Mirapexin

Package leaflet: Information for the user

MIRAPEXIN 0.088 mg tablets, 0.18 mg tablets, 0.35 mg tablets, 0.7 mg tablets

pramipexole
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MIRAPEXIN is and what it is used for
2. What you need to know before taking MIRAPEXIN
3. How to take MIRAPEXIN
4. Possible side effects
5. How to store MIRAPEXIN
6. Contents of the pack and other information

1. What MIRAPEXIN is and what it is used for

MIRAPEXIN contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors located in the brain. Stimulation of dopamine receptors in the brain triggers nerve impulses that help control body movements.
MIRAPEXIN is used for:

• the treatment of symptoms of primary Parkinson’s disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease).
• the treatment of moderate to severe primary restless legs syndrome (RLS) in adults.

2. What you should know before taking MIRAPEXIN

Do not take MIRAPEXIN

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

Warnings and precautions
Talk to your doctor before taking MIRAPEXIN. Inform your doctor if you have (or have had) or develop any medical condition or symptom, especially if it belongs to the following list:

• Kidney disease.
• Hallucinations (seeing, hearing, or sensing things that are not real). Most hallucinations are visual.
• Dyskinesia (e.g., abnormal, uncontrollable movements of limbs). If you have advanced Parkinson's disease and are also taking levodopa, you may develop dyskinesia during the titration phase of MIRAPEXIN.
• Dystonia (inability to maintain body and neck in an upright position (axial dystonia)). In particular, forward bending of the head and neck (also known as antecollis), forward bending of the lumbar spine (also known as camptocormia), or lateral bending of the trunk (also known as pleurothotonus or Pisa syndrome) may occur.
• Drowsiness and sudden onset of sleep episodes.
• Psychosis (e.g., symptoms similar to schizophrenia).
• Vision disturbances. During treatment with MIRAPEXIN, regular eye examinations are required.
• Severe heart or blood vessel diseases. Especially at the beginning of treatment, your blood pressure should be monitored regularly to prevent postural hypotension (a drop in blood pressure upon standing).
• Worsening of restless legs syndrome symptoms. If you notice that symptoms occur earlier than usual in the evening (or even in the afternoon), are more intense, affect larger areas of the affected limbs, or involve other limbs. Your doctor may reduce the dose or discontinue treatment.

Inform your doctor if you, your family members, or caregivers notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others. These phenomena are called impulse control disorders and may include behaviors such as gambling addiction, compulsive eating, excessive spending, or abnormally increased sexual desire or interest with increased sexual thoughts or feelings. Your doctor may need to adjust the dose or discontinue therapy.
Inform your doctor if you, your family members, or caregivers notice that you are developing mania (agitation, feelings of euphoria or overexcitement) or delirium (reduced awareness, confusion, or loss of sense of reality). Your doctor may need to adjust the dose or discontinue therapy.
Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of MIRAPEXIN. If symptoms persist for more than a few weeks, your doctor may need to modify your treatment.
Inform your doctor if you experience inability to maintain body and neck in an upright position (axial dystonia). If this occurs, your doctor may decide to adjust or change your treatment.

Children and adolescents
The use of MIRAPEXIN is not recommended in children or adolescents under 18 years of age.

Other medicines and MIRAPEXIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines, dietary products, or supplements obtained without a prescription.
You must avoid taking MIRAPEXIN together with antipsychotic medicines.
Be cautious if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and gastric ulcers)
• amantadine (which may be used to treat Parkinson's disease)
• mexiletine (used to treat 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 (used to treat various types of cancer)
• quinine (which may be used to prevent painful nocturnal leg cramps and to treat falciparum malaria (malignant malaria))
• procainamide (used to treat irregular heartbeats)

If you are taking levodopa, a reduction in its dose is recommended when starting treatment with MIRAPEXIN.
Be cautious if you are taking any sedative medicine or consuming alcohol. In such cases, MIRAPEXIN may impair your ability to drive or operate machinery.

