MIRAPEXIN 1 mg. 30 tablets

BOEHRINGER
MIRAPEXIN 1 mg. 30 tablets
€ 59.00
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WHAT MIRAPEXIN and what it is used
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:
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);
treatment of moderate to severe primary Restless Legs Syndrome in adults.
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:
kidney disease;
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);
deterioration. You may experience that symptoms start earlier than usual, be more intense and occur in other limbs.
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.
Tell your doctor if you or your family / caregiver you notice / notice that develop mania (anxiety, euphoric mood or mood) or delirium (weakening of the survival instinct, confusion, loss of sense of reality). 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.
MIRAPEXIN can be taken with or without food. Swallow the tablets with water.

Parkinson's disease
The daily dose is divided equally into three separate doses.
The usual daily dose during the first week is 1 tablet MIRAPEXIN 0,088 mg three times daily (equivalent to 0,264 mg daily):

1st week
Number of tablets 1 tablet MIRAPEXIN 0,088 mg three times daily
Total daily dose (mg) 0,264
The dose will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
Second week, third 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 daily
Total daily dose (mg) 0,54 1,1
The usual maintenance dose is 1,1 mg per day. However, it may need to further increase your dose. If necessary, your doctor may increase your dose to a maximum of 3,3 mg of pramipexole a day. It is also possible maintenance dose lower than three tablets MIRAPEXIN 0.088 mg per day.

Lowest maintenance dose Highest maintenance dose
Number of tablets 1 tablet MIRAPEXIN 0,088 mg three times a day 1 tablet MIRAPEXIN 1,1 mg tid
Total daily dose (mg) 0,264 3,3
Patients with renal impairment
If you have moderate or severe renal impairment, your doctor will prescribe a lower dose. In this case it will have to take the tablets only once or twice daily. If you have moderate kidney disease, the usual starting dose is 1 tablet MIRAPEXIN 0,088 mg twice daily. In severe renal impairment, the usual starting dose is just 1 tablet MIRAPEXIN 0,088 mg twice daily one.

Restless Legs Syndrome
The dose is usually taken once daily in the evening, 2-3 hours before bedtime.
The usual daily dose during the first week is 1 tablet MIRAPEXIN 0,088 mg once daily (equivalent to 0,088 mg daily):

1st week
Number of tablets 1 tablet MIRAPEXIN 0,088 mg once daily
Total daily dose (mg) 0,088

The dose will be increased every 4-7 days, as recommended 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 tablets OR two MIRAPEXIN 0,088 mg 1 tablet MIRAPEXIN 0,35 mg tablets OR two 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 form).

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. Then again, you can increase the dose as you did the first time. Check with your doctor.
Your doctor will review your treatment after 3 months to decide whether to continue treatment or not.

Patients with renal impairment
If you have severe renal impairment, treatment with MIRAPEXIN may not be suitable for you.

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
Do not worry. Just skip that dose completely and then take your next dose at the usual time. Do not try to make up the missed dose.

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. Symptoms include:
akinesia (loss of muscle movement);
rigid muscles;
fever;
unstable blood pressure;
tachycardia (increased heart rate);
confusion;
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 00 people 1;
Rare: may affect up to 1 in 1000 people;
Very rare: may affect up to 1 in 10,000 people.
If you suffer from Parkinson's disease, where you can experience the following side effects:
Very common:
dyskinesia (abnormal, involuntary movements of the limbs);
drowsiness;
dizziness;
nausea.
Common:
gust of abnormal behavior;
hallucinations (seeing, hearing or feeling things that are not there);
confusion;
fatigue;
insomnia (insomnia);
fluid retention, usually in the legs (peripheral edema);
headache;
hypotension (low blood pressure);
abnormal dreams;
constipation;
visual impairment;
vomiting;
weight loss including decreased appetite.
Uncommon:
Paranoia (eg. excessive fear for their own health);
Delusion;
excessive daytime somnolence and sudden sleep onset episodes;
amnesia (memory disturbance);
hyperkinesia (increased movements and inability to keep still);
weight gain;
allergic reactions (eg. rash, itching, hypersensitivity reactions);
fainting;
heart failure (heart problems which can cause shortness of breath or ankle swelling) *;
inappropriate antidiuretic hormone *;
restlessness;
dyspnea (difficulty breathing);
hiccups;
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) *;
delirium (weakening of the survival instinct, confusion, loss of sense of reality).
Rare:
mania (agitation, feelings of elation or excitement).
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 suffer from Restless Legs Syndrome, you may experience the following side effects:
Very common:
nausea (feeling sick).
Common:
Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness;
tiredness (fatigue);
headache;
vivid dreams;
vivid dreams;
constipation;
dizziness;
vomiting.
Uncommon:
gust of abnormal behavior *;
heart failure (heart problems which can cause shortness of breath or ankle swelling) *;
inappropriate antidiuretic hormone *;
Dyskinesia (eg abnormal, uncontrolled movements of the limbs);
hyperkinesia (increased movements and inability to keep still) *;
Paranoia (eg excessive fear for one's health) *;
Delusion *;
amnesia (memory disturbance) *;
hallucinations (seeing, hearing or feeling things that are not there);
confusion;
excessive daytime somnolence and sudden sleep onset episodes;
weight gain;
hypotension (low blood pressure);
fluid retention, usually in the legs (peripheral edema);
allergic reactions (such as rash, itching, hypersensitivity reactions);
fainting;
restlessness;
visual impairment;
weight loss including decreased appetite;
dyspnea (difficulty breathing);
hiccups;
pneumonia (lung infection) *;
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) *;
mania (agitation, feelings of elation or excitement) *;
delirium (weakening of the survival instinct, confusion, loss of sense of reality) *.
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 1395 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.

Adverse event reporting
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported side effects, you can do your bit to obtain more information on the safety of this medicine.

5. How to store MIRAPEXIN
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 30 ° C.
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