OPRYMEA 0.088 MG Tablets

Зміст інструкції

1. Oprymea 0.088 mg tablets, 0.18 mg tablets, 0.35 mg tablets, 0.7 mg tablets, 1.1 mg tablets
   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
2. 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
   1. What is Oprymea and what is it 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
3. Oprymea 0.26 mg prolonged-release tablets, 0.52 mg prolonged-release tablets, 1.05 mg prolonged-release tablets
   1. What is Oprymea and what is it 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. Content of the pack and other information

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

pramipexole

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What 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 located in the brain. Stimulation
of dopamine receptors in the brain triggers nerve impulses that help to control the
movements of the body.
Oprymea is used for:

• the treatment of symptoms of Parkinson's disease. in adults. It can 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 need to know before taking 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 precautionsTalk to your doctor before taking Oprymea. Tell your doctor if you have (have had) or develop any medical condition or symptom, especially if you belong to the following list:
• Kidney disease.
• Hallucinations (seeing, hearing or perceiving things that are not there). Most hallucinations are visual.
• Dyskinesia (e.g. abnormal, uncontrolled movements of the 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 keep the body and neck upright (axial dystonia)). In

particular, you may experience forward flexion of the head and neck (also known as anterior torticollis), forward flexion of the lower back (also known as camptocormia) or lateral curvature of the back (also known as pleurototonia or Pisa syndrome). If these symptoms occur, your doctor may decide to change the treatment.

• Sleepiness and sudden onset of sleep.
• Psychosis (e.g. comparable to symptoms of schizophrenia).
• Changes in vision. During treatment with Oprymea, you should undergo regular eye checks.
• Severe heart or blood vessel disease. Especially at the beginning of treatment, your blood pressure will need to be checked regularly. This is to avoid postural hypotension (a drop in blood pressure when getting up).
• Worsening of the symptoms of restless legs syndrome. If you notice that the symptoms occur earlier than usual in the evening (or even in the afternoon), are more intense or involve more extensive parts of the affected limbs or involve other limbs. The doctor may reduce the dose or stop treatment. Tell your doctor if you or your family/caregiver notice that you are developing an urge or desire to behave in a way that is unusual for you and you are unable to resist the impulse, drive or temptation to perform certain activities that could be harmful to you or others. These are called impulse control disorders and may include behaviors such as gambling, excessive eating or shopping, an abnormal and increased sexual drive, or increased thoughts or sensations. Your doctor may need to adjust or stop the dose. Tell your doctor if you or a family member or anyone who cares for you notices that you are developing mania (agitation, feeling euphoric or overexcited) or delirium (reduced awareness, confusion or loss of sense of reality). Your doctor may need to adjust the dose or stop therapy. Tell your doctor if you experience symptoms such as depression, apathy, anxiety, feeling tired, sweating or pain after stopping treatment or reducing the dose of Oprymea. If the symptoms persist for more than a few weeks, your doctor may need to adjust the therapy Children and adolescentsThe use of Oprymea is not recommended in children or adolescents under the age of 18 years. Other medicines and OprymeaTell 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 may have obtained even without a prescription. You should avoid taking Oprymea in combination with antipsychotic medicines. Be careful if you are taking the following medicines:
• cimetidine (to treat excess acid in the stomach and stomach 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 for the prevention of painful night cramps and for the treatment of a type of malaria known as malignant malaria)
• procainamide (to treat irregular heartbeats). If you are taking levodopa, it is recommended to reduce the dose when starting treatment with Oprymea. Be careful if you are taking any sedative medicine (sedative effect) or if you are

taking alcohol. In these cases, Oprymea may impair your ability to drive or operate machinery.