MIRAPEXIN with food, drinks, and alcohol
You should be cautious if consuming alcohol during treatment with MIRAPEXIN.
MIRAPEXIN may be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine. Your doctor will discuss whether you should continue taking MIRAPEXIN.
The effect of MIRAPEXIN on the fetus is unknown. Therefore, do not take MIRAPEXIN during pregnancy unless your doctor tells you to do so.
MIRAPEXIN must not be taken during breastfeeding. MIRAPEXIN may reduce milk production. It may also pass into breast milk and reach the infant. If taking MIRAPEXIN is unavoidable, breastfeeding must be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
MIRAPEXIN may cause hallucinations (seeing, hearing, or sensing things that are not real). If this occurs, do not drive or operate machinery.
MIRAPEXIN has been associated with drowsiness and sudden onset of sleep episodes, particularly in patients with Parkinson's disease. If you experience these side effects, avoid driving and do not operate machinery. Inform your doctor if this occurs.

3. How to take MIRAPEXIN

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor. Your doctor will determine the correct dosage for you.
MIRAPEXIN may be taken with or without food. The tablets should be swallowed with water.
Parkinson's disease
The daily dose should be 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):

	1 week
Number of tablets	1 tablet of MIRAPEXIN 0.088 mg three times daily
Total daily dose (mg)	0.264

This dose will be increased every 5-7 days according to the doctor's instructions until symptoms are controlled (maintenance dose).

	Week 2	Week 3
Number of tablets	1 tablet of MIRAPEXIN 0.18 mg three times daily OR 2 tablets of MIRAPEXIN 0.088 mg three times daily	1 tablet of MIRAPEXIN 0.35 mg three times daily OR 2 tablets of MIRAPEXIN 0.18 mg three times daily
Total daily dose (mg)	0.54	1.1

The usual maintenance dose is 1.1 mg daily. However, your dose may be further increased. If necessary, your doctor may increase the tablet dose up to a maximum of 3.3 mg of pramipexole per day. A lower maintenance dose is also possible, corresponding to three MIRAPEXIN 0.088 mg tablets daily.

	Lowest maintenance dose	Highest maintenance dose
Number of tablets	1 tablet of MIRAPEXIN 0.088 mg three times daily	1 tablet of MIRAPEXIN 0.7 mg and 1 tablet of MIRAPEXIN 0.35 mg three times daily
Total daily dose (mg)	0.264	3.15

Patients with renal disease
If you have moderate or severe renal 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 disease,
the usual starting dose is 1 tablet of MIRAPEXIN 0.088 mg twice daily. In case of severe renal
disease, the usual starting dose is only 1 tablet of MIRAPEXIN 0.088 mg once daily.
Restless legs syndrome
The dose is usually taken once daily in the evening, 2–3 hours before going to bed.
During the first week, the usual dose is 1 tablet of MIRAPEXIN 0.088 mg once daily (equivalent to 0.088 mg daily):

	1 week
Number of tablets	1 tablet of MIRAPEXIN 0.088 mg
Total daily dose (mg)	0.088

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

	2nd week	3rd week	4th week
Number of tablets	1 tablet of MIRAPEXIN 0.18 mg OR 2 tablets of MIRAPEXIN 0.088 mg	1 tablet of MIRAPEXIN 0.35 mg OR 2 tablets of MIRAPEXIN 0.18 mg OR 4 tablets of MIRAPEXIN 0.088 mg	1 tablet of MIRAPEXIN 0.35 mg and 1 tablet of MIRAPEXIN 0.18 mg OR 3 tablets of MIRAPEXIN 0.18 mg OR 6 tablets of MIRAPEXIN 0.088 mg
Total daily dose (mg)	0.18	0.35	0.54

The daily dose must not exceed 6 tablets of MIRAPEXIN 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexole salt).
If you stop taking the tablets for more than a few days and wish to restart treatment, you must begin again with the lowest dose. You can then gradually return to your previous dose, as you did the first time. Ask your doctor for advice.
Your doctor will review your treatment after 3 months to decide whether it should be continued.

