OPRYMEA 3.15 mg PROLONGED-RELEASE TABLETS

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Oprymea and what is it used for
2. What you need to know before you take Oprymea
3. How to take Oprymea
4. Possible side effects
5. Storage of 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 called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopamine receptors triggers nerve impulses in the brain that help control body movements.

Oprymea is used to treat 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 you take Oprymea

Do not take Oprymea

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

Warnings and precautions

Consult your doctor before starting treatment with Oprymea. Inform your doctor if you have or have had any disease or symptom, 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 using levodopa, you may experience dyskinesia during the gradual increase in the dose of Oprymea.
• Dystonia (inability to keep the trunk and neck straight and upright (axial dystonia)). In particular, you may experience forward flexion of the head and neck (also called antecollis), forward flexion of the lumbar region (also called camptocormia), or sideways curvature of the back (also called pleurothotonus or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• Somnolence and episodes of sudden sleep.
• Psychosis (e.g., similar to symptoms of schizophrenia).
• Visual disturbance. You should have regular eye examinations during treatment with Oprymea.
• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the start of treatment, to avoid postural hypotension (a drop in blood pressure when standing up).

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave abnormally and cannot resist the impulse, instinct, or temptation to perform certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sexual desire, or increased concern about an increase in sexual thoughts and feelings. Your doctor may need to adjust or interrupt the dose.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling elated or overexcited) or delirium (decreased level of consciousness, confusion, loss of contact with reality). Your doctor may need to adjust or interrupt your dose.

Inform your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with Oprymea. If the 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. Sometimes, parts of the tablets may be excreted and seen in the stool, which may look like whole tablets.

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

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 take any other medicines. This includes medicines, herbal medicines, natural foods, or nutritional supplements that you have obtained without a prescription.

You should avoid using Oprymea with antipsychotic medicines.

Be cautious if you are using the following medicines:

• cimetidine (for the treatment of excess acid and ulcers in the stomach)
• amantadine (which may be used in the treatment of Parkinson's disease)
• mexiletine (for the treatment of irregular heartbeats, a condition known as ventricular arrhythmia)
• zidovudine (which may be used to treat acquired immune deficiency syndrome (AIDS), a disease of the human immune system)
• cisplatin (for the treatment of various types of cancer)
• quinine (which may be used to prevent painful leg cramps that occur at night and to treat a type of malaria known as falciparum malaria (malignant malaria))
• procainamide (for the treatment of irregular heartbeat)

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

Be cautious if you are using sedative medicines (with a sedative effect) or if you drink alcohol. In these cases, Oprymea may affect your ability to drive and operate machinery.

Taking Oprymea with food, drinks, and alcohol

You should be cautious if you drink alcohol during treatment with Oprymea. You can take Oprymea with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will tell you whether you should continue treatment with Oprymea.

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

Oprymea should not be used during breastfeeding. Oprymea may decrease milk production. Additionally, it may pass into breast milk and reach your baby. If the use of Oprymea is essential, breastfeeding should be discontinued.

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

Driving and using machines

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

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

3. How to take Oprymea

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will tell you the correct dosage.

Take Oprymea prolonged-release tablets once a day at the same time every day.

You can take Oprymea with or without food. The tablets should be swallowed whole with water.

Do not chew, divide, or crush the prolonged-release tablets. If you do, there is a risk of overdosing, as the medicine may be released in 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).

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

Patient with renal disease

If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg prolonged-release tablets on alternate days during the first week.

After that, your doctor may increase the frequency of administration to one prolonged-release tablet of 0.26 mg every day. If it is necessary to increase your dose further, your doctor may adjust the dose in levels of 0.26 mg of pramipexole.

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

If you are switching from Oprymea immediate-release tablets

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

The day before the switch, take your Oprymea immediate-release tablets as you normally would. The next morning, take your Oprymea prolonged-release tablet and do not take any more Oprymea immediate-release tablets.

If you take more Oprymea than you should

If you accidentally ingest too many tablets,

• consult your doctor or the nearest hospital emergency department immediately.
• you may experience vomiting, restlessness, or any of the side effects described 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 the usual time, take your tablet and continue with the next tablet at the usual time.

