Oprymea

Patient Information Leaflet

Oprymea 0.088 mg tablets, 0.18 mg tablets, 0.35 mg tablets, 0.7 mg tablets, 1.1 mg tablets

pramipexole
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
  Contents of this leaflet:

1. What Oprymea is and what it is used for
2. What you need to know before taking 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 located in the brain. Stimulation of
dopamine receptors in the brain triggers nerve impulses that help control body movements.
Oprymea is used for:

• the treatment of symptoms of Parkinson's disease in adults. It may be used alone or in combination with levodopa (another medicine for Parkinson's disease).
• the treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults.

2. What you should know before taking Oprymea

Do not take Oprymea

• if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor before taking Oprymea. Inform your doctor if you have (had) or develop any medical condition or symptom, especially if it belongs to the following list:

• Kidney disease.

• Hallucinations (seeing, hearing, or sensing things that are not real). Most hallucinations are visual.

• Dyskinesia (e.g., abnormal, uncontrollable movements of limbs). If you suffer from advanced Parkinson's disease and are also taking levodopa, you may develop dyskinesia during the titration of Oprymea.

• Dystonia (inability to maintain upright posture of body and neck (axial dystonia)). In particular, forward bending of head and neck (also known as anterocollis), forward bending of the lumbar spine (also known as camptocormia), or lateral curvature of the back (also known as pleurothotonus or Pisa syndrome) may occur. If you experience any of these symptoms, your doctor may decide to modify your treatment.

• Drowsiness and sudden onset of sleep episodes.

• Psychosis (e.g., symptoms comparable to schizophrenia).

• Vision changes. You should have regular eye examinations during treatment with Oprymea.

• Severe heart or blood vessel diseases. Especially at the beginning of treatment, your blood pressure should be monitored regularly to prevent postural hypotension (a drop in blood pressure upon standing).

• Worsening of restless legs syndrome symptoms. If you notice that symptoms occur earlier than usual in the evening (or even in the afternoon), are more intense, affect larger areas of the affected limbs, or involve other limbs, your doctor may reduce the dose or discontinue treatment. Inform your doctor if you or your family/caregiver notice that you are developing an impulse or desire to behave in an unusual way and are unable to resist the impulse, urge, or temptation to carry out certain activities that could be dangerous for you or others. These are called impulse control disorders and may include behaviors such as gambling addiction, excessive eating or shopping, abnormally increased sexual drive, or increased sexual thoughts or feelings. Your doctor may need to adjust or stop the dose. Inform your doctor if you, a family member, or caregiver notice signs of mania (agitation, feelings of euphoria or overexcitement) or delirium (reduced awareness, confusion, or loss of sense of reality). Your doctor may consider it necessary to adjust the dose or discontinue therapy. Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of Oprymea. If symptoms persist for more than a few weeks, your doctor may need to adapt the treatment. Children and adolescents The use of Oprymea is not recommended in children or adolescents under 18 years of age. Other medicines and Oprymea Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes prescription and non-prescription drugs, herbal remedies, health foods, or supplements. You must avoid taking Oprymea together with antipsychotic medicines. Be cautious if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and gastric ulcers)

• amantadine (which may be used to treat Parkinson's disease)

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

• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a disease of the human immune system)

• cisplatin (to treat various types of cancer)

• quinine (which may be used to prevent painful nighttime cramps and to treat falciparum malaria (malignant malaria))

• procainamide (to treat irregular heartbeats). If you are taking levodopa, a reduction of its dose is recommended when starting treatment with Oprymea. Be cautious if you are taking any sedative (sleep-inducing) medicine or consuming alcohol. In these cases, Oprymea may impair your ability to drive or operate machinery. Oprymea with food, drinks, and alcohol You should be cautious if consuming alcohol during treatment with Oprymea. Oprymea can be taken with or without food. Pregnancy and breastfeeding If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss with you whether to continue taking Oprymea. The effect of Oprymea on fetuses is unknown. Therefore, do not take Oprymea during pregnancy unless your doctor tells you to do so. Oprymea must not be used during breastfeeding. Oprymea may reduce milk production and may pass into breast milk, potentially affecting the infant. If taking Oprymea is unavoidable, breastfeeding must be discontinued. Consult your doctor or pharmacist before taking any medicine. Driving and using machines Oprymea may cause hallucinations (seeing, hearing, or sensing things that are not real). If this occurs, do not drive or operate machinery. Oprymea has been associated with drowsiness and sudden onset of sleep episodes, particularly in patients with Parkinson's disease. If these side effects occur, avoid driving and do not operate machinery. Inform your doctor if this happens.