Patients with kidney disease
If you have severe kidney disease, treatment with MIRAPEXIN may not be suitable for you.

If you take more MIRAPEXIN than you should
If you accidentally take too many tablets:

• contact your doctor immediately or go to the nearest hospital emergency department.
• You may experience vomiting, restlessness, or any of the side effects listed in section 4 (Possible side effects).

If you forget to take MIRAPEXIN
Do not worry. Simply skip the missed dose completely and take the next dose at your usual time.
Do not take a double dose to make up for the missed dose.

If you stop taking MIRAPEXIN
Do not stop taking MIRAPEXIN without first talking to your doctor. If you need to discontinue treatment with this medicine, your doctor will gradually reduce the dose. This reduces the risk of worsening symptoms.
If you have Parkinson’s disease, you must not stop treatment with MIRAPEXIN abruptly.
Sudden discontinuation may lead to the development of a medical condition called neuroleptic malignant syndrome, which could pose a greater health risk. Symptoms include:

• akinesia (loss of muscular movement)
• muscular rigidity
• fever
• unstable blood pressure
• tachycardia (increased heart rate)
• confusion
• reduced level of consciousness (e.g. coma)

If you stop or reduce treatment with MIRAPEXIN, you may also develop a medical condition called dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you must contact your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them. The assessment of these adverse reactions is based on the following frequencies:

Very common	may affect more than 1 in 10 people
Common	may affect up to 1 in 10 people
Uncommon	may affect up to 1 in 100 people
Rare	may affect up to 1 in 1,000 people
Very rare	may affect up to 1 in 10,000 people
Not known	frequency cannot be estimated from the available data

If you have Parkinson’s disease, you may experience the following side effects:
Very common:

• Dyskinesia (e.g. involuntary, abnormal movements of limbs)
• Somnolence
• Dizziness
• Nausea (feeling unwell)

Common:

• Impulse to behave in an unusual way
• Hallucinations (seeing, hearing or sensing things that are not real)
• Confusion
• Fatigue (feeling of tiredness)
• Sleeplessness (insomnia)
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (feeling unwell)
• Weight loss accompanied by reduced appetite

Uncommon:

• Paranoia (e.g. excessive fear for one’s own well-being)
• Delirium
• Excessive daytime sleepiness and sudden onset sleep episodes
• Amnesia (memory disorders)
• 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 ankle swelling)*
• 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 could 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 causing significant concern to you or others, for example increased sexual urges.
• Excessive and uncontrollable shopping or spending.
• Uncontrolled 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 your appetite)*
• Delirium (reduced awareness, confusion, loss of sense of reality)

Rare:

• Spontaneous penile erection

Not known:

• After stopping or reducing the dose of MIRAPEXIN, symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating, or pain may occur (dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviors; they will explain how to manage or
reduce the symptoms.
For side effects marked with *, it is not possible to estimate the frequency precisely because
these side effects were not observed in clinical studies involving 2,762 patients treated with
pramipexole. 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 (feeling unwell)
• Symptoms occurring earlier than usual, more intense, or involving other limbs (worsening of restless legs syndrome symptoms).

Common:

• Sleep disturbances, such as difficulty sleeping (insomnia) and somnolence
• Fatigue (feeling of tiredness)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (feeling unwell)

Uncommon:

