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Mirapexin 0,7 mg. 30 tablets

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MIRAPEXIN contains the active substance pramipexole and belongs to a group of medicines called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopamine receptors triggers nerve impulses in the brain, which helps control body movements.

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What MIRAPEXIN is and what it is used for

MIRAPEXIN contains the active substance pramipexole and belongs to a group of medicines called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopamine receptors triggers nerve impulses in the brain, which helps control body movements.

MIRAPEXIN is used for:

for the treatment of symptoms of primary Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine used to treat 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 (have had) or develop any medical conditions or symptoms, especially the following:

kidney disease;

hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual.

dyskinesia (eg abnormal, involuntary movements of the limbs). If you have advanced Parkinson's disease and are also taking levodopa, dyskinesia may occur during dose escalation of MIRAPEXIN;

drowsiness and episodes of sudden sleep onset;

psychoses (eg comparable to the symptoms of schizophrenia);

visual disturbances. You should have regular eye examinations during treatment with MIRAPEXIN;

severe heart or vascular disease. You need to monitor your blood pressure regularly, especially when starting treatment. This is necessary to avoid orthostatic hypotension (drop in blood pressure when straightening the legs);

deterioration. You may feel that the symptoms start earlier than usual, are more intense and manifest in other limbs.

Tell your doctor if you or your family / caregiver notice that you have a tendency or an irresistible desire to behave in a way that is unusual for you and that you cannot resist the impulse, urge or temptation to take certain actions that may harm yourself or others. These are called impulse control disorders and may include behaviors such as gambling addiction, overeating or spending, unusually strong sexual desire, or obsession with sexual thoughts and feelings. Your doctor may need to adjust the dose or stop treatment.

Tell your doctor if you or your family / caregiver notice that you develop mania (anxiety, euphoria or agitation) or delirium (weakening of the instinct for self-preservation, confusion, loss of sense of reality). Your doctor may need to adjust the dose or stop treatment.

Children and adolescents

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

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 medicines, medicinal foods or supplements that you have received without a prescription.

You should avoid taking MIRAPEXIN at the same time as antipsychotic medicines.

Be careful if you are taking the following medicines:

cimetidine (used to treat increased stomach acidity and stomach ulcers);

amantadine (which can be used to treat Parkinson's disease);

mexiletine (used to treat irregular heartbeat, a condition known as ventricular arrhythmia);

zidovudine (which can be used to treat acquired immune deficiency syndrome (AIDS), a disease of the human immune system);

cisplatin (used to treat various types of cancer);

quinine (which can be used to prevent painful, nocturnal leg cramps and to treat a specific type of malaria known as falciparum malaria);

procainamide (used to treat cardiac arrhythmia).

If you are taking levodopa, it is recommended that the dose of levodopa be reduced when you start treatment with MIRAPEXIN.

Be careful if you are taking any medications that have a calming effect (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, drink and alcohol

You should be careful when drinking alcohol during treatment with MIRAPEXIN. MIRAPEXIN can be taken with or without food.

Pregnancy and lactation

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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 unknown. Therefore, do not take MIRAPEXIN if you are pregnant unless your medicine

A maintenance dose of less than three MIRAPEXIN 0.088 mg tablets per 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 1.1 mg three times a day

Total daily dose (mg) 0.264 3.3

Patients with renal impairment

If you have moderate or severe kidney damage, your doctor will prescribe a lower dose. In this case, you will only need to take the tablets once or twice a day. If you have moderate kidney damage, the usual starting dose is 1 tablet of MIRAPEXIN 0.088 mg twice a day. In severe renal impairment, the usual starting dose is only 1 tablet of MIRAPEXIN 0.088 mg once daily.

Restless legs syndrome

The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.

The usual daily dose for the first week is 1 MIRAPEXIN 0.088 mg tablet once a day (equivalent to 0.088 mg a day):

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).

Week 2 Week 3 Week 4

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 MIRAPEXIN 0.088 mg tablets or a dose of 0.54 mg (0.75 mg pramipexole as salt).