3. How to take Oprymea

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist. Your doctor will determine the correct dosage for you.
Oprymea may be taken with or without food. The tablets should be swallowed with water.

Parkinson’s disease
The daily dose should be divided into 3 equal doses.
During the first week, the usual dose is 1 tablet of Oprymea 0.088 mg three times daily (equivalent to 0.264 mg per day):

Week 1
Number of tablets: 1 tablet of Oprymea 0.088 mg three times daily
Total daily dose (mg): 0.264

This dose will be increased every 5–7 days according to your doctor's instructions until symptoms are controlled (maintenance dose).

Week 2        Week 3
Number of tablets: 1 tablet of Oprymea 0.18 mg three times daily    1 tablet of Oprymea 0.35 mg three times daily
           or                             or
           2 tablets of Oprymea 0.088 mg three times daily    2 tablets of Oprymea 0.18 mg three times daily
Total daily dose (mg): 0.54                               1.1

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

Minimum maintenance dose        Maximum maintenance dose
Number of tablets: 1 tablet of Oprymea 0.088 mg three times daily    1 tablet of Oprymea 1.1 mg three times daily
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 need to take the tablets only once or twice daily. If you have moderate kidney disease, the usual starting dose is 1 tablet of Oprymea 0.088 mg twice daily. If you have severe kidney disease, the usual starting dose is only 1 tablet of Oprymea 0.088 mg daily.

Restless Legs Syndrome
The dose is usually taken once daily in the evening, 2–3 hours before going to bed.
During the first week, the usual dose is 1 tablet of Oprymea 0.088 mg once daily (equivalent to 0.088 mg per day):

This dose will be increased every 4–7 days according to the doctor's instructions until symptoms are controlled (maintenance dose).

The daily dose must not exceed 6 tablets of Oprymea 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
If you stop taking the medication for more than a few days and wish to restart treatment, you must begin again with the lowest dose. You may then return to your previous dose as you did the first time. Ask your doctor for advice.
Your doctor will review your treatment after 3 months to decide whether to continue it or not.

Patients with kidney disease
If you have severe kidney disease, treatment with Oprymea may not be suitable for you.

If you take more Oprymea than you should
If you accidentally take too many tablets:

• Contact your doctor immediately or go to the nearest hospital emergency department.
• Symptoms may include vomiting, restlessness, or any of the side effects listed in section 4 (Possible side effects).

If you forget to take Oprymea
Do not worry. Simply miss the forgotten dose completely and take the next dose at the usual time. Do not take a double dose 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 need to discontinue treatment with this medicine, your doctor will gradually reduce the dose. This reduces the risk of worsening symptoms.
If you have Parkinson’s disease, you must not stop treatment with Oprymea abruptly. Sudden discontinuation could lead to the development of a medical condition called neuroleptic malignant syndrome, which may pose a greater health risk. Symptoms include:

• akinesia (loss of muscular movement)
• muscle rigidity
• fever
• unstable blood pressure
• tachycardia (increased heart rate)
• confusion
• reduced level of consciousness (e.g. coma)

If you stop or reduce treatment with Oprymea, you might also develop a medical condition called dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, feeling tired, sweating, or pain. If you experience these symptoms, you must contact your doctor.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The assessment 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. involuntary, abnormal movements of limbs)
• Drowsiness
• Dizziness
• Nausea (feeling unwell)

Common:

• Impulse to behave in an unusual way
• Hallucinations (seeing, hearing or sensing things that are not there)
• Confusion
• Fatigue (feeling of tiredness)
• Sleeplessness (insomnia)
• Fluid retention, usually in the legs (peripheral oedema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (feeling unwell)
• Weight loss accompanied by decreased appetite

Uncommon:

• Paranoia (e.g. excessive fear for your own well-being)
• Delirium
• Excessive daytime sleepiness and sudden onset sleep episodes
• Amnesia (memory disorders)
• Hyperkinesia (increased movements and inability to stay still)
• Weight gain
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that may cause shortness of breath and swelling of the ankles)*
• Inappropriate antidiuretic hormone secretion*
• Restlessness
• Dyspnoea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, urge or temptation to perform an action that could be harmful to you or others, which may include:
  • Strong urge to gamble excessively despite serious personal and family consequences.
  • Altered or increased sexual interest and behaviour causing significant concern to you and others, e.g. increased sexual drive
  • Uncontrollable excessive shopping or eating
  • Binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite)*
• Delirium (reduced awareness, confusion, loss of sense of reality)

Rare:

• Spontaneous penile erection

Not known:

• After stopping or reducing the dose of Oprymea, symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating or pain may occur (dopamine agonist withdrawal syndrome or DAWS). Inform your doctor if you experience any of these behaviours; they will discuss with you how to manage and reduce the symptoms.

