MIRAPEXIN 2.1 mg. 30 tablets
MIRAPEXIN contains the active substance pramipexole and refers to a group of medicines called dopamine agonists which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors causes nerve impulses in the brain, which helps to control body movements.
MIRAPEXIN is used to treat the symptoms of primary Parkinson's disease in adults. It can be used alone or in combination with levodopa (another drug for treatment of Parkinson's disease).
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
Talk to your doctor before taking MIRAPEXIN. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially these:
hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual;
Dyskinesia (eg abnormal, uncontrolled movements of the limbs). If you have advanced Parkinson's disease and are also taking levodopa, it might develop dyskinesia during the uptitration of MIRAPEXIN;
somnolence and episodes of sudden sleep onset;
Psychosis (eg comparable with symptoms of schizophrenia);
visual disturbances. You should have regular eye examinations during treatment with MIRAPEXIN;
severe heart or vascular disease. Regularly monitor blood pressure, especially at the beginning of treatment. This is necessary to avoid orthostatic hypotension (drop in blood pressure on standing up).
Tell your doctor if you or your family / caregiver you notice that you develop a tendency or urge to behave in an unusual way for you and you can not resist the impulse urge or temptation to perform certain actions, which may harm themselves or others. They are called disorders of impulse control and may include behaviors such as compulsive gambling, excessive eating or spending an unusually strong sexual desire or obsession with sexual thoughts and feelings. You may need your doctor may adjust your dose or stop treatment.
Children and adolescents
Not recommended the use of MIRAPEXIN in children and adolescents under 18 years.
Other medicines and MIRAPEXIN
Tell your doctor or pharmacist if you are taking, you 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.
Be careful 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 for the treatment of syndrome acquired immune deficiency (AIDS), a disease of the human immune system);
cisplatin (to treat various types of cancer);
quinine (which can be used to prevent painful nocturnal leg cramps and for the treatment of a certain type of malaria, falciparum malaria known as (malignant malaria);
procainamide (for the treatment of cardiac arrhythmias).
If you are taking levodopa, it is recommended to reduce the dose of levodopa, when you start treatment with MIRAPEXIN.
Be careful if you are taking any medicines that calm you down (have a sedative effect) or if you drink alcohol. In these cases MIRAPEXIN may affect your ability to drive and use machines.
MIRAPEXIN with food, drinks and alcohol
You should be cautious while drinking alcohol during treatment with MIRAPEXIN. MIRAPEXIN can be taken with or without food.
Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. Your doctor will discuss with you whether 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.
MIRAPEXIN should not be used during breastfeeding. MIRAPEXIN can reduce the production of breast milk. It can also pass into breast milk and affect your child. If necessary treatment with MIRAPEXIN, breastfeeding should be stopped.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
MIRAPEXIN can 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 episodes of sudden sleep onset, particularly in patients with Parkinson's disease. If you get experience these side effects should not drive or operate machinery. You should tell your doctor if this happens.
3. How to take MIRAPEXIN
Always take this medicine exactly as your doctor has told you. If you're not sure, ask your doctor. Your doctor will advise the correct dosage.
Take MIRAPEXIN prolonged-release tablets only once a day and each day at about the same time.
MIRAPEXIN can be taken with or without food. Swallow the tablets whole with water.
The prolonged release tablets should not be chewed, divided, or crush. If you do, you can take a larger dose because the drug can be released into your body too quickly.
The usual daily dose during the first week is 0,26 mg pramipexole. The dose will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
Dose schedule of MIRAPEXIN prolonged-release tablets by increasing doses
Week Daily dose (mg) Number of tablets
1 00:26 A prolonged-release tablet MIRAPEXIN 0,26 mg
2 00:52 A prolonged-release tablet MIRAPEXIN 0,52 mg
Two prolonged-release tablets MIRAPEXIN 0,26 mg.
3 1:05 One prolonged-release tablet MIRAPEXIN 1,05 mg
Two prolonged-release tablets MIRAPEXIN 0,52 mg
Four prolonged-release tablets MIRAPEXIN 0,26 mg.
The usual maintenance dose is 1,05 mg per day. However, it may need to further increase your dose. If necessary, your doctor may increase your dose to a maximum of 3,15 mg of pramipexole a day. It is also possible maintenance dose lower than one prolonged release tablet MIRAPEXIN 0,26 mg per day.
Patients with renal impairment
If you have kidney damage, 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. Then your doctor may increase the frequency of dosing to an extended release tablet formulation of 0,26 mg daily. If it is necessary to further increase the dose, your doctor may adjust it with 0,26 mg pramipexole.
