Leaflet: information for the user

Pramipexol pensa 1.05 mg prolonged-release tablets EFG

Read this leaflet carefully before you start taking this medicine, because 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, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Pramipexol Pensa 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 Pensa 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 Pensa

• if you are allergic to pramipexol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Pramipexol Pensa. Inform your doctor if you have or have had any disease 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 using levodopa, you may experience dyskinesia during the progressive increase in the dose of Pramipexol Pensa.

• Dystonia (inability to maintain 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 pleurototonos or Pisa syndrome). In this case, your doctor may choose to modify your treatment.

• Drowsiness and sudden episodes of sleep.
• Psychosis (e.g., similar to the symptoms of schizophrenia).
• Visual disturbances. You should undergo regular eye examinations during treatment with Pramipexol Pensa.
• Severe heart or blood vessel disease. You should undergo regular 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 impulses or urges to behave in an unusual way 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, 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 (diminished 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 stopping or reducing treatment with Pramipexol Pensa. If the problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Children and adolescents

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

Use of Pramipexol Pensa with other medicines

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

Avoid using Pramipexol Pensa 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 immunodeficiency 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 Pensa.

Be cautious if you are using sedative tranquilizers or if you drink alcohol. In these cases, Pramipexol Pensa may affect your ability to drive and operate machinery.

Taking Pramipexol Pensa with food, drinks and alcohol

Be cautious if you drink alcohol during treatment with Pramipexol Pensa.
You can take Pramipexol Pensa with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medicine.

Your doctor will tell you if you should continue treatment with Pramipexol Pensa.
It is not known how Pramipexol Pensa affects the fetus. Therefore, do not take Pramipexol Pensa if you are pregnant unless your doctor tells you to.

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Pramipexol Pensa 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. In case of doubt, consult your doctor again. Your doctor will indicate the correct dosage.

TakePramipexolPensaextended-release tablets once a day and at the same hour every day.

You can takePramipexolPensawith or without food. The tablets must be swallowed whole with water.

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).

The usual maintenance dose is 1.05 mg per day. However, it may be necessary to increase your dose further. 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 extended-release tablet ofPramipexol Pensa0.26 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 extended-release tablets every other day during the first week. After that, your doctor may increase the frequency of doses to 1 extended-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 switching fromPramipexol Pensatablets (immediate-release)

Your doctor will base your dose ofPramipexol Pensaextended-release tablets on the dose ofPramipexol Pensaimmediate-release tablets you were taking.

The day before the switch, take yourPramipexol Pensaimmediate-release tablets as you normally would. The next morning, take yourPramipexol Pensaextended-release tablet and do not take any morePramipexol Pensaimmediate-release tablets.

If you take more Pramipexol Pensa than you should

If you accidentally take too many tablets, you may experience vomiting, restlessness, or any of the adverse effects described in section 4 (Possible adverse effects).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pramipexol Pensa

If you forget to take your dose ofPramipexol Pensa, 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 and 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 interrupt treatment with Pramipexol

Do not stop your treatment withPramipexol Pensawithout 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, you should 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 Pensa, 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.

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

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
• Illusions (seeing, hearing or feeling things that are not present)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Excess fluid, usually in the legs (peripheral edema)
• Headache
• Low blood pressure
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (urge to vomit)
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g. excessive concern about your health)
• Delirium
• Excessive daytime somnolence and sudden episodes of sleep
• Amnesia (memory alteration)
• Hypokinesia (increase in movements and inability to remain still)
• Weight gain
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Syncopal episode
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of the antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hypophonia
• Pneumonia (lung infection)
• Inability to resist the impulse, instinct or temptation to perform an action that may be harmful to you or others, which may include:

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

• Delirium (diminished consciousness, confusion, loss of contact with reality)

Rare:

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

Unknown frequency:

After stopping or reducing treatment with Pramipexol Pensa: may occur depression, apathy, anxiety, fatigue, sweating or pain (which is 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.

For the side effects marked with * it is not possible to provide a precise estimate of the frequency, as these side effects were not observed in clinical trials between 2,762 patients treated with pramipexol. The frequency category is likely not higher than "uncommon".

Reporting of side effects:

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

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

This medication does not requireany special temperatureof conservation.

Medications should not be thrown down the drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pramipexol Pensaprolonged-release tablets

• The active ingredient is pramipexol.

Each tablet contains 1.05 mg of pramipexol as 1.5 mg of dihydrochloride monohydrate of pramipexol.

• The other components are hypromellose, calcium phosphate dibasic, magnesium stearate, and anhydrous colloidal silica.

Appearance ofPramipexol Pensa prolonged-release tabletsand content of the packaging

Pramipexol Pensa 1.05 mg prolonged-release tablets:The 10 mm tablets are white or almost white, cylindrical, biconvex, and marked with 105 on one side..

Aluminum/OPA-Al-PVC blister: 10 and 30 prolonged-release tablets..

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Ferrer Internacional, S.A.

Joan Buscallà 1-9, 08173 Sant Cugat del Vallés (Barcelona)

or

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6, Tres Cantos, 28760 Madrid

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Pramipexol Pensa 1.05 mg Prolonged-release tablets EFG

Italy: Pramipexolo Pensa Pharma 1.05 mg prolonged-release tablets

Last review date of this leaflet: October2024

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