For side effects marked with *, a precise frequency estimate is not possible, as these side effects were not observed in clinical studies involving 2762 patients treated with pramipexole. The frequency category is unlikely to be higher than "uncommon".

If you suffer from Restless Legs Syndrome, you may experience the following side effects:
Very common:

• Nausea (feeling unwell)
• Symptoms occurring earlier than usual, more intense, or involving other limbs (worsening of Restless Legs Syndrome symptoms)

Common:

• Sleep disturbances, such as difficulty sleeping (insomnia) and drowsiness
• Fatigue (feeling of tiredness)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (feeling unwell)

Uncommon:

• Impulse to behave in an unusual way*
• Heart failure (heart problems that may cause shortness of breath and swelling of the ankles)*
• Inappropriate antidiuretic hormone secretion*
• Dyskinesia (e.g. involuntary, abnormal movements of limbs)
• Hyperkinesia (increased movements and inability to stay still)*
• Paranoia (e.g. excessive fear for your own well-being)*
• Delirium*
• Amnesia (memory disorders)*
• Hallucinations (seeing, hearing or sensing things that are not there)
• Confusion
• Excessive daytime sleepiness and sudden onset sleep episodes
• Weight gain
• Hypotension (low blood pressure)
• Fluid retention, usually in the legs (peripheral oedema)
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Fainting
• Restlessness
• Visual disturbances
• Weight loss accompanied by decreased appetite
• Dyspnoea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)*
• Inability to resist the impulse, urge or temptation to perform an action that could be harmful to you or others, which may include:
  • Strong urge to gamble excessively despite serious personal and family consequences
  • Altered or increased sexual interest and behaviour causing significant concern to you and others, e.g. increased sexual drive
  • Uncontrollable excessive shopping or eating
  • Binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite)*
• Mania (agitation, feeling of euphoria or overexcitement)*
• Delirium (reduced awareness, confusion, loss of sense of reality)*

Rare:

• Spontaneous penile erection

Not known:

• After stopping or reducing the dose of Oprymea, symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating or pain may occur (dopamine agonist withdrawal syndrome or DAWS). Inform your doctor if you experience any of these behaviours; they will discuss with you how to manage and reduce the symptoms.

For side effects marked with *, a precise frequency estimate is not possible, as these side effects were not observed in clinical studies involving 1395 patients treated with pramipexole. The frequency category is unlikely to be higher than "uncommon".

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 packaging to protect the tablets from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What 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 of pramipexole, equivalent to 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate, respectively.
• The other components are mannitol, maize starch, pregelatinized maize starch, povidone K25, anhydrous colloidal silica, and magnesium stearate.

Description of the appearance of Oprymea and contents of the pack

Oprymea 0.088 mg tablets are white, round, with bevelled edges, and marked with "P6" on one side.
Oprymea 0.18 mg tablets are white, oval, with bevelled edges, scored on both sides, and marked with "P7" on both halves of one surface. The tablet can be divided into two equal doses.
Oprymea 0.35 mg tablets are white, oval, with bevelled edges, scored on both sides, and marked with "P8" on both halves of one surface. The tablet can be divided into two equal doses.
Oprymea 0.7 mg tablets are white, round, with bevelled edges, scored on both sides, and marked with "P9" on both halves of one surface. The tablet can be divided into two equal doses.
Oprymea 1.1 mg tablets are white, round, with bevelled edges, scored on both sides. The tablet can be divided into two equal doses.

Carton packs containing 20, 30, 60, 90, and 100 tablets are available, each tablet in an aluminum blister pack of 10 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: +370 5 236 27 40

България (Bulgaria)
КРКА България ЕООД
Teл.: +359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Česká republika (Czech Republic)
KRKA ČR, s.r.o.
Tel: +420 (0) 221 115 150

Magyarország (Hungary)
KRKA Magyarország Kereskedelmi Kft.
Tel.: +36 (1) 355 8490

Danmark (Denmark)
KRKA Sverige AB
Tlf.: +46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: +356 21 445 885

Deutschland (Germany)
TAD Pharma GmbH
Tel: +49 (0) 4721 606-0

Nederland (Netherlands)
KRKA Belgium, SA.
Tel: +32 (0) 487 50 73 62 (BE)