Oprymea with food, drinks and alcohol
You should be careful if you drink alcohol while taking Oprymea.
Oprymea can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The
doctor will discuss with you whether to continue taking Oprymea.
The effect of Oprymea on the fetus is unknown. Therefore, do not take Oprymea if you are pregnant unless your
doctor tells you to do so.
Oprymea should not be used during breastfeeding. Oprymea may reduce milk production.
It may also pass into the milk and reach the baby. If taking Oprymea is unavoidable,
breastfeeding should be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Oprymea can cause hallucinations (seeing, hearing or perceiving things that are not there). If this happens
do not drive or operate machinery.
Oprymea has been associated with sleepiness and sudden onset of sleep, particularly
in patients with Parkinson's disease. If these side effects occur, avoid driving and
do not operate machinery. Tell your doctor if this happens.

3. How to take Oprymea

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist. The doctor will indicate the correct dosage.
Oprymea can be taken with or without food. The tablets must be swallowed with water.

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

1week
Number of tablets 1 Oprymea tablet of 0.088 mg three times a day
Total daily dose (mg) 0.264
This dose will be increased every 5-7 days as directed by your doctor until the symptoms are
controlled (maintenance dose).

2week3week
Number of tablets 1 Oprymea tablet
0.18 mg three times a day

or
2 Oprymea tablets of
0.088 mg three times a day
1 Oprymea tablet of
0.35 mg three times a day

or
2 Oprymea tablets of
0.18 mg 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 also be
further increased. If necessary, your doctor may increase the dose of tablets up to a
maximum of 3.3 mg per day of pramipexole. A minimum maintenance dose of three Oprymea 0.088 mg tablets per day is also possible.

Minimum maintenance dose Maximum maintenance dose
Number of tablets 1 Oprymea tablet of
0.088 mg three times a day
1 Oprymea tablet of
1.1 mg three times a day
Total daily dose (mg) 0.264 3.3

Patients with kidney disease
If you suffer from 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 suffer from moderate
kidney disease, the usual initial dose is 1 Oprymea tablet of 0.088 mg twice a day. In case of severe
kidney disease, the usual initial dose is only 1 Oprymea 0.088 mg tablet per day.

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

This dose will be increased every 4 – 7 days as directed by your doctor until the symptoms
are controlled (maintenance dose).

The daily dose should not exceed 6 Oprymea 0.088 mg tablets or a dose of 0.54 mg
(0.75 mg pramipexole salt).
If you stop taking it for a period longer than a few days and intend to resume treatment,
you must start again from the lowest dose. You can then return to your 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 suffer from 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 emergency room of the nearest hospital.
• You may experience vomiting, a feeling of restlessness or any of the undesirable effects described in chapter 4 (Possible side effects ).If you forget to take OprymeaDo not worry. Simply skip the dose completely and then take the next dose at the usual time. Do not take a double dose to make up for a missed dose. If you stop taking OprymeaDo not stop taking Oprymea without first talking to your doctor. If you need to stop 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 should not suddenly stop treatment with Oprymea. Sudden discontinuation could induce the development of a medical condition called neuroleptic malignant syndrome, which can pose a greater risk to your health. 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 taking Oprymea or reduce it, you may 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 should contact your doctor. If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Very common:

• Dyskinesia (e.g. involuntary, abnormal movements of the limbs)
• Sleepiness
• Dizziness
• Nausea (feeling unwell)

Common:

• Urge to behave unusually
• Hallucinations (seeing, hearing or perceiving things that are not there)
• Confusion
• Fatigue (feeling tired)
• Difficulty sleeping (insomnia)
• Fluid retention, usually in the legs (Peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision changes
• Vomiting (feeling unwell)
• Weight loss accompanied by decreased appetite Uncommon:
• Paranoia (e.g. excessive fear for one’s well-being)
• Delirium
• Excessive daytime sleepiness and sudden onset of sleep episodes
• Amnesia (memory disorders)
• Hyperkinesia (increased movements and inability to remain calm)
• Weight gain
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that can cause shortness of breath and swelling of the ankles)*
• Inappropriate secretion of antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, urge or temptation to perform an action that could be harmful to you and others, which may include:
• A strong urge to gamble excessively despite serious personal and family consequences.
• Altered or increased sexual interest and behaviour that is distressing to you and others, for example, an increased sexual drive
• Uncontrollable shopping or eating
• Uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than necessary to satisfy your appetite)*
• Delirium (reduced awareness, confusion, loss of sense of reality) Rare:
• Mania (agitation, feeling of euphoria or overexcitement)
• Spontaneous penile erection Not known:
• After stopping or reducing the dose of Oprymea, depression, apathy, anxiety, feeling tired, sweating or pain (dopamine agonist withdrawal syndrome or DAWS) may occur. Tell your doctor if you experience any of these behaviours; they will discuss with you how tomanage and reduce the symptoms.For side effects marked with * a precise frequency estimate is not possible, as these side effects have not been observed in clinical studies on 2762 patients treated with

