Article Contents
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
-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
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
-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
If you are pregnant or
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
Also, it can pass into the breast milk and can reach your baby. If use of Oprymea is unavoidable,
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):
| 1st week |
Number of tablets | 1 tablet Oprymea 0.088 mg three times a day |
Total daily dose (mg) | 0.264 |
This will be increased every 5 – 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
| 2nd week | 3rd week |
Number of tablets | 1 tablet Oprymea 0.18 mg | 1 tablet Oprymea 0.35 mg |
| three times a day | three times a day |
| OR | OR |
| 2 tablets Oprymea 0.088 mg | 2 tablets Oprymea 0.18 mg |
| three times a day | three times a day |
Total daily dose (mg) | 0.54 | 1.1 |
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.
| Lowest maintenance dose | Highest maintenance dose |
Number of tablets | 1 tablet Oprymea 0.088 mg | 1 tablet Oprymea 1.1 mg three |
| three times a day | times a day |
Total daily dose (mg) | 0.264 | 3.3 |
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:
Very common | may affect more than 1 in 10 people |
Common | may affect up to 1 in 10 people |
Uncommon | may affect up to 1 in 100 people |
Rare | may affect up to 1 in 1,000 people |
Very rare | may affect up to 1 in 10,000 people |
Not known | Frequency cannot be estimated from the available data |
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
-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
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:
- Pramipexole accord - pramipexole dihydrochloride monohydrate
- Sifrol - pramipexole dihydrochloride monohydrate
- Pramipexole teva - pramipexole dihydrochloride monohydrate
- Mirapexin - pramipexole dihydrochloride monohydrate
Prescription drugs listed. Substance: "Pramipexole dihydrochloride monohydrate"
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
-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
-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,
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien | Lietuva |
KRKA Belgium, SA. | UAB KRKA Lietuva |
Tél/Tel: + 32 (0) 487 50 73 62 | Tel: + 370 5 236 27 40 |
България | Luxembourg/Luxemburg |
КРКА България ЕООД | KRKA Belgium, SA. |
Teл.: + 359 (02) 962 34 50 | Tél/Tel: + 32 (0) 487 50 73 62 (BE) |
Česká republika | Magyarország |
KRKA ČR, s.r.o. | KRKA Magyarország Kereskedelmi Kft. |
Tel: + 420 (0) 221 115 150 | Tel.: + 361 (0) 355 8490 |
Danmark | Malta |
KRKA Sverige AB | E. J. Busuttil Ltd. |
Tlf: + 46 (0)8 643 67 66 (SE) | Tel: + 356 21 445 885 |
Deutschland | Nederland |
TAD Pharma GmbH | Focus Care Pharmaceuticals B.V. |
Tel: +31 (0)75 612 05 11 | |
Eesti | Norge |
KRKA, d.d., Novo mesto Eesti filiaal | KRKA Sverige AB |
Tel: + 372 (0) 6 671 658 | Tlf: + 46 (0)8 643 67 66 (SE) |
Ελλάδα | Österreich |
QUALIA PHARMA S.A. | KRKA Pharma GmbH, Wien |
Τηλ: + 30 210 6256177 | Tel: + 43 (0)1 66 24 300 |
España | Polska |
KRKA Farmacéutica, S.L. | |
Tel: + 34 911 61 03 81 | Tel.: + 48 (0)22 573 7500 |
France | Portugal |
KRKA France Eurl | KRKA Farmacêutica, Sociedade Unipessoal Lda. |
Tél: + 33 (0)1 57 40 82 25 | Tel: + 351 (0)21 46 43 650 |
Hrvatska | România |
KRKA - FARMA d.o.o. | KRKA Romania S.R.L., Bucharest |
Tel: + 385 1 6312 100 | Tel: + 4 021 310 66 05 |
Ireland | Slovenija |
KRKA Pharma Dublin, Ltd. | KRKA, d.d., Novo mesto |
Tel: + 353 1 293 91 80 | Tel: + 386 (0) 1 47 51 100 |
Ísland | Slovenská republika |
KRKA Sverige AB | KRKA Slovensko, s.r.o. |
Sími: + 46 (0)8 643 67 66 (SE) | Tel: + 421 (0) 2 571 04 501 |
Italia | Suomi/Finland |
KRKA Farmaceutici Milano S.r.l. | KRKA Finland Oy |
Tel: + 39 02 3300 8841 | Puh/Tel: + 358 20 754 5330 |
Κύπρος | Sverige |
Kipa Pharmacal Ltd. | KRKA Sverige AB |
Τηλ: + 357 24 651 882 | Tel: + 46 (0)8 643 67 66 (SE) |
Latvija | United Kingdom |
KRKA Latvija SIA | Consilient Health (UK) Ltd. |
Tel: + 371 6 733 86 10 | Tel: + 44 (0)203 751 1888 |
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
Oprymea 0.52 mg
Oprymea 1.05 mg
Oprymea 1.57 mg
Oprymea 2.1 mg
Oprymea 2.62 mg
Oprymea 3.15 mg
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
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
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
-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
If you are pregnant or

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
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
You can take Oprymea with or without food. Swallow the tablets whole with water.
