Prospecto:information for the user

MIRAPEXIN 0.088mg tablets

MIRAPEXIN 0.18mg tablets

MIRAPEXIN 0.35mg tablets

MIRAPEXIN 0.7mg tablets

pramipexol

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people 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 prospectus.See section 4.

MIRAPEXIN contains the active ingredient pramipexol and belongs to a group of medicines 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.

MIRAPEXIN 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 the symptoms of moderate to severe idiopathic restless legs syndrome in adults.

Do not take MIRAPEXIN

• if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take MIRAPEXIN.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 there). Most hallucinations are visual.
• discinesia (e.g., abnormal involuntary movements of the limbs). If you have advanced Parkinson's disease and are also taking levodopa, you may experience discinesia during the progressive increase in MIRAPEXIN dose.
• distonia (inability to maintain the trunk and neck straight and upright [axial distonia]). 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 pleurototonos or Pisa syndrome).
• drowsiness and sudden episodes of sleep.
• psychosis (e.g., similar to schizophrenia symptoms).
• vision changes. You should undergo regular eye check-ups during treatment with MIRAPEXIN.
• 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 restless legs syndrome. If you experience thatsymptoms start earlier than usualin the evening (or even in the afternoon),are more intense oraffect larger areas of the affected limbs oraffect other limbs.Your doctor may reduce your dose or stop treatment.

Inform your doctor if you, your family or caregivers notice that you are developing unusual 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 appetite or sexual interest with increased sexual thoughts and feelings.Your doctor may need to adjust your dose or stop treatment.

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

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

Inform your doctor if you are noticing inability to maintain the trunk and neck straight and upright (axial distonia). In this case, your doctor may decide to adjust or modify your treatment.

Children and adolescents

MIRAPEXIN is not recommended for use in children or adolescents under 18 years.

Other medicines and MIRAPEXIN

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

Avoid using MIRAPEXIN with antipsychotic medicines.

Be cautious if you are using the following medicines:

• 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 immunodeficiency 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 taking levodopa, it is recommended to reduce the levodopa dose when starting treatment with MIRAPEXIN.

Be cautious if you are using sedative tranquilizers or if you drink alcohol. In these cases, MIRAPEXIN may affect your ability to drive and operate machinery.

Taking MIRAPEXIN with food, drinks and alcohol

You should be cautious if you drink alcohol during treatment with MIRAPEXIN.

You can take MIRAPEXIN 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 before using this medicine. Your doctor will tell you if you should continue treatment with MIRAPEXIN.

The effect of MIRAPEXIN on the fetus is not known. Therefore, do not take MIRAPEXIN if you are pregnant unless your doctor tells you to.

MIRAPEXIN should not be used during breastfeeding. MIRAPEXIN may decrease milk production. Additionally, it may pass into breast milk and reach your baby. If the use of MIRAPEXIN is necessary, breastfeeding should be discontinued.

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery

MIRAPEXIN may cause hallucinations (seeing, hearing or feeling things that are not there). If this happens, do not drive or operate machinery.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor again. Your doctor will indicate the correct dosage.

You can take MIRAPEXIN 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 MIRAPEXIN 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 three tablets of MIRAPEXIN 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 insufficiency, the usual starting dose is 1 tablet of MIRAPEXIN 0.088 mg twice a day. If you have severe kidney insufficiency, the usual starting dose is 1 tablet of MIRAPEXIN 0.088 mg per day.

Restless Legs Syndrome

The dose is usually taken once a day, at night, 2-3 hours before bedtime.

During the first week, the usual dose is 1 tablet of MIRAPEXIN 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 should not exceed 6 tablets of MIRAPEXIN 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexol salt).

If you stop taking your tablets for a few days and want to start treatment again, 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, MIRAPEXIN may not be a suitable treatment for you.

