Mirapexin
pramipexole
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What MIRAPEXIN is and what it is used for
What you need to know before you take MIRAPEXIN
How to take MIRAPEXIN
Possible side effects
How to store MIRAPEXIN
Contents of the pack and other information
MIRAPEXIN contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
treat the symptoms of primary Parkinson’s disease in adults. It can be used alone or in
combination with levodopa (another medicine for Parkinson’s disease).
treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.
if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in
section 6).
Talk to your doctor before taking MIRAPEXIN. Tell your doctor if you have (had) or develop any medical conditions 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, uncontrolled movements of the limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you might develop dyskinesia during the up-
titration of MIRAPEXIN.
Dystonia (inability of keeping your body and neck straight and upright (axial dystonia)). In particular, you may experience forward flexion of the head and neck (also called antecollis), forward bending of the lower back (also called camptocormia) or sidewards bending of the back (also called pleurothotonus or Pisa Syndrome).
Sleepiness and episodes of suddenly falling asleep
Psychosis (e.g. comparable with symptoms of schizophrenia)
Vision impairment. You should have regular eye examinations during treatment with MIRAPEXIN.
Severe heart or blood vessels disease. You will need to have your blood pressure checked regularly, especially at the beginning of treatment. This is to avoid postural hypotension (a fall in
blood pressure on standing up).
Augmentation. You may experience that symptoms start earlier than usual, be more intense and involve other limbs.
Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings. Yourdoctormayneedto adjustorstopyourdose.
Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion or loss of reality). Yourdoctor mayneedtoadjustorstopyourdose.
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your MIRAPEXIN treatment. If the problems persist more than a few weeks, your doctor may need to adjust your treatment.
Tell your doctor if you are developing an inability of keeping your body and neck straight and upright (axial dystonia). If this happens, your doctor may want to adjust or change your medication.
MIRAPEXIN is not recommended for use in children or adolescents under 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.
You should avoid taking MIRAPEXIN together with antipsychotic medicines. Take care if you are taking the following medicines:
cimetidine (to treat excess stomach acid and stomach ulcers)
amantadine (which can be used to treat Parkinson’s disease)
mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia)
zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system)
cisplatin (to treat various types of cancers)
quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria))
procainamide (to treat irregular heart beat)
If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with MIRAPEXIN.
Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol. In these cases MIRAPEXIN may affect your ability to drive and operate machinery.
You should be cautious while drinking alcohol during treatment with MIRAPEXIN.
MIRAPEXIN can be taken with or without food.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine. Your doctor will then discuss with you if you should continue to take MIRAPEXIN.
The effect of MIRAPEXIN on the unborn child is not known. Therefore, do not take MIRAPEXIN if you are pregnant unless your doctor tells you to do so.
MIRAPEXIN should not be used during breast-feeding. MIRAPEXIN can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of MIRAPEXIN is unavoidable, breast-feeding should be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.
MIRAPEXIN can cause hallucinations (seeing, hearing or feeling things that are not there). If affected,
do not drive or use machines.
MIRAPEXIN has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’s disease. If you experience these side effects, you must not drive or operate machinery. You should tell your doctor if this occurs.
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The doctor will advise you on the right dosing.
You can take MIRAPEXIN with or without food. Swallow the tablets with water.
The daily dose is to be taken divided into 3 equal doses.
During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg three times a day (equivalent to 0.264 mg daily):
1st week | |
Number of tablets | 1 tablet MIRAPEXIN 0.088 mg three times a day |
Total daily dose (mg) | 0.264 |
This will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
2nd week | 3rd week | |
Number of tablets | 1 tablet MIRAPEXIN 0.18 mg three times a day OR 2 tablets MIRAPEXIN 0.088 mg three times a day | 1 tablet MIRAPEXIN 0.35 mg three times a day OR 2 tablets MIRAPEXIN 0.18 mg three times a day |
Total daily dose (mg) | 0.54 | 1.1 |
The usual maintenance dose is 1.1 mg per day. However, your dose may have to be increased even further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day. A lower maintenance dose of three MIRAPEXIN 0.088 mg tablets a day is also possible.