Do not chew, divide or crush the
- Nimvastid - Krka, d.d., Novo mesto
- Tolura - Krka, d.d., Novo mesto
- Ifirmasta (irbesartan krka) - Krka, d.d., Novo mesto
- Enyglid - Krka, d.d., Novo mesto
- Dasselta - Krka, d.d., Novo mesto
Prescription drugs listed. Manufacturer: "Krka, d.d., Novo mesto"
During the first week, the usual daily dose is 0.26 mg pramipexole. The dose will be increased every
Ascending dose schedule of Oprymea
Week | Daily dose (mg) | Number of tablets |
0.26 | One Oprymea 0.26 mg | |
0.52 | One Oprymea 0.52 mg | |
|
| OR |
|
| two Oprymea 0.26 mg |
1.05 | One Oprymea 1.05 mg | |
|
| OR |
|
| two Oprymea 0.52 mg |
|
| OR |
|
| four Oprymea 0.26 mg |
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
Patients with kidney disease
If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg
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
Take your Oprymea (immediate release) tablets as normal the day before you switch. Then take your Oprymea
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:
Very common | may affect more than 1 in 10 people |
Common | may affect up to 1 in 10 people |
Uncommon | may affect up to 1 in 100 people |
Rare | may affect up to 1 in 1,000 people |
Very rare | may affect up to 1 in 10,000 people |
Not known | Frequency cannot be estimated from the available data |
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
-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
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
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
Oprymea 3.15 mg

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,
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien | Lietuva |
KRKA Belgium, SA. | UAB KRKA Lietuva |
Tél/Tel: + 32 (0) 487 50 73 62 | Tel: + 370 5 236 27 40 |
България | Luxembourg/Luxemburg |
КРКА България ЕООД | KRKA Belgium, SA. |
Teл.: + 359 (02) 962 34 50 | Tél/Tel: + 32 (0) 487 50 73 62 (BE) |
Česká republika | Magyarország |
KRKA ČR, s.r.o. | KRKA Magyarország Kereskedelmi Kft. |
Tel: + 420 (0) 221 115 150 | Tel.: + 361 (0) 355 8490 |
Danmark | Malta |
KRKA Sverige AB | E. J. Busuttil Ltd. |
Tlf: + 46 (0)8 643 67 66 (SE) | Tel: + 356 21 445 885 |
Deutschland | Nederland |
TAD Pharma GmbH | Focus Care Pharmaceuticals B.V. |
Tel: +31 (0)75 612 05 11 | |
Eesti | Norge |
KRKA, d.d., Novo mesto Eesti filiaal | KRKA Sverige AB |
Tel: + 372 (0) 6 671 658 | Tlf: + 46 (0)8 643 67 66 (SE) |
Ελλάδα | Österreich |
QUALIA PHARMA S.A. | KRKA Pharma GmbH, Wien |
Τηλ: + 30 210 6256177 | Tel: + 43 (0)1 66 24 300 |
España | Polska |
KRKA Farmacéutica, S.L. | |
Tel: + 34 911 61 03 81 | Tel.: + 48 (0)22 573 7500 |
France | Portugal |
KRKA France Eurl | KRKA Farmacêutica, Sociedade Unipessoal Lda. |
Tél: + 33 (0)1 57 40 82 25 | Tel: + 351 (0)21 46 43 650 |
Hrvatska | România |
KRKA - FARMA d.o.o. | KRKA Romania S.R.L., Bucharest |
Tel: + 385 1 6312 100 | Tel: + 4 021 310 66 05 |
Ireland | Slovenija |
KRKA Pharma Dublin, Ltd. | KRKA, d.d., Novo mesto |
Tel: + 353 1 293 91 80 | Tel: + 386 (0) 1 47 51 100 |
Ísland | Slovenská republika |
KRKA Sverige AB | KRKA Slovensko, s.r.o. |
Sími: + 46 (0)8 643 67 66 (SE) | Tel: + 421 (0) 2 571 04 501 |
Italia | Suomi/Finland |
KRKA Farmaceutici Milano S.r.l. | KRKA Finland Oy |
Tel: + 39 02 3300 8841 | Puh/Tel: + 358 20 754 5330 |
Κύπρος | Sverige |
Kipa Pharmacal Ltd. | KRKA Sverige AB |
Τηλ: + 357 24 651 882 | Tel: + 46 (0)8 643 67 66 (SE) |
Latvija | United Kingdom |
KRKA Latvija SIA | Consilient Health (UK) Ltd. |
Tel: + 371 6 733 86 10 | Tel: + 44 (0)203 751 1888 |
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
Oprymea 0.52 mg
Oprymea 1.05 mg
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
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
Children and adolescents
- Sifrol - N04BC05
- Pramipexole teva - N04BC05
- Pramipexole accord - N04BC05
- Mirapexin - N04BC05
Prescription drugs listed. ATC Code: "N04BC05"
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
-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
If you are pregnant or
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
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
You can take Oprymea with or without food. Swallow the tablets whole with water.
