Introduction

Prospect: information for the patient

Pramipexol Sandoz Pharmaceutical 0.26 mg prolonged-release tablets EFG

Pramipexol Sandoz Pharmaceutical 1.05 mg prolonged-release tablets EFG

Pramipexol Sandoz Pharmaceutical 2.1 mg prolonged-release tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.This prospect contains important information for you.

Keep this prospect, as you may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed only for you, and you must 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 prospect. See section 4.

1. What is Pramipexol Sandoz Pharmaceutical and what is it used for

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).

2. What you need to know before starting to take Pramipexol Sandoz Pharmaceutical

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 lumbar region (also known as camptocormia), or lateral curvature of the back (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 Pramipexol Sandoz Farmacéutica dosage.

Drowsiness and sudden episodes of sleep.

Psychosis (e.g., similar to schizophrenia symptoms).
Visual disturbances.

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, 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 unusual impulses or urges to behave in a certain way that may harm you or others. This is known as impulse control disorder and may include behaviors such as excessive gaming, eating, or spending, abnormal high libido, or excessive concern about increased sexual thoughts and feelings.Your doctor may need to adjust or stop your dosage.

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

Inform your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing pramipexol treatment. 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 that release the active ingredient gradually after ingestion. Occasionally, parts of the tablets may be excreted and appear in the stool, which may resemble intact tablets. Inform your doctor if you find tablet fragments in your stool.

Children and adolescents

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

Other medications and Pramipexol Sandoz

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

Avoid using pramipexol with antipsychotic medications.

Be cautious if you are using the following medications:

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 levodopa dosage when starting treatment with Pramipexol Sandoz Farmacéutica.

Be cautious if you are using tranquilizers (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

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, consult your doctor or pharmacist before using this medication.Your doctor will tell you if you should continue treatment with pramipexol.

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

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

Consult your doctor or pharmacist before using any medication.

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.

3. How to take Pramipexol Sandoz Pharmaceutical

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 as indicated by your doctor, until your symptoms are controlled (maintenance dose).

Dosage escalation schedule for Pramipexol Sandoz Farmacéutica prolonged-release tablets
Week	Daily dose (mg)	Number of tablets
1	0.26	1 prolonged-release tablet of Pramipexol Sandoz Farmacéutica 0.26 mg
2	0.52	1 prolonged-release tablet of Pramipexol Sandoz Farmacéutica 0.56 mg 2 prolonged-release tablets of Pramipexol Sandoz Farmacéutica 0.26 mg
3	1.05	1 prolonged-release tablet of Pramipexol Sandoz Farmacéutica 1.05 mg 2 prolonged-release tablets of Pramipexol Sandoz Farmacéutica 0.52 mg 4 prolonged-release tablets of Pramipexol Sandoz Farmacéutica 0.26 mg

The usual maintenance dose is 1.05 mg per day. However, it may be necessary to increase your dose. If necessary, your doctor may increase your dose of tablets up to a maximum of 3.15 mg of pramipexol per day. It is also possible to reduce the maintenance dose to 1 prolonged-release tablet of Pramipexol Sandoz Farmacéutica 0.26 mg per day.

Patients with kidney 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 of doses to 1 prolonged-release tablet of 0.26 mg per day. If necessary, your doctor may adjust your dose in increments of 0.26 mg of pramipexol.

If you have severe kidney disease, your doctor may consider it necessary to switch you to a different pramipexol medication. If during treatment your kidney problems worsen, contact your doctor as soon as possible.

If you are changing from Pramipexol immediate-release tablets

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

The day before the change, take your Pramipexol immediate-release tablets as you normally would. The next morning, take your pramipexol prolonged-release tablet and do not take any more Pramipexol immediate-release tablets.

If you take more Pramipexol Sandoz Farmacéutica than you should

If you accidentally take too many tablets, consult your doctor or the nearest hospital emergency service immediately.

Consult your doctor or pharmacist immediately.
You may experience vomiting, restlessness, or any of the adverse effects described in section 4 (Possible adverse effects).

If you have taken more Pramipexol Sandoz Farmacéutica than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to take Pramipexol Sandoz Farmacéutica

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

If you forget to take your dose more than 12 hours after your usual time, simply take the next dose at your usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pramipexol Sandoz Farmacéutica

Do not stop your treatment with Pramipexol Sandoz Farmacéutica without consulting your doctor first. If you need to stop your treatment with this medication, your doctor will gradually reduce your dose. This reduces the risk of worsening your symptoms.