Eesti (Estonia)
KRKA, d.d., Novo mesto Eesti filiaal
Tel: +372 (0) 6 671 658

Norge (Norway)
KRKA Sverige AB
Tlf: +46 (0)8 643 67 66 (SE)

Ελλάδα (Greece)
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: +30 2100101613

Österreich (Austria)
KRKA Pharma GmbH, Wien
Tel: +43 (0)1 66 24 300

España (Spain)
KRKA Farmacéutica, S.L.
Tel: +34 911 61 03 80

Polska (Poland)
KRKA-POLSKA Sp. z o.o.
Tel.: +48 (0)22 573 7500

France
KRKA France Eurl
Tél: +33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: +351 (0)21 46 43 650

Hrvatska (Croatia)
KRKA - FARMA d.o.o.
Tel: +385 1 6312 101

România (Romania)
KRKA Romania S.R.L., Bucharest
Tel: +4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: +353 1 413 3710

Slovenija (Slovenia)
KRKA, d.d., Novo mesto
Tel: +386 (0) 1 47 51 100

Ísland (Iceland)
LYFIS ehf.
Sími: +354 534 3500

Slovenská republika (Slovakia)
KRKA Slovensko, s.r.o.
Tel: +421 (0) 2 571 04 501

Italia (Italy)
KRKA Farmaceutici Milano S.r.l.
Tel: +39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Κύπρος (Cyprus)
KI.PA. (PHARMACAL) LIMITED
Τηλ: +357 24 651 882

Sverige (Sweden)
KRKA Sverige AB
Tel: +46 (0)8 643 67 66 (SE)

Latvija (Latvia)
KRKA Latvija SIA
Tel: +371 6 733 86 10

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Patient information leaflet: information for the patient

Oprymea 0.26 mg prolonged-release tablets, 0.52 mg prolonged-release tablets, 1.05 mg prolonged-release tablets, 1.57 mg prolonged-release tablets, 2.1 mg prolonged-release tablets, 2.62 mg prolonged-release tablets, 3.15 mg prolonged-release tablets

Pramipexole
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
  Contents of this leaflet:

1. What Oprymea is and what it is used for
2. What you need to know before taking 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 located in the brain. Stimulation of
dopamine receptors in the brain triggers nerve impulses that help control body movements.
Oprymea is used to treat the symptoms of idiopathic Parkinson's disease in adults.
It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).

2. What you should know before taking Oprymea

Do not take Oprymea

• if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor before taking Oprymea. Inform your doctor if you have (had) or develop any medical condition or symptom, especially if it belongs to the following list:

• Kidney disease.

• Hallucinations (seeing, hearing or sensing things that are not real). Most hallucinations are visual.

• Dyskinesia (e.g. abnormal, uncontrollable movements of limbs). If you have advanced Parkinson's disease and are also taking levodopa, you may develop dyskinesia during the titration of Oprymea.

• Dystonia (inability to maintain an upright posture of body and neck (axial dystonia)). In particular, forward bending of head and neck (also known as antecollis), forward bending of the lumbar spine (also known as camptocormia), or lateral curvature of the spine (also known as pleurothotonus or Pisa syndrome) may occur. If you experience any of these symptoms, your doctor may decide to adjust your treatment.

• Drowsiness and sudden onset of sleep episodes.

• Psychosis (e.g. symptoms comparable to schizophrenia).

• Vision disorders. During treatment with Oprymea, you should undergo regular eye examinations.

• Severe heart or blood vessel diseases. Especially at the beginning of treatment, your blood pressure should be monitored regularly to prevent postural hypotension (a drop in blood pressure upon standing). Inform your doctor if you, your family members or caregivers notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These phenomena are called impulse control disorders and may include behaviours such as gambling addiction, binge eating, compulsive spending, abnormally increased sexual desire, or preoccupation due to increased sexual thoughts or sensations. Your doctor may need to adjust the dose or discontinue therapy. Inform your doctor if you or a family member or caregiver notice the development of mania (agitation, feelings of euphoria or overexcitement) or delirium (reduced awareness, confusion, loss of sense of reality). Your doctor may consider it necessary to adjust the dose or stop treatment. Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing the dose of Oprymea. If symptoms persist for longer than a few weeks, your doctor may need to adjust treatment. Oprymea prolonged-release tablet is a specially designed tablet for gradual release of the active ingredient once ingested. It is possible that parts of the tablets may be expelled and observed in the faeces, appearing as intact tablets. Inform your doctor if you find tablet fragments in your faeces. Children and adolescents The use of Oprymea is not recommended in children or adolescents under 18 years of age. Other medicines and Oprymea Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines, dietary products or supplements obtained without a prescription. You must avoid taking Oprymea together with antipsychotic medicines. Be cautious if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and gastric ulcers)

• amantadine (which may be used to treat Parkinson's disease)

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

• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a disease of the human immune system)

• cisplatin (to treat various types of cancer)

• quinine (which may be used to prevent painful nocturnal cramps and to treat a type of malaria known as falciparum malaria (malignant malaria))

• procainamide (to treat irregular heartbeats).

