Mirapexin 0.18 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MIRAPEXIN 0.088 mg tablets

MIRAPEXIN 0.18 mg tablets

MIRAPEXIN 0.35 mg tablets

MIRAPEXIN 0.7 mg tablets

pramipexole

Read the entire 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

What is in 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 called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopaminergic receptors triggers nerve impulses in the brain that help control body movements.

MIRAPEXIN is used to:

• treat the symptoms of idiopathic Parkinson's disease in adults. It may be used alone or in combination with levodopa (another medicine for Parkinson's disease).
• treat moderate to severe idiopathic restless legs syndrome in adults.

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 starting to take MIRAPEXIN. Inform your doctor if you have or have had any illness or symptom, especially any of the following:

• Kidney disease.

• Hallucinations (seeing, hearing, or feeling things that are not present). Most hallucinations are visual.

• Dyskinesia (e.g., abnormal involuntary movements of the limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you may develop dyskinesia during the gradual dose increase of MIRAPEXIN.

• Dystonia (inability to keep the trunk and neck straight and upright [axial dystonia]). Specifically, you may experience forward bending of the head and neck (also known as antecollis), forward curvature of the lumbar region (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome).

• Somnolence and sudden episodes of falling asleep.

• Psychosis (e.g., symptoms resembling schizophrenia).

• Vision disturbances. You should undergo regular eye examinations during treatment with MIRAPEXIN.

• Severe heart or blood vessel disease. You should have regular blood pressure monitoring, especially at the beginning of treatment, to prevent postural hypotension (a drop in blood pressure upon standing).

• Worsening of restless legs syndrome. If you notice that symptoms start earlier than usual at night (or even in the afternoon), are more intense, affect larger areas of the affected limbs, or affect other limbs, your doctor may reduce your dose or discontinue treatment.

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is called impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, or abnormally increased sexual drive or interest with increased sexual thoughts and feelings. Your doctor may need to adjust your dose or discontinue treatment.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling elated or overexcited) or delirium (reduced consciousness, confusion, or loss of contact with 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 when stopping or reducing treatment with MIRAPEXIN. If these problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Inform your doctor if you notice an inability to keep your trunk and neck straight and upright (axial dystonia). In such cases, your doctor may decide to adjust or modify your treatment.

Children and adolescents

MIRAPEXIN is not recommended for use 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 need to take any other medicines. This includes medicines, herbal remedies, natural foods, or nutritional supplements obtained without a prescription.

You should avoid using MIRAPEXIN together with antipsychotic medications.

Use caution if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and stomach ulcers)
• amantadine (which may be used in the treatment of Parkinson’s disease)
• mexiletine (used to treat irregular heartbeat, a disorder 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 leg cramps at night and to treat a type of malaria known as falciparum malaria [malignant malaria])
• procainamide (used to treat irregular heartbeat)

If you are taking levodopa, it is recommended to reduce the levodopa dose when starting treatment with MIRAPEXIN.

Use caution if you are taking sedative medicines (with sedative effects) or drinking alcohol. In these cases, MIRAPEXIN may affect your ability to drive and operate machinery.

Taking MIRAPEXIN with food, drinks, and alcohol

You should exercise caution if drinking alcohol during treatment with MIRAPEXIN.

You may take MIRAPEXIN with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will advise you whether you should continue treatment with MIRAPEXIN.

The effect of MIRAPEXIN on the fetus is unknown. Therefore, do not take MIRAPEXIN during pregnancy unless your doctor instructs you to do so.

MIRAPEXIN should not be used during breastfeeding. MIRAPEXIN may reduce the production of breast milk. In addition, it may pass into breast milk and reach your baby. If the use of MIRAPEXIN is essential, breastfeeding must be discontinued.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

MIRAPEXIN may cause hallucinations (seeing, hearing, or feeling things that are not present). If this occurs, do not drive or use machines.

MIRAPEXIN has been associated with somnolence and sudden episodes of falling asleep, especially in patients with Parkinson’s disease. If you experience these adverse effects, you should not drive or operate machinery. Inform your doctor if this happens to you.

3. How to take MIRAPEXIN

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor again. Your doctor will tell you the correct dosage.

You may take MIRAPEXIN with or without food. The tablets should be swallowed with water.

Parkinson's Disease

The daily dose should be taken in 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 daily):

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

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

Patients with renal disease

If you have moderate or severe kidney 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 impairment, the usual starting dose is 1 tablet of MIRAPEXIN 0.088 mg twice daily. If you have severe renal impairment, the usual starting dose is 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 bedtime.

During the first week, the usual dose is 1 tablet of MIRAPEXIN 0.088 mg once daily (equivalent to 0.088 mg per day):

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

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 your tablets for a few days and wish to restart treatment, you must begin again with the smallest dose and then gradually increase the dose as you did the first time. Consult your doctor if you have any doubts.

Your doctor will evaluate your treatment after 3 months to decide whether to continue or discontinue therapy.

Patients with renal disease

If you have severe kidney disease, MIRAPEXIN may not be an appropriate treatment for you.

