Oprymea (pramipexole dihydrochloride monohydrate) – Package leaflet - N04BC05

Package leaflet: Information for the patient

Oprymea 0.088 mg tablets

Oprymea 0.18 mg tablets

Oprymea 0.35 mg tablets

Oprymea 0.7 mg tablets

Oprymea 1.1 mg tablets

Pramipexole

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 Oprymea is and what it is used for

2.What you need to know before you take Oprymea

3.How to take Oprymea

4.Possible side effects

5.How to store Oprymea

6.Contents of the pack and other information

1.What Oprymea is and what it is used for

Oprymea contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.

Oprymea is used to treat the symptoms of primary Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease).

2. What you need to know before you take Oprymea

Do not take Oprymea:

-if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Oprymea. Tell your doctor if you have or have had or develop any medical conditions or symptoms, especially any of the following:

-Kidney disease

-Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual

-Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you might develop dyskinesia during the up-titration of Oprymea

-Sleepiness and episodes of suddenly falling asleep

-Psychosis (e.g. comparable with symptoms of schizophrenia)

-Vision impairment. You should have regular eye examinations during treatment with Oprymea

-Severe heart or blood vessels disease. You will need to have your blood pressure checked regularly, especially at the beginning of treatment. This is to avoid postural hypotension (a fall

in blood pressure on standing up).

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion or loss of reality). Your doctor may need to adjust or stop your dose.

Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Oprymea treatment. If the problems persist more than a few weeks, your doctor may need to adjust your treatment.

Children and adolescents

Oprymea is not recommended for use in children or adolescents under 18 years.

Other medicines and Oprymea

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.

You should avoid taking Oprymea together with antipsychotic medicines.

Take care if you are taking the following medicines:

-cimetidine (to treat excess stomach acid and stomach ulcers)

-amantadine (which can be used to treat Parkinson’s disease)

-mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia)

-zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system)

-cisplatin (to treat various types of cancers)

-quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria))

-procainamide (to treat irregular heart beat)

If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with Oprymea.

Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol. In these cases Oprymea may affect your ability to drive and operate machinery.

Oprymea with food, drink and alcohol

You should be cautious while drinking alcohol during treatment with Oprymea. Oprymea can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will then discuss with you if you should continue to take Oprymea.

The effect of Oprymea on the unborn child is not known. Therefore, do not take Oprymea if you are pregnant unless your doctor tells you to do so.

Oprymea should not be used during breast-feeding. Oprymea can reduce the production of breast milk.

Also, it can pass into the breast milk and can reach your baby. If use of Oprymea is unavoidable, breast-feeding should be stopped.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Oprymea can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.

Oprymea has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’s disease. If you experience these side effects, you must not drive or operate machinery. Please tell your doctor if this occurs.

3.How to take Oprymea

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The doctor will advise you on the right dosing.

You can take Oprymea with or without food. Swallow the tablets with water.

Parkinson’s disease

The daily dose is to be taken divided into 3 equal doses.

During the first week, the usual dose is 1 tablet Oprymea 0.088 mg three times a day (equivalent to 0.264 mg daily):

This will be increased every 5 – 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).

The usual maintenance dose is 1.1 mg per day. However, your dose may have to be increased even further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day. A lower maintenance dose of three Oprymea 0.088 mg tablets a day is also possible.

Patients with kidney disease

If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you will have to take the tablets only once or twice a day. If you have moderate kidney disease, the usual starting dose is 1 tablet Oprymea 0.088 mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet Oprymea 0.088 mg a day.

If you take more Oprymea than you should

If you accidentally take too many tablets:

-Contact your doctor or nearest hospital casualty department immediately for advice.

-You may experience vomiting, restlessness, or any of the side effects as described in section 4. "Possible side effects".

If you forget to take Oprymea

Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not try to make up for the missed dose.

If you stop taking Oprymea

Do not stop taking Oprymea without first talking to your doctor. If you have to stop taking this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening symptoms.

If you suffer from Parkinson’s disease you should not stop treatment with Oprymea abruptly. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include:

-akinesia (loss of muscle movement)

-rigid muscles

-fever

-unstable blood pressure

-tachycardia (increased heart rate)

-confusion

-depressed level of consciousness (e.g. coma).