If you are taking levodopa, it is recommended to reduce its dose when starting treatment with Oprymea. Be cautious if you are taking any sedative (sleep-inducing) medicines or consuming alcohol. In these cases, Oprymea may impair your ability to drive or operate machinery. Oprymea with food, drinks and alcohol You should be cautious if consuming alcohol during treatment with Oprymea. Oprymea can be taken with or without food. Pregnancy and breastfeeding If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss with you whether to continue taking Oprymea. The effect of Oprymea on fetuses is unknown. Therefore, do not take Oprymea during pregnancy unless your doctor tells you to do so. Oprymea must not be taken during breastfeeding. Oprymea may reduce milk production and may also pass into breast milk and reach the infant. If taking Oprymea is unavoidable, breastfeeding must be discontinued. Consult your doctor or pharmacist before taking any medicine. Driving and using machines Oprymea may cause hallucinations (seeing, hearing or sensing things that are not real). If this occurs, do not drive or operate machinery. Oprymea has been associated with drowsiness and sudden onset of sleep episodes, particularly in patients with Parkinson's disease. If these side effects occur, avoid driving and do not operate machinery. Inform your doctor if this happens.

3. How to take Oprymea

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist. Your doctor will determine the correct dosage for you.
Take Oprymea prolonged-release tablets only once daily, at approximately the same time each day.
Oprymea may be taken with or without food. Swallow the tablets whole with water.
Do not chew, divide, or crush the prolonged-release tablets. If you do so,

there is a risk of overdose, as the medicine may be released too quickly into your body.
During the first week, the usual daily dose is 0.26 mg of pramipexole.
This dose will be increased every 5–7 days according to your doctor's instructions until symptoms are controlled (maintenance dose).

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

Patients with kidney disease
If you have kidney disease, your doctor may instruct you to take the usual starting dose of 0.26 mg prolonged-release tablets every other day during the first week. Afterwards, your doctor may increase the dosing frequency to one 0.26 mg prolonged-release tablet daily. If further dose increases are needed, your doctor may increase the dose by increments of 0.26 mg of pramipexole.
If you have severe kidney problems, your doctor may decide to prescribe a different pramipexole-containing medicine. If your kidney problems worsen during treatment, you must contact your doctor as soon as possible.

Switching from Oprymea tablets (immediate-release)
Your doctor will determine the appropriate dose of Oprymea prolonged-release tablets based on the dose of Oprymea immediate-release tablets you were previously taking.
Take your usual dose of Oprymea immediate-release tablets the day before switching. Then, take Oprymea prolonged-release tablets the following morning and no longer take Oprymea immediate-release tablets.

If you take more Oprymea than you should
If you accidentally take too many tablets:

• contact your doctor immediately or go to the nearest hospital emergency department.
• Symptoms such as vomiting, restlessness, or any of the adverse effects described in section 4 “Possible side effects” may occur.

If you forget to take Oprymea
If you forget to take a dose of Oprymea but remember within 12 hours of your usual dosing time, take the tablet immediately and then take the next dose at the usual time. If more than 12 hours have passed, simply take the next dose at the regular time. Do not take a double dose 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 need to discontinue treatment with this medicine, your doctor will gradually reduce the dose. This reduces the risk of symptom worsening. If you have Parkinson’s disease, you must not stop treatment with Oprymea abruptly. Sudden discontinuation may lead to the development of a medical condition called neuroleptic malignant syndrome, which may pose a serious health risk. Symptoms include:

• akinesia (loss of muscle movement)
• muscle rigidity
• fever
• unstable blood pressure
• tachycardia (increased heart rate)
• confusion
• reduced level of consciousness (e.g. coma).

