Oprymea 0.35 mg tablets

2. What you need to know before taking Oprymea

Do not take Oprymea

• if you are allergic to pramipexole 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.
• 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 curvature of the lumbar region (also called camptocormia), or curvature of the back to the sides (also called pleurothotonus or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• Somnolence and sudden episodes of sleep.
• Psychosis (e.g., similar to symptoms of schizophrenia).
• Visual impairment. You should undergo regular eye exams during treatment with Oprymea.
• Severe heart or blood vessel disease. You should undergo regular 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 that symptoms start earlier than usual, are more intense, and affect other limbs.

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 gambling addiction, excessive eating or spending, abnormally high sexual appetite, or concern about increased thoughts and feelings of sex. Your doctor may need to adjust or discontinue 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 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 stopping or reducing treatment with Oprymea. If 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 Medications and Oprymea

Inform your doctor or pharmacist if you are taking, have recently taken, 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 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 medications (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 plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will indicate 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 indicates it.

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.

Consult your doctor or pharmacist before using any medication.

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 sudden episodes of 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 the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of 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 divided into 3 equal doses.

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

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 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 pramipexole per day. It is also possible to reduce the maintenance dose to three tablets of Oprymea 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 kidney failure, the usual starting dose is 1 tablet of Oprymea 0.088 mg twice a day. If you have severe kidney failure, the usual starting dose is 1 tablet of Oprymea 0.088 mg per day.

Restless Legs Syndrome

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

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 should 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 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 a suitable 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 emergency department of the nearest hospital 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

Do not 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 stop 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, you should not stop your treatment with Oprymea abruptly. Sudden interruption can cause the appearance of a disorder 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 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 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 for one's health)
• Delusion
• Excessive daytime somnolence and sudden episodes of sleep
• Amnesia (memory impairment)
• 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 yourself or others, including:
• • Strong impulse to gamble excessively despite serious personal or family consequences.
  • Altered or increased sexual interest and disturbing behavior for you or others, for example, increased sexual appetite.
  • Uncontrolled excessive shopping or spending.
  • Binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming 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 stopping or reducing treatment with Oprymea: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS) may occur.

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

For the adverse effects marked with * it is not possible to have a precise estimate of the frequency, as these adverse effects were not observed in clinical trials among 2,762 patients treated with pramipexole. The frequency category is probably not higher than "uncommon".

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

Very Common:

• Nausea

Common:

• Changes in sleep patterns, such as insomnia and somnolence
• Fatigue
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (nausea)

Uncommon:

• Need to behave in an unusual way*
• Heart failure (heart problems that can cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of antidiuretic hormone*
• Dyskinesia (e.g., abnormal involuntary movements of the limbs)
• Hyperkinesia (increased movement and inability to remain still)*
• Paranoia (e.g., excessive concern for one's health)*
• Delusion*
• Amnesia (memory impairment)*
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Excessive daytime somnolence and sudden episodes of sleep
• Weight gain
• Hypotension (low blood pressure)
• Excess fluid, usually in the legs (peripheral edema)
• Allergic reactions (e.g., skin rash, itching, hypersensitivity)
• Fainting
• Restlessness
• Visual disturbance
• Weight loss, including loss of appetite
• Dyspnea (difficulty breathing)
• Hiccup
• Pneumonia (lung infection)
• Inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, including:

• Strong impulse to gamble excessively despite serious personal or family consequences.*
• Altered or increased sexual interest and disturbing behavior for you or others, for example, increased sexual appetite.*
• Uncontrolled excessive shopping or spending.*
• Binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming 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)*

Frequency Not Known:

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

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

For the adverse effects marked with * it is not possible to have a precise estimate of the frequency, as these adverse effects were not observed in clinical trials among 1,395 patients treated with pramipexole. The frequency category is probably not higher than "uncommon".

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the blister 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 via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Oprymea Composition

• The active ingredient 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 ingredients are: mannitol, corn starch, pregelatinized corn starch, colloidal anhydrous silica, povidone K25, magnesium stearate.

Product Appearance and Package Contents

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

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

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

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

Oprymea 1.1 mg tablets are white, round, with beveled edges, both sides 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. Not all 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

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