Lowest maintenance dose | Highest maintenance dose | |
Number of tablets | 1 tablet MIRAPEXIN 0.088 mg three times a day | 1 tablet MIRAPEXIN 0.7 mg and 1 tablet MIRAPEXIN 0.35 mg three times a day |
Total daily dose (mg) | 0.264 | 3.15 |
Patients with kidney disease
If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you will have to take the tablets only once or twice a day. If you have moderate kidney disease, the
usual starting dose is 1 tablet MIRAPEXIN 0.088 mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet MIRAPEXIN 0.088 mg a day.
The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.
During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg once a day (equivalent to
0.088 mg daily):
1st week | |
Number of tablets | 1 tablet MIRAPEXIN 0.088 mg |
Total daily dose (mg) | 0.088 |
This will be increased every 4-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
2nd week | 3rd week | 4th week | |
Number of tablets | 1 tablet MIRAPEXIN 0.18 mg OR 2 tablets MIRAPEXIN 0.088 mg | 1 tablet MIRAPEXIN 0.35 mg OR 2 tablets MIRAPEXIN 0.18 mg OR 4 tablets MIRAPEXIN 0.088 mg | 1 tablet MIRAPEXIN 0.35 mg and 1 tablet MIRAPEXIN 0.18 mg OR 3 tablets MIRAPEXIN 0.18 mg OR 6 tablets MIRAPEXIN 0.088 mg |
Total daily dose (mg) | 0.18 | 0.35 | 0.54 |
The daily dose should not exceed 6 tablets MIRAPEXIN 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
If you stop taking your tablets for more than a few days and want to restart the treatment, you must start again at the lowest dose. You can then build up the dose again, as you did the first time. Ask your doctor for advice.
Your doctor will review your treatment after 3 months to decide whether or not to continue the treatment.
Patients with kidney disease
If you have severe kidney disease, MIRAPEXIN may not be a suitable treatment for you.
If you accidentally take too many tablets,
Contact your doctor or nearest hospital casualty department immediately for advice.
You may experience vomiting, restlessness, or any of the side effects as described in section 4 “Possible side effects”.
Do not worry. Simply leave out that dose completely and then take your next dose at the right time.
Do not try to make up for the missed dose.
Do not stop taking MIRAPEXIN without first talking to your doctor. If you have to stop taking this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening symptoms.
If you suffer from Parkinson’s disease you should not stop treatment with MIRAPEXIN abruptly. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include:
akinesia (loss of muscle movement)
rigid muscles
fever
unstable blood pressure
tachycardia (increased heart rate)
confusion
depressed level of consciousness (e.g. coma)
If you stop or reduce MIRAPEXIN you may also develop a medical condition called dopamine
agonist withdrawal syndrome. The symptoms include depression, apathy, anxiety, fatigue, sweating or pain. If you experience these symptoms you should contact your physician.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Evaluation of these side effects 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 suffer from Parkinson’s disease, you may experience the following side effects:
Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
Sleepiness
Dizziness
Nausea (sickness)
Urge to behave in an unusual way
Hallucinations (seeing, hearing or feeling things that are not there)
Confusion
Tiredness (fatigue)
Sleeplessness (insomnia)
Excess of fluid, usually in the legs (peripheral oedema)
Headache
Hypotension (low blood pressure)
Abnormal dreams
Constipation
Visual impairment
Vomiting (being sick)
Weight loss including decreased appetite
Paranoia (e.g. excessive fear for one’s own well-being)
Delusion
Excessive daytime sleepiness and suddenly falling asleep
Amnesia (memory disturbance)
Hyperkinesia (increased movements and inability to keep still)
Weight increase
Allergic reactions (e.g. rash, itching, hypersensitivity)
Fainting
Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
Inappropriate antidiuretic hormone secretion*
Restlessness
Dyspnoea (difficulties to breathe)
Hiccups
Pneumonia (infection of the lungs)
Inability to resist the impulse, drive or temptation to perform an action that could 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 behaviour of significant concern to you or to others, for example, an increased sexual drive.
Uncontrollable excessive shopping or spending
Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*
Delirium (decreased awareness, confusion, loss of reality)
Mania (agitation, feeling elated or over-excited)
After stopping or reducing your MIRAPEXIN treatment: Depression, apathy, anxiety, fatigue,
sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 2,762 patients treated with pramipexole. The frequency category is probably not greater than “uncommon”.