If you stop or reduce treatment with Oprymea, you may also develop a medical condition called dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you must contact your doctor.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them. The assessment of these adverse reactions is based on the following frequencies:

If you have Parkinson's disease, you may experience the following side effects:
Very common:

• Dyskinesia (e.g. involuntary, abnormal movements of limbs)

• Somnolence

• Dizziness

• Nausea (feeling unwell)
  Common:

• Impulse to behave in an unusual way

• Hallucinations (seeing, hearing or sensing things that are not there)

• Confusion

• Fatigue (feeling tired)

• Difficulty sleeping (insomnia)

• Fluid retention, usually in the legs (peripheral oedema)

• Headache

• Hypotension (low blood pressure)

• Abnormal dreams

• Constipation

• Vision disturbances

• Vomiting (feeling unwell)

• Weight loss accompanied by loss of appetite
  Uncommon:

• Paranoia (e.g. excessive worry about your well-being)

• Delirium

• Excessive daytime sleepiness and sudden onset of sleep episodes

• Amnesia (memory problems)

• Hyperkinesia (increased movements and inability to stay still)

• Weight gain

• Allergic reactions (e.g. skin rash, itching, hypersensitivity)

• Fainting

• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*

• Inappropriate antidiuretic hormone secretion*

• Restlessness

• Dyspnoea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)

• Inability to resist the impulse, urge or temptation to carry out an action that could be harmful to you or others, which may include:

• Strong urge to gamble excessively despite serious personal or family consequences

• Altered or increased sexual interest and behaviour causing significant concern to you or others, for example increased sexual urges

• Excessive and uncontrollable shopping or spending

• Uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite)*

• Delirium (reduced awareness, confusion, loss of sense of reality)
  Rare:

• Mania (agitation, feeling of euphoria or over-excitement)

• Spontaneous penile erection
  Not known:

• After stopping or reducing the dose of Oprymea, symptoms such as depression, apathy, anxiety, fatigue, sweating or pain may occur (dopamine agonist withdrawal syndrome or DAWS).
  Tell your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.
  For side effects marked with *, it is not possible to estimate the frequency precisely, as these side effects were not observed in clinical studies involving 2,762 patients treated with pramipexole. The frequency category is likely no more than "uncommon".

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 packaging to protect it from moisture.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Oprymea contains

• The active substance is pramipexole. Each prolonged-release tablet contains 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg or 3.15 mg of pramipexole, equivalent to 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg or 4.5 mg of pramipexole dihydrochloride monohydrate, respectively.
• The other components are hypromellose, maize starch, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Oprymea and package contents
Oprymea 0.26 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets imprinted with "P1" on one side, with bevelled edges and possible specks.
Oprymea 0.52 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets imprinted with "P2" on one side, with bevelled edges and possible specks.
Oprymea 1.05 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets imprinted with "P3" on one side, with bevelled edges and possible specks.
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 specks.
Oprymea 2.1 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets imprinted with "P4" on one side, with bevelled edges and possible specks.
Oprymea 2.62 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets imprinted with "P13" on one side and "262" on the other side, with bevelled edges and possible specks.
Oprymea 3.15 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets imprinted with "P5" on one side and "315" on the other side, with bevelled edges and possible specks.

Packages containing 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Danmark
KRKA Sverige AB
Tlf.: + 46 (0)8 643 67 66 (SE)

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 101

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Package leaflet: information for the patient

Oprymea 0.26 mg prolonged-release tablets, 0.52 mg prolonged-release tablets, 1.05 mg prolonged-release tablets

Pramipexole
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
  Contents of this leaflet:
  1. What Oprymea is and what it is used for
  2. What you need to know before taking 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 located in the brain. Stimulation
of dopamine receptors in the brain triggers nerve impulses that help control body movements.
Oprymea is used to treat the symptoms of idiopathic Parkinson's disease in adults.
It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).

2. What you should know before taking Oprymea

Do not take Oprymea

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

Warnings and precautions

Talk to your doctor before taking Oprymea. Inform your doctor if you have (or have had) or develop any medical condition or symptom, especially if it belongs to the following list:

• Kidney disease.
• Hallucinations (seeing, hearing, or sensing things that are not there). Most hallucinations are visual.
• Dyskinesia (e.g., abnormal, uncontrollable movements of limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you may develop dyskinesia during the titration of Oprymea.
• Dystonia (inability to maintain upright posture of body and neck (axial dystonia)). In particular, forward bending of head and neck (also known as antecollis), forward bending of the lumbar spine (also known as camptocormia), or lateral curvature of the spine (also known as pleurothotonus or Pisa syndrome) may occur. If any of these symptoms occur, your doctor may decide to adjust your treatment.
• Drowsiness and sudden onset of sleep episodes.
• Psychosis (e.g., symptoms similar to schizophrenia).
• Vision disorders. During treatment with Oprymea, you should undergo regular eye examinations.
• Severe heart or blood vessel diseases. Especially at the beginning of treatment, your blood pressure should be monitored regularly to prevent postural hypotension (a drop in blood pressure upon standing). Inform your doctor if you, your family members, or caregivers notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others. These phenomena are called impulse control disorders and may include behaviors such as gambling addiction, binge eating, compulsive spending, abnormally increased sexual desire, or preoccupation due to increased sexual thoughts or sensations. Your doctor may need to adjust the dose or discontinue therapy. Inform your doctor if you or a family member or caregiver notices the development of mania (agitation, feelings of euphoria or over-excitement) or delirium (reduced awareness, confusion, loss of sense of reality). Your doctor may consider it necessary to adjust the dose or discontinue therapy. Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of Oprymea. If symptoms persist for longer than a few weeks, your doctor may need to adjust your therapy.

