Oprymea 2.62 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Oprymea 0.26 mg prolonged-release tablets EFG

Oprymea 0.52 mg prolonged-release tablets EFG

Oprymea 1.05 mg prolonged-release tablets EFG

Oprymea 1.57 mg prolonged-release tablets EFG

Oprymea 2.1 mg prolonged-release tablets EFG

Oprymea 2.62 mg prolonged-release tablets EFG

Oprymea 3.15 mg prolonged-release tablets EFG

pramipexole

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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. Storage of 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 called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopaminergic receptors triggers nerve impulses in the brain 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 need to know before starting 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

Consult your doctor before starting to take Oprymea. Inform your doctor if you have or have had any illness or symptoms, especially any of the following:

• Kidney disease.
• Hallucinations (seeing, hearing or feeling things that are not present). Most hallucinations are visual.
• Dyskinesia (e.g., abnormal involuntary movements of the limbs). If you have advanced Parkinson's disease and are also taking levodopa, you may develop dyskinesia during the gradual dose increase of Oprymea.
• Dystonia (inability to keep the trunk and neck straight and upright (axial dystonia)). Specifically, you might experience forward bending of the head and neck (also called antecollis), forward bending of the lumbar region (also called camptocormia), or sideways curvature of the back (also called pleurothotonus or Pisa syndrome). In such cases, your doctor may decide to modify your treatment.
• Somnolence and sudden sleep episodes.
• Psychosis (e.g., symptoms similar to schizophrenia).
• Vision disorders. You should undergo periodic eye examinations during treatment with Oprymea.
• Severe heart or blood vessel disease. You should have periodic blood pressure checks, especially at the beginning of treatment, to prevent postural hypotension (a drop in blood pressure upon standing).

Inform your doctor if you, your family, or caregivers notice that you are developing urges or impulses to behave in an unusual way and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings. Your doctor may need to adjust or stop your dose.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling elated or overexcited) or delirium (reduced awareness, confusion, loss of touch with reality). Your doctor may need to adjust or stop your dose.

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

Oprymea prolonged-release tablets are specially designed tablets from which the active substance is gradually released after the tablet is ingested. Occasionally, parts of the tablets may be excreted and seen in the stools, which may resemble intact tablets.

Inform your doctor if you find tablet fragments in your stools.

Children and adolescents

Oprymea is not recommended for use 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 need to take any other medicines. This includes medicines, herbal remedies, natural health products, or nutritional supplements obtained without a prescription.

You must avoid using Oprymea together with antipsychotic medications.

Use caution if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and stomach ulcers)
• amantadine (which may be used in the treatment of Parkinson's disease)
• mexiletine (used 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 (used to treat various types of cancer)
• quinine (which may be used to prevent painful nighttime leg cramps and to treat falciparum malaria (malignant malaria))
• procainamide (used to treat irregular heartbeat)

If you are taking levodopa, it is recommended to reduce the dose of levodopa when starting treatment with Oprymea.

Use caution if you are taking sedative medicines (with sedative effects) or drinking alcohol. In these cases, Oprymea may affect your ability to drive or operate machinery.

Taking Oprymea with food, drinks, and alcohol

You should exercise caution if you drink alcohol during treatment with Oprymea. You may take Oprymea with or without food.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will advise you whether you should continue treatment with Oprymea.

The effect of Oprymea on the fetus is unknown. Therefore, do not take Oprymea if you are pregnant unless your doctor specifically instructs you to do so.

Oprymea must not be used during breastfeeding. Oprymea may reduce the production of breast milk and may also pass into breast milk and reach your baby. If the use of Oprymea is essential, breastfeeding must be discontinued.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Oprymea may cause hallucinations (seeing, hearing, or feeling things that are not present). If this occurs, do not drive or operate machinery.

Oprymea has been associated with somnolence and sudden onset of sleep episodes, especially in patients with Parkinson's disease. If you experience these adverse effects, you must not drive or operate machinery. Inform your doctor if this occurs.

3. How to take Oprymea

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the correct dosage for you.

Take Oprymea prolonged-release tablets once daily, at the same time each day.

You may take Oprymea with or without food. The tablets must be swallowed whole with water.

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

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 your symptoms are controlled (maintenance dose).

Dosing escalation schedule for Oprymea prolonged-release tablets
Week	Daily dose (mg)	Number of tablets
1	0.26	1 prolonged-release tablet of Oprymea 0.26 mg.

Dosing escalation schedule for Oprymea prolonged-release tablets
Week	Daily dose (mg)	Number of tablets
2	0.52	one prolonged-release tablet of Oprymea 0.52 mg, or two prolonged-release tablets of Oprymea 0.26 mg.
3	1.05	one prolonged-release tablet of Oprymea 1.05 mg, or two prolonged-release tablets of Oprymea 0.52 mg, or four prolonged-release tablets of Oprymea 0.26 mg

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

Patients with kidney disease

If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg prolonged-release tablets 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 adjust your dose in increments of 0.26 mg of pramipexole.