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. Evaluation of these side effects is based on the following frequencies:

If you suffer from Parkinson’s disease, you may experience the following side effects:

Very common:

-Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)

-Sleepiness

-Dizziness

-Nausea (sickness)

Common:

-Urge to behave in an unusual way

-Hallucinations (seeing, hearing or feeling things that are not there)

-Confusion

-Tiredness (fatigue)

-Sleeplessness (insomnia)

-Excess of fluid, usually in the legs (peripheral oedema)

-Headache

-Hypotension (low blood pressure)

-Abnormal dreams

-Constipation

-Visual impairment

-Vomiting (being sick)

-Weight loss including decreased appetite

Uncommon:

-Paranoia (e.g. excessive fear for one’s own well-being)

-Delusion

-Excessive daytime sleepiness and suddenly falling asleep

-Amnesia (memory disturbance)

-Hyperkinesia (increased movements and inability to keep still)

-Weight increase

-Allergic reactions (e.g. rash, itching, hypersensitivity)

-Fainting

-Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*

-Inappropriate antidiuretic hormone secretion*

-Restlessness

-Dyspnoea (difficulties to breathe)

-Hiccups

-Pneumonia (infection of the lungs)

-Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:

-Strong impulse to gamble excessively despite serious personal or family consequences.

-Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.

-Uncontrollable excessive shopping or spending

-Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*

-Delirium (decreased awareness, confusion, loss of reality)

Rare:

-Mania (agitation, feeling elated or over-excited)

Not known:

-After stopping or reducing your Oprymea treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviours; he will discuss ways of managing or reducing the symptoms.

For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 2,762 patients treated with pramipexole. The frequency category is probably not greater than "uncommon".

If you suffer from other indication, you may experience the following side effects:

Very common:

-Nausea (sickness).

Common:

-Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness

-Tiredness (fatigue)

-Headache

-Abnormal dreams

-Constipation

-Dizziness

-Vomiting (being sick)

Uncommon:

-Urge to behave in an unusual way*

-Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*

-Inappropriate antidiuretic hormone secretion*

-Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)

-Hyperkinesia (increased movements and inability to keep still)*

-Paranoia (e.g. excessive fear for one’s own well-being)*

-Delusion*

-Amnesia (memory disturbance)*

-Hallucinations (seeing, hearing or feeling things that are not there)

-Confusion

-Excessive daytime sleepiness and suddenly falling asleep

-Weight increase

-Hypotension (low blood pressure)

-Excess of fluid, usually in the legs (peripheral oedema)

-Allergic reactions (e.g. rash, itching, hypersensitivity)

-Fainting

-Restlessness

-Visual impairment

-Weight loss including decreased appetite

-Dyspnoea (difficulties to breathe)

-Hiccups

-Pneumonia (infection of the lungs)*

-Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:

-Strong impulse to gamble excessively despite serious personal or family consequences.*

-Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.*

-Uncontrollable excessive shopping or spending.*

-Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*

-Mania (agitation, feeling elated or over-excited)*

-Delirium (decreased awareness, confusion, loss of reality)*

Not known:

-After stopping or reducing your Oprymea treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviors; he will discuss ways of managing or reducing the symptoms.

For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 1,395 patients treated with pramipexole. The frequency category is probably not greater than "uncommon".

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 via 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 Oprymea

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 packaging after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

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 Oprymea contains

-The active substance is pramipexole. Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg or 1.1 mg pramipexole as 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 1.5 mg pramipexole dihydrochloride monohydrate, respectively.

-The other ingredients are mannitol, maize starch, pregelatinised maize starch, povidone K25, colloidal anhydrous silica and magnesium stearate.

What Oprymea looks like and contents of the pack

Oprymea 0.088 mg tablets are white, round, with bevelled edges and imprint "P6" on one side of the tablet.

Oprymea 0.18 mg tablets are white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet. The tablet can be divided into equal doses.

Oprymea 0.35 mg tablets are white, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet. The tablet can be divided into equal doses.

Oprymea 0.70 mg tablets are white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet. The tablet can be divided into equal doses.

Oprymea 1.1 mg tablets are white, round, with bevelled edges, both sides scored. The tablet can be divided into equal doses.

