Package Insert: Information for the Patient

Pramipexol Sandoz Pharmaceutical 0.26 mg Extended-Release Tablets EFG

Pramipexol Sandoz Pharmaceutical 1.05 mg Extended-Release Tablets EFG

Pramipexol Sandoz Pharmaceutical 2.1 mg Extended-Release Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should 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 package insert. See section 4.

Pramipexol Sandoz Pharmaceutical contains the active ingredient pramipexol 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 that help control the body's movements.

Pramipexol 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).

Do not take Pramipexol Sandoz Farmacéutica

If you are allergic to pramipexol or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Pramipexol Sandoz Farmacéutica.Inform your doctor if you have or have had any disease or symptom, especially any of the following:

• Kidney disease.
• Hallucinations (seeing, hearing or feeling things that are not present). Most hallucinations are visual.
• Dystonia.
• Difficulty maintaining the trunk and neck straight and upright (axial dystonia). Specifically, you may experience forward flexion of the head and neck (also known as antecolis), forward curvature of the lower back (also known as camptocormia) or curvature of the back to the sides (also known as pleurotonos or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• Dyskinesia (e.g., abnormal involuntary movements of the limbs).

If you have advanced Parkinson's disease and are also using levodopa, you may experience dyskinesia during the progressive increase in the dose of Pramipexol Sandoz Farmacéutica.

• Drowsiness and sudden episodes of sleep.

• Psychosis (e.g., similar to the symptoms of schizophrenia).
• Alteration of vision.

You should undergo periodic eye examinations during treatment with Pramipexol Sandoz Farmacéutica.

• Severe heart or blood vessel disease.

You should undergo periodic blood pressure checks, especially at the beginning of treatment, in order to avoid postural hypotension (a drop in blood pressure when standing up).

Inform your doctor if you, your family or caregivers notice that you are developing impulses or urges to behave in an unusual way in yourself and that you cannot resist the impulse, instinct or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as excessive gaming, excessive eating or spending, abnormal high sexual appetite or excessive concern about an increase in sexual thoughts and feelings.Your doctor may need to adjust or stop your dose.

Inform your doctor if you, your family or caregivers notice that you are developing mania (agitation, feeling overexcited or overstimulated) or delirium (decreased consciousness, confusion, loss of contact with reality).Your doctor may need to adjust or stop your dose.

Inform your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating or pain when interrupting or reducing treatment with pramipexol. If the problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Pramipexol prolonged-release tablets are specially designed tablets from which the active ingredient is released gradually once the tablet is ingested. Occasionally, parts of the tablets may be excreted and appear in the stool, which may look like whole tablets. Inform your doctor if you find fragments of tablets in your stool.

Children and adolescents

Pramipexol Sandoz Farmacéutica is not recommended for use in children or adolescents under 18 years old.

Other medicines and Pramipexol Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.This includes medicines, herbal remedies, natural foods or nutritional supplements that you have obtained without a prescription.

You should avoid using pramipexol with antipsychotic medicines.

Be cautious if you are using the following medicines:

• cimetidine (for the treatment of excess acid and stomach ulcers),
• amantadine (which may be used in the treatment of Parkinson's disease),
• mexiletine (for the treatment of irregular heartbeats, a condition known as ventricular arrhythmia),
• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a human immunological disease),
• cisplatin (for treating various types of cancer),
• quinine (which may be used to prevent painful leg cramps that occur at night and to treat a type of malaria known as malignant malaria),
• procainamide (for treating irregular heartbeats).

If you are using levodopa, it is recommended to reduce the dose of levodopa when starting treatment with Pramipexol Sandoz Farmacéutica.

Be cautious if you are using tranquilizing medicines (with sedative effect) or if you drink alcohol. In these cases, pramipexol may affect your ability to drive and operate machinery.

Taking Pramipexol Sandoz Farmacéutica with food, drinks and alcohol

You should be cautious if you drink alcohol during treatment with pramipexol.

You can take pramipexol with or without food.

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.Your doctor will tell you if you should continue treatment with pramipexol.

The effect of pramipexol on the fetus is not known. Therefore, do not take pramipexol if you are pregnant unless your doctor tells you to.

Pramipexol should not be used during breastfeeding. Pramipexol may decrease milk production. In addition, pramipexol may pass into breast milk and reach your baby. If the use of pramipexol is necessary, breastfeeding should be interrupted.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Pramipexol may cause hallucinations (seeing, hearing or feeling things that are not present). If this happens, do not drive or operate machinery.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Your doctor will indicate the correct dosage.

Take Pramipexol Sandoz Farmacéutica prolonged-release tablets once a day and at the same hour every day.

You can take pramipexol with or without food. The tablets should be swallowed whole with water.

Do not chew, break, or crush the prolonged-release tablets. If you do, there is a risk of overdose, as the medication may be released in your body too quickly.

During the first week, the usual daily dose is 0.26 mg of pramipexol.

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