Leaflet: information for the user

Pramipexol Normon 0.18 mg tablets EFG

pramipexol

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

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

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

3. How to take Pramipexol Normon

4. Possible side effects

5. Storage of Pramipexol Normon

6. Contents of the pack and additional information

Pramipexol belongs to a group of medicines called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopamine receptors triggers nerve impulses in the brain that help control the body's movements.

Pramipexol is used for:

• treating 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).

treating the symptoms of moderate to severe idiopathic Restless Legs Syndrome in adults.

Do not take Pramipexol Normon

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

Warnings and precautions

Consult your doctor before starting to take pramipexol. 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.

• 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 progressive increase in pramipexol dosage.

• Dystonia. Inability to maintain the trunk and neck straight and upright (axial dystonia). Specifically, you may experience forward flexion of the head and neck (also known as antecolis), forward curvature of the lumbar region (also known as camptocormia), or lateral curvature of the back (also known as pleurototonos or Pisa syndrome). In this case, your doctor may decide to modify your treatment.

• Drowsiness and sudden episodes of sleep.

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

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

• Alteration of vision. You should undergo periodic eye examinations during pramipexol treatment.

• Severe heart or blood vessel disease. You should undergo periodic blood pressure checks, especially at the beginning 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 other limbs, your doctor may reduce your dosage or discontinue treatment.

Inform your doctor if you, your family, or caregivers notice that you are developing unusual impulses or urges to behave in ways that may harm you or others. This is known as impulse control disorder and may include behaviors such as compulsive gambling, excessive spending, abnormal increase in sexual thoughts and feelings, or excessive eating.Your doctor may need to adjust or discontinue your dosage.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling overexcited or overstimulated) or delirium (diminished consciousness, confusion, or loss of contact with reality).Your doctor may need to adjust or discontinue your dosage.

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

Inform your doctor if you notice an inability to maintain the 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 old.

Other medications and Pramipexol Normon

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications. This includes medications, herbal remedies, natural foods, or nutritional supplements obtained without a prescription.

Avoid using pramipexol with antipsychotic medications.

Exercise caution if you are using the following medications:

• 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 human immunological disease),
• cisplatin (for treating 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 malignant malaria),
• procainamide (for treating irregular heartbeats).

If you are using levodopa, it is recommended to reduce the levodopa dosage when starting pramipexol treatment.

Exercise caution if you are using tranquilizers (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

Be cautious if you drink alcohol during pramipexol treatment.

You can take pramipexol with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medication. Your doctor will inform you if you should continue pramipexol treatment.

Pramipexol has not been shown to affect the fetus. Therefore, do not take pramipexol if you are pregnant unless your doctor advises 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 pramipexol use is necessary, breastfeeding should be discontinued.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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 drowsiness and sudden episodes of sleep, especially in patients with Parkinson's disease. If you experience these adverse effects, do not drive or operate machinery. Inform your doctor if this happens.

Pramipexol Normon contains sodium

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

Follow exactly the administration instructions of Pramipexol Normon indicated by your doctor.In case of doubt, consult your doctor again. Your doctor will indicate 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 per day).

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 per day); 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 per day).

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 per day).

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 insufficiency, the usual starting dose is 0.088 mg twice a day. If you have severe renal insufficiency, the usual starting dose is 0.088 mg per day.

Restless Legs Syndrome:

The dose is usually administered once a day, at night, 2-3 hours before bedtime.

During the first week, the usual dose is 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): 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 per day); 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 per day); during the fourth week the dose is half a tablet of pramipexol 0.7 mg and 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 per day).

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 start treatment again, 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 evaluate your treatment after 3 months to decide whether to continue or not with the treatment.

Patients with kidney disease

If you have severe kidney disease, pramipexol may not be an appropriate treatment for your restless legs syndrome.

If you take more Pramipexol Normon than you should

If you accidentally take too many tablets,

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

If you have taken pramipexol more than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount taken. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If you forget to take Pramipexol Normon

Don't worry. Omit that dose completely and take the next dose at the correct time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pramipexol Normon

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

If you have Parkinson's disease, you should not stop your treatment with pramipexol abruptly. Sudden discontinuation may cause the appearance of a condition called neuroleptic malignant syndrome, which can represent 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 treatment or reduce the dose of pramipexol, 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 doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The classification of side effects is based on the following frequencies:

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

Very common:

• Dyskinesia (e.g. abnormal involuntary movements of the limbs).
• Drowsiness.
• Dizziness.
• Nausea:

Common:

• Need to behave in an unusual way.
• Hallucinations (seeing, hearing or feeling things that are not present).
• Confusion.
• Fatigue (tiredness).
• Insomnia.
• Edema periphericum (excess fluid, usually in the legs).
• Headache.
• Hypotension (low blood pressure).
• Abnormal dreams.
• Constipation.
• Visual disturbances.
• Vomiting.
• Weight loss including loss of appetite.

Uncommon:

• Paranoia (e.g. excessive concern about your health).
• Delusion.
• Excessive daytime somnolence and sudden onset of sleep.
• Amnesia (memory disturbance).
• Hypokinesia (increase in movement and inability to remain still).
• Weight gain.
• Allergic reactions (e.g. skin rash, itching, hypersensitivity).
• Syncope (fainting).
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles).*
• Inadequate secretion of antidiuretic hormone.*
• Restlessness.
• Hypophonia (soft voice).
• 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, including:

• 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.
• Uncontrolled excessive spending.
• Binge eating (ingestion of large amounts of food in a short period of time) or compulsive eating (ingestion of more food than normal and more than needed to satisfy hunger).*

• Delirium (diminished consciousness, confusion, loss of contact with reality).

Rare:

• Mania (agitation, feeling elated or overexcited).*

Frequency unknown:

• After stopping or reducing treatment with pramipexol: 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 side effects marked with * it is not possible to provide a precise estimate of the frequency, as these side effects were not observed in clinical trials involving 2,762 patients treated with pramipexol. The frequency category is probably not higher than "uncommon".

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

Very common:

• Nausea.
• Symptoms that start earlier than usual, are more intense or affect other limbs (increased restless legs syndrome).

Common::

• Changes in sleep pattern, such as insomnia and somnolence.
• Fatigue (tiredness).
• Headache.
• Abnormal dreams.
• Constipation.
• Dizziness.
• Vomiting (urge to vomit).

Uncommon::

• Need to behave in an unusual way.*
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles).*
• Inadequate secretion of antidiuretic hormone.*
• Dyskinesia (e.g. abnormal involuntary movements of the limbs).
• Hypokinesia (increase in movement and inability to remain still).*
• Paranoia (e.g. excessive concern about your health).*
• Delusion.*
• Amnesia (memory disturbance).*
• Hallucinations (seeing, hearing or feeling things that are not present).
• Confusion.
• Excessive daytime somnolence and sudden onset of sleep.
• Weight gain.
• Hypotension (low blood pressure).
• Edema periphericum (excess fluid, usually in the legs).
• Allergic reactions (e.g. skin rash, itching, hypersensitivity).
• Syncope (fainting