Boxes of 20, 30, 60, 90 and 100 tablets in blisters of 10 tablets are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

Package leaflet: Information for the patient

Oprymea 0.26 mg prolonged-release tablets

Oprymea 0.52 mg prolonged-release tablets

Oprymea 1.05 mg prolonged-release tablets

Oprymea 1.57 mg prolonged-release tablets

Oprymea 2.1 mg prolonged-release tablets

Oprymea 2.62 mg prolonged-release tablets

Oprymea 3.15 mg prolonged-release tablets

Pramipexole

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 Oprymea is and what it is used for

2.What you need to know before you take Oprymea

3.How to take Oprymea

4.Possible side effects

5.How to store Oprymea

6.Contents of the pack and other information

1. What Oprymea is and what it is used for

Oprymea contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.

Oprymea is used to treat the symptoms of primary Parkinson’s disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease).

2. What you need to know before you take Oprymea

Do not take Oprymea:

-if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Oprymea. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:

-Kidney disease

-Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual

-Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you might develop dyskinesia during the up- titration of Oprymea

-Sleepiness and episodes of suddenly falling asleep

-Psychosis (e.g. comparable with symptoms of schizophrenia)

-Vision impairment. You should have regular eye examinations during treatment with Oprymea

-Severe heart or blood vessels disease. You will need to have your blood pressure checked regularly, especially at the beginning of treatment. This is to avoid postural hypotension (a fall in blood pressure on standing up).

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion or loss of reality). Your doctor may need to adjust or stop your dose.

Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Oprymea treatment. If the problems persist more than a few weeks, your doctor may need to adjust your treatment.

Oprymea prolonged-release tablet is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested. Parts of tablets may occasionally be passed and seen in the stool (faeces) and may look like whole tablets. Inform your doctor if you find tablet pieces in your faeces.

Children and adolescents

Oprymea is not recommended for use in children or adolescents under 18 years.

Other medicines and Oprymea

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.

You should avoid taking Oprymea together with antipsychotic medicines.

Take care if you are taking the following medicines:

-cimetidine (to treat excess stomach acid and stomach ulcers)

-amantadine (which can be used to treat Parkinson’s disease)

-mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia)

-zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system)

-cisplatin (to treat various types of cancers)

-quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria))

-procainamide (to treat irregular heart beat).

If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with Oprymea.

Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol. In these cases Oprymea may affect your ability to drive and operate machinery.

Oprymea with food, drink and alcohol

You should be cautious while drinking alcohol during treatment with Oprymea. Oprymea can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine. Your doctor will then discuss with you if you should continue to take Oprymea.

The effect of Oprymea on the unborn child is not known. Therefore, do not take Oprymea if you are pregnant unless your doctor tells you to do so.

Oprymea should not be used during breast-feeding. Oprymea can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of Oprymea is unavoidable, breast-feeding should be stopped.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Oprymea can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.

Oprymea has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’s disease. If you experience these side effects, you must not drive or operate machinery. You should tell your doctor if this occurs.

3. How to take Oprymea

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The doctor will advise you on the right dosing.

Take Oprymea prolonged-release tablets only once a day and each day at about the same time.

You can take Oprymea with or without food. Swallow the tablets whole with water.

Do not chew, divide or crush the prolonged-release tablets. If you do, there is a danger you could overdose, because the medicine may be released into your body too quickly.

During the first week, the usual daily dose is 0.26 mg pramipexole. The dose will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).

Ascending dose schedule of Oprymea prolonged-release tablets

The usual maintenance dose is 1.05 mg per day. However, your dose may have to be increased even further. If necessary, your doctor may increase your dose up to a maximum of 3.15 mg of pramipexole a day. A lower maintenance dose of one Oprymea 0.26 mg prolonged-release tablet a day is also possible.

Patients with kidney disease

If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg prolonged-release tablets only every other day for the first week. After that, your doctor may increase the dosing frequency to one 0.26 mg prolonged-release tablet every day. If a further dose increase is necessary, your doctor may adjust it in steps of 0.26 mg pramipexole.

If you have serious kidney problems, your doctor may need to switch you to a different pramipexole medicine. If during treatment your kidney problems get worse, you should contact your doctor as soon as possible.