pramipexole. The frequency category is unlikely to be greater than “uncommon”.
If you suffer from Restless Legs Syndrome, you may develop the following side effects:

Very common:

• Nausea (feeling unwell)
• Symptoms that start earlier than usual, are more intense or involve other limbs (worsening of Restless Legs Syndrome symptoms). Common:
• Sleep disturbances, such as difficulty falling asleep (insomnia) and sleepiness
• Fatigue (feeling tired)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (feeling unwell) Uncommon:
• Urge to behave unusually*
• Heart failure (heart problems that can cause shortness of breath and swelling of the ankles)*
• Inappropriate secretion of antidiuretic hormone*
• Dyskinesia (e.g. involuntary, abnormal movements of the limbs)
• Hyperkinesia (increased movements and inability to remain calm)*
• Paranoia (e.g. excessive fear for one’s well-being)*
• Delirium*
• Amnesia (memory disorders)*
• Hallucinations (seeing, hearing or perceiving things that are not there)
• Confusion
• Excessive daytime sleepiness and sudden onset of sleep episodes
• Weight gain
• Hypotension (low blood pressure)
• Fluid retention, usually in the legs (peripheral edema)
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Fainting
• Restlessness
• Vision changes
• Weight loss accompanied by decreased appetite
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)*
• Inability to resist the impulse, urge or temptation to perform an action that could be harmful to you and others, which may include:
• A strong urge to gamble excessively despite serious personal and family consequences
• Altered or increased sexual interest and behaviour that is distressing to you and others, for example, an increased sexual drive
• Uncontrollable shopping or eating
• Uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than necessary 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, depression, apathy, anxiety, feeling tired, sweating or pain (dopamine agonist withdrawal syndrome or DAWS) may occur. Tell your doctor if you experience any of these behaviours; they will discuss with you how tomanage and reduce the symptoms.For side effects marked with * a precise frequency estimate is not possible, as these side effects have not been observed in clinical studies on 1395 patients treated with pramipexole. The frequency category is unlikely to be greater than “uncommon”. Reporting of side effectsIf you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in 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 pack after Exp. The expiry date
refers to the last day of that month.
Store in the original package to protect the tablets from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Oprymea contains

• The active ingredient 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 ingredients are mannitol, corn starch, pregelatinized corn starch, povidone K25, anhydrous colloidal silica and magnesium stearate. Description of Oprymea and contents of the packOprymea 0.088 mg tablets are white, round, with bevelled edges and with “P6” imprinted on one side. Oprymea 0.18 mg tablets are white, oval, with bevelled edges, both sides notched, with “P7” imprinted 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, both sides notched, with “P8” imprinted 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, both sides notched, with “P9” imprinted 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, both sides notched. The tablet can be divided into two equal doses. Cartons containing 20, 30, 60, 90 and 100 tablets are available, containing blisters of

aluminium, each containing 10 tablets.
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 on this medicinal product, 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
Teл.: + 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 DeutschlandTAD Pharma GmbH Tel: + 49 (0) 4721 606-0 NederlandKRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) EestiKRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658 NorgeKRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) ΕλλάδαKRKA ΕΛΛΑΣ ΕΠΕ Τηλ: + 30 2100101613 ÖsterreichKRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300 EspañaKRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80 PolskaKRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500 FranceKRKA France Eurl Tél: + 33 (0)1 57 40 82 25 PortugalKRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650 HrvatskaKRKA - FARMA d.o.o. Tel: + 385 1 6312 101 RomâniaKRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05 IrelandKRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710 SlovenijaKRKA, 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.