Do not chew, divide or crush the
C
During the first week, the usual daily dose is 0.26 mg pramipexole. The dose will be increased every
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
Week Daily dose (mg) Number of tablets
10.26One Oprymea 0.26 mg
20.52One Oprymea 0.52 mg
31.05One Oprymea 1.05 mg
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
Patients with kidney disease
If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg
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
Take your Oprymea (immediate release) tablets as normal the day before you switch. Then take your Oprymea
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:
Very common | may affect more than 1 in 10 people |
Common | may affect up to 1 in 10 people |
Uncommon | may affect up to 1 in 100 people |
Rare | may affect up to 1 in 1,000 people |
Very rare | may affect up to 1 in 10,000 people |
Not known | Frequency cannot be estimated from the available data |
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
-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
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
-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
-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,
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien | Lietuva |
KRKA Belgium, SA. | UAB KRKA Lietuva |
Tél/Tel: + 32 (0) 487 50 73 62 | Tel: + 370 5 236 27 40 |
България | Luxembourg/Luxemburg |
КРКА България ЕООД | KRKA Belgium, SA. |
Teл.: + 359 (02) 962 34 50 | Tél/Tel: + 32 (0) 487 50 73 62 (BE) |
Česká republika | Magyarország |
KRKA ČR, s.r.o. | KRKA Magyarország Kereskedelmi Kft. |
Tel: + 420 (0) 221 115 150 | Tel.: + 361 (0) 355 8490 |
Danmark | Malta |
KRKA Sverige AB | E. J. Busuttil Ltd. |
Tlf: + 46 (0)8 643 67 66 (SE) | Tel: + 356 21 445 885 |
Deutschland | Nederland |
TAD Pharma GmbH | Focus Care Pharmaceuticals B.V. |
Tel: +31 (0)75 612 05 11 | |
Eesti | Norge |
KRKA, d.d., Novo mesto Eesti filiaal | KRKA Sverige AB |
Tel: + 372 (0) 6 671 658 | Tlf: + 46 (0)8 643 67 66 (SE) |
Ελλάδα | Österreich |
QUALIA PHARMA S.A. | KRKA Pharma GmbH, Wien |
Τηλ: + 30 210 6256177 | Tel: + 43 (0)1 66 24 300 |
España | Polska |
KRKA Farmacéutica, S.L. | |
Tel: + 34 911 61 03 81 | Tel.: + 48 (0)22 573 7500 |
France | Portugal |
KRKA France Eurl | KRKA Farmacêutica, Sociedade Unipessoal Lda. |
Tél: + 33 (0)1 57 40 82 25 | Tel: + 351 (0)21 46 43 650 |
Hrvatska | România |
KRKA - FARMA d.o.o. | KRKA Romania S.R.L., Bucharest |
Tel: + 385 1 6312 100 | Tel: + 4 021 310 66 05 |
Ireland | Slovenija |
KRKA Pharma Dublin, Ltd. | KRKA, d.d., Novo mesto |
Tel: + 353 1 293 91 80 | Tel: + 386 (0) 1 47 51 100 |
Ísland | Slovenská republika |
KRKA Sverige AB | KRKA Slovensko, s.r.o. |
Sími: + 46 (0)8 643 67 66 (SE) | Tel: + 421 (0) 2 571 04 501 |
Italia | Suomi/Finland |
KRKA Farmaceutici Milano S.r.l. | KRKA Finland Oy |
Tel: + 39 02 3300 8841 | Puh/Tel: + 358 20 754 5330 |
Κύπρος | Sverige |
Kipa Pharmacal Ltd. | KRKA Sverige AB |
Τηλ: + 357 24 651 882 | Tel: + 46 | (0)8 643 67 66 (SE) |
Latvija | United Kingdom | |
KRKA Latvija SIA | Consilient Health (UK) Ltd. | |
Tel: + 371 6 733 86 10 | Tel: + 44 | (0)203 751 1888 |
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
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