Oprymea 0.70 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Oprymea 0.088 mg tablets EFG

Oprymea 0.18 mg tablets EFG

Oprymea 0.35 mg tablets EFG

Oprymea 0.7 mg tablets EFG

Oprymea 1.1 mg tablets EFG

pramipexole

Read the entire 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects 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 taking Oprymea
3. How to take Oprymea
4. Possible adverse 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 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 for:

treating the symptoms of idiopathic Parkinson's disease in adults. It may be used alone or in combination with levodopa (another medicine for Parkinson's disease).

treating moderate to severe idiopathic Restless Legs Syndrome in adults.

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 increase of the Oprymea dose.
• 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 lumbar region (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 resembling schizophrenia).
• Vision disorders. You should undergo regular 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).
• Worsening of symptoms. You may experience symptoms starting earlier than usual, becoming more intense, or affecting other limbs.

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges 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 spending or eating, abnormally increased sex drive, or preoccupation with increased 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 (reduced awareness, confusion, or loss of contact with reality). Your doctor may need to adjust or discontinue 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.

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 foods, or nutritional supplements obtained without a prescription.

You must avoid using Oprymea together with antipsychotic medicines.

Use caution if you are taking the following medicines:

• cimetidine (used to treat excess 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, it is recommended to reduce the levodopa dose when starting treatment with Oprymea.

Use caution if you are taking sedative medicines 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 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 during pregnancy unless your doctor instructs you to do so.

Oprymea must not be used during breastfeeding. Oprymea may reduce the production of breast milk and 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 episodes of falling asleep, 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 to you.

3. How to take Oprymea

Follow exactly the instructions for use 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.

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

Parkinson's disease

The daily dose should be taken in three equal doses.

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

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 1.1 mg daily. However, your dose may need to be increased further. If necessary, your doctor could increase your tablet dose to a maximum of 3.3 mg of pramipexole per day. It is also possible to reduce the maintenance dose to three tablets of Oprymea 0.088 mg daily.

Patients with renal 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 impairment, the usual starting dose is 1 tablet of Oprymea 0.088 mg twice daily. If you have severe renal impairment, the usual starting dose is 1 tablet of Oprymea 0.088 mg once daily.

Restless Legs Syndrome

The dose is usually taken once daily, at night, 2–3 hours before going to bed. During the first week, the usual dose is 1 tablet of Oprymea 0.088 mg once daily (equivalent to 0.088 mg daily):

This dose will be increased every 4–7 days according to your doctor's instructions, until your symptoms are controlled (maintenance dose).

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

If you stop taking your tablets for a few days and wish to restart treatment, you must begin 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 or not to continue treatment.

Patients with renal 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 ingest too many tablets:

• consult 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 adverse effects."

If you forget to take Oprymea

Do not worry. Completely miss that dose and take the next dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Oprymea

Do not interrupt your treatment with Oprymea without first consulting your doctor. If you need to interrupt 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 interrupt your treatment with Oprymea abruptly. Sudden interruption may cause a disorder called neuroleptic malignant syndrome, which may pose a very serious health risk. 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 interrupt 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, 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:

If you have Parkinson's disease, 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 manner
• Hallucinations (seeing, hearing or feeling things that are not present)
• Confusion
• Tiredness (fatigue)
• Insomnia
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision blurred
• 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 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 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.
  • Uncontrollable excessive spending or shopping.
  • 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 touch 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; he or she will explain how to manage or reduce the symptoms.

For adverse effects marked with *, a precise frequency estimate is not available, 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."

If you have Restless Legs Syndrome, you may experience the following adverse effects:

Very common:

• Nausea

Common:

• Changes in sleep pattern, such as insomnia and somnolence
• Tiredness (fatigue)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (feeling sick)

Uncommon:

• Urge to behave in an unusual manner*

• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*

• Inappropriate antidiuretic hormone secretion*

• Dyskinesia (e.g., abnormal involuntary movements of limbs)

• Hyperkinesia (increased movements and inability to stay still)*

• Paranoia (e.g., excessive concern about your health)*

• Delusion*

• Amnesia (memory impairment)*

• Hallucinations (seeing, hearing or feeling things that are not present)

• Confusion

• Excessive daytime sleepiness and sudden sleep episodes

• Weight gain

• Hypotension (low blood pressure)

• Fluid retention, usually in the legs (peripheral edema)

• Allergic reactions (e.g., skin rash, itching, hypersensitivity)

• Fainting

• Restlessness

• Blurred vision

• Weight loss including loss of appetite

• 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.*

• Uncontrollable excessive spending or shopping.*

• 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)*

• Mania (agitation, feeling elated or overexcited)*

• Delirium (reduced consciousness, confusion, loss of touch with reality)*

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; he or she will explain how to manage or reduce the symptoms.

For adverse effects marked with *, a precise frequency estimate is not available, as these adverse effects were not observed in clinical trials involving 1,395 patients treated with pramipexole. The frequency category is likely no higher than "uncommon."

Reporting of adverse reactions

If you experience any adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse reactions, 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 the 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 from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oprymea

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

Appearance of the product and contents of the pack

Oprymea 0.088 mg tablets are white, round, with bevelled edges and marked with "P6" on one side.

Oprymea 0.18 mg tablets are white, oval, with bevelled edges, both sides scored, marked with "P7" on both halves on one side. The tablet can be divided into equal doses.

Oprymea 0.35 mg tablets are white, oval, with bevelled edges, both sides scored, marked with "P8" on both halves on one side. The tablet can be divided into equal doses.

Oprymea 0.7 mg tablets are white, round, with bevelled edges, both sides scored, marked with "P9" on both halves on one side. The tablet can be divided into equal doses.

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

Available pack sizes are 20, 30, 60, 90 or 100 tablets in blisters of 10 tablets. 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:

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.