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

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What 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 is Oprymea and what is it used for

Oprymea contains the active substance pramipexole and belongs to a group of medicines known as
dopamine agonists that stimulate dopamine receptors located in the brain. Stimulation
of dopamine receptors in the brain triggers nerve impulses that help control the
movements of the body.
Oprymea is used for the treatment of 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 need to know before taking 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 precautionsTalk to your doctor before taking Oprymea. Tell your doctor if you have (have had) or develop any medical condition or symptom, especially if you belong to the following list:
• Kidney disease.
• Hallucinations (seeing, hearing or perceiving things that are not there). Most hallucinations are visual.
• Dyskinesia (e.g. abnormal, uncontrolled movements of the 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 keep the body and neck upright (axial dystonia)). In

particular, you may experience forward flexion of the head and neck (also known as torticollis
anterior), forward flexion of the lower back (also known as camptocormia) or lateral curvature
of the spine (also known as pleurototonia or Pisa syndrome). If the
above symptoms occur, your doctor may decide to modify the treatment.

• Sleepiness and sudden onset of sleep episodes.
• Psychosis (e.g. comparable to symptoms of schizophrenia).
• Impaired vision. During treatment with Oprymea, you should undergo regular eye examinations.
• Severe heart or blood vessel disease. Especially at the beginning of treatment, your blood pressure should be checked regularly. This is to avoid postural hypotension (a drop in blood pressure when getting up). Tell your doctor if you, your family members or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you are unable to resist the impulse, urge or temptation to perform certain activities that may harm yourself or others. These phenomena are called impulse control disorders and may include behaviors such as gambling addiction, overeating or excessive spending, unusually high sexual drive or preoccupation with increased sexual thoughts or sensations. Your doctor may need to adjust the dose or stop therapy. Tell your doctor if you or a family member or anyone caring for you notices that you are developing mania (agitation, feeling of euphoria or overexcitement) or delirium (reduced awareness, confusion, loss of sense of reality). Your doctor may need to adjust the dose or stop therapy. Tell your doctor if you experience symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating or pain after stopping treatment or reducing the dosage of Oprymea. If the symptoms persist for more than a few weeks, your doctor may need to adjust the therapy. Oprymea extended-release tablets are tablets specifically designed for the gradual release of the active ingredient once the tablet is swallowed. Parts of the tablets may be expelled and observed in the stool and may appear as whole tablets. Tell your doctor if you should find pieces of tablet in your stool. Children and adolescentsThe use of Oprymea is not recommended in children or adolescents under the age of 18 years. Other medicines and OprymeaTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Including medicines, herbal preparations, dietary products or supplements obtained without a prescription. You should avoid taking Oprymea in combination with antipsychotic medicines. Be careful if you are taking the following medicines:
• cimetidine (to treat excess acid in the stomach and stomach 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 for the prevention of painful nocturnal cramps and for the treatment of a type of malaria known as malignant malaria)
• procainamide (to treat irregular heartbeats).

If you are taking levodopa, it is recommended to reduce the dose when starting treatment with
Oprymea.
Be careful if you are taking any calming medicine (sedative effect) or if you are
drinking 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 you drink 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 or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine. The
doctor will discuss with you whether to continue taking Oprymea.
The effect of Oprymea on fetuses is unknown. Therefore, do not take Oprymea if you are pregnant
unless your doctor tells you to do so.
Oprymea should not be taken during breastfeeding. Oprymea may reduce milk production.
It may also pass into the milk and reach the baby. If taking Oprymea is unavoidable,
breastfeeding should be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Oprymea can cause hallucinations (seeing, hearing or perceiving things that are not there). If this should happen
do not drive or operate machinery.
Oprymea has been associated with sleepiness 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. Tell your doctor if this happens.