• Impulse to behave in an unusual way*
• Heart failure (heart problems that may cause shortness of breath or ankle swelling)*
• Inappropriate antidiuretic hormone secretion*
• Dyskinesia (e.g. involuntary, abnormal movements of limbs)
• Hyperkinesia (increased movements and inability to stay still)*
• Paranoia (e.g. excessive fear for one’s own well-being)*
• Delirium*
• Amnesia (memory disorders)*
• Hallucinations (seeing, hearing or sensing things that are not real)
• Confusion
• Excessive daytime sleepiness and sudden onset 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
• Visual disturbances
• Weight loss accompanied by reduced appetite
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)*
• Inability to resist the impulse, urge or temptation to perform an action that could 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 causing significant concern to you or others, for example increased sexual urges.*
• Excessive and uncontrollable shopping or spending.*
• Uncontrolled 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 your appetite)*
• Mania (agitation, feeling of euphoria or overexcitement)*
• Delirium (reduced awareness, confusion, loss of sense of reality)*

Rare:

• Spontaneous penile erection

Not known:

• After stopping or reducing the dose of MIRAPEXIN, symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating, or pain may occur (dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviors; they will explain how to manage or
reduce the symptoms.
For side effects marked with *, it is not possible to estimate the frequency precisely because
these side effects were not observed in clinical studies involving 1,395 patients treated with
pramipexole. The frequency category is likely not higher than “uncommon”.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 packaging after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30 °C.
Keep in the original packaging to protect the tablets from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package Contents and Other Information

What MIRAPEXIN contains
The active substance is pramipexole.
Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg or 0.7 mg of pramipexole, respectively, as
0.125 mg, 0.25 mg, 0.5 mg or 1 mg of pramipexole dihydrochloride monohydrate.
The other components are mannitol, maize starch, anhydrous colloidal silica, povidone K25, magnesium stearate.

Description of the appearance of MIRAPEXIN and contents of the pack
MIRAPEXIN 0.088 mg tablets are white, round, flat and cannot be divided.
MIRAPEXIN 0.18 mg and MIRAPEXIN 0.35 mg tablets are white, oval-shaped and flat. They are scored on both sides and can be divided into two equal parts.
MIRAPEXIN 0.7 mg tablets are white, round and flat. They are scored on both sides and can be divided into two equal parts.
All tablets have the Boehringer Ingelheim logo imprinted on one side and the codes P6, P7, P8 or P9 on the other side, representing the tablet strength of 0.088 mg, 0.18 mg, 0.35 mg and 0.7 mg respectively.
All strengths of MIRAPEXIN are available in aluminium blisters containing 10 tablets, packed in cardboard cartons containing 3 or 10 blisters (30 or 100 tablets).
Not all pack sizes may be marketed.

Marketing Authorization 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Boehringer Ingelheim SComm Boehringer Ingelheim RCV GmbH & Co KG
Tél/Tel: +32 2 773 33 11 Lietuvos filialas
Tel: +370 5 2595942

България Luxembourg/Luxemburg
Бьорингер Ингелхайм РЦВ ГмбХ и Ко.КГ - Boehringer Ingelheim SComm
клон България Tél/Tel: +32 2 773 33 11
Тел: +359 2 958 79 98

Česká republika Magyarország
Boehringer Ingelheim spol. s r.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +420 234 655 111 Magyarországi Fióktelepe
Tel.: +36 1 299 89 00

Danmark Malta
Boehringer Ingelheim Danmark A/S Boehringer Ingelheim Ireland Ltd.
Tlf: +45 39 15 88 88 Tel: +353 1 295 9620

Deutschland Nederland
BIOTHERAX biochemisch-pharmazeutische Boehringer Ingelheim B.V.
Gesellschaft mbH Tel: +31 (0) 800 22 55 889
Tel: +49 (0) 800 77 90 900

Eesti Norge
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Danmark Norwegian branch
Eesti filiaal Tlf: +47 66 76 13 00
Tel: +372 612 8000

Ελλάδα Österreich
Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E. Boehringer Ingelheim RCV GmbH & Co KG
Tηλ: +30 2 10 89 06 300 Tel: +43 1 80 105-7870

España Polska
Boehringer Ingelheim España, S.A. Boehringer Ingelheim Sp. z o.o.
Tel: +34 93 404 51 00 Tel: +48 22 699 0 699

