Leaflet: information for the user

MIRAPEXIN 0.26mg prolonged-release tablets

MIRAPEXIN 0.52mg prolonged-release tablets

MIRAPEXIN 1.05mg prolonged-release tablets

MIRAPEXIN 1.57mg prolonged-release tablets

MIRAPEXIN 2.1mg prolonged-release tablets

MIRAPEXIN 2.62mg prolonged-release tablets

MIRAPEXIN 3.15mg prolonged-release tablets

pramipexol

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1.What MIRAPEXIN is and what it is used for

2.What you need to know before you start taking MIRAPEXIN

3.How to take MIRAPEXIN

4.Possible side effects

5.Storage of MIRAPEXIN

6.Contents of the pack and additional information

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 to treat 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).

Do not take MIRAPEXIN

• if you are allergic to pramipexol 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.
• Dyskinesia (e.g., abnormal involuntary movements of the limbs). If you have advanced Parkinson's disease and are also taking levodopa, you may experience dyskinesia during the progressive increase in MIRAPEXIN dose.
• 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 pleurototonos or Pisa syndrome).
• Drowsiness and sudden onset of sleep.
• Psychosis (e.g., similar to schizophrenia symptoms).
• Visual disturbances. You should undergo periodic eye examinations during treatment with MIRAPEXIN.
• 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).

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 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 an increase in sexual thoughts and feelings.Your doctor may need to adjust your dose or discontinue 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 discontinue 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 dystonia). In this case, your doctor may decide to adjust or modify your treatment.

MIRAPEXIN prolonged-release tablets are specially designed tablets from which the active ingredient is released gradually once the tablet is ingested. Occasionally, parts of the tablets may be excreted and appear in the feces that may look like intact tablets. Inform your doctor if you find fragments of tablets in the feces.

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 tranquilizing medicines (with sedative effect) 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

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 onset 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 indicated by your doctor.In case of doubt, consult your doctor again. Your doctor will indicate the correct dosage.

Take MIRAPEXIN prolonged-release tablets once a day and at the same hour every day.

You can take MIRAPEXIN with or without food. The tablets must be swallowed whole with water.

During the first week, the usual daily dose is 0.26mg of pramipexol. 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 1.05mg 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 3.15mg of pramipexol per day. It is also possible to reduce the maintenance dose to 1 prolonged-release MIRAPEXIN 0.26mg tablet per day.

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. After that, your doctor may increase the frequency of doses to 1 prolonged-release MIRAPEXIN 0.26 mg tablet per day. If you need to increase your dose further, your doctor may adjust your dose in 0.26 mg pramipexol levels.

If you have severe kidney disease, your doctor may consider it necessary to change to a different pramipexol medication. If your kidney problems worsen during treatment, contact your doctor as soon as possible.

If you are switching from MIRAPEXIN immediate-release tablets

Your doctor will base your MIRAPEXIN prolonged-release tablets dose on the dose of MIRAPEXIN immediate-release tablets you were taking.

The day before the switch, take your MIRAPEXIN immediate-release tablets as you normally would. The next morning, take your MIRAPEXIN prolonged-release tablet and do not take any more MIRAPEXIN immediate-release tablets.

If you take too much MIRAPEXIN

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

If you forget to take your MIRAPEXIN dose, but remember to take it within 12 hours of your usual time, take your tablet and continue with the next tablet at your usual time.

If you forget to take your dose more than 12 hours after the usual time, simply take the next dose at your usual time. Do not take a double dose to make up 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 your 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 pose 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 your 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.The classification of side effects is based on the following frequencies:

You may experience the following side effects:

Very common:

• Discinesia (e.g., abnormal involuntary movements of the limbs)
• Drowsiness
• Dizziness
• Nausea

Common:

• Unusual behavior
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Peripheral edema (excess fluid, usually in the legs)
• Headache
• Low blood pressure
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting
• Weight loss, including loss of appetite

Uncommon:

• Paranoia (e.g., excessive concern about health)
• Delusion
• Excessive daytime somnolence and sudden onset of sleep

• 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 yourself 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 yourself or others, for example, increased libido.
• 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 (decreased consciousness, confusion, loss of contact with reality)

Rare:

• Mania (agitation, feeling elated or overexcited)
• Spontaneous penile erection

Frequency not known:

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

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

For the side effects marked with * it is not possible to provide a precise estimate of frequency, as these side effects were not observed in clinical trials among 2,762 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 prospectus. You can also report them directly through the national notification system included in theAppendixV. 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 box after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

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. This will help protect the environment..

Composition of MIRAPEXIN

The active ingredient is pramipexole.

Each tablet contains 0.26mg, 0.52mg, 1.05mg, 1.57mg, 2.1mg, 2.62mg or 3.15mg of pramipexoleas 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3mg, 3.75mg or 4.5mg of dihydrochloride monohydrate of pramipexole, respectively.

The other components are: hypromellose 2208, cornstarch, carbomer 941, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the package

The prolonged-release tablets of MIRAPEXIN 0.26mg and 0.52mg are white or off-white, round and beveled.

The prolonged-release tablets of MIRAPEXIN 1.05mg, 1.57mg, 2.1mg, 2.62mg and 3.15mg are white or off-white and oval.

All tablets have the Boehringer Ingelheim logo embossed on one side, and the codes P1, P2, P3, P12, P4, P13 or P5 on the other side representing the dose level of the tablet:0.26mg, 0.52mg, 1.05mg, 1.57mg, 2.1mg, 2.62mg or 3.15mg, respectively.

All doses of MIRAPEXIN are presented in aluminum blisters of 10 tablets per blister, in boxes with 1, 3 or 10 blisters (10, 30 or 100 prolonged-release tablets). Some package sizes may only be marketed.

Holder of the marketing authorization

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 medicinal product, please contact the local representative of the marketing authorization holder:

Last update of thissummary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.