Leaflet: information for the user

Pramipexol pensa 0.18 mg tablets EFG

Read the entire leaflet carefully before starting to take the medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you and must not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects,consult your doctor, or pharmacist,evenifthey are not listed in this leaflet.

1. What is Pramipexol Pensa and what it is used for

2. What you need to know before starting to take Pramipexol Pensa

3. How to take Pramipexol Pensa

4. Possible side effects

5. Storage of Pramipexol Pensa

6. Contents of the pack and additional informationadditional

Pramipexol Pensacontains the active ingredient pramipexol andbelongs to a group of medications called dopamine agonists, which stimulate dopamine receptors in the brain.The stimulation of dopamine receptors triggers nerve impulses in the brain that help control the body's movements.

Pramipexol Pensa is used for:

-treat the symptoms of idiopathic Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medication for Parkinson's disease).

-treat the symptoms of moderate to severe idiopathic Restless Legs Syndrome in adults

Do not take Pramipexol Pensa

– if you are allergic to pramipexol or any of the othercomponents of this medicine(listed in section 6).

Warnings and precautions

Consult your doctor before taking 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 pleurototonus or Pisa syndrome). In this case, your doctor may choose to modify your treatment.

– Somnolence and sudden onset of sleep.
– Psychosis (e.g., similar to schizophrenia symptoms).

– Vision changes. You should undergo periodic eye examinations during treatment with Pramipexol Pensa.

– 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).

– Increased symptoms of restless legs syndrome. If you experience symptoms starting earlier than usual in the evening (or even in the afternoon), are more intense, or affect larger areas of the affected limbs or other limbs, your doctor may reduce your dose or discontinue treatment.

Inform your doctor if you or your family/caregiver notice that you are developing impulses or unusual urges that you cannot resist or control, which may harm you or others. These impulse control disorders may include behaviors such as compulsive gambling, compulsive eating or buying, abnormal sexual desire, or increased sexual thoughts.Your doctor may consider adjusting or discontinuing 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 discontinue your dose.

Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with Pramipexol Pensa. If these 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 that 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 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 (to treat 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

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

Pregnancy and breastfeeding

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

Pramipexol Pensa has not been shown to have an effect on 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. It may also pass into breast milk and reach your baby. If the use of Pramipexol Pensa is necessary, 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 somnolence and sudden onset 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.

You can takePramipexol Pensawith or without food.The tablets should be swallowed with water.

Other doses of products with pramipexol are available for doses that cannot be met with this medication.

Parkinson's Disease

The daily dose should be taken divided into 3 equal doses.

During the first week, the recommended dose is 1 tablet ofpramipexol0.088 mgthree times a day(equivalent to 0.264 mg per day):

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 1.1 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 3.3 mg of pramipexol per day.It is also possible to reduce the maintenance dose to three tablets ofpramipexol0.088 mg per day.

Patients with kidney disease

If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you should take the tablets only once or twice a day.

If you have moderate renal insufficiency, the usual starting dose is 1 tablet ofpramipexol0.088 mg twice a day.

If you have severe renal insufficiency, the usual starting dose is 1 tablet ofpramipexol0.088 mg per day.

Restless Legs Syndrome

The dose is usually taken once a day, at night, 2-3 hours before bedtime.

During the first week, the usual dose is 1 tablet of pramipexol 0.088 mg once a day (equivalent to 0.088 mg per day):

This dose will be increased every 4-7 days as indicated by your doctor, until your symptoms are controlled (maintenance dose).

The daily dose for the treatment of restless legs syndrome should not exceed 6 tablets of pramipexol 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexol base).

If you stop taking your tablets for a few days and want to start again, you should start with the smallest dose and then gradually increase the dose as you did the first time. Consult your doctor if you have any doubts.

Your doctor will evaluate your treatment after 3 months to decide whether to continue or not with the treatment.

Patients with kidney disease:

If you have severe kidney disease, it is possible thatpramipexolmay not be an appropriate treatment for your restless legs syndrome.

If you take more Pramipexol Pensa than you should

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.

-you may experience vomiting, restlessness, or any of the adverse effects described in section 4.