France Portugal
Boehringer Ingelheim France S.A.S. Boehringer Ingelheim Portugal, Lda.
Tél: +33 3 26 50 45 33 Tel: +351 21 313 53 00

Hrvatska România
Boehringer Ingelheim Zagreb d.o.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +385 1 2444 600 Vienna - Bucharest Branch Office
Tel: +40 21 302 28 00

Ireland Slovenija
Boehringer Ingelheim Ireland Ltd. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +353 1 295 9620 Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland Slovenská republika
Vistor hf. Boehringer Ingelheim RCV GmbH & Co KG
Sími: +354 535 7000 organizačná zložka
Tel: +421 2 5810 1211

Italia Suomi/Finland
Boehringer Ingelheim Italia S.p.A. Boehringer Ingelheim Finland Ky
Tel: +39 02 5355 1 Puh/Tel: +358 10 3102 800

Κύπρος Sverige
Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E. Boehringer Ingelheim AB
Tηλ: +30 2 10 89 06 300 Tel: +46 8 721 21 00

Latvija United Kingdom (Northern Ireland)
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Ireland Ltd.
Latvijas filiāle Tel: +353 1 295 9620
Tel: +371 67 240 011

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

Package leaflet: information for the user

MIRAPEXIN 0.26 mg prolonged-release tablets, 0.52 mg prolonged-release tablets, 1.05 mg prolonged-release tablets, 1.57 mg prolonged-release tablets, 2.1 mg prolonged-release tablets, 2.62 mg prolonged-release tablets, 3.15 mg prolonged-release tablets

pramipexole
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MIRAPEXIN is and what it is used for
2. What you need to know before taking MIRAPEXIN
3. How to take MIRAPEXIN
4. Possible side effects
5. How to store MIRAPEXIN
6. Contents of the pack and other information

1. What MIRAPEXIN is and what it is used for

MIRAPEXIN contains the active substance pramipexole and belongs to a group of medicines known as dopaminergic agonists, which stimulate dopamine receptors located in the brain. Stimulation of dopamine receptors in the brain triggers nerve impulses that help control body movements.
MIRAPEXIN is used for the treatment of symptoms of idiopathic Parkinson’s disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease).

2. What you need to know before taking MIRAPEXIN

Do not take MIRAPEXIN

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

Warnings and precautions
Talk to your doctor before taking MIRAPEXIN. Inform your doctor if you have (or have had) or develop any medical condition or symptom, especially if it belongs to the following list:

• Kidney disease.
• Hallucinations (seeing, hearing, or sensing things that are not real). Most hallucinations are visual.
• Dyskinesia (e.g., abnormal, uncontrollable movements of limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you may develop dyskinesia during the titration phase of MIRAPEXIN.
• Dystonia (inability to maintain body and neck in an upright position (axial dystonia)). In particular, you may experience forward bending of head and neck (also known as anterocollis), forward bending of the lumbar spine (also known as camptocormia), or lateral flexion of the trunk (also known as pleurothotonus or Pisa syndrome).
• Drowsiness and sudden onset of sleep episodes.
• Psychosis (e.g., symptoms similar to schizophrenia).
• Vision disturbances. During treatment with MIRAPEXIN, you should undergo regular eye examinations.
• Severe heart or blood vessel diseases. Especially at the beginning of treatment, your blood pressure should be monitored regularly to prevent postural hypotension (a drop in blood pressure upon standing).