If you have Parkinson's disease, do not stop your treatment with pramipexol abruptly. Sudden discontinuation may cause the appearance of a condition called neuroleptic malignant syndrome, which can pose a significant risk to your health. These 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 Pramipexol Sandoz Farmacéutica, you may also experience a medical condition called dopamine agonist withdrawal syndrome.

The symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you should contact your doctor.

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

4. Possible Adverse Effects

Like all medications, this medication may cause side effects, although not everyone will experience them. The classification of 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 100 people
Rare	may affect up to 1 in 1,000 people
Very rare	may affect up to 1 in 10,000 people
Frequency not known	cannot be estimated from available data

You may experience the following side effects:

Very common:

Dyskinesia (e.g. abnormal involuntary movements of the limbs)
Drowsiness
Dizziness
Nausea

Common:

Need to behave in an unusual way
Hallucinations (seeing, hearing or feeling things that are not present)
Confusion
Fatigue (tiredness)
Insomnia
Excess fluid, usually in the legs (peripheral edema)
Headache
Hypotension (low blood pressure)
Abnormal dreams
Constipation
Restlessness
Amnesia (memory alteration)
Visual disturbances
Vomiting (urge to vomit)
Weight loss including loss of appetite

Uncommon:

Paranoia (e.g. excessive concern about health)
Delusion
Excessive daytime somnolence and sudden onset of sleep
Amnesia (memory alteration)
Hypokinesia (increase in movement and inability to remain still)
Weight gain
Allergic reactions (e.g. skin rash, itching, hypersensitivity)
Syncope (fainting)
Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
Inadequate secretion of antidiuretic hormone*
Restlessness
Dyspnea (difficulty breathing)
Hypophonia (soft voice)
Pneumonia (lung infection)
Inability to resist the impulse, instinct or temptation to perform an action that may be harmful to you or others, including:
- Strong impulse to gamble excessively despite serious personal or family consequences.*
- Altered or increased sexual interest and concerning behavior for you or others, for example, increased sexual appetite.*
- Uncontrollable excessive 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 (decreased consciousness, confusion, loss of contact with reality)

Rare:

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

Frequency not known:

After interrupting or reducing treatment with pramipexol: may cause depression, apathy, anxiety, fatigue, sweating or pain (known as dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviors; he will explain how to manage or reduce the symptoms.

The side effects marked with * cannot be precisely estimated in frequency, as these side effects were not observed in clinical trials involving 2,762 patients treated with pramipexol. The frequency category is likely not higher than "uncommon".

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Pramipexol Sandoz Pharmaceutical

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD/EXP”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Unused medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Pramipexol Sandoz Pharmaceutical 0.26 mg Composition

The active ingredient is pramipexol. Each tablet contains 0.26 mg of pramipexol as 0.375 mg of pramipexol dihydrochloride monohydrate.
The other components are: hypromellose, calcium phosphate dibasic, magnesium stearate, and anhydrous colloidal silica.

Pramipexol Sandoz Pharmaceutical 1.05 mg Composition

The active ingredient is pramipexol. Each tablet contains 1.05 mg of pramipexol as 1.5 mg of pramipexol dihydrochloride monohydrate.
The other components are: hypromellose, calcium phosphate dibasic, magnesium stearate, and anhydrous colloidal silica.

Pramipexol Sandoz Pharmaceutical 2.1 mg Composition

The active ingredient is pramipexol. Each tablet contains 2.1 mg of pramipexol as 3 mg of pramipexol dihydrochloride monohydrate.
The other components are: hypromellose, calcium phosphate dibasic, magnesium stearate, and anhydrous colloidal silica.

Product Appearance and Packaging Contents

Pramipexol Sandoz Pharmaceutical 0.26 mg are prolonged-release tablets, white or almost white, cylindrical, flat, and beveled, marked with 026 on one face. Each package contains 30 tablets.

Pramipexol Sandoz Pharmaceutical 1.05 mg are prolonged-release tablets, white or almost white, cylindrical, and biconvex, marked with 105 on one face. Each package contains 30 tablets.

Pramipexol Sandoz Pharmaceutical 2.1 mg are prolonged-release tablets, white or almost white, cylindrical, and biconvex, marked with 210 on one face. Each package contains 30 tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, S.A.

Corporate Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos

Madrid (SPAIN)

Ferrer Internacional, S.A.

Joan Buscallà, 1-9, 08173 Sant Cugat del Vallés

Barcelona (SPAIN)

Last Review Date of this Leaflet: January 2025

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/