If you have severe kidney disease, your doctor may consider it necessary for you to switch to a different pramipexole-containing medicine. If during treatment your kidney problems worsen, contact your doctor as soon as possible.

If you are switching from Oprymea immediate-release tablets

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

On the day before switching, take your immediate-release Oprymea tablets as usual. On the following morning, take your prolonged-release Oprymea tablet and do not take any further immediate-release Oprymea tablets.

If you take more Oprymea than you should

If you accidentally ingest too many tablets,

• consult your doctor or the nearest hospital emergency service immediately.
• you may experience vomiting, restlessness, or any of the adverse effects described in section 4, "Possible adverse effects".

If you forget to take Oprymea

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

If you forget your dose and more than 12 hours have passed, simply take the next dose at your regular time. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Oprymea

Do not stop your treatment with Oprymea without first consulting your doctor. If you need to discontinue treatment with this medicine, your doctor will gradually reduce your dose. This reduces the risk of worsening symptoms.

If you have Parkinson's disease, you must not abruptly stop treatment with Oprymea. Sudden interruption may trigger a disorder called neuroleptic malignant syndrome, which may pose a serious health risk. These 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 interrupt treatment or reduce the dose of Oprymea, you may also experience a medical condition known as dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, 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 adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The classification of adverse effects is based on the following frequencies:

Very common	may affect more than 1 in 10 people
Common	may affect up to 1 in 10 people
Uncommon	may affect up to 1 in 100 people
Rare	may affect up to 1 in 1,000 people
Very rare	may affect up to 1 in 10,000 people
Frequency not known	cannot be estimated from the available data

You may experience the following adverse effects:

Very common:

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

Frequent:

• Need to behave in an unusual way
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision disturbance
• Nausea (feeling sick)
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g. excessive concern about your health)
• Delusion
• Excessive daytime sleepiness and sudden episodes of falling asleep
• Amnesia (memory impairment)
• 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 swelling of the ankles)*
• Inappropriate antidiuretic hormone secretion*
• 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 or others, which may include:
  • Strong urge to gamble excessively despite serious personal or family consequences.
  • Altered or increased sexual interest and behavior that is concerning to you or others, for example, increased sex drive.
  • Compulsive buying or uncontrolled spending.
  • Binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)*
• Delirium (reduced consciousness, confusion, loss of touch with reality)

Rare:

• Mania (agitation, feeling elated or overexcited)

Frequency not known:

• After discontinuing or reducing treatment with Oprymea: depression, apathy, anxiety, fatigue, sweating, or pain may occur (known as dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

For the adverse effects marked with *, it is not possible to provide an accurate estimate of frequency, as these adverse effects were not observed in clinical trials involving 2,762 patients treated with pramipexole. The frequency category is likely no higher than "uncommon."

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it concerns possible adverse reactions not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse reactions, you can help provide more information on the safety of this medicinal product.

5. Storage of Oprymea

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton, after EXP or CAD, respectively. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medicine does not require any special storage temperature.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oprymea

• 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 as 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, corn starch, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the pack

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

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

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

Oprymea 1.57 mg prolonged-release tablets are white or almost white, round (10 mm in diameter), slightly biconvex tablets engraved with P12 on one side, bevelled edges, and possible specks.

Oprymea 2.1 mg prolonged-release tablets are white or almost white, round (10 mm in diameter), slightly biconvex tablets engraved with P4 on one side, bevelled edges, and possible specks.

Oprymea 2.62 mg prolonged-release tablets are white or almost white, round (10 mm in diameter), slightly biconvex tablets engraved with P13 on one side and 262 on the other side, bevelled edges, and possible specks.

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

Pack sizes of 10, 30, 90 and 100 tablets in blisters of 10 tablets are available. Only certain 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:

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

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

Bulgaria
????????
???? ???????? ????
Tel.: +359 (02) 962 34 50

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

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

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

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

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

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

Netherlands
Focus Care Pharmaceuticals B.V.
Tel: +31 (0)75 612 05 11

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

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

Greece
QUALIA PHARMA S.A.
Tel: +30 210 6256177

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

Spain
KRKA Farmacéutica, S.L.
Tel: +34 911 61 03 81

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

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

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

Ireland
KRKA Pharma Dublin, Ltd.
Tel: +353 1 293 91 80

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

Iceland
LYFIS ehf.
Sími: +354 534 3500

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

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

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

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

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

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

United Kingdom
Consilient Health (UK) Ltd.
Tel: +44 (0)203 751 1888

Date of the most recent review of this leaflet:

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