Inform your doctor if you, your family members, or caregivers notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others. These phenomena are called impulse control disorders and may include behaviors such as gambling addiction, binge eating, excessive spending, or abnormally increased sexual desire or interest, with heightened sexual thoughts or feelings. Your doctor may need to adjust your dose or discontinue treatment.
Inform your doctor if you, your family members, or caregivers notice symptoms of mania (agitation, feelings of euphoria or overexcitement) or delirium (reduced awareness, confusion, loss of sense of reality). Your doctor may need to adjust your dose or discontinue treatment.
Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of MIRAPEXIN. If symptoms persist for more than a few weeks, your doctor may need to modify your treatment.
Inform your doctor if you develop an inability to maintain your body and neck in an upright position (axial dystonia). If this occurs, your doctor may decide to adjust or change your treatment.
MIRAPEXIN prolonged-release tablets are specially designed to gradually release the active ingredient after ingestion. It is possible that parts of the tablet may be expelled and seen in the stool, appearing as intact tablets. Inform your doctor if you find pieces of tablets in your stool.

Children and adolescents
The use of MIRAPEXIN is not recommended in children or adolescents under 18 years of age.

Other medicines and MIRAPEXIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal remedies, dietary products, or supplements obtained without a prescription.
You must avoid taking MIRAPEXIN together with antipsychotic medicines.
Be cautious if you are taking any of the following medicines:

• cimetidine (used to treat excess stomach acid and gastric ulcers)
• amantadine (which may be used to treat Parkinson’s disease)
• mexiletine (used to treat 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 (used to treat various types of cancer)
• quinine (which may be used to prevent painful nighttime leg cramps and to treat a type of malaria known as falciparum malaria (malignant malaria))
• procainamide (used to treat irregular heartbeats)

If you are taking levodopa, a reduction in dose is recommended when starting treatment with MIRAPEXIN.
Be cautious if you are taking any sedative medicine or consuming alcohol. In such cases, MIRAPEXIN may impair your ability to drive or operate machinery.

MIRAPEXIN with food, drinks, and alcohol
You should be cautious if consuming alcohol during treatment with MIRAPEXIN.
MIRAPEXIN can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine. Your doctor will discuss with you whether to continue taking MIRAPEXIN.
The effect of MIRAPEXIN on the unborn baby is not known. Therefore, do not take MIRAPEXIN during pregnancy unless your doctor tells you to do so.
MIRAPEXIN must not be taken during breastfeeding. MIRAPEXIN may reduce milk production and may pass into breast milk, potentially affecting the infant. If taking MIRAPEXIN is unavoidable, breastfeeding must be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
MIRAPEXIN may cause hallucinations (seeing, hearing, or sensing things that are not real). If this occurs, do not drive or operate machinery.
MIRAPEXIN has been associated with drowsiness and sudden onset of sleep episodes, particularly in patients with Parkinson’s disease. If you experience these side effects, avoid driving and do not use machinery. Inform your doctor if this occurs.

3. How to take MIRAPEXIN

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor.
Your doctor will determine the correct dose for you.
Take MIRAPEXIN prolonged-release tablets once daily, every day, approximately at the same time.
MIRAPEXIN may be taken with or without food. Swallow the tablets whole with water.

Do not chew, divide, or crush the prolonged-release tablets. Doing so may result in overdose, as the medicine could be released too quickly into your body.
During the first week, the usual daily dose is 0.26 mg of pramipexole.
This dose will be increased every 5–7 days as directed by your doctor until symptoms are controlled (maintenance dose).

Titration schedule for MIRAPEXIN prolonged-release tablets
Week	Daily dose (mg)	Number of tablets
1	0.26	One prolonged-release tablet of MIRAPEXIN 0.26 mg.
2	0.52	One prolonged-release tablet of MIRAPEXIN 0.52 mg, OR two prolonged-release tablets of MIRAPEXIN 0.26 mg.
3	1.05	One prolonged-release tablet of MIRAPEXIN 1.05 mg, OR two prolonged-release tablets of MIRAPEXIN 0.52 mg, OR four prolonged-release tablets of MIRAPEXIN 0.26 mg.

The usual maintenance dose is 1.05 mg daily. However, your dose may be further increased. If necessary, your doctor may increase the dose up to a maximum of 3.15 mg of pramipexole per day. A lower maintenance dose may also be used, equivalent to one MIRAPEXIN 0.26 mg prolonged-release tablet daily.