If you have severe kidney problems, you may need your doctor to switch you to a different pramipexole medicine. If during treatment your kidney problems get worse, you should contact your doctor as soon as possible.
If you switch from treatment with MIRAPEXIN (immediate release) tablets
Your doctor will decide the dose of MIRAPEXIN prolonged-release tablets on the dose of MIRAPEXIN (immediate release) tablets you were taking.
Take MIRAPEXIN (immediate release) tablets as normal the day before you switch. Then take your MIRAPEXIN prolonged-release tablets next morning and do not take more MIRAPEXIN (immediate release) tablets.
If you take more MIRAPEXIN than
If accidentally take too many tablets:
you should immediately contact your doctor or go to the nearest emergency center, for advice;
may experience vomiting, restlessness, or any of the side effects that are described in section 4 (Possible side effects).
If you forget to take MIRAPEXIN
If you forget to take a dose of MIRAPEXIN, but remember within 12 hours of your usual time, take your tablet immediately and take the next one at the usual time. If you forget for more than 24 hours, simply take the next single dose at the usual time.
Do not take a double dose to make up for forgotten tablet.
If you stop taking MIRAPEXIN
Do not stop taking MIRAPEXIN, without first consulting your doctor. If you need to stop taking this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening symptoms.
If you have Parkinson's disease should not suddenly stop treatment with MIRAPEXIN. A sudden stop could cause you to develop a condition called neuroleptic malignant syndrome which may represent a major health risk.
akinesia (loss of muscle movement);
unstable blood pressure;
tachycardia (increased heart rate);
reduced level of consciousness (coma).
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.
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 1000 people;
Very rare: may affect up to 1 in 10,000 people.
When you can experience the following side effects:
dyskinesia (abnormal, involuntary movements of the limbs);
gust of abnormal behavior;
hallucinations (seeing, hearing or feeling things that are not there);
fluid retention, usually in the legs (peripheral edema);
hypotension (low blood pressure);
weight loss including decreased appetite.
Paranoia (eg. excessive fear for their own health);
excessive daytime somnolence and sudden sleep onset episodes;
amnesia (memory disturbance);
hyperkinesia (increased movements and inability to keep still);
allergic reactions (eg. rash, itching, hypersensitivity reactions);
heart failure (heart problems which can cause shortness of breath or ankle swelling) *;
inappropriate antidiuretic hormone *;
dyspnea (difficulty breathing);
pneumonia (infection of the lungs);
inability to resist the impulse, the urge or temptation to perform certain actions that can harm you or others and may include:
a strong impetus to excessive gambling, despite substantial consequences for you or your family;
changed or increased sexual interest and behavior is essential to you or others, such as increased sexual desire;
uncontrollable excessive shopping or spending;
overeating (eating large amounts of food in a short period of time) or compulsive overeating (eating more food than usual or more than is necessary to satisfy their hunger) *.
Tell your doctor if you experience any of these conditions; He will discuss ways to control or reduce symptoms.
Adverse reactions marked with * a precise determination of frequency is impossible, since these side effects were not observed during clinical trials of 2762 patients treated with pramipexole. The group of frequencies likely to be no more than "uncommon".
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet.
5. How to store MIRAPEXIN
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture. This medicinal product does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and further information
What MIRAPEXIN contains
The active ingredient is pramipexole.
Each tablet contains 0,26 mg, 0,52 mg, 1,05 mg, 1, 57 mg, 2,1 mg, 2 mg or 62 mg 3,15 pramipexole in the form of 0,375 mg, 0,75 mg, 1 , 5 mg, 2, 25 mg, 3 mg, 3 mg or 75 mg 4,5 pramipexole dihydrochloride monohydrate, respectively.
The other ingredients are hypromellose 2208, corn starch, Carbomer 941, colloidal anhydrous silica, magnesium stearate.
What MIRAPEXIN looks like and contents of the pack
MIRAPEXIN 0,26 mg and 0,52 mg prolonged-release tablets are white to off-white, round, 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 off-white oval shaped.
All tablets are embossed code symbol Boehringer Ingelheim company and the codes P1, P2, P3, P12, P4, P13, or P5 on the other side, showing the concentration of active substance respectively 0,26 mg, 0,52 mg, 1 , 05 mg, 1,57 mg, 2,1 mg, 2,62 mg and 3,15.
All strengths of MIRAPEXIN are available in aluminum blister strips of 10 tablets per strip, in cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets).
Not all pack sizes may be marketed.