Leaflet: information for the patient

Oprymea 0.26 mg prolonged-release EFG tablets

Oprymea 0.52 mg prolonged-release EFG tablets

Oprymea 1.05 mg prolonged-release EFG tablets

Oprymea 1.57 mg prolonged-release EFG tablets

Oprymea 2.1 mg prolonged-release EFG tablets

Oprymea 2.62 mg prolonged-release EFG tablets

Oprymea 3.15 mg prolonged-release EFG tablets

pramipexol

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

• Keep this leaflet, as 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, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Oprymea is and what it is used for
2. What you need to know before you start taking Oprymea
3. How to take Oprymea
4. Possible side effects
5. Storage of Oprymea
6. Contents of the pack and additional information

Oprymea contains the active ingredient pramipexol and belongs to a group of medications called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopamine receptors triggers nerve impulses in the brain that help control the body's movements.

Oprymea is used to treat the symptoms of idiopathic Parkinson's disease in adults. It may be used alone or in combination with levodopa (another medication for Parkinson's disease).

Do not take Oprymea

• if you are allergic to pramipexol or any of the other components of this medication (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 disease or symptoms, especially any of the following:

• kidney disease.
• hallucinations (seeing, hearing, or feeling things that are not present). Most hallucinations are visual.
• discinesia (e.g., abnormal involuntary movements of the limbs). If you have advanced Parkinson's disease and are also using levodopa, you may experience discinesia during the progressive increase in Oprymea dosage.
• distonía (inability to maintain the trunk and neck straight and upright (axial distonía)). Specifically, you may experience forward flexion of the head and neck (also known as antecolis), forward curvature of the lumbar region (also known as camptocormia), or lateral curvature of the back (also known as pleurotónos or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• drowsiness and sudden episodes of sleep.
• psychosis (e.g., similar to schizophrenia symptoms).
• vision changes. You should undergo periodic eye exams during Oprymea treatment.
• severe heart or blood vessel disease. You should undergo periodic blood pressure checks, especially at the beginning 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 in an unusual way and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as excessive gaming, eating, or spending, abnormally high sexual appetite, or excessive concern about increased sexual thoughts and feelings. Your doctor may need to adjust or discontinue your dosage.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling overexcited or overstimulated) or delirium (diminished consciousness, confusion, loss of contact with reality).Your doctor may need to adjust or discontinue your dosage.

Inform your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing Oprymea treatment. 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 that gradually release the active ingredient once the tablet is ingested. Occasionally, parts of the tablets may be excreted and appear in the stool, which may resemble intact 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 old.

Other Medications and Oprymea

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications, herbal remedies, natural foods, or nutritional supplements that you have obtained without a prescription.

You should avoid using Oprymea with antipsychotic medications.

Be cautious if you are using the following medications:

• cimetidine (for the treatment of excess acid and stomach ulcers)
• amantadine (which may be used to treat Parkinson's disease)
• mexiletine (for the treatment of irregular heartbeats, a condition known as ventricular arrhythmia)
• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a human immunological disease)
• 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 malignant malaria)
• procainamide (for the treatment of irregular heartbeats)

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

Be cautious if you are using tranquilizing medications (with sedative effects) or if you consume 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 consume alcohol during Oprymea treatment. You can take Oprymea with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will inform you if you should continue Oprymea treatment.

The effect of Oprymea on the fetus is unknown. Therefore, do not take Oprymea if you are pregnant unless your doctor advises 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 Oprymea use is necessary, breastfeeding should be discontinued.

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machinery

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 drowsiness and sudden episodes of sleep, especially in patients with Parkinson's disease. If you experience these adverse effects, you should not drive or operate machinery. Inform your doctor if this happens.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will indicate the correct dosage.

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

You can 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 medication may be released in your body too quickly.

During the first week, the usual daily dose is 0.26 mg of pramipexol.

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 tablet dose up to a maximum of 3.15 mg of pramipexol per day. It is also possible to reduce the maintenance dose to 1 prolonged-release Oprymea 0.26 mg tablet per day.

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.

After that, your doctor may increase the frequency of doses to 1 prolonged-release Oprymea 0.26 mg tablet per day. If you need to increase your dose further, your doctor may adjust your dose in 0.26 mg pramipexol levels.

If you have severe kidney disease, your doctor may consider it necessary to change to a different pramipexol medication. 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 Oprymea prolonged-release tablet dose on the Oprymea immediate-release tablet dose 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 take 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 Oprymea dose, but remember to take it within 12 hours of your usual time, take your tablet and continue with the next tablet at your usual time.

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

If you interrupt treatment with Oprymea

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

If you have Parkinson's disease, do not stop your treatment with Oprymea abruptly. Sudden discontinuation may cause the appearance of a condition called neuroleptic malignant syndrome, which can represent a significant 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 treatment or reduce the dose of Oprymea, you may also experience a medical condition called dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, contact your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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)
• Drowsiness
• Dizziness
• Nausea

Common:

• Need to behave in an unusual way
• Illusions (seeing, hearing or feeling things that are not present)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Excess fluid, usually in the legs (peripheral edema)
• Headache
• Low blood pressure
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (urge to vomit)
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g. excessive concern about your health)
• Delusion
• Excessive daytime sleepiness and sudden episodes of sleep
• Amnesia (memory disturbance)
• Hypokinesia (increase in movements and inability to remain 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)*
• Inadequate secretion of the antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hypophonia (soft voice)
• 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 concerning behavior for you or others, for example, increased sexual appetite.
  • Uncontrollable excessive spending.
  • Binge eating (ingestion of large amounts of food in a short period of time) or compulsive eating (ingestion of more food than normal and more than needed to satisfy hunger)*
• Delirium (decreased consciousness, confusion, loss of contact with reality)

Rare:

• Mania (agitation, feeling elated or overexcited)

Frequency not known:

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

Inform 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 provide a precise estimate of the frequency, as these side effects were not observed in clinical trials among 2,762 patients treated with pramipexol. The frequency category is likely to be no higher than "uncommon".

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theApendice V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and the box after EXP or CAD, respectively. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature..

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Oprymea

• 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 dihydrochloride monohydrate of pramipexole, respectively.
• The other components are: hypromellose, cornstarch, 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, engraved with P1 on one side, with beveled edges and possible spots.

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

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

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

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

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

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

They are available in blister packs of 10 tablets, and cartons of 10, 30, 90 and 100 tablets. Only some 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 more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Belgium/Belgique/Belgien

KRKA Belgium, SA.

Tel: + 32 (0) 487 50 73 62

Lithuania

UAB KRKA Lietuva

Tel: + 370 5 236 27 40

Bulgaria

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

Te.: + 359 (02) 962 34 50

Luxembourg/Luxemburg

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

E. 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.

Τηλ: + 30 210 6256177

Austria

KRKA Pharma GmbH, Wien

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

Slovak Republic

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

KRKA Finland Oy

Puh/Tel: + 358 20 754 5330

Cyprus

KI.PA. (PHARMACAL) LIMITED

Τηλ: + 357 24 651 882

Sweden

KRKA Sverige AB

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

Lithuania

KRKA Latvija SIA

Tel: + 371 6 733 86 10

United Kingdom

Consilient Health (UK) Ltd.

Tel: + 44 (0)203 751 1888

Date of the last update of the leaflet:

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