Pramipexole Sandoz Farmaceutica 1.05 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pramipexole Sandoz Farmacéutica 0.26 mg prolonged-release tablets EFG

Pramipexole Sandoz Farmacéutica 1.05 mg prolonged-release tablets EFG

Pramipexole Sandoz Farmacéutica 2.1 mg prolonged-release tablets EFG

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, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Pramipexole Sandoz Farmacéutica is and what it is used for
2. What you need to know before taking Pramipexole Sandoz Farmacéutica
3. How to take Pramipexole Sandoz Farmacéutica
4. Possible side effects
5. How to store Pramipexole Sandoz Farmacéutica
6. Contents of the pack and other information

1. What Pramipexole Sandoz Farmacéutica is and what it is used for

Pramipexole Sandoz Farmacéutica 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.

Pramipexole 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 taking Pramipexole Sandoz Farmacéutica

Do not take Pramipexole Sandoz Farmacéutica

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 Pramipexole Sandoz Farmacéutica. 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.
• 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). In such cases, your doctor may consider adjusting your treatment.
• Dyskinesia (e.g., abnormal involuntary movements of the limbs).

If you have advanced Parkinson's disease and are also taking levodopa, you may experience dyskinesia during the gradual increase of the dose of Pramipexole Sandoz Farmacéutica.

• Somnolence and sudden episodes of falling asleep.

• Psychosis (e.g., symptoms similar to schizophrenia).

• Vision disturbances.

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

• Severe heart or blood vessel disease.

You should have regular blood pressure checks, especially at the beginning of treatment, to prevent postural 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, drive, 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, abnormally increased sex drive, or preoccupation with increased sexual thoughts and feelings. Your doctor may need to adjust or stop your dose.

Inform your doctor if you, your family, or caregivers notice the development of mania (agitation, feeling elated or overexcited) or delirium (reduced awareness, confusion, loss of contact with reality). Your doctor may need to adjust or interrupt your dose.

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

Pramipexole prolonged-release tablets are specially designed tablets that gradually release the active ingredient 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 find tablet fragments in your stools.

Children and adolescents

Pramipexole Sandoz Farmacéutica is not recommended for use in children or adolescents under 18 years of age.

Other medicines and Pramipexole Sandoz

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 health products, or nutritional supplements obtained without a prescription.

You should avoid using pramipexole 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 nighttime leg cramps and to treat a type of malaria known as falciparum malaria (malignant malaria)),
• procainamide (used to treat irregular heartbeat).

If you are taking levodopa, a reduction in the levodopa dose is recommended when starting treatment with Pramipexole Sandoz Farmacéutica.

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

Taking Pramipexole Sandoz Farmacéutica with food, drinks, and alcohol

You should exercise caution if you drink alcohol during treatment with pramipexole.

You may take pramipexole with or without food.

Pregnancy, breastfeeding, and fertility

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

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

Pramipexole should not be used during breastfeeding. Pramipexole may reduce the production of breast milk and may pass into breast milk, reaching your baby. If pramipexole treatment is essential, breastfeeding must be discontinued.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Pramipexole 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 must not drive or operate machinery. Inform your doctor if this happens.

3. How to take Pramipexole Sandoz Farmacéutica

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

Take Pramipexole Sandoz Farmacéutica prolonged-release tablets once daily, at the same time each day.

Pramipexole may be taken with or without food. The tablets must be swallowed whole with water.

Do not chew, divide, or crush the prolonged-release tablets. Doing so may result in overdose, as the medicine could be released into your body too quickly.

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 may also be possible to reduce the maintenance dose to one prolonged-release tablet of Pramipexole Sandoz Farmacéutica 0.26 mg daily.

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 on alternate days during the first week.

Afterwards, 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 it necessary to switch 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 immediate-release pramipexole tablets

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

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

If you take more Pramipexole Sandoz Farmacéutica than you should

If you accidentally take too many tablets:

• contact 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 have taken more Pramipexole Sandoz Farmacéutica than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and amount taken.

If you forget to take Pramipexole Sandoz Farmacéutica

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

If you remember more than 12 hours after your usual time, 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 Pramipexole Sandoz Farmacéutica

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

If you have Parkinson's disease, do not stop treatment with pramipexole abruptly. Sudden discontinuation may cause a condition called neuroleptic malignant syndrome, which may pose a serious health risk. 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 Pramipexole Sandoz Farmacéutica, you may also experience a medical condition called 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 everybody will experience them. The classification of adverse effects is based on 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:

• Need 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
• Restlessness
• Amnesia (memory impairment)
• Vision disturbance
• Vomiting (feeling sick)
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g. excessive concern about your health)
• Delusion
• Excessive daytime sleepiness and sudden sleep attacks
• 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 swollen ankles)*
• Inappropriate antidiuretic hormone secretion*
• 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, e.g. 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 needed to satisfy hunger).*
• Delirium (reduced consciousness, confusion, loss of contact with reality)

Rare:

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

Frequency not known:

• After stopping or reducing treatment with pramipexole: 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; he or she 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 reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Pramipexole Sandoz Farmacéutica

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

Do not use this medicine after the expiry date stated on the packaging after “CAD/EXP”. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pramipexole Sandoz Farmacéutica 0.26 mg

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

Composition of Pramipexole Sandoz Farmacéutica 1.05 mg

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

Composition of Pramipexole Sandoz Farmacéutica 2.1 mg

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

Appearance of the product and contents of the pack

Pramipexole Sandoz Farmacéutica 0.26 mg are prolonged-release tablets, white or almost white, cylindrical, flat and bevelled, marked with "026" on one side. Each pack contains 30 tablets.

Pramipexole Sandoz Farmacéutica 1.05 mg are prolonged-release tablets, white or almost white, cylindrical and biconvex, marked with "105" on one side. Each pack contains 30 tablets.

Pramipexole Sandoz Farmacéutica 2.1 mg are prolonged-release tablets, white or almost white, cylindrical and biconvex, marked with "210" on one side. Each pack contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos

Madrid (SPAIN)

Date of the most recent review of this leaflet: January 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/