Patients with renal disease
If you have renal disease, your doctor may instruct you to take the usual starting dose of prolonged-release 0.26 mg tablets only every other day during the first week. Subsequently, your doctor may increase the dosing frequency to one prolonged-release 0.26 mg tablet daily. If a further dose increase is needed, your doctor may increase it by 0.26 mg of pramipexole.

If you have severe renal problems, your doctor may decide to prescribe a different pramipexole-containing medicine. If your renal problems worsen during treatment, you must contact your doctor as soon as possible.

Switching from MIRAPEXIN tablets (immediate-release)
Your doctor will determine the dose of MIRAPEXIN prolonged-release tablets based on the dose of MIRAPEXIN immediate-release tablets you were previously taking.

Continue taking MIRAPEXIN immediate-release tablets as usual the day before switching. Then, take MIRAPEXIN prolonged-release tablets the following morning 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 immediately or go to the nearest hospital emergency department.
• Symptoms such as vomiting, restlessness, or any of the adverse effects listed in section 4 (Possible side effects) may occur.

If you forget to take MIRAPEXIN
If you forget to take a dose of MIRAPEXIN but remember within 12 hours of your usual dosing time, take the tablet immediately and then take the next dose at the usual time. If more than 12 hours have passed, simply take the next dose at the regular time. Do not take a double dose to make up for the missed dose.

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

If you have Parkinson’s disease, you must not stop treatment with MIRAPEXIN abruptly. Sudden discontinuation may lead to a medical condition called neuroleptic malignant syndrome, which may pose a greater health risk. Symptoms include:

• akinesia (loss of muscular movement)
• muscular rigidity
• fever
• unstable blood pressure
• tachycardia (increased heart rate)
• confusion
• reduced level of consciousness (e.g., coma)

If you stop or reduce treatment with MIRAPEXIN, you may also develop a medical condition called dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you must contact your doctor.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
The assessment of these adverse reactions is based on the following frequencies:

Very common	may affect more than 1 in 10 people
Common	may affect up to 1 in 10 people
Uncommon	may affect up to 1 in 100 people
Rare	may affect up to 1 in 1,000 people
Very rare	may affect up to 1 in 10,000 people
Not known	frequency cannot be estimated from the available data

It may cause the following side effects:
Very common:

• Dyskinesia (e.g. involuntary, abnormal movements of limbs)
• Somnolence
• Dizziness
• Nausea (feeling of discomfort)

Common:

• Impulse to behave unusually
• Hallucinations (seeing, hearing or sensing things that are not there)
• Confusion
• Fatigue (feeling of tiredness)
• Insomnia (difficulty sleeping)
• Fluid retention, usually in the legs (peripheral oedema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (feeling of discomfort)
• Weight loss accompanied by reduced appetite

Uncommon:

• Paranoia (e.g. excessive fear for one's well-being)
• Delirium
• Excessive daytime sleepiness and sudden onset of sleep episodes
• Amnesia (memory disorders)
• Hyperkinesia (increased movements and inability to remain 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
• Dyspnoea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, urge or temptation to carry out an action that may be harmful to oneself or others, which may include:
• Strong urge to gamble excessively despite serious personal or family consequences.
• Altered or increased sexual interest and behaviour causing significant concern to oneself or others, for example increased sexual urges.
• Excessive and uncontrollable shopping or spending
• Uncontrolled 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 awareness, confusion, loss of sense of reality)

Rare:

• Mania (agitation, feeling of euphoria or over-excitement)
• Spontaneous penile erection

Not known:

• After stopping or reducing the dose of MIRAPEXIN, symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating or pain may occur (dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviours; they will explain how to manage or
reduce the symptoms.
For side effects marked with *, it is not possible to estimate the frequency precisely since these side effects were not observed in clinical studies involving 2,762 patients treated with pramipexole. The frequency category is likely no higher than "uncommon".
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MIRAPEXIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store in the original container to protect the medicine from moisture.
This medicine does not require any special storage temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MIRAPEXIN contains
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, respectively 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.
The other components are hypromellose 2208, corn starch, carbomer 941, anhydrous colloidal silica,
magnesium stearate.