If you take more MIRAPEXIN than you should

If you accidentally ingest too many tablets:

• consult your doctor or the nearest hospital emergency department immediately.
• you may experience vomiting, restlessness, or any of the adverse effects described in section 4, “Possible side effects.”

If you forget to take MIRAPEXIN

Do not worry. Simply skip that dose and take the next dose at the correct time. Do not take a double dose to make up for missed doses.

If you interrupt treatment with MIRAPEXIN

Do not stop your treatment with MIRAPEXIN without first consulting your doctor. If you need to interrupt treatment with this medicine, your doctor will gradually reduce your 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 condition called neuroleptic malignant syndrome, which can pose a serious health risk. Symptoms include:

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

If you interrupt treatment or reduce the dose of MIRAPEXIN, you may also develop a medical condition known as dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you should contact your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. The classification of adverse effects is based on the following frequencies:

If you have Parkinson's disease, you may experience the following adverse effects:

Very common:

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

Common:

• Urge to behave in an unusual manner
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Tiredness (fatigue)
• Insomnia
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision disturbances
• Vomiting
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g., excessive concern about your health)

• Delusion

• Excessive daytime sleepiness and sudden episodes of falling asleep

• Amnesia (memory impairment)

• 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 swelling of the ankles)*

• Inappropriate secretion of antidiuretic hormone*

• Restlessness

• Dyspnea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)

• Inability to resist the impulse, instinct, or temptation to carry out an action that may 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 that is concerning to you or others, for example, increased libido.

• Uncontrollable excessive spending or shopping.

• Binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than necessary to satisfy hunger).*

• Delirium (reduced consciousness, confusion, loss of touch with reality)

Rare:

• Mania (agitation, feeling elated or overexcited)

Frequency not known:

• After stopping or reducing treatment with MIRAPEXIN: depression, apathy, anxiety, fatigue, sweating, or pain may occur (known as 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 adverse effects marked with *, a precise estimation of frequency cannot be provided, as these adverse effects were not observed in clinical trials involving 2,762 patients treated with pramipexole. The frequency category is likely no higher than "uncommon."

If you have restless legs syndrome, you may experience the following adverse effects:

Very common:

• Nausea
• Symptoms starting earlier than usual, becoming more intense, or affecting other limbs (worsening of restless legs syndrome).

Common:

• Changes in sleep patterns, such as insomnia and somnolence
• Tiredness (fatigue)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting

Uncommon:

• Urge to behave in an unusual manner*

• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*

• Inappropriate secretion of antidiuretic hormone*

• Dyskinesia (e.g., abnormal involuntary movements of the limbs)

• Hyperkinesia (increased movements and inability to stay still)*

• Paranoia (e.g., excessive concern about your health)*

• Delusion*

• Amnesia (memory impairment)*

• Hallucinations (seeing, hearing, or feeling things that are not present)

• Confusion

• Excessive daytime sleepiness and sudden episodes of falling asleep

• Weight gain

• Hypotension (low blood pressure)

• Fluid retention, usually in the legs (peripheral edema)

• Allergic reactions (e.g., skin rash, itching, hypersensitivity)

• Fainting

• Restlessness

• Vision disturbances

• Weight loss including loss of appetite

• Dyspnea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)*

• Inability to resist the impulse, instinct, or temptation to carry out an action that may 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 that is concerning to you or others, for example, increased libido.*

• Uncontrollable excessive spending or shopping.*

• Binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than necessary to satisfy hunger).*

• Mania (agitation, feeling elated or overexcited)*

• Delirium (reduced consciousness, confusion, loss of touch with reality)*

Frequency not known:

• After stopping or reducing treatment with MIRAPEXIN: depression, apathy, anxiety, fatigue, sweating, or pain may occur (known as 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 adverse effects marked with *, a precise estimation of frequency cannot be provided, as these adverse effects were not observed in clinical trials involving 1,395 patients treated with pramipexole. The frequency category is likely no higher than "uncommon."

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 box after EXP. The expiry date is the last day of the month indicated.

Do not store above 30 °C.

Keep in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of MIRAPEXIN

The active substance is pramipexole.

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

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

Appearance of the product and contents of the pack

MIRAPEXIN 0.088 mg tablets are white, round, flat and unmarked.

MIRAPEXIN 0.18 mg and MIRAPEXIN 0.35 mg tablets are white, oval and flat. The tablets are scored on both sides and can be divided into two equal parts.

MIRAPEXIN 0.7 mg tablets are white, round and flat. The tablets are scored on both sides and can be divided into two equal parts.

All tablets have the Boehringer Ingelheim company symbol in relief on one side, and the codes P6, P7, P8 or P9 on the other side, indicating the tablet strength: 0.088 mg, 0.18 mg, 0.35 mg and 0.7 mg, respectively.

All strengths of MIRAPEXIN are available in aluminum blister strips containing 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets). Only certain 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 more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary: {MM/YYYY}.

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.euopa.eu.