If you take more MIRAPEXIN 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 MIRAPEXIN

Don't worry. Omit that dose completely and take the next dose at the correct time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with MIRAPEXIN

Do not stop your treatment with MIRAPEXIN 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 MIRAPEXIN abruptly. Sudden discontinuation may cause the appearance of a condition called neuroleptic malignant syndrome, which can represent a significant risk to your health. 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 MIRAPEXIN, 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 have Parkinson'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 there)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Edema periphericum (excess fluid, usually in the legs)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting
• Weight loss, including loss of appetite

Uncommon:

• Paranoia (e.g., excessive concern about your health)
• Delusion
• Excessive daytime somnolence and sudden sleep episodes
• Amnesia (memory alteration)
• Hypokinesia (increase in movement and inability to remain still)
• Weight gain
• Allergic reactions (e.g., skin rash, itching, hypersensitivity)
• Syncope (fainting)
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hypophonia (low 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 (diminished consciousness, confusion, loss of contact with reality)

Rare:

• Mania (agitation, feeling elated or overexcited)

Frequency not known:

• After stopping or reducing treatment with MIRAPEXIN: 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 have restless legs syndrome, you may experience the following side effects:

Very common:

• Nausea
• Symptoms that start earlier than usual, are more intense, or affect other limbs (increase in restless legs syndrome).

Common:

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

Uncommon:

• Need to behave in an unusual way*
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of antidiuretic hormone*
• Dyskinesia (e.g., abnormal involuntary movements of the limbs)
• Hypokinesia (increase in movement and inability to remain still)*
• Paranoia (e.g., excessive concern about your health)*
• Delusion*
• Amnesia (memory alteration)*
• Hallucinations (seeing, hearing, or feeling things that are not there)
• Confusion
• Excessive daytime somnolence and sudden sleep episodes
• Weight gain
• Hypotension (low blood pressure)
• Edema periphericum (excess fluid, usually in the legs)
• Allergic reactions (e.g., skin rash, itching, hypersensitivity)
• Syncope (fainting)
• Restlessness
• Visual disturbances
• Weight loss, including loss of appetite
• Dyspnea (difficulty breathing)
• Hypophonia (low 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).*

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

Frequency not known:

• After stopping or reducing treatment with MIRAPEXIN: 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 adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the national reporting system included in theAppendix V.By reporting adverse reactions, you can contribute to providing more information on 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 box after CAD. The expiration date is the last day of the month indicated.

Do not store above 30 °C..

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 MIRAPEXIN

The active ingredient is pramipexol.

Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg or 0.7 mg of pramipexol as 0.125 mg, 0.25 mg, 0.5 mg or 1 mg of dihydrochloride monohydrate of pramipexol, respectively.

The other components are mannitol, cornstarch, anhydrous colloidal silica, povidone K 25 and magnesium stearate.

Appearance of the product and contents of the package

MIRAPEXIN 0.088 mg tablets are white, round, flat and without a notch.

MIRAPEXIN 0.18 mg and MIRAPEXIN 0.35 mg tablets are white, oval and flat. The tablets are scored on both sides and can be divided in half.

MIRAPEXIN 0.7 mg tablets are white, round and flat. The tablets are scored on both sides and can be divided in half.

All tablets have the company's logo of Boehringer Ingelheim in relief on one side, and codes P6, P7, P8 or P9 on the other side, representing the tablet dose: 0.088 mg, 0.18 mg, 0.35 mg and 0.7 mg, respectively.

All doses of MIRAPEXIN are presented in aluminum foil blisters of 10 tablets per blister, in boxes with 3 or 10 blisters (30 or 100 tablets). Some package sizes may only be marketed.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Responsible for manufacturing

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Rottendorf Pharma GmbH

Ostenfelder Strasse 51 – 61

59320 Ennigerloh

Germany

Boehringer Ingelheim France

100-104 avenue de France

75013 Paris

France

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:{MM/AAAA}.

For more detailed information about this medicine, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.