Oprymea prolonged-release tablet is a specially designed tablet for gradual release of the active ingredient once swallowed. It is possible that parts of the tablet may be expelled and seen in the stool, and may look like intact tablets. Inform your doctor if you find pieces of the tablet in your stool.

Children and adolescents
The use of Oprymea is not recommended in children or adolescents under 18 years of age.

Other medicines and Oprymea
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal remedies, dietary products, or supplements obtained without a prescription. You must avoid taking Oprymea together with antipsychotic medicines. Be cautious if you are taking any of the following medicines:

• cimetidine (used to treat excess stomach acid and gastric ulcers)
• amantadine (which may be used to treat Parkinson’s disease)
• mexiletine (for treating irregular heartbeats, a condition known as ventricular arrhythmia)
• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a disease of the human immune system)
• cisplatin (for treating various types of cancer)
• quinine (which may be used to prevent painful nighttime leg cramps and to treat a type of malaria known as falciparum malaria (malignant malaria))
• procainamide (for treating irregular heartbeats)

If you are taking levodopa, it is recommended to reduce its dose when starting treatment with Oprymea. Be cautious if you are taking any sedative (sleep-inducing) medicines or consuming alcohol. In these cases, Oprymea may impair your ability to drive or operate

machinery.
Oprymea with food, drinks, and alcohol
You should be cautious if consuming alcohol during treatment with Oprymea.
Oprymea can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will discuss with you whether to continue taking Oprymea.
The effect of Oprymea on the fetus is unknown. Therefore, do not take Oprymea during pregnancy unless your doctor tells you to do so.
Oprymea must not be taken during breastfeeding. Oprymea may reduce milk production. It may also pass into breast milk and reach the infant. If taking Oprymea is unavoidable, breastfeeding must be discontinued.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Oprymea may cause hallucinations (seeing, hearing, or sensing things that are not there). If this occurs, do not drive or use machines.
Oprymea has been associated with drowsiness and sudden onset of sleep episodes, particularly in patients with Parkinson’s disease. If these side effects occur, avoid driving and do not use machinery. Inform your doctor if this happens.

3. How to take Oprymea

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist. Your doctor will determine the correct dosage for you.
Take Oprymea prolonged-release tablets once daily, at approximately the same time each day.
Oprymea may be taken with or without food. Swallow the tablets whole with water.

Do not chew, divide, or crush the prolonged-release tablets. Doing so may result in overdose, as the medicine could be released too quickly into your body.
During the first week, the usual daily dose is 0.26 mg of pramipexole.
This dose will be increased every 5–7 days, as directed by your doctor, until symptoms are controlled (maintenance dose).
The starter pack of Oprymea is intended only for initiating treatment with Oprymea.
The Oprymea starter pack contains three blister strips—one strip for each of the first three weeks of treatment. The three strips are labelled "Week 1", "Week 2", and "Week 3".
The daily dose of Oprymea increases each week.

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

Patients with kidney disease
If you have kidney disease, your doctor may instruct you to take the usual starting dose of 0.26 mg prolonged-release tablets every other day during the first week. Afterwards, your doctor may increase the frequency to one 0.26 mg prolonged-release tablet daily. If further dose increases are needed, your doctor may increase the dose by 0.26 mg of pramipexole.
If you have severe kidney problems, your doctor may consider prescribing a different pramipexole-containing medicine. If your kidney problems worsen during treatment, you must contact your doctor as soon as possible.

Switching from Oprymea tablets (immediate-release)
Your doctor will determine the dose of Oprymea prolonged-release tablets based on the dose of Oprymea immediate-release tablets you were previously taking.
Continue taking your Oprymea immediate-release tablets as usual the day before switching. Then, take Oprymea prolonged-release tablets the following morning and stop taking Oprymea immediate-release tablets.