If you are switching from Oprymea (immediate release) tablets

Your doctor will base your dose of Oprymea prolonged-release tablets on the dose of Oprymea (immediate release) tablets you were taking.

Take your Oprymea (immediate release) tablets as normal the day before you switch. Then take your Oprymea prolonged-release tablets next morning and do not take any more Oprymea (immediate release) tablets.

If you take more Oprymea than you should

If you accidentally take too many tablets,

-Contact your doctor or nearest hospital casualty department immediately for advice.

-You may experience vomiting, restlessness, or any of the side effects as described in chapter 4 "Possible side effects".

If you forget to take Oprymea

If you forget to take a dose of Oprymea, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.

If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet dose.

If you stop taking Oprymea

Do not stop taking Oprymea without first talking to your doctor. If you have to stop taking this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening symptoms.

If you suffer from Parkinson’s disease you should not stop treatment with Oprymea abruptly. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include:

-akinesia (loss of muscle movement)

-rigid muscles

-fever

-unstable blood pressure

-tachycardia (increased heart rate)

-confusion

-depressed level of consciousness (e.g. coma).

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.

Evaluation of these side effects is based on the following frequencies:

You may experience the following side effects:

Very common:

-Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)

-Sleepiness

-Dizziness

-Nausea (sickness)

Common:

-Urge to behave in an unusual way

-Hallucinations (seeing, hearing or feeling things that are not there)

-Confusion

-Tiredness (fatigue)

-Sleeplessness (insomnia)

-Excess of fluid, usually in the legs (peripheral oedema)

-Headache

-Hypotension (low blood pressure)

-Abnormal dreams

-Constipation

-Visual impairment

-Vomiting (being sick)

-Weight loss including decreased appetite

Uncommon:

-Paranoia (e.g. excessive fear for one’s own well-being)

-Delusion

-Excessive daytime sleepiness and suddenly falling asleep

-Amnesia (memory disturbance)

-Hyperkinesia (increased movements and inability to keep still)

-Weight increase

-Allergic reactions (e.g. rash, itching, hypersensitivity)

-Fainting

-Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*

-Inappropriate antidiuretic hormone secretion*

-Restlessness

-Dyspnoea (difficulties to breathe)

-Hiccups

-Pneumonia (infection of the lungs)

-Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:

-Strong impulse to gamble excessively despite serious personal or family consequences.

-Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.

-Uncontrollable excessive shopping or spending

-Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*

-Delirium (decreased awareness, confusion, loss of reality)

Rare:

-Mania (agitation, feeling elated or over-excited)

Not known:

-After stopping or reducing your Oprymea treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviors; he will discuss ways of managing or reducing the symptoms.

For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 2,762 patients treated with pramipexole. The frequency category is probably not greater than "uncommon".

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 via 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 Oprymea

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 packaging after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

This medicine does not require any special temperature storage conditions.

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 Oprymea contains

-The active substance is pramipexole. Each prolonged-release tablet contains 0.26 mg, 0.52 mg,

1.05mg, 1.57 mg, 2.1 mg, 2.62 mg or 3.15 mg pramipexole as 0.375 mg, 0.75 mg, 1.5 mg,

2.25mg, 3 mg, 3.75 mg or 4.5 mg pramipexole dihydrochloride monohydrate, respectively.

-The other ingredients are hypromellose, maize starch, colloidal anhydrous silica and magnesium stearate.

What Oprymea looks like and contents of the pack

Oprymea 0.26 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P1 on one side, with bevelled edges and possible spots. Oprymea 0.52 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P2 on one side, with bevelled edges and possible spots. Oprymea 1.05 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P3 on one side, with bevelled edges and possible spots. Oprymea 1.57 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P12 on one side, with bevelled edges and possible spots. Oprymea 2.1 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P4 on one side, with bevelled edges and possible spots. Oprymea 2.62 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P13 on one side and 262 on the other side, with bevelled edges and possible spots.

Oprymea 3.15 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P5 on one side and 315 on the other side, with bevelled edges and possible spots.

