

Driving and using machines
Ontilyv taken together with levodopa can cause dizziness, make you feel lightheaded or sleepy.
Do not drive and do not use machines if you experience any of these side effects.

Ontilyv contains lactose and sodium

• Lactose: if you have been diagnosed with 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. it is essentially ‘sodium-free’.

3. How to take Ontilyv

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.
Ontilyv should preferably be taken before going to sleep.
Take Ontilyv 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 Ontilyv, 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
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, inform your doctor or pharmacist or go immediately to
a doctor to understand what you have taken.

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

If you stop taking Ontilyv
Do not stop treatment with Ontilyv unless your doctor tells you to, as otherwise your
symptoms may worsen.
If you stop treatment with Ontilyv, 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 Ontilyv are generally mild to moderate and occur mainly during the first weeks
of treatment. Some side effects may be due to an increased effect caused by the use of Ontilyv 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 movements, or painful muscle stiffness

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
• strange dreams
• having experiences or seeing things that are not there (hallucinations)
• low blood pressure when standing up, leading to dizziness, lightheadedness 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
• altered sense of taste
• excessive movements of the body
• fainting
• anxiety
• depression
• hearing sounds that are not there
• nightmares
• sleep disorders
• abnormal urine color
• need to wake up at night to urinate
• 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. You can also report side effects directly through the national reporting system listed in
Appendix V. 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/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 Ontilyv Contains

• The active ingredient is opicapone. Each hard capsule contains 50 mg of opicapone.
• The other ingredients are: o capsule content: 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, simeticone

Description of the Appearance of Ontilyv and Package Contents
Ontilyv 50 mg hard capsules are dark blue, approximately 19 mm long, with the words “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 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]

Other Sources of Information
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.