Oprymea 0.26 mg prolonged-release tablets EFG

Patient Information Leaflet

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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 taking Oprymea
3. How to take Oprymea
4. Possible side effects
5. How to store Oprymea
6. Contents of the pack and other information

1. What Oprymea is and what it is used for

Oprymea contains the active substance pramipexole and belongs to a group of medicines called dopaminergic 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 to take Oprymea

Do not take Oprymea

• if you are allergic to pramipexole or to any of the other components 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 known as antecollis), forward curvature of the lower back (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome). In such cases, your doctor may consider modifying your treatment.
• Somnolence and sudden sleep episodes.
• Psychosis (e.g., symptoms similar to schizophrenia).
• Vision impairment. You should undergo regular eye examinations during treatment with Oprymea.
• Severe heart or blood vessel disease. You should have regular 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 cravings to behave in ways that are unusual for you 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 ingredient is gradually released after ingestion. Occasionally, parts of the tablets may be excreted and seen in the stools, appearing as whole 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 herbal remedies, natural foods, or nutritional supplements obtained without a prescription.

You should avoid using Oprymea together with antipsychotic medicines.

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 heartbeat, a condition known as ventricular arrhythmia)
• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a human immune system disease)
• cisplatin (used to treat various types of cancer)
• quinine (which may be used to prevent painful leg cramps at night and to treat a type of malaria known as falciparum malaria (malignant malaria))
• procainamide (used to treat irregular heartbeat)

If you are taking levodopa, a reduction in the levodopa dose is recommended when starting treatment with Oprymea.

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

Taking Oprymea with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan 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 during pregnancy unless your doctor instructs you to do so.

Oprymea should not be used during breastfeeding. Oprymea may reduce breast milk production. In addition, it may 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 using machines

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 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 happens.

3. How to take Oprymea

Follow exactly the instructions for using 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.

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 daily. However, your dose may need to be increased further. If necessary, your doctor may increase your tablet dose 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 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 your dose needs to be increased further, your doctor may adjust it in increments of 0.26 mg of pramipexole.

If you have severe kidney disease, your doctor may consider switching you to a different pramipexole 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 dose of Oprymea prolonged-release tablets on the dose of Oprymea immediate-release tablets you were previously taking.

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

If you take more Oprymea than you should

If you accidentally take too many tablets:

• contact your doctor or the nearest hospital emergency department immediately.
• you may experience vomiting, agitation, or any of the adverse effects described in section 4, "Possible side 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 your tablet and continue with the next dose at the usual time.

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

If you stop taking 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 helps reduce the risk of worsening symptoms.

If you have Parkinson's disease, you should not stop treatment with Oprymea abruptly. Sudden discontinuation may lead to a condition called neuroleptic malignant syndrome, which can pose a serious health risk. These symptoms include:

• akinesia (loss of muscular 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 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:

You may experience the following adverse effects:

Very common:

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

Common:

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

Uncommon:

• Paranoia (e.g. excessive concern about your health)
• Delusion
• Excessive daytime sleepiness and sudden sleep episodes
• Amnesia (memory impairment)
• Hyperkinesia (increased movements and inability to stay still)
• Weight gain
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that may cause breathlessness or swollen 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 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 behavior concerning to you or others, e.g. increased libido.
  • Compulsive or uncontrolled 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 hunger)*
  • Delirium (reduced 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).

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

For adverse effects marked with *, an accurate estimation of frequency is not possible, 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 effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the blister and carton, indicated as EXP or CAD, respectively. The expiry date refers to the last day of the month shown.

Store in the original packaging 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 unused medicines and their packaging. This helps 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, maize starch, colloidal anhydrous 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 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 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 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 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 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 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 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. However, 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 regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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