If you suffer from Restless Legs Syndrome, you may experience the following side effects:
Nausea (sickness)
Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
Tiredness (fatigue)
Headache
Abnormal dreams
Constipation
Dizziness
Vomiting (being sick)
Urge to behave in an unusual way*
Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
Inappropriate antidiuretic hormone secretion*
Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
Hyperkinesia (increased movements and inability to keep still)*
Paranoia (e.g. excessive fear for one’s own well-being)*
Delusion*
Amnesia (memory disturbance)*
Hallucinations (seeing, hearing or feeling things that are not there)
Confusion
Excessive daytime sleepiness and suddenly falling asleep
Weight increase
Hypotension (low blood pressure)
Excess of fluid, usually in the legs (peripheral oedema)
Allergic reactions (e.g. rash, itching, hypersensitivity)
Fainting
Restlessness
Visual impairment
Weight loss including decreased appetite
Dyspnoea (difficulties to breathe)
Hiccups
Pneumonia (infection of the lungs)*
Inability to resist the impulse, drive or temptation to perform an action that could 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 behaviour of significant concern to you or to others, for example, an increased sexual drive.*
Uncontrollable excessive shopping or spending*
Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*
Mania (agitation, feeling elated or over-excited)*
Delirium (decreased awareness, confusion, loss of reality)*
After stopping or reducing your MIRAPEXIN treatment: Depression, apathy, anxiety, fatigue,
sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 1,395 patients treated with pramipexole. The frequency category is probably not greater than “uncommon”.
If you get 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 thenationalreportingsystem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package to protect the tablets from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is pramipexole.
Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, or 0.7 mg pramipexole as 0.125 mg, 0.25 mg,
0.5 mg, or 1 mg pramipexole dihydrochloride monohydrate, respectively.
The other ingredients are mannitol, maize starch, anhydrous colloidal silica, povidone K 25 and magnesium stearate.
MIRAPEXIN 0.088 mg tablets are white, of round shape, flat, and without scoring.
MIRAPEXIN 0.18 mg tablets and MIRAPEXIN 0.35 mg tablets are white, of oval shape, and flat. Tablets are scored on both sides and breakable in halves.
MIRAPEXIN 0.7 mg tablets are white, of round shape, and flat. Tablets are scored on both sides and breakable in halves.
All tablets have the Boehringer Ingelheim company symbol embossed on one side and the codes P6, P7, P8, or P9 on the other side, representing the tablet strengths 0.088 mg, 0.18 mg, 0.35 mg, and
0.7 mg, respectively.
All strengths of MIRAPEXIN are available in aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets). Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim Pharma GmbH & Co. KG D-55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim France 100-104 avenue de France 75013 Paris
France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
SCS Boehringer Ingelheim Comm.V
Tél/Tel: +32 2 773 33 11
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel: +370 5 2595942
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ -
клон България
Тел: +359 2 958 79 98
SCS Boehringer Ingelheim Comm.V
Tél/Tel: +32 2 773 33 11
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe Tel: +36 1 299 89 00
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
BIOTHERAX biochemisch-pharmazeutische Gesellschaft mbH
Tel: +49 (0) 800 77 90 900
Boehringer Ingelheim b.v. Tel: +31 (0) 800 22 55 889
Boehringer Ingelheim RCV GmbH & Co KG
Eesti filiaal
Tel: +372 612 8000
Boehringer Ingelheim Norway KS
Tlf: +47 66 76 13 00
Boehringer Ingelheim Ellas A.E.
Tηλ: +30 2 10 89 06 300
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105-7870
Boehringer Ingelheim España, S.A. Tel: +34 93 404 51 00
Boehringer Ingelheim Sp.zo.o. Tel: +48 22 699 0 699
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00
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Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucureşti
Tel: +40 21 302 28 00
Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620
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Tel: +386 1 586 40 00
Vistor hf.
Sími: +354 535 7000
Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka
Tel: +421 2 5810 1211
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Tel: +39 02 5355 1
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Puh/Tel: +358 10 3102 800
Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300
Boehringer Ingelheim AB Tel: +46 8 721 21 00
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
This leaflet was last revised in {MM/YYYY}.