PRAMIPEXOL PENSA 0.18 mg TABLETS

2. What you need to know before you take Pramipexole Pensa

Do not take Pramipexole Pensa

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

Warnings and precautions

Tell your doctor before taking Pramipexole Pensa. Inform your doctor if you have or have had any disease or symptom, especially any of the following: - Kidney disease. - Hallucinations (seeing, hearing or feeling things that are not present). Most hallucinations are visual.

Inform your doctor if you or your family/caregiver notice that you are developing impulses or anxiety to behave in an unusual way and cannot resist the impulse or temptation to carry out certain activities that could harm you or others. Such impulse control disorders can include behaviors such as gambling, compulsive eating or shopping, abnormally increased sexual desire, or increased sexual thoughts. Your doctor may consider adjusting or stopping the dose.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling elated or overexcited) or delirium (decreased consciousness, confusion, loss of contact with reality). It may be necessary for your doctor 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 Pramipexole Pensa. If problems persist for more than a few weeks, it may be necessary for your doctor to adjust your treatment.

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

Using Pramipexole Pensa with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines. This includes medicines, herbal remedies, natural products, or nutritional supplements that you have obtained without a prescription.

You should avoid using Pramipexole 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 immune deficiency syndrome (AIDS), a disease of the human immune system);

- cisplatin (for the treatment of various types of cancer);

- quinine (which may be used for the prevention of painful leg cramps that occur at night and for the treatment of a type of malaria known as falciparum malaria (malignant malaria));

- procainamide (for the treatment of irregular heartbeat)

If you are using levodopa, it is recommended to decrease the dose of levodopa when starting treatment with Pramipexole Pensa.

Be cautious if you are using sedative medicines (with a sedative effect) or if you drink alcohol. In these cases, Pramipexole Pensa may affect your ability to drive and operate machinery.

Taking Pramipexole Pensa with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide whether you should continue treatment with Pramipexole Pensa.

The effect of Pramipexole Pensa on the fetus is not known. Therefore, do not take Pramipexole Pensa if you are pregnant unless your doctor tells you to.

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Pramipexole Pensa may cause hallucinations (seeing, hearing, or feeling things that are not present). If this happens, 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 side effects, do not drive or operate machinery. Tell your doctor if this happens to you.

3. How to take Pramipexole Pensa

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor again. Your doctor will tell you the correct dose.

You can take Pramipexole Pensa with or without food. The tablets should be swallowed with water.

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

Parkinson's disease

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

During the first week, the recommended dose is 1 tablet of pramipexole 0.088 mg three times a day (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 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 pramipexole per day. It is also possible to reduce the maintenance dose to three tablets of pramipexole 0.088 mg per day.

Patient 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 kidney impairment, the usual starting dose is 1 tablet of pramipexole 0.088 mg twice a day.

If you have severe kidney impairment, the usual starting dose is 1 tablet of pramipexole 0.088 mg once a day.

Restless Legs Syndrome

The dose is usually given once a day, in the evening, 2-3 hours before bedtime.

During the first week, the usual dose is 1 tablet of pramipexole 0.088 mg once a day (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 should not exceed 6 tablets of pramipexole 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexole salt).

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

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

Patient with kidney disease:

If you have severe kidney disease, pramipexole may not be a suitable treatment for your Restless Legs Syndrome.

If you take more Pramipexole Pensa than you should

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

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

If you forget to take Pramipexole Pensa

Do not worry. Omit that dose completely and take the next dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you stop taking Pramipexole Pensa

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

If you have Parkinson's disease, you should not stop your treatment with pramipexole abruptly. Sudden interruption can cause the appearance of a disorder called neuroleptic malignant syndrome, which can be 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 stop or reduce the dose of pramipexole, you may also suffer from a medical disorder 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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Pramipexol Pensa can cause adverse effects, although not all people will experience 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 the limbs)

• Somnolence

-Dizziness

-Nausea

Common:

-Need to behave in an unusual way

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

-Confusion

-Fatigue

• Insomnia

-Excess fluid, usually in the legs (peripheral edema)

-Headache

-Hypotension (low blood pressure)

-Abnormal dreams

-Constipation

• Visual disturbance

-Vomiting (nausea)

-Weight loss, including loss of appetite

Uncommon:

-Paranoia (e.g., excessive concern about one's health)-Delirium-Excessive daytime somnolence and sudden sleep episodes

-Amnesia (memory impairment)-Hyperkinesia (increased movement and inability to remain still)-Weight gain-Allergic reactions (e.g., skin rash, itching, hypersensitivity)

-Fainting

-Heart failure (heart problems that can 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 oneself or others, including:

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

• Altered or increased sexual interest and disturbing behavior for oneself or others, for example, increased sexual appetite.
• Uncontrolled excessive shopping or spending
• Binge eating (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)
• Delirium (decreased 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: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS) may occur.

Inform your doctor if you experience any of these behaviors; they will decide on ways to control or reduce the symptoms

For the adverse effects marked with *, it is not possible to provide a precise estimate of the frequency, as these adverse 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 adverse effects:

Very Common:

• Nausea
• Symptoms that start earlier than usual, are more intense, or affect other limbs (worsening of Restless Legs Syndrome).

Common:

• Changes in sleep patterns, such as insomnia and somnolence
• Fatigue
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (nausea)

Uncommon:

• Need to behave in an unusual way*
• Heart failure (heart problems that can cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of antidiuretic hormone*
• Dyskinesia (e.g., abnormal involuntary movements of the limbs)
• Hyperkinesia (increased movement and inability to remain still)*
• Paranoia (e.g., excessive concern about one's health)*
• Delusion*
• Amnesia (memory impairment)*

• 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)
• Fainting
• Restlessness
• Visual 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 oneself or others, including:

• Strong impulse to gamble excessively despite serious personal or family consequences.*
• Altered or increased sexual interest and disturbing behavior for oneself or others, for example, increased sexual appetite.*
• Uncontrolled excessive shopping or spending.*
• Binge eating (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).*
• Mania (agitation, feeling elated or overexcited)*
• Delirium (decreased consciousness, confusion, loss of contact with reality)*

Unknown Frequency:

-After stopping or reducing treatment with Pramipexol Pensa: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS) may occur.

Inform your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

For the adverse effects marked with *, it is not possible to provide a precise estimate of the frequency, as these adverse effects were not observed in clinical trials in 1,395 patients treated with pramipexol. The frequency category is likely not higher than "uncommon".

Reporting Adverse Effects

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

5. Storage of Pramipexol Pensa

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Additional Information

Composition of Pramipexol Pensa

The active ingredient is pramipexol.

Each tablet contains 0.18 mg of pramipexol base.

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

Appearance and Packaging of the Product

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

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 of 30 tablets, 100 tablets.

Only some 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 medicine is authorized in the 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 last revision of this leaflet:December 2024

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