If you forgot to take Pramipexol Pensa

Don't worry. Omit that dose completely and take the next dose at the correct time. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Pramipexol Pensa

Do not stop your treatment withpramipexolwithout 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 symptoms.

If you have Parkinson's disease, do not stop your treatment withpramipexolabruptly.A sudden interruption may cause the appearance of a condition called neuroleptic malignant syndrome, which can represent a very serious 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 interrupt the treatment or reduce the dose of pramipexol, 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,Pramipexol Pensamay cause side effects, although not everyone will experience them. The classification of side effects is based on the following frequencies:

If you haveParkinson's disease, you may experience the following side effects:

Very common:

-Dyskinesia (e.g. abnormal involuntary movements of the limbs)

-Somnolence

-Dizziness

-Nausea

Common:

-Abnormal behavior

-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

-Vision disturbance

-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 sleep episodes

-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)*

-Inappropriate secretion of antidiuretic hormone*

-Restlessness

-Dyspnea (difficulty breathing)

-Hiccup

-Pneumonia (lung infection)*

-Inability to resist the impulse, instinct or temptation to perform an action that may be harmful to you or others, including:

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 (known as dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviors; he will decide 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 in 2,762 patients treated with pramipexol. The frequency category is likely not higher than “uncommon”.

If you have Restless Legs Syndrome, you may experience the following side effects:

Very common:

• Nausea
• Symptoms that start earlier than usual, are more intense or affect other limbs (increase in restless legs syndrome).

Common:

• Changes in sleep pattern, such as insomnia and somnolence
• Fatigue (tiredness)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (urge to vomit)

Uncommon:

• Abnormal behavior*
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inappropriate secretion of antidiuretic hormone*
• Dyskinesia (e.g. abnormal involuntary movements of the limbs)
• Hypokinesia (increase in movement and inability to remain still)*
• Paranoia (e.g. excessive concern about your health)*
• Delusion*
• Amnesia (memory alteration)*

• Hallucinations (seeing, hearing or feeling things that are not present)
• Confusion
• Excessive daytime somnolence and sudden sleep episodes
• Weight gain
• Hypotension (low blood pressure)
• Excess fluid, usually in the legs (peripheral edema)
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Syncope (fainting)
• Restlessness
• Vision disturbance
• Weight loss including loss of appetite
• Dyspnea (difficulty breathing)
• Hiccup
• Pneumonia (lung infection)*
• Inability to resist the impulse, instinct or temptation to perform an action that may be harmful to you or others, including:
• • Fuerte impulso de jugar excesivamente a pesar de las serias consecuencias personales o familiares.*
  • Interés sexual alterado o aumentado y comportamiento preocupante para usted o para otros, por ejemplo, aumento del apetito sexual.*
  • Compra o gasto excesivo incontrolable.*
  • Atracón (ingesta de grandes cantidades de comida en un corto periodo de tiempo) o ingesta compulsiva (ingesta de más comida de lo normal y más de la necesaria para satisfacer el hambre).*
• Manía (agitación, sentirse exaltado o sobreexcitado)*
• Delirio (disminución de la consciencia, confusión, pérdida de contacto con la realidad)*

Unknown frequency:

-After stopping or reducing treatment with Pramipexol Pensa: may occur 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 decide 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 in 1,395 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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.
Do not takethis medicationafter the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.
This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Pramipexol pensa Composition

The active ingredient is pramipexol.

Each tablet contains 0.18 mg of pramipexol base.

The other components are: mannitol, cornstarch, hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate.

Product Appearance and Packaging Contents

Pramipexol pensa 0.18 mg tablets:white, biconvex, oblong, scored on both sides (dimensions: approximately 8mm × 4mm).

The tablet can be divided into two equal halves.

It is presented in OPA/aluminum/PVC/aluminum blister strips of 10 tablets per strip, in boxes containing 3 or 10 blister strips.

Packaging of30 tablets, 100 tablets.

Only some packaging sizes may be commercially marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 MartorellesBarcelona

Spain

Responsible Manufacturer

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

This medicinal product is authorized in the Member States of the EEA with the following names:

IT: Pramipexolo Pensa 0.18 mg compresse.

ES: Pramipexol Pensa 0.18 mg comprimidos EFG

Last review date of this leaflet:December 2024

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