3. How to take Oprymea

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist. The doctor will indicate the correct dosage.
Take Oprymea prolonged-release tablets only once a day and every day
approximately at the same time.
Oprymea can 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,
there is a risk of overdose, because the medicine may be released
too quickly inside 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 the doctor's instructions until the symptoms
are controlled (maintenance dose).
The usual maintenance dose is 1.05 mg per day. However, your dose may also be
further increased. If necessary, the doctor may increase the dose of tablets up to a
maximum of 3.15 mg per day of pramipexole. A lower maintenance dose of
one Oprymea 0.26 mg prolonged-release tablet per day is also possible.

Patients with kidney disease
If you suffer from kidney disease, your doctor may tell you to take the usual initial dose of
prolonged-release tablets of 0.26 mg only every other day for the first week.
Subsequently, the doctor may increase the frequency of the dose to one prolonged-release
tablet of 0.26 mg every day. If a further dose increase is necessary, the doctor may
increase it by 0.26 mg of pramipexole.
If you suffer from severe kidney problems, your doctor may consider it necessary to give you a different medicine
also based on pramipexole. If your kidney problems worsen during treatment, you should
contact your doctor as soon as possible.

If you are switching from Oprymea tablets (immediate-release)
The doctor will base the choice of dose of Oprymea prolonged-release tablets on the dose of
Oprymea tablets (immediate-release) that you were taking.
Take Oprymea tablets (immediate-release) as usual the day before switching.
Then take Oprymea prolonged-release tablets the next morning and do not take any more
Oprymea tablets (immediate-release).

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

• contact your doctor immediately or go to the emergency room of the nearest hospital.
• Vomiting, a feeling of restlessness, or any of the undesirable effects described in chapter 4 “Possible undesirable effects” may occur. If you forget to take OprymeaIf you forget to take a dose of Oprymea, but remember within 12 hours of the usual time for taking it, take the tablet immediately and then the next one at the usual time. If more than 12 hours have already passed, simply take the next dose at the usual time. Do not take a double dose to make up for a missed dose. If you stop taking OprymeaDo not stop taking Oprymea without first talking to your doctor. If you need to stop treatment with this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening of symptoms. If you suffer from Parkinson's disease, you should not stop treatment with Oprymea abruptly. Sudden discontinuation could induce the development of a medical condition called

malignant neuroleptic syndrome which may represent a greater risk to health. 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 taking Oprymea or reduce it, you may 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 should contact your doctor. If you have any further 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 gets them.
The assessment of these side effects is based on the following frequencies:

If you suffer from Parkinson's disease, you may develop the following side effects:

Very common:

• Dyskinesia (e.g. involuntary, abnormal movements of the limbs)
• Drowsiness
• Dizziness
• Nausea (feeling unwell) Common:
• Urge to behave unusually
• Hallucinations (seeing, hearing or feeling things that are not there)
• Confusion
• Fatigue (feeling tired)
• Sleeplessness (insomnia)
• Fluid retention, usually in the legs (peripheral edema)
• 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 own well-being)
• Delirium
• Excessive daytime sleepiness and sudden onset of sleep
• Amnesia (memory disorders)
• Hyperkinesia (increased movements and inability to stay calm)
• Weight gain
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that can cause shortness of breath or swelling of the ankles)*
• Inappropriate secretion of antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the urge, drive or temptation to perform an action that may 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 that causes significant distress to you or others, for example an increase in 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, feeling of euphoria or overexcitement)
• Spontaneous penile erection Not known:
• After stopping or reducing the dose of Oprymea, depression, apathy, anxiety, feeling tired, sweating or pain (dopamine agonist withdrawal syndrome or DAWS) may occur. Tell your doctor if you experience any of these behaviours; they will explain how to manage orreduce the symptoms.For side effects marked with * a precise estimate of the frequency cannot be made as these side effects have not been observed in clinical studies involving 2,762 patients treated with pramipexole. The frequency category is likely no greater than “uncommon”. Reporting of side effectsIf you get any side effects, 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 pack 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 particular storage temperature.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Oprymea contains