If you take more Oprymea than you should
If you accidentally take too many tablets:

• Contact your doctor immediately or go to the nearest hospital emergency department.
• Symptoms may include vomiting, restlessness, or any of the side effects listed in section 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 dosing time, take the missed tablet immediately and then take the next dose at your usual time. If more than 12 hours have passed, simply take the next dose at the regular time. Do not take a double dose to make up for the missed dose.

If you stop taking Oprymea
Do not stop taking Oprymea without first discussing it with your doctor. If you need to discontinue treatment with this medicine, your doctor will gradually reduce the dose. This reduces the risk of symptom worsening. If you have Parkinson’s disease, you must not stop treatment with Oprymea abruptly. Sudden discontinuation may lead to a serious medical condition called neuroleptic malignant syndrome, which may pose a greater health risk. Symptoms include:

• akinesia (loss of muscular movement)
• muscle rigidity
• fever
• unstable blood pressure
• tachycardia (increased heart rate)
• confusion
• reduced level of consciousness (e.g., coma).

If you stop or reduce treatment with Oprymea, you may also develop a medical condition called dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you must contact your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The assessment 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., involuntary, abnormal limb movements)

• Somnolence

• Dizziness

• Nausea (feeling unwell)
  Common:

• Impulse to behave in an unusual way

• Hallucinations (seeing, hearing, or sensing things that are not there)

• Confusion

• Fatigue (feeling tired)

• Sleeplessness (insomnia)

• Fluid retention, usually in the legs (peripheral oedema)

• Headache

• Hypotension (low blood pressure)

• Abnormal dreams

• Constipation

• Vision disturbances

• Vomiting (feeling unwell)

• Weight loss accompanied by decreased appetite
  Uncommon:

• Paranoia (e.g., excessive fear for your well-being)

• Delirium

• Excessive daytime sleepiness and sudden onset sleep episodes

• Amnesia (memory disorders)

• Hyperkinesia (increased movement and inability to stay still)

• Weight gain

• Allergic reactions (e.g., skin rash, itching, hypersensitivity)

• Fainting

• Heart failure (heart problems that may cause shortness of breath or ankle swelling)*

• Inappropriate antidiuretic hormone secretion*

• Restlessness

• Dyspnoea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)

• Inability to resist the impulse, urge, or temptation to carry out an action that could be harmful to you or others, which may include:

• Strong urge to gamble excessively despite serious personal or family consequences

• Altered or increased sexual interest and behaviour causing significant concern to you or others, for example increased sexual drive

• Excessive and uncontrollable shopping or spending

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

• Delirium (reduced awareness, confusion, loss of sense of reality)
  Rare:

• Mania (agitation, feelings of euphoria or over-excitement)

• Spontaneous penile erection
  Not known:

• After stopping or reducing the dose of Oprymea, symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain may occur (dopamine agonist withdrawal syndrome or DAWS).
  Tell your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.
  For side effects marked with *, an exact frequency estimate cannot be provided, as these side effects were not observed in clinical studies involving 2,762 patients treated with pramipexole. The frequency category is likely no higher than "uncommon".

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you 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 pack after "Exp". The expiry date refers to the last day of that month.
Store in the original packaging to protect it from moisture.
No special storage temperature requirements apply for this medicine.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Oprymea contains

• The active substance is pramipexole. Each prolonged-release tablet contains 0.26 mg, 0.52 mg or 1.05 mg of pramipexole, equivalent to 0.375 mg, 0.75 mg or 1.5 mg of pramipexole dihydrochloride monohydrate, respectively.
• The other ingredients are hypromellose, maize starch, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Oprymea and package contents

Oprymea 0.26 mg prolonged-release tablets are white or almost white, round (10 mm diameter), slightly biconvex tablets with bevelled edges, imprinted with "P1" on one side, and may have slight specks.

Oprymea 0.52 mg prolonged-release tablets are white or almost white, round (10 mm diameter), slightly biconvex tablets with bevelled edges, imprinted with "P2" on one side, and may have slight specks.

Oprymea 1.05 mg prolonged-release tablets are white or almost white, round (10 mm diameter), slightly biconvex tablets with bevelled edges, imprinted with "P3" on one side, and may have slight specks.

3-week starter pack: The pack contains 21 prolonged-release tablets in 3 packages:

• The package labelled "Week 1" contains 1 blister with 7 tablets of 0.26 mg,
• The package labelled "Week 2" contains 1 blister with 7 tablets of 0.52 mg,
• The package labelled "Week 3" contains 1 blister with 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Tel: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf.: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Eesti
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
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.