Description of the appearance of MIRAPEXIN and package contents
MIRAPEXIN 0.26 mg and 0.52 mg prolonged-release tablets are white to almost white, round in shape with bevelled edges.
MIRAPEXIN 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, and 3.15 mg prolonged-release tablets are white to almost white and oval-shaped.
All tablets have the Boehringer Ingelheim logo engraved on one side and the code P1, P2, P3, P12, P4, P13, or P5 on the other side, corresponding to the tablet strengths of 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, and 3.15 mg, respectively.
All MIRAPEXIN strengths are available in aluminum blisters containing 10 tablets each, packed in cardboard cartons containing 1, 3, or 10 blisters (10, 30, or 100 prolonged-release tablets). Not all pack sizes may be marketed.

Marketing Authorization 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Boehringer Ingelheim SComm Boehringer Ingelheim RCV GmbH & Co KG
Tél/Tel: +32 2 773 33 11 Lietuvos filialas
Tel: +370 5 2595942

България Luxembourg/Luxemburg
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ - Boehringer Ingelheim SComm
клон България Tél/Tel: +32 2 773 33 11
Тел: +359 2 958 79 98

Česká republika Magyarország
Boehringer Ingelheim spol. s r.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +420 234 655 111 Magyarországi Fióktelepe
Tel: +36 1 299 89 00

Danmark Malta
Boehringer Ingelheim Danmark A/S Boehringer Ingelheim Ireland Ltd.
Tlf: +45 39 15 88 88 Tel: +353 1 295 9620

Deutschland Nederland
BIOTHERAX biochemisch-pharmazeutische Boehringer Ingelheim B.V.
Gesellschaft mbH Tel: +31 (0) 800 22 55 889
Tel: +49 (0) 800 77 90 900

Eesti Norge
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Danmark Norwegian branch
Eesti filiaal Tlf: +47 66 76 13 00
Tel: +372 612 8000

Ελλάδα Österreich
Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E. Boehringer Ingelheim RCV GmbH & Co KG
Tηλ: +30 2 10 89 06 300 Tel: +43 1 80 105-7870

España Polska
Boehringer Ingelheim España, S.A. Boehringer Ingelheim Sp.zo.o.
Tel: +34 93 404 51 00 Tel: +48 22 699 0 699

France Portugal
Boehringer Ingelheim France S.A.S. Boehringer Ingelheim Portugal, Lda.
Tél: +33 3 26 50 45 33 Tel: +351 21 313 53 00

Hrvatska România
Boehringer Ingelheim Zagreb d.o.o. Boehringer Ingelheim RCV GmbH & Co KG Vienna
Tel: +385 1 2444 600 - Bucharest Branch Office
Tel: +40 21 302 28 00

Ireland Slovenija
Boehringer Ingelheim Ireland Ltd. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +353 1 295 9620 Ljubljana Branch
Tel: +386 1 586 40 00

Ísland Slovenská republika
Vistor hf. Boehringer Ingelheim RCV GmbH & Co KG
Sími: +354 535 7000 organisational unit
Tel: +421 2 5810 1211

Italia Suomi/Finland
Boehringer Ingelheim Italia S.p.A. Boehringer Ingelheim Finland Ky
Tel: +39 02 5355 1 Puh/Tel: +358 10 3102 800

Κύπρος Sverige
Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E. Boehringer Ingelheim AB
Tηλ: +30 2 10 89 06 300 Tel: +46 8 721 21 00

Latvija United Kingdom (Northern Ireland)
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Ireland Ltd.
Latvijas filiāle Tel: +353 1 295 9620
Tel: +371 67 240 011

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