• The active substance is pramipexole. Each prolonged-release tablet contains 0.26 mg, 0.52 mg, 1.05 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 ingredients are hypromellose, corn starch, anhydrous colloidal silicon dioxide and magnesium stearate. Description of the appearance of Oprymea and contents of the packOprymea 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 chamfered edges and possible mottling. 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 chamfered edges and possible mottling. 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 chamfered edges and possible mottling. Oprymea 1.57 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets incised with P12 on one side, with chamfered edges and possible mottling. 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 chamfered edges and possible mottling. 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 chamfered edges and possible mottling. 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 chamfered edges and possible mottling. Packs of 10, 30, 90 and 100 tablets in blisters of 10 tablets are available. Not all pack sizes may be marketed. Marketing Authorisation HolderKRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia ManufacturerKRKA, 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, contact the local representative of the marketing authorisation holder: België/Belgique/BelgienKRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 LietuvaUAB KRKA Lietuva Tel: + 370 5 236 27 40 БългарияКРКА България ЕООД Teл.: + 359 (02) 962 34 50 Luxembourg/LuxemburgKRKA 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 DeutschlandTAD Pharma GmbH Tel: + 49 (0) 4721 606-0 NederlandKRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) EestiKRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658 NorgeKRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) ΕλλάδαKRKA ΕΛΛΑΣ ΕΠΕ Τηλ: + 30 2100101613 ÖsterreichKRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300 EspañaKRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80 PolskaKRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500 FranceKRKA France Eurl Tél: + 33 (0)1 57 40 82 25 PortugalKRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650 HrvatskaKRKA - FARMA d.o.o. Tel: + 385 1 6312 101 RomâniaKRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05 IrelandKRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710 SlovenijaKRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100 ÍslandLYFIS ehf. Sími: + 354 534 3500 Slovenská republikaKRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 501 ItaliaKRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8841 Suomi/FinlandKRKA 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 medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

