Pramipexole Pensa 2.1 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pramipexole Pensa 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, 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

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 Pramipexole Pensa is and what it is used for

Pramipexole 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.

Pramipexole 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).

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 starting to take Pramipexole Pensa. 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.
• Dyskinesia (e.g., abnormal involuntary movements of the limbs).

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

• Dystonia (inability to keep the trunk and neck straight and upright (axial dystonia)). In particular, you might 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 modifying your treatment.

• Somnolence and sudden sleep episodes.

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

• Visual disturbances. 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 prevent postural hypotension (a drop in blood pressure upon standing).

Inform your doctor if you, your family, or caregivers notice that you are developing urges or cravings to behave in ways unusual for you and that you cannot resist the urge, impulse, 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 high 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 symptoms 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 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.

Use of 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.

Be cautious if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and 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 leg cramps 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, it is recommended to reduce the dose of levodopa when starting treatment with Pramipexole Pensa.

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

Taking Pramipexole Pensa with food, drinks, and alcohol

Be cautious if you drink alcohol during treatment with Pramipexole Pensa. You may take Pramipexole Pensa 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 before using 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 instructs you to do so.

Pramipexole Pensa must not be used during breastfeeding. Pramipexole Pensa may reduce the production of breast milk. It may also 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 operate machinery.

Pramipexole Pensa has been associated with somnolence and sudden sleep episodes, 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 provided by your doctor. If in doubt, consult your doctor again. Your doctor will determine the correct dosage for you.

Take Pramipexol Pensa prolonged-release tablets once daily, at the same time each day.

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

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 per day. 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 Pensa 0.26 mg per day.

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 every other day during the first week. Afterwards, your doctor may increase the frequency to one prolonged-release tablet of 0.26 mg 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 switching 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 Pramipexole Pensa tablets (immediate-release)

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

On the day before the switch, take your Pramipexole Pensa immediate-release 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 Pensa than you should

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

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

If you forget to take Pramipexole Pensa

If you forget to take your dose of Pramipexole Pensa but remember within 12 hours of your usual time, take your tablet and continue with the next dose 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 make up for the missed dose.

If you stop taking Pramipexole

Do not stop your treatment with Pramipexole Pensa 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 Pensa, 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 may cause adverse effects, although not everyone experiences 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:

• Urge to behave in an unusual way
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (feeling the need to vomit)
• Weight loss, including loss of appetite

Uncommon:

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

• Delirium

• Excessive daytime sleepiness and sudden episodes of falling asleep

• Amnesia (memory impairment)

• Hyperkinesia (increased movements and inability to remain still)

• Weight gain

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

• Fainting

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

• Inappropriate secretion of antidiuretic hormone*

• Restlessness

• 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, which may include:

• Strong urge to gamble excessively despite serious personal or family consequences.

• Altered or increased sexual interest and behavior that is concerning to you or others, for example, increased sexual appetite.

• Uncontrollable excessive spending or shopping.

• Binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than necessary 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 discontinuing 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 *, 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 effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 effects, 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/or blister after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

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

6. Contents of the pack and other information

Composition of Pramipexol Pensa prolonged-release tablets

• The active substance is pramipexole.

Each tablet contains 2.1 mg of pramipexole as 3 mg of pramipexole dihydrochloride monohydrate.

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

Appearance of Pramipexol Pensa prolonged-release tablets and contents of the pack

Pramipexol Pensa 2.1 mg prolonged-release tablets: 10 mm white or almost white, cylindrical, biconvex tablets marked with "210" on one side.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6, Tres Cantos, 28760 Madrid

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Pramipexol Pensa 2.1 mg Prolonged-release tablets EFG

Italy: Pramipexolo Pensa Pharma 2.1 mg compresse a rilascio prolungato

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

Detailed and up-to-date 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/