Package Insert: Information for the Patient

Oprymea 0.088 mg EFG Tablets

Oprymea 0.18 mg EFG Tablets

Oprymea 0.35 mg EFG Tablets

Oprymea 0.7 mg EFG Tablets

Oprymea 1.1 mg EFG Tablets

pramipexol

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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 body movements.

Oprymea is used for:

treating 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).

treating the symptoms of moderate to severe idiopathic Restless Legs Syndrome in adults.

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 symptom, especially any of the following:

• Kidney disease.
• Alucinations (seeing, hearing or feeling things that are not present). Most alucinations 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 progressive increase in Oprymea dosage.
• Dystonia (inability to maintain the trunk and neck straight and upright (axial dystonia)). 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 pleurototonus or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• Drowsiness and sudden onset of sleep.
• Psychosis (e.g., similar to schizophrenia symptoms).
• Visual disturbances. You should undergo periodic eye examinations 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).
• Increased symptoms. You may experience symptoms starting earlier than usual, being more intense and affecting other limbs.

Inform your doctor if you, your family or caregivers notice that you are developing impulses or urges to behave in an unusual way in you and 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 an increase in sexual thoughts and feelings. Your doctor may need to adjust or discontinue your dose.

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

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

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 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 immunodeficiency syndrome (AIDS), a human immunological system disease)
• cisplatin (for treating 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 treating irregular heartbeats)

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

Be cautious if you are using tranquilizing medications (with 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 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 or intend to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will tell you if you should continue Oprymea treatment.

Oprymea's effect 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 Oprymea use is necessary, breastfeeding should be interrupted.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Oprymea may cause alucinations (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 onset 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 as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will indicate the correct dosage.

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

Parkinson's Disease

The daily dose should be taken in 3 equal doses.

During the first week, the usual dose is 1 Oprymea tablet 0.088 mg three times a day (equivalent to 0.264 mg per day):

This dose will be increased every 5-7 days as indicated by your doctor, until your symptoms are controlled (maintenance dose).

The usual maintenance dose is 1.1 mg per day. However, it may be necessary to increase your dose further. If necessary, your doctor may increase your dose of tablets up to a maximum of 3.3 mg of pramipexol per day. It is also possible to reduce the maintenance dose to 3 Oprymea tablets 0.088 mg per day.

Patients with kidney disease

If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you should take the tablets only once or twice a day. If you have moderate renal insufficiency, the usual starting dose is 1 Oprymea tablet 0.088 mg twice a day. If you have severe renal insufficiency, the usual starting dose is 1 Oprymea tablet 0.088 mg per day.

Restless Legs Syndrome

The dose is usually administered once a day, at night, 2-3 hours before bedtime. During the first week, the usual dose is 1 Oprymea tablet 0.088 mg once a day (equivalent to 0.088 mg per day):

This dose will be increased every 4-7 days as indicated by your doctor, until your symptoms are controlled (maintenance dose).

The daily dose for the treatment of restless legs syndrome should not exceed 6 Oprymea tablets 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexol base).

If you stop taking your tablets for a few days and want to resume treatment, you should start again with the smallest dose and then gradually increase the dose as you did the first time. Consult your doctor if you have any doubts.

Your doctor will evaluate your treatment after 3 months to decide whether to continue or not with the treatment.

Patients with kidney disease:

If you have severe kidney disease, Oprymea may not be an appropriate treatment for your restless legs syndrome.

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

Don't worry. Omit that dose completely and take the next dose at the correct 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 pose 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

If you haveParkinson's disease, 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
• Hallucinations (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:

• 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.*
• Uncontrolled 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)*

• Mania (agitation, feeling elated or overexcited)*
• Delirium (decreased consciousness, confusion, loss of contact with reality)*

Unknown frequency:

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

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 involving 2,762 patients treated with pramipexol. The frequency category is likely not higher than "uncommon".

If you haveRestless Legs Syndrome, you may experience the following side effects:

Very common:

Common:

Uncommon:

• 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.*
• Uncontrolled 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)*

• Mania (agitation, feeling elated or overexcited)*
• Delirium (decreased consciousness, confusion, loss of contact with reality)*

Unknown frequency:

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

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 involving 1,395 patients treated with pramipexol. The frequency category is likely not 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 thenational reporting system included in Appendix 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 light.

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

Composition of Oprymea

• The active ingredient is pramipexol. Each Oprymea tablet contains 0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg, or 1.1 mg of pramipexol as 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, or 1.5 mg of pramipexol dihydrochloride monohydrate, respectively.
• The other components are: mannitol, cornstarch, pregelatinized cornstarch, anhydrous colloidal silica, povidone K25, magnesium stearate.

Appearance of the product and contents of the pack

Oprymea 0.088 mg tablets are white, round, with beveled edges and marked with "P6" on one of its faces.

Oprymea 0.18 mg tablets are white, oval, with beveled edges, both faces scored, with the mark "P7" on the two halves on one of its faces. The tablet can be divided into equal doses.

Oprymea 0.35 mg tablets are white, oval, with beveled edges, both faces scored, with the mark "P8" on the two halves on one of its faces. The tablet can be divided into equal doses.

Oprymea 0.7 mg tablets are white, round, with beveled edges, both faces scored, with the mark "P9" on the two halves on one of its faces. The tablet can be divided into equal doses.

Oprymea 1.1 mg tablets are white, round, with beveled edges, both faces scored. The tablet can be divided into equal doses.

Available in boxes of 20, 30, 60, 90, or 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

Responsible for manufacturing

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 medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.