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

pramipexole

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

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

Oprymea contains the active substance pramipexole and belongs to a group of medicines known as
dopamine agonists that stimulate dopamine receptors located in the brain. Stimulation
of dopamine receptors in the brain triggers nerve impulses that help to control the
movements of the body.
Oprymea is used for the treatment of 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 need to know before taking 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 precautionsTalk to your doctor before taking Oprymea. Tell your doctor if you have (have had) or develop any medical condition or symptom, especially if you belong to the following list:
• Kidney disease.
• Hallucinations (seeing, hearing or perceiving things that are not there). Most hallucinations are visual.
• Dyskinesia (e.g. abnormal, uncontrolled movements of the 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 keep the body and neck upright (axial dystonia)). In particular, you may experience forward flexion of the head and neck (also known as anterior torticollis), forward flexion of the lower back (also known as camptocormia) or lateral curvature of the spine (also known as pleurototonia or Pisa syndrome). If the above symptoms occur, your doctor may decide to modify the treatment.
• Sleepiness and sudden onset of sleep episodes.
• Psychosis (e.g. comparable to symptoms of schizophrenia).
• Impaired vision. During treatment with Oprymea, you should undergo regular eye checks.
• Severe heart or blood vessel disease. Especially at the beginning of treatment, your blood pressure will need to be checked regularly. This is to avoid postural hypotension (a drop in blood pressure when standing up). Tell your doctor if you, your family members or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you are unable to resist the impulse, drive or temptation to carry out certain activities that may harm yourself or others. These phenomena are called impulse control disorders and may include behaviors such as gambling, overeating or excessive spending, unusually high sexual drive or preoccupation with excessive sexual thoughts or feelings. Your doctor may need to adjust the dose or stop therapy. Tell your doctor if you or a family member or anyone who cares for you notices that you are developing mania (agitation, feeling of euphoria or overexcitement) or delirium (reduced awareness, confusion, loss of sense of reality). Your doctor may need to adjust the dose or stop therapy. Tell your doctor if you experience symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating or pain after stopping treatment or reducing the dose of Oprymea. If the symptoms persist for more than a few weeks, your doctor may need to adjust the therapy. Oprymea extended-release tablet is a tablet specifically designed for the gradual release of the active ingredient once the tablet is swallowed. It is possible that parts of the tablets are expelled and observed in the stool and that they appear as whole tablets. Tell your doctor if you should find pieces of tablet in your stool. Children and adolescentsThe use of Oprymea is not recommended in children or adolescents under the age of 18 years. Other medicines and OprymeaTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Including medicines, herbal preparations, dietary products or supplements obtained without a prescription. You should avoid taking Oprymea in combination with antipsychotic medicines. Be careful if you are taking the following medicines:
• cimetidine (to treat excess acid in the stomach 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 acquired immunodeficiency syndrome (AIDS), a disease of the human immune system)
• cisplatin (to treat various types of cancer)
• quinine (which can be used for the prevention of painful nocturnal cramps and for the treatment of 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 the dose when starting treatment with Oprymea. Be careful if you are taking any sedative medicine (sedative effect) or if you are drinking 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 you drink alcohol while taking Oprymea.
Oprymea can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine. The
doctor will discuss with you whether to continue taking Oprymea.
The effect of Oprymea on the fetus is unknown. Therefore, do not take Oprymea if you are pregnant unless
your doctor tells you to do so.
Oprymea should not be taken during breastfeeding. Oprymea may reduce milk production.
It can also pass into the milk and reach the baby. If taking Oprymea is unavoidable,
breastfeeding should be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Oprymea can cause hallucinations (seeing, hearing or perceiving things that are not there). If this should happen
do not drive or use machines.
Oprymea has been associated with sleepiness and sudden onset of sleep episodes, particularly
in patients with Parkinson's disease. If these side effects occur, avoid driving and
do not use machines. Tell your doctor if this should happen.

3. How to take Oprymea

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist. The doctor will indicate the correct dosage.
Take Oprymea prolonged-release tablets only once a day and every day
approximately at the same time.
Oprymea can 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,
there is a risk of overdose, because the medicine may be released
too quickly inside 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 the doctor's instructions until the symptoms
are controlled (maintenance dose).
The Oprymea starter pack is only to be used for starting treatment with
Oprymea.
The Oprymea starter pack contains three blisters of tablets - one strip for
each of the first three weeks of treatment. The three strips are marked with "Week 1",
"Week 2" and "Week 3".
The daily dose of Oprymea to be taken increases every week.
The usual maintenance dose is 1.05 mg per day. However, your dose may also be
further increased. If necessary, the doctor may increase the dose of tablets up to a
maximum of 3.15 mg per day of pramipexole. A lower maintenance dose of one Oprymea 0.26 mg prolonged-release tablet per day is also possible.

Patients with kidney disease
If you suffer from kidney disease, your doctor may tell you to take the usual starting dose of
prolonged-release tablets of 0.26 mg only on alternate days for the first week.
Subsequently, the doctor may increase the frequency of the dose to one prolonged-release tablet of 0.26 mg every day. If a further increase in the dose is necessary, the doctor may
increase it by 0.26 mg of pramipexole.
If you have severe kidney problems, your doctor may deem it necessary to give you a different medicine
also based on pramipexole. If your kidney problems worsen during treatment, you should
contact your doctor as soon as possible.

If you are switching from Oprymea tablets (immediate-release)
The doctor will base the choice of the dose of Oprymea prolonged-release tablets on the dose of
Oprymea tablets (immediate-release) that you were taking.
Take Oprymea tablets (immediate-release) as usual the day before switching.
Then take Oprymea prolonged-release tablets the next morning and do not take any more
Oprymea tablets (immediate-release).