If you stop taking the tablets for more than a few days and want to resume treatment, you must start again with the lowest dose. You can then increase the dose again, as you did the first time. Consult your doctor.

Your doctor will review your treatment after 3 months and decide whether to continue treatment or not.

Patients with renal impairment

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

If you take more MIRAPEXIN than you should

If you accidentally take too many tablets:

you should contact your doctor immediately or go to the nearest emergency center for advice;

nausea, anxiety or any of the side effects described in section 4 (Possible side effects) may occur.

If you forget to take MIRAPEXIN

Do not worry. Just skip this dose completely and take your next dose at the usual time. Do not try to make up for a forgotten dose.

If you stop taking MIRAPEXIN

Do not stop taking MIRAPEXIN without first talking to 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, you should not suddenly stop treatment with MIRAPEXIN. Abrupt cessation can cause you to develop a condition called neuroleptic malignant syndrome, which can pose a significant health risk. Symptoms include:

akinesia (loss of muscle mobility);

stiff muscles;

fever;

unstable blood pressure;

tachycardia (fast heart rate);

state of confusion;

decreased 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.

The evaluation of these adverse reactions is based on the following frequency categories:

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 1,000 people;

Rare: may affect up to 1 in 1,000 people;

Very rare: may affect up to 1 in 10,000 people

If you suffer from Parkinson's disease, you may experience the following side effects:

Very common:

dyskinesia (unusual, involuntary movements of the limbs);

drowsiness;

dizziness;

nausea.

Common:

urge for unusual behavior;

hallucinations (seeing, hearing or feeling things that are not there);

state of confusion;

fatigue;

insomnia;

fluid retention, usually in the lower extremities (peripheral edema);

headache;

hypotension (low blood pressure);

pathological dreams;

constipation;

visual impairment;

vomiting;

weight loss, including decreased appetite.

Uncommon:

paranoia (eg excessive fear for one's own health);

delusion;

excessive daytime sleepiness and episodes of sudden sleep onset;

amnesia (memory impairment);

hyperkinesia (frequent movements and inability to settle at rest);

weight gain;

allergic reactions (eg rash, itching, hypersensitivity reactions);

nausea;

heart failure (heart problems that can cause shortness of breath or bloating

Tell your doctor if you experience any of these conditions; he will discuss ways to control or reduce symptoms.

For adverse reactions marked with * precise frequency determination is not possible as these adverse reactions were not observed in clinical trials in 1,395 patients treated with pramipexole. The frequency group is probably no more 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.

Reporting of side effects

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 through the national reporting system. By reporting side effects, you can help to get more information about 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 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 in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information

What MIRAPEXIN contains

The active ingredient is: pramipexole.

Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg or 1.1 mg of pramipexole as 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 1.5 mg of pramipexole dihydrochloride monohydrate, respectively.

The other ingredients are: mannitol, corn starch, colloidal, anhydrous silica, povidone K 25 and magnesium stearate.

What MIRAPEXIN looks like and contents of the pack

MIRAPEXIN 0.088 mg tablets are white, round, flat and without score line.

MIRAPEXIN 0.18 mg tablets and MIRAPEXIN 0.35 mg tablets are white, elliptical and flat. The tablets have a score line on both sides and can be divided into two equal halves.

MIRAPEXIN 0.7 mg tablets and MIRAPEXIN 1.1 mg tablets are white, round and smooth. The tablets have a score line on both sides and can be divided into two equal halves.

All tablets have the Boehringer Ingelheim logo engraved on one side and the code P6, P7, P8, P9, or P11 on the other side, representing the amount of active substance in the tablets, 0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg and 1.1, respectively. mg.

All concentrations of MIRAPEXIN are supplied in aluminum blister strips of 10 tablets in a strip placed in cardboard boxes containing 3 or 10 blister strips (30 or 100 tablets).

Not all pack sizes may be marketed.

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