Ontilyv

Package leaflet: Information for the patient

Ontilyv 25 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 effects, including those not listed in this leaflet, contact 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 taking 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 and is used for the treatment of Parkinson's disease and the movement disorders associated with it. Parkinson's disease is a progressive disorder of the nervous system that causes tremors and impairs movement.
Ontilyv is intended for use in adults who are already taking medicines 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 Ontilyv

Do not take Ontilyv

• 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 (MAOIs) (e.g. phenelzine, tranylcypromine or moclobemide). Ask your doctor or pharmacist whether 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 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 impulse or desire to behave in a way that is unusual for you, or if you are unable to resist the impulse, desire or temptation to carry out activities that could be harmful to you or others. These types of behaviours 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 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 treatment;
• safinamide, a medicine used for Parkinson’s disease. There is no experience with taking Ontilyv and safinamide at the same time. Your doctor may need to adjust your treatment;
• 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 affect the immune system, such as methotrexate. Ontilyv may increase their effects;
• medicines containing quinidine, a medicine used to treat heart rhythm disorders or malaria. Taking Ontilyv together with quinidine at the same time may reduce the effect of Ontilyv.

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.
Ontilyv is not recommended during pregnancy. Use an effective contraceptive if there is any possibility you could become pregnant.
It is not known whether Ontilyv passes into breast milk. Since the risk to the infant cannot be ruled out, you must stop breastfeeding during treatment with Ontilyv.

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

Ontilyv contains lactose and sodium

• Lactose: if your doctor has diagnosed you with an intolerance to certain sugars, consult 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 exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 50 mg once daily.
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.

Dosage of other medicines used to treat Parkinson's disease
When you start taking Ontilyv, it may be necessary to adjust the dosage 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 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 Ontilyv
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 missed dose.

If you stop taking Ontilyv
Do not stop treatment with Ontilyv unless your doctor tells you to, because otherwise your symptoms may worsen.
If you stop treatment with Ontilyv, your doctor may need to adjust the dosage 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 everyone gets them.
The side effects caused by Ontilyv are generally mild to moderate and occur mostly during the first weeks of treatment. Some side effects may be due to an increased effect caused by using Ontilyv 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, uncontrolled, difficult or painful movements of the body

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
• 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 contractions, stiffness or pain
• pain in arms or legs
• altered sense of taste
• excessive body movements
• fainting
• anxiety
• depression
• hearing non-existent sounds
• nightmares
• sleep disorders
• abnormal urine colour
• need to wake at night to urinate
• shortness of breath
• high or low blood pressure

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 detailed in Annex 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 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: 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 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 Ontilyv contains

• The active substance is opicapone. Each hard capsule contains 25 mg of opicapone.
• The other components are:
  – capsule content: 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 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 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.
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]

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

Ontilyv 50 mg hard capsules

opicapone
Please read this entire 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 taking 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 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.
Ontilyv 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 related movement disorders.

2. What you need to know before taking Ontilyv

Do not take Ontilyv

• 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 (MAOIs) (e.g. phenelzine, tranylcypromine or moclobemide). Ask your doctor or pharmacist whether 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 have experienced loss of appetite, weight loss, weakness or exhaustion over 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 impulse or desire to behave in a way that is unusual for you, or if you are unable to resist the impulse, desire or temptation to carry out activities that could be dangerous for you or others. These types of behaviours 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 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 treatment;
• safinamide, a medicine used for Parkinson’s disease. There is no experience with taking Ontilyv and safinamide at the same time. Your doctor may need to adjust your treatment;
• 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 affect the immune system, such as methotrexate. Ontilyv may increase their effects;
• medicines containing quinidine, a medicine used to treat abnormal heart rhythms or malaria. Taking Ontilyv together with quinidine may reduce the effect of Ontilyv.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Ontilyv is not recommended during pregnancy. Use an effective contraceptive method if there is any possibility of becoming pregnant.
It is not known whether Ontilyv passes into breast milk. Since the risk to the infant cannot be ruled out, you must discontinue 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 or operate machinery if you experience any of these side effects.

Ontilyv 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. it is essentially ‘sodium-free’.

3. How to take Ontilyv

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 50 mg once daily.
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 to hospital immediately. Take the medicine pack and this leaflet with you. This will help your doctor understand what you have taken.

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

If you have any questions 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 everyone experiences 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 using Ontilyv 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 and uncontrollable movements, 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
• unusual dreams
• experiencing events or seeing objects 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 eye
• 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
• altered sense of taste
• excessive body movements
• fainting
• anxiety
• depression
• hearing sounds that are not real
• nightmares
• sleep disorders
• abnormal urine colour
• need to wake up at night to urinate
• shortness of breath
• high or low blood pressure

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 Ontilyv

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/outer carton after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
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 any medicine 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 Ontilyv contains

• The active substance is opicapone. Each hard capsule contains 50 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, titanium dioxide (E 171), propylene glycol, concentrated ammonia solution, simethicone

Description of the appearance of Ontilyv and contents of the pack
Ontilyv 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 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.