Boxes of 10, 30, 90 and 100 tablets in blisters of 10 tablets are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

Package leaflet: Information for the patient

Oprymea 0.26 mg prolonged-release tablets

Oprymea 0.52 mg prolonged-release tablets

Oprymea 1.05 mg prolonged-release tablets

Pramipexole

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 Oprymea is and what it is used for

2.What you need to know before you take Oprymea

3.How to take Oprymea

4.Possible side effects

5.How to store Oprymea

6.Contents of the pack and other information

1. What Oprymea is and what it is used for

Oprymea contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.

Oprymea is used to treat the symptoms of primary Parkinson’s disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease).

2. What you need to know before you take Oprymea

Do not take Oprymea:

-if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Oprymea. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:

-Kidney disease

-Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual

-Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you might develop dyskinesia during the up- titration of Oprymea

-Sleepiness and episodes of suddenly falling asleep

-Psychosis (e.g. comparable with symptoms of schizophrenia)

-Vision impairment. You should have regular eye examinations during treatment with Oprymea

-Severe heart or blood vessels disease. You will need to have your blood pressure checked regularly, especially at the beginning of treatment. This is to avoid postural hypotension (a fall in blood pressure on standing up).

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion or loss of reality). Your doctor may need to adjust or stop your dose.

Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Oprymea treatment. If the problems persist more than a few weeks, your doctor may need to adjust your treatment.

Oprymea prolonged-release tablet is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested. Parts of tablets may occasionally be passed and seen in the stool (faeces) and may look like whole tablets. Inform your doctor if you find tablet pieces in your faeces.

Children and adolescents

Oprymea is not recommended for use in children or adolescents under 18 years.

Other medicines and Oprymea

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.

You should avoid taking Oprymea together with antipsychotic medicines.

Take care if you are taking the following medicines:

-cimetidine (to treat excess stomach acid and stomach ulcers);

-amantadine (which can be used to treat Parkinson’s disease);

-mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia);

-zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system);

-cisplatin (to treat various types of cancers);

-quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria));

-procainamide (to treat irregular heart beat).

If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with Oprymea.

Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol. In these cases Oprymea may affect your ability to drive and operate machinery.

Oprymea with food, drink and alcohol

You should be cautious while drinking alcohol during treatment with Oprymea. Oprymea can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will then discuss with you if you should continue to take Oprymea.

The effect of Oprymea on the unborn child is not known. Therefore, do not take Oprymea if you are

pregnant unless your doctor tells you to do so.

Oprymea should not be used during breast-feeding. Oprymea can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of Oprymea is unavoidable, breast-feeding should be stopped.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Oprymea can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.

Oprymea has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’s disease. If you experience these side effects, you must not drive or operate machinery. You should tell your doctor if this occurs.

3. How to take Oprymea

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The doctor will advise you on the right dosing.

Take Oprymea prolonged-release tablets only once a day and each day at about the same time.

You can take Oprymea with or without food. Swallow the tablets whole with water.

Do not chew, divide or crush the prolonged-release tablets. If you do, there is a danger you could overdose, because the medicine may be released into your body too quickly.

C \-.: A

During the first week, the usual daily dose is 0.26 mg pramipexole. The dose will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).

The Oprymea treatment initiation pack is only to be used for the beginning of the treatment with Oprymea.

The Oprymea treatment initiation pack contains three blister strips of tablets - one strip for each of the first three weeks of your treatment. The three strips are marked with "Week 1", "Week 2" and

"Week 3".

The daily dose you take of Oprymea increases each week.

Ascending dose schedule of Oprymea prolonged-release tablets

Week Daily dose (mg) Number of tablets

10.26One Oprymea 0.26 mg prolonged-release tablet on blister "Week 1".

20.52One Oprymea 0.52 mg prolonged-release tablet on blister "Week 2".

31.05One Oprymea 1.05 mg prolonged-release tablet on blister "Week 3".

The usual maintenance dose is 1.05 mg per day. However, your dose may have to be increased even further. If necessary, your doctor may increase your dose up to a maximum of 3.15 mg of pramipexole a day. A lower maintenance dose of one Oprymea 0.26 mg prolonged-release tablet a day is also possible.

