PRAMIPEXOL PENSA 2.1 mg PROLONGED-RELEASE 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 you start taking Pramipexole 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 gradual increase in Pramipexole Pensa dose.

• Dystonia (inability to keep the trunk and neck straight and upright (axial dystonia)). In particular, you may experience forward flexion of the head and neck (also called antecollis), forward curvature of the lumbar region (also called camptocormia), or sideways curvature of the back (also called pleurothotonus or Pisa syndrome). In this case, your doctor may choose to modify your treatment.

• Somnolence and sudden episodes of sleep.
• Psychosis (e.g., similar to symptoms of schizophrenia).
• Visual disturbance. You should have regular eye examinations during treatment with Pramipexole Pensa.
• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the start of treatment, to avoid postural hypotension (a drop in blood pressure when standing up).

Tell your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in an unusual way for you and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sexual desire, or increased concern about an increase in sexual thoughts and feelings. Your doctor may need to adjust or stop your dose.

Tell 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). Your doctor may need to adjust or interrupt your dose.

Tell 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, 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.

Using Pramipexole Pensa with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 to prevent painful leg cramps that occur at night and to treat 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 reduce the levodopa dose 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

Be cautious if you drink alcohol during treatment with Pramipexole Pensa. You can 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 tell you if 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.

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 happens, do not drive or operate machinery.

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

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor again. Your doctor will tell you the correct dosage.

Take Pramipexole Pensa prolonged-release tablets once a day at the same time each day.

You can take Pramipexole Pensa with or without food. The tablets should 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, 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 pramipexole per day. It is also possible to reduce the maintenance dose to 1 prolonged-release tablet of Pramipexole Pensa 0.26 mg per day.

Patient with renal impairment

If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg prolonged-release tablets on alternate days during the first week. Then, your doctor may increase the frequency of administration to 1 prolonged-release tablet of 0.26 mg per day. If it is necessary to increase your dose further, your doctor may adjust your dose in levels of 0.26 mg of pramipexole.

If you have severe kidney disease, your doctor may consider it necessary to switch to a different pramipexole medicine. If your kidney problems worsen during treatment, contact your doctor as soon as possible.

If you are switching from Pramipexole Pensa immediate-release tablets

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

The day before the switch, take your Pramipexole Pensa immediate-release tablets as you normally would. The next morning, take your Pramipexole prolonged-release tablet and do not take any more Pramipexole immediate-release tablets.

If you take more Pramipexole Pensa than you should

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

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 ingested.

If you forget to take Pramipexole Pensa

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

If you forget to take your dose after more than 12 hours, simply take your next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Pramipexole Pensa

Do not stop your treatment with Pramipexole Pensa 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, do not stop your treatment with Pramipexole suddenly. Sudden interruption can cause a condition called neuroleptic malignant syndrome, which can be a 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 treatment or reduce the dose of Pramipexole 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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)
• 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
• 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 disturbance)
• 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)*
• Inadequate secretion of antidiuretic hormone*
• Restlessness
• Shortness of breath
• Hiccup
• 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 buying 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

Frequency not known:

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

Tell 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 have an accurate estimate of the frequency, as these side effects were not observed in clinical trials among 2,762 patients treated with pramipexole. The frequency category is likely not higher than "uncommon".

Reporting of side effects:

If you experience side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton and/or blister after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pramipexol Pensaprolonged-release tablets

• The active ingredient is pramipexole.

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

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

Appearance ofPramipexol Pensa prolonged-release tabletsand package contents

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

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

Only some 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 Member States of the European Economic Area under the following names:

Spain: Pramipexol Pensa 2.1 mg Prolonged-Release Tablets EFG

Italy: Pramipexolo Pensa Pharma 2.1 mg prolonged-release tablets

Date of the last revision of this leaflet: October2024

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