MIRAPEXIN 0.26 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take MIRAPEXIN

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

Tell your doctor before you start taking MIRAPEXIN. Inform your doctor if you have or have had any disease or symptoms, 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 gradual increase in the dose of MIRAPEXIN.
• 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 flexion of the lumbar region (also called camptocormia) or sideways curvature of the back (also called pleurothotonus or Pisa syndrome).
• Somnolence and sudden episodes of sleep.
• Psychosis (e.g. similar to symptoms of schizophrenia).
• Visual disturbance. You should have regular eye examinations during treatment with MIRAPEXIN.
• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the start of treatment, to avoid postural hypotension (a drop in blood pressure when standing up).

Tell your doctor if you, your family or caregivers notice that you are developing impulses or cravings 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 may harm you or others. This is called impulse control disorder and can include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sexual urges or increased sexual thoughts and feelings. Your doctor may need to adjust your dose or stop your treatment.

Tell 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 your dose or stop your treatment.

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

Tell your doctor if you notice inability to keep your 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 substance is gradually released after the tablet is swallowed. Sometimes parts of the tablets may be excreted and seen in the stool, which may look like whole tablets. Tell your doctor if you find tablet fragments in your stool.

Children and adolescents

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

Other medicines and MIRAPEXIN

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines, herbal remedies, natural products or nutritional supplements that you have obtained without a prescription.

You should 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 disorder known as ventricular arrhythmia)
• zidovudine (which may be used to treat acquired immune deficiency 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 taking levodopa, it is recommended to reduce the dose of levodopa when starting treatment with MIRAPEXIN.

Be cautious if you are using sedative medicines (with a 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, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking 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 essential, breastfeeding should be discontinued.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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 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. Tell your doctor if this happens to you.

3. How to take MIRAPEXIN

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. Your doctor will tell you the correct dose.

Take MIRAPEXIN prolonged-release tablets once a day at the same time each day.

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

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

Patient with renal disease

If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg prolonged-release tablets on alternate days during the first week. Then, your doctor may increase the frequency of administration to 1 prolonged-release tablet of 0.26 mg every day. If it is necessary to increase your dose further, your doctor may adjust your dose in levels of 0.26 mg of pramipexole.

If you have severe kidney disease, your doctor may consider it necessary to switch to a different pramipexole medicine. 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 dose of MIRAPEXIN prolonged-release tablets 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 more MIRAPEXIN than you should

If you accidentally take too many tablets,

• contact your doctor or the nearest hospital emergency department immediately.
• you may experience vomiting, restlessness or any of the side effects described in section 4, "Possible side effects".

If you forget to take MIRAPEXIN

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

If you forget to take your dose and it is more than 12 hours after your usual time, simply take your next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking MIRAPEXIN

Do not stop your treatment with MIRAPEXIN without consulting your doctor first. If you need to stop your treatment with this medicine, your doctor will reduce your dose gradually. This reduces the risk of worsening symptoms.

If you have Parkinson's disease, do not stop your treatment with MIRAPEXIN abruptly. Sudden interruption can cause the appearance of a disorder called neuroleptic malignant syndrome, which can be a serious risk to your health. The 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 or reduce treatment with MIRAPEXIN, 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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The classification of side effects is based on the following frequencies:

You may experience the following side effects:

Very common:

• Dyskinesia (e.g. abnormal involuntary movements of the limbs)
• Somnolence
• Dizziness
• Nausea

Common:

• Need to behave in ways that are unusual for you
• Hallucinations (seeing, hearing or feeling things that are not there)
• Confusion
• Fatigue
• Insomnia
• Excess fluid, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbance
• Vomiting
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g. excessive concern about your health)
• Delusion
• Excessive daytime somnolence and sudden episodes of sleep
• Amnesia (memory disturbance)
• 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
• Shortness of breath
• Hiccup
• Pneumonia (infection of the lungs)
• 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 behavior that is concerning to you or others, for example, increased sexual appetite.
• Uncontrollable excessive shopping or spending.
• Binge eating (eating large amounts of food in a short period) or compulsive eating (eating 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 stopping or reducing treatment with MIRAPEXIN: depression, apathy, anxiety, fatigue, sweating or pain may occur (known as dopamine agonist withdrawal syndrome or DAWS).

Tell 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 have an exact estimate of the frequency, as these side effects were not observed in clinical trials among 2,762 patients treated with pramipexole. The frequency category is probably no higher than "uncommon".

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of MIRAPEXIN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry date is the last day of the month shown.

Store in the original packaging to protect from moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

Composition of MIRAPEXIN

The active substance is pramipexole.

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

The other ingredients are: hypromellose 2208, corn starch, carbomer 941, colloidal anhydrous silica, magnesium stearate.

Appearance and package contents of the product

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

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

All tablets have the Boehringer Ingelheim symbol 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: 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg or 3.15 mg, respectively.

All doses of MIRAPEXIN are presented in aluminum blister strips of 10 tablets per strip, in boxes with 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets). Only some pack sizes may be marketed.

Marketing authorisation holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

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

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

Date of last revision of thisleaflet:{MM/AAAA}.

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