Patients with kidney disease

If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg

prolonged-release tablets only every other day for the first week. After that, your doctor may increase the dosing frequency to one 0.26 mg prolonged-release tablet every day. If a further dose increase is necessary, your doctor may adjust it in steps of 0.26 mg pramipexole.

If you have serious kidney problems, your doctor may need to switch you to a different pramipexole medicine. If during treatment your kidney problems get worse, you should contact your doctor as soon as possible.

If you are switching from Oprymea (immediate release) tablets

Your doctor will base your dose of Oprymea prolonged-release tablets on the dose of Oprymea (immediate release) tablets you were taking.

Take your Oprymea (immediate release) tablets as normal the day before you switch. Then take your Oprymea prolonged-release tablets next morning and do not take any more Oprymea (immediate release) tablets.

If you take more Oprymea than you should

If you accidentally take too many tablets,

-Contact your doctor or nearest hospital casualty department immediately for advice.

-You may experience vomiting, restlessness, or any of the side effects as described in chapter 4 "Possible side effects".

If you forget to take Oprymea

If you forget to take a dose of Oprymea, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.

If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet dose.

If you stop taking Oprymea

Do not stop taking Oprymea without first talking to your doctor. If you have to stop taking this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening symptoms.

If you suffer from Parkinson’s disease you should not stop treatment with Oprymea abruptly. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include:

-akinesia (loss of muscle movement)

-rigid muscles

-fever

-unstable blood pressure

-tachycardia (increased heart rate)

-confusion

-depressed level of consciousness (e.g. coma).

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.

Evaluation of these side effects is based on the following frequencies:

You may experience the following side effects:

Very common:

-Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)

-Sleepiness

-Dizziness

-Nausea (sickness)

Common:

-Urge to behave in an unusual way

-Hallucinations (seeing, hearing or feeling things that are not there)

-Confusion

-Tiredness (fatigue)

-Sleeplessness (insomnia)

-Excess of fluid, usually in the legs (peripheral oedema)

-Headache

-Hypotension (low blood pressure)

-Abnormal dreams

-Constipation

-Visual impairment

-Vomiting (being sick)

-Weight loss including decreased appetite

Uncommon:

-Paranoia (e.g. excessive fear for one’s own well-being)

-Delusion

-Excessive daytime sleepiness and suddenly falling asleep

-Amnesia (memory disturbance)

-Hyperkinesia (increased movements and inability to keep still)

-Weight increase

-Allergic reactions (e.g. rash, itching, hypersensitivity)

-Fainting

-Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*

-Inappropriate antidiuretic hormone secretion*

-Restlessness

-Dyspnoea (difficulties to breathe)

-Hiccups

-Pneumonia (infection of the lungs)

-Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:

-Strong impulse to gamble excessively despite serious personal or family consequences.

-Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.

-Uncontrollable excessive shopping or spending

-Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*

-Delirium (decreased awareness, confusion, loss of reality)

Rare:

-Mania (agitation, feeling elated or over-excited)

Not known:

-After stopping or reducing your Opymea treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviors; he will discuss ways of managing or reducing the symptoms.

For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 2,762 patients treated with pramipexole. The frequency category is probably not greater than "uncommon".

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 via 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 Oprymea

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 packaging after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

This medicine does not require any special temperature storage conditions.

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 Oprymea contains

-The active substance is pramipexole. Each prolonged-release tablet contains 0.26 mg, 0.52 mg or 1.05 mg pramipexole as 0.375 mg, 0.75 mg or 1.5 mg pramipexole dihydrochloride monohydrate, respectively.

-The other ingredients are hypromellose, maize starch, colloidal anhydrous silica and magnesium stearate.

What Oprymea looks like and contents of the pack

Oprymea 0.26 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P1 on one side, with bevelled edges and possible spots. Oprymea 0.52 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P2 on one side, with bevelled edges and possible spots. Oprymea 1.05 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P3 on one side, with bevelled edges and possible spots.

3-week treatment initiation pack contains 21 prolonged-release tablets in 3 packages:

-the package marked "Week 1" contains 1 blister of 7 tablets of 0.26 mg,

-the package marked "Week 2" contains 1 blister of 7 tablets of 0.52 mg,

-the package marked "Week 3" contains 1 blister of 7 tablets of 1.05 mg.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu