Mirapexin 1.05 mg prolonged-release tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

MIRAPEXIN 0.26 mg prolonged-release tablets

MIRAPEXIN 0.52 mg prolonged-release tablets

MIRAPEXIN 1.05 mg prolonged-release tablets

MIRAPEXIN 1.57 mg prolonged-release tablets

MIRAPEXIN 2.1 mg prolonged-release tablets

MIRAPEXIN 2.62 mg prolonged-release tablets

MIRAPEXIN 3.15 mg prolonged-release tablets

pramipexole

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet Contents

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. Package contents and additional 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 can be used alone or in combination with levodopa (another medicine for Parkinson's disease).

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 symptoms, 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 might experience forward bending of the head and neck (also known as antecollis), forward curvature of the lower back (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome).
• Drowsiness and sudden sleep episodes.
• Psychosis (e.g., symptoms resembling schizophrenia).
• Vision disturbances. You should undergo periodic 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 avoid orthostatic hypotension (a drop in blood pressure upon standing).

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 known as impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, or abnormally increased sexual drive with heightened 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 touch 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.

MIRAPEXIN prolonged-release tablets are specially designed tablets from which the active ingredient is gradually released after ingestion. Occasionally, parts of the tablets may be excreted and seen in the stools, which may resemble intact tablets. Inform your doctor if you notice tablet fragments in your stools.

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 medicinal herbs, natural foods, or nutritional supplements obtained without a prescription.

You should avoid using MIRAPEXIN together with antipsychotic medicines.

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 heartbeats, a condition 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 a sedative effect) or drinking alcohol. In these cases, MIRAPEXIN may affect your ability to drive or operate machinery.

Taking MIRAPEXIN with food, drinks, and alcohol

Exercise caution if you drink 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 are planning 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 specifically 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 operate machinery.

MIRAPEXIN has been associated with drowsiness and sudden sleep episodes, especially in patients with Parkinson’s disease. If you experience these adverse effects, you must not drive or operate machinery. Inform your doctor if this happens.

3. How to take MIRAPEXIN

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor again. Your doctor will determine the correct dosage for you.

Take MIRAPEXIN prolonged-release tablets once daily, at the same time each day.

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

During the first week, the usual daily dose is 0.26 mg of pramipexole. 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 1.05 mg daily. However, your dose may need to be increased further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.15 mg of pramipexole per day. It is also possible to reduce the maintenance dose to one prolonged-release MIRAPEXIN 0.26 mg tablet per day.

Patients with renal disease

If you have kidney disease, 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. After that, your doctor may increase the frequency to one 0.26 mg prolonged-release tablet daily. If further dose increases are needed, your doctor may adjust your dose in increments of 0.26 mg of pramipexole.

If you have severe kidney disease, your doctor may consider switching you to a different pramipexole-containing medicine. If during treatment your kidney problems worsen, contact your doctor as soon as possible.

If you are switching from MIRAPEXIN immediate-release tablets

Your doctor will base your dose of MIRAPEXIN prolonged-release tablets on the dose of MIRAPEXIN immediate-release tablets you were previously taking.

On the day before switching, take your MIRAPEXIN immediate-release tablets as usual. The following morning, take your MIRAPEXIN prolonged-release tablet and do not take any further MIRAPEXIN immediate-release tablets.

If you take more MIRAPEXIN than you should

If you accidentally take too many tablets:

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

If you forget to take MIRAPEXIN

If you forget to take your dose of MIRAPEXIN but remember within 12 hours of your usual time, take your tablet and continue with your next dose at the usual time.

If you forget to take your dose more than 12 hours have passed, simply take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking MIRAPEXIN

Do not stop your treatment with MIRAPEXIN without first consulting your doctor. If you need to discontinue treatment with this medicine, your doctor will gradually reduce your dose. This helps reduce the risk of worsening symptoms.

If you have Parkinson’s disease, you should not abruptly stop treatment with MIRAPEXIN. Sudden discontinuation may lead to a condition called neuroleptic malignant syndrome, which can pose a serious health risk. Symptoms include:

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

If you stop treatment or reduce the dose of MIRAPEXIN, you may also experience 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 can cause adverse effects, although not everyone will experience them. Adverse effects are classified according to the following frequencies:

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 way
• 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
• Visual disturbance
• Vomiting
• Weight loss including loss of appetite

Uncommon:

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

• Delusion

• Excessive daytime sleepiness and sudden sleep episodes

• 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 ankle swelling)*

• 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 concerning to you or others, for example, increased libido.
  • Compulsive buying or spending.
  • Binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).*

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

Rare:

• Mania (agitation, feeling elated or overexcited)
• Spontaneous penile erection

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 *, an accurate estimation of frequency is not possible, 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".

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 can also report them directly through the national reporting system included 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 stated on the carton after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that 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 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, or 3.15 mg of pramipexole as 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, or 4.5 mg of pramipexole dihydrochloride monohydrate, respectively.

The other components are: hypromellose 2208, corn starch, carbomer 941, colloidal anhydrous silica, magnesium stearate.

Nature of the product and pack contents

MIRAPEXIN 0.26 mg and 0.52 mg prolonged-release tablets are white or yellowish-white, round, and bevel-edged.

MIRAPEXIN 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, and 3.15 mg prolonged-release tablets are white or yellowish-white and oval-shaped.

All tablets have the Boehringer Ingelheim symbol in relief on one side, and codes P1, P2, P3, P12, P4, P13, or P5 on the other side indicating the tablet strength: 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, or 3.15 mg, respectively.

All MIRAPEXIN strengths are available in aluminum blister strips containing 10 tablets per strip, in cartons containing 1, 3, or 10 blister strips (10, 30, or 100 prolonged-release 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 package leaflet:

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