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

• contact your doctor immediately or go to the emergency room of the nearest hospital.
• Vomiting, a feeling of restlessness or any of the undesirable effects described in chapter 4 “Possible undesirable effects” may occur. If you forget to take OprymeaIf you forget to take a dose of Oprymea, but notice it within 12 hours of the usual time for taking it, take the tablet immediately and then the next one at the usual time. If more than 12 hours have already passed, simply take the next dose at the usual time. Do not take a double dose to make up for a missed dose. If you stop taking OprymeaDo not stop taking Oprymea without first talking to your doctor. If you need to stop treatment with this medicine, the doctor will gradually reduce the dose. This reduces the risk of worsening of symptoms. If you suffer from Parkinson's disease, you should not stop treatment with Oprymea abruptly. Sudden discontinuation could induce the development of a medical condition called neuroleptic malignant syndrome, which may pose a greater risk to your health. 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 taking Oprymea or reduce it, you may 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 should contact your doctor. If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you suffer from Parkinson's disease, you may develop the following side effects:

Very common:

• Dyskinesia (e.g. involuntary, abnormal movements of the limbs)
• Somnolence
• Dizziness
• Nausea (feeling sick) Common:
• Urge to behave unusually
• Hallucinations (seeing, hearing or feeling things that are not there)
• Confusion
• Fatigue (feeling tired)
• Insomnia
• Fluid retention, usually in the legs (peripheral oedema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision disturbances
• Vomiting (feeling sick)
• Weight loss accompanied by loss of appetite Uncommon:
• Paranoia (e.g. excessive fear for your well-being)
• Delirium
• Excessive daytime sleepiness and sudden onset of sleep
• Amnesia (memory disorders)
• Hyperkinesia (increased movements and inability to stay calm)
• Weight gain
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that can cause shortness of breath or swelling of the ankles)*
• Inappropriate secretion of antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, drive or temptation to perform an action that may 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 that causes significant distress to you or others, for example an 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, feeling of euphoria or overexcitement)
• Spontaneous penile erection Not known:
• After stopping or reducing the dosage of Oprymea, depression, apathy, anxiety, feeling tired, 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 orreduce the symptoms.For side effects marked with * a precise estimate of the frequency cannot be made as these side effects have not been observed in clinical studies involving 2,762 patients treated with pramipexole. The frequency category is likely no greater than “uncommon”. Reporting of side effectsIf you get any side effects, 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 pack after Exp. The expiry date
refers to the last day of that month.
Store in the original package to protect it from moisture.
This medicine does not require any particular storage temperature.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Oprymea contains

• The active ingredient 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, corn starch, colloidal anhydrous silica and magnesium stearate. Description of the appearance of Oprymea and content of the packOprymea 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 spotting. 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 spotting. 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 spotting. 3 weeks of initiation of treatment pack contains 21 prolonged-release tablets in 3 packs:
• The pack marked with "Week 1" contains 1 blister of 7 tablets of 0.26 mg,
• The pack marked with "Week 2" contains 1 blister of 7 tablets of 0.52 mg,
• The pack marked with "Week 3" contains 1 blister of 7 tablets of 1.05 mg. Marketing Authorisation HolderKRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia ManufacturerKRKA, 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, contact the local representative of the marketing authorisation holder: België/Belgique/BelgienKRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 LietuvaUAB KRKA Lietuva Tel: + 370 5 236 27 40 БългарияКРКА България ЕООД Teл.: + 359 (02) 962 34 50 Luxembourg/LuxemburgKRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 (BE) Česká republikaKRKA ČR, s.r.o. Tel: + 420 (0) 221 115 150 MagyarországKRKA Magyarország Kereskedelmi Kft. Tel.: + 36 (1) 355 8490 DanmarkKRKA Sverige AB Tlf.: + 46 (0)8 643 67 66 (SE) Malta
• E. J. Busuttil Ltd. Tel: + 356 21 445 885 DeutschlandTAD Pharma GmbH Tel: + 49 (0) 4721 606-0 NederlandKRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) EestiNorge

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