If you forget to take a dose and it is more than 12 hours after the usual time, simply take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Oprymea

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

If you have Parkinson's disease, do not stop your treatment with Oprymea abruptly. Sudden interruption can cause the appearance of a disorder called neuroleptic malignant syndrome, which can be a serious risk to your health. These symptoms include:

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

If you stop or reduce treatment with Oprymea, you may also experience a medical disorder called dopamine agonist withdrawal syndrome. The 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 on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

You may experience the following side effects:

Very common:

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

Common:

• Need to behave in an unusual way
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Fatigue
• Insomnia
• Excess fluid, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbance
• Vomiting (nausea)
• Weight loss, including loss of appetite

Uncommon:

• Paranoia (e.g., excessive concern about your health)
• Delusion
• Excessive daytime somnolence and episodes of sudden sleep
• Amnesia (memory disturbance)
• Hyperkinesia (increased movement and inability to remain still)
• 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)*
• Inadequate secretion of antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hiccup
• Pneumonia (lung infection)
• Inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you or others, which may include:
• • Strong impulse to gamble excessively despite serious personal or family consequences.
  • Altered or increased sexual interest and behavior that is concerning to you or others, for example, increased sexual appetite.
  • Uncontrolled buying or spending.
  • Binge eating (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)*
• Delirium (decreased level of consciousness, confusion, loss of contact with reality)

Rare:

• Mania (agitation, feeling elated or overexcited)

Frequency not known:

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

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

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

Reporting of side effects

If you experience 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 Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 blister and the carton after EXP or CAD, respectively. The expiry date is the last day of the month stated.

Store in the original package to protect from moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Oprymea Composition

• The active ingredient 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 ingredients are: hypromellose, corn starch, colloidal anhydrous silica, and magnesium stearate.

Product Appearance and Package Contents

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, with beveled edges and possible stains.

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, with beveled edges and possible stains.

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, with beveled edges and possible stains.

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, with beveled edges and possible stains.

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, with beveled edges and possible stains.

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, with beveled edges and possible stains.

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, with beveled edges and possible stains.

They are available in packs of 10, 30, 90, and 100 tablets in blisters of 10 tablets. Only some 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/België/Belgique

KRKA Belgium, SA.

Tel: + 32 (0) 487 50 73 62

Lithuania/Lietuva

UAB KRKA Lietuva

Tel: + 370 5 236 27 40

Bulgaria/????????

???? ???????? ????

Tel: + 359 (02) 962 34 50

Luxembourg/Luxemburg

KRKA Belgium, SA.

Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Czech Republic/??????

KRKA CR, s.r.o.

Tel: + 420 (0) 221 115 150

Hungary/Magyarország

KRKA Magyarország Kereskedelmi Kft.

Tel: + 36 (1) 355 8490

Denmark/Danmark

KRKA Sverige AB

Tlf: + 46 (0)8 643 67 66 (SE)

Malta

• J. Busuttil Ltd.

Tel: + 356 21 445 885

Germany/Deutschland

TAD Pharma GmbH

Tel: + 49 (0) 4721 606-0

Netherlands/Nederland

Focus Care Pharmaceuticals B.V.

Tel: +31 (0)75 612 05 11

Estonia/Eesti

KRKA, d.d., Novo mesto Eesti filiaal

Tel: + 372 (0) 6 671 658

Norway/Norge

KRKA Sverige AB

Tlf: + 46 (0)8 643 67 66 (SE)

Greece/Ελλ?δα

QUALIA PHARMA S.A.

Τηλ: + 30 210 6256177

Austria/Österreich

KRKA Pharma GmbH, Wien

Tel: + 43 (0)1 66 24 300

Spain/Espa?a

KRKA Farmacéutica, S.L.

Tel: + 34 911 61 03 81

Poland/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

Croatia/Hrvatska

KRKA - FARMA d.o.o.

Tel: + 385 1 6312 100

Romania/România

KRKA Romania S.R.L., Bucharest

Tel: + 4 021 310 66 05

Ireland

KRKA Pharma Dublin, Ltd.

Tel: + 353 1 293 91 80

Slovenia/Slovenija

KRKA, d.d., Novo mesto

Tel: + 386 (0) 1 47 51 100

Iceland/Ísland

LYFIS ehf.

Sími: + 354 534 3500

Slovakia/Slovenská republika

KRKA Slovensko, s.r.o.

Tel: + 421 (0) 2 571 04 501

Italy/Italia

KRKA Farmaceutici Milano S.r.l.

Tel: + 39 02 3300 8841

Finland/Suomi

KRKA Finland Oy

Puh/Tel: + 358 20 754 5330

Cyprus/Κ?προς

KI.PA. (PHARMACAL) LIMITED

Τηλ: + 357 24 651 882

Sweden/Sverige

KRKA Sverige AB

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

Latvia/Latvija

KRKA Latvija SIA

Tel: + 371 6 733 86 10

United Kingdom

Consilient Health (UK) Ltd.

Tel: + 44 (0)203 751 1888

Date of Last Revision of this Leaflet:

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