PRAMIPEXOL NORMON 0.7 mg TABLETS

2. What you need to know before you take Pramipexol Normon

Do not take Pramipexol Normon

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

Warnings and precautions

Talk to your doctor before starting to take pramipexol. 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 the dose of pramipexol.

• 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 flexion of the lumbar region (also called camptocormia), or lateral flexion of the spine (also called pleurothotonus or Pisa syndrome). In this case, your doctor may decide to adjust your treatment.

• Somnolence and sudden episodes of sleep.

• Changes in behavior (e.g., gambling, compulsive shopping), increased libido (i.e., increased sexual desire), compulsive eating.

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

• Visual impairment. You should have regular eye examinations during treatment with pramipexol.

• 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).

• Increased Restless Legs Syndrome. If you experience symptoms starting earlier than usual at night (or even in the afternoon), are more intense, or affect larger areas of the affected limbs or affect other limbs. Your doctor may reduce your dose or stop treatment.

Tell your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave abnormally 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 addiction to gambling, 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, or loss of contact with reality). Your doctor may need to adjust or stop your dose.

Tell your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with Pramipexol Normon. If problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Tell your doctor if you notice an inability to keep your trunk and neck straight and upright (axial dystonia). In this case, your doctor may decide to adjust or modify your treatment.

Children and adolescents

Pramipexol Normon is not recommended for use in children or adolescents under 18 years of age.

Other medicines and Pramipexol Normon

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines. This includes medicines, herbal remedies, natural products, or nutritional supplements that you have obtained without a prescription.

You should avoid using pramipexol 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 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 dose of levodopa when starting treatment with pramipexol.

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

Taking Pramipexol Normon with food, drinks, and alcohol

You should be cautious if you drink alcohol during treatment with pramipexol.

You can take pramipexol 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 tell you if you should continue treatment with pramipexol.

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

Pramipexol should not be used during breastfeeding. Pramipexol may decrease milk production. Additionally, pramipexol may pass into breast milk and reach your baby. If the use of pramipexol is essential, you should stop breastfeeding.

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

Driving and using machines

Pramipexol may cause hallucinations (seeing, hearing, or feeling things that are not present). If this happens, do not drive or operate machinery.

Pramipexol 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.

Pramipexol Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Pramipexol Normon

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

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

Parkinson's disease:

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

During the first week, the usual dose is 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): during the second week, the dose is 1 tablet of pramipexol 0.18 mg three times a day or 2 doses of 0.088 mg three times a day (equivalent to 0.54 mg daily); during the third week, the dose is half a tablet of pramipexol 0.7 mg three times a day or 2 tablets of pramipexol 0.18 mg three times a day (equivalent to 1.1 mg daily).

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 (1.1 mg three times a day). It is also possible to reduce the maintenance dose to 0.088 mg three times a day (equivalent to 0.264 mg 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 kidney impairment, the usual starting dose is 0.088 mg twice a day. If you have severe kidney impairment, the usual starting dose is 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 0.088 mg once a day (equivalent to 0.088 mg daily).

This dose will be increased every 4-7 days according to your doctor's instructions, until your symptoms are controlled (maintenance dose): during the second week, the dose is 1 tablet of pramipexol 0.18 mg per day or 2 doses of 0.088 mg per day (equivalent to 0.18 mg daily); during the third week, the dose is half a tablet of pramipexol 0.7 mg per day or 2 tablets of pramipexol 0.18 mg per day or 4 doses of 0.088 mg per day (equivalent to 0.35 mg daily); during the fourth week, the dose is half a tablet of pramipexol 0.7 mg plus 1 tablet of pramipexol 0.18 mg per day or 3 tablets of pramipexol 0.18 mg per day or 6 doses of 0.088 mg per day (equivalent to 0.54 mg daily).

The daily dose for the treatment of Restless Legs Syndrome should not exceed a dose of 0.54 mg (0.75 mg of pramipexol 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. Consult your doctor if you have any doubts.

Your doctor will assess your treatment after 3 months to decide whether to continue or stop treatment.

Patients with kidney disease

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

If you take more Pramipexol Normon than you should

If you accidentally take too many tablets,

• contact your doctor or the nearest hospital emergency department immediately.
• you may experience vomiting, restlessness, or any of the side effects described in section 4 (Possible side effects).

If you have taken more pramipexol than you should, contact your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you forget to take Pramipexol Normon

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 Pramipexol Normon

Do not stop your treatment with pramipexol 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 pramipexol abruptly. Sudden interruption can cause a disorder called neuroleptic malignant syndrome, which can be a serious risk to your health. These symptoms include:

• akinesia (loss of muscle movement)
• muscle stiffness
• 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 pramipexol, you may also experience 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 product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, pramipexole can have adverse effects, although not all people suffer from 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 your health).
• Delusion.
• Excessive daytime somnolence and sudden episodes of sleep.
• 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).*
• Inadequate secretion of antidiuretic hormone.*
• Restlessness.
• Hiccup.
• Dyspnea (difficulty breathing).
• 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 worrying behavior for you 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).

Frequency Not Known:

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

Tell your doctor if you experience any of these behaviors; he 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 among 2,762 patients treated with pramipexole. 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 your health).*
• Delusion.*
• Amnesia (memory impairment).*
• Hallucinations (seeing, hearing, or feeling things that are not present).
• Confusion.
• Excessive daytime somnolence and sudden episodes of sleep.
• 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 you or others, which may include:

• Strong impulse to gamble excessively despite serious personal or family consequences.*
• Altered or increased sexual interest and worrying behavior for you 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).*

Frequency Not Known:

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

Tell your doctor if you experience any of these behaviors; he 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 among 1,395 patients treated with pramipexole. The frequency category is likely not higher than "uncommon".

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Medicines and Health Products Agency's pharmacovigilance system: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Pramipexole Normon

Keep this medicine out of the reach and sight of children.

Do not store above 30°C. Store in the original packaging to protect from light.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pramipexole Normon

The active ingredient is pramipexole. Each tablet contains 0.7 mg of pramipexole, equivalent to 1 mg of pramipexole dihydrochloride monohydrate.

The other ingredients are: mannitol (E-421), microcrystalline cellulose, sodium glycolate starch (from potato), colloidal silica, povidone, and magnesium stearate.

Appearance of the Product and Package Contents

Pramipexole Normon 0.7 mg are white or almost white, round, biconvex, scored tablets with serigraphy "P 0.70". The tablet can be divided into two equal halves. It is available in packages of 30 and 100 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Prospectus:February 2024

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