Pramipexole Pensa 0.18 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pramipexole Pensa 0.18 mg Tablets EFG

Read the entire 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet.

Leaflet Contents

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

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

Pramipexol Pensa contains the active substance pramipexole and belongs to a group of medicines called dopaminergic agonists, which stimulate dopamine receptors in the brain. Stimulation of dopaminergic receptors triggers nerve impulses in the brain that help control body movements.

Pramipexol Pensa is used to:

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

• treat moderate to severe idiopathic Restless Legs Syndrome in adults

2. What you need to know before taking Pramipexole Pensa

Do not take Pramipexole Pensa

• 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 taking Pramipexole Pensa. Inform your doctor if you have or have had any illness 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 taking levodopa, you may experience dyskinesia during the gradual dose increase of Pramipexole Pensa.
• 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 bending of the lumbar spine (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome). In such cases, your doctor may consider modifying your treatment.
• Somnolence and sudden episodes of sleep.
• Psychosis (e.g., symptoms similar to schizophrenia).
• Vision disorders. You should undergo periodic eye examinations during treatment with Pramipexole Pensa.
• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the beginning of treatment, to avoid postural hypotension (a drop in blood pressure upon standing).
• Worsening symptoms of restless legs syndrome. If you notice that symptoms begin earlier in the evening (or even in the afternoon), are more intense, affect larger areas of the affected limbs, or affect 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 urges to behave in an unusual way and are unable to resist the impulse or temptation to carry out certain activities that could harm you or others. These impulse control disorders may include behaviors such as pathological gambling, compulsive eating or shopping, abnormally increased libido, 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 elated or overexcited) or delirium (reduced awareness, confusion, loss of touch 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 Pramipexole Pensa. If these problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Children and adolescents
Pramipexole Pensa is not recommended for use in children or adolescents under 18 years of age.

Taking Pramipexole Pensa with other medicines

Tell 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 foods, or nutritional supplements obtained without a prescription.

You should avoid using Pramipexole Pensa 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 human immune system disease)
• cisplatin (used to treat various types of cancer)
• quinine (which may be used to prevent painful leg cramps occurring at night 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 Pensa.

Be cautious if you are taking sedative medicines (with sedative effects) or drinking alcohol. In these cases, Pramipexole Pensa may affect your ability to drive or operate machinery.

Taking Pramipexole Pensa with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

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

Pramipexole Pensa should not be used during breastfeeding. Pramipexole Pensa may reduce the production of breast milk. In addition, it may pass into breast milk and reach your baby. If the use of Pramipexole Pensa is essential, breastfeeding must be discontinued.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Pramipexole Pensa has been associated with somnolence and sudden episodes of sleep, 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 Pramipexol Pensa

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

You may take Pramipexol Pensa with or without food. The tablets should be swallowed with water.

Other strengths of pramipexole-containing products are available for doses that cannot be achieved with this medicine.

Parkinson's Disease

The daily dose should be taken in 3 equal doses.

During the first week, the recommended dose is 1 tablet of pramipexole 0.088 mg three times daily (equivalent to 0.264 mg daily):

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 1.1 mg daily. However, your dose may need to be increased further. If necessary, your doctor could increase your tablet dose up to a maximum of 3.3 mg of pramipexole per day. It is also possible to reduce the maintenance dose to three pramipexole 0.088 mg tablets daily.

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 impairment, the usual starting dose is 1 tablet of pramipexole 0.088 mg twice daily.

If you have severe renal impairment, the usual starting dose is 1 tablet of pramipexole 0.088 mg once daily.

Restless Legs Syndrome

The dose is usually administered once daily, at night, 2–3 hours before bedtime.

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

This dose will be increased every 4-7 days according to your doctor's instructions, until your symptoms are controlled (maintenance dose).

The daily dose for the treatment of restless legs syndrome must not exceed 6 tablets of pramipexole 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).

If you stop taking your tablets for a few days and wish to restart treatment, you must begin again 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 discontinue therapy.

Patients with kidney disease:

If you have severe kidney disease, pramipexole may 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and amount ingested.

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

If you forget to take Pramipexol Pensa

Do not worry. Completely skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

If you stop taking Pramipexol Pensa

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

If you have Parkinson's disease, you must not stop your treatment with pramipexole abruptly. Sudden discontinuation may lead to a condition called neuroleptic malignant syndrome, which can 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, you may also experience a medical condition known as 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, Pramipexole Pensa may cause adverse effects, although not everyone experiences them. The classification of adverse effects is based on the following frequencies:

If you have Parkinson's disease, you may experience the following adverse effects:

Very common:

• Dyskinesia (e.g., abnormal involuntary movements of 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

• Vision disorders

• Vomiting (feeling sick)

• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g., excessive concern about your health)

• Delirium

• 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 swelling of the ankles)*

• Inappropriate antidiuretic hormone secretion*

• Restlessness

• Dyspnea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)

• Inability to resist the impulse, urge, or temptation to carry out an activity that could be harmful, such as:

• 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 shopping or spending

• Compulsive eating (eating large amounts of food in a short period of time) or bulimia (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 Pramipexol Pensa: 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 decide on ways to manage or reduce the symptoms.

For adverse effects marked with *, a precise estimation of frequency cannot be provided, 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".

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

Very common:

• Nausea
• Symptoms starting earlier than usual, becoming more intense, or affecting other limbs (worsening of restless legs syndrome).

Common:

• Changes in sleep patterns, such as insomnia and somnolence
• Tiredness (fatigue)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (feeling sick)

Uncommon:

• Need to behave in an unusual way*

• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*

• Inappropriate antidiuretic hormone secretion*

• Dyskinesia (e.g., abnormal involuntary movements of limbs)

• Hyperkinesia (increased movements and inability to stay still)*

• Paranoia (e.g., excessive concern about your health)*

• Delusion*

• Amnesia (memory impairment)*

• Hallucinations (seeing, hearing, or feeling things that are not present)

• Confusion

• Excessive daytime sleepiness and sudden sleep attacks

• Weight gain

• Hypotension (low blood pressure)

• Fluid retention, usually in the legs (peripheral edema)

• Allergic reactions (e.g., skin rash, itching, hypersensitivity)

• Fainting

• Restlessness

• Vision disorders

• Weight loss including loss of appetite

• Dyspnea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)*

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

  • 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 shopping or spending.*
  • Binge eating (consuming 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).*

• Mania (agitation, feeling elated or overexcited)*

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

Frequency not known:

• After stopping or reducing treatment with Pramipexol Pensa: 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 *, a precise estimation of frequency cannot be provided, as these adverse effects were not observed in clinical trials involving 1,395 patients treated with pramipexole. The frequency category is likely no higher than "uncommon".

Reporting of adverse reactions

If you experience any 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 Pensa

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of Pramipexol pensa

The active substance is pramipexole.

Each tablet contains 0.18 mg of pramipexole base.

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

Appearance of the product and contents of the pack

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

The tablet can be divided into two equal halves.

Packaged in OPA/aluminum/PVC/aluminum blister strips containing 10 tablets per strip, in boxes containing 3 or 10 blister strips.

Pack sizes of 30 tablets, 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles-Barcelona

Spain

Manufacturer

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

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

IT: Pramipexolo Pensa 0,18 mg compresse.

ES: Pramipexol Pensa 0,18 mg comprimidos EFG

Date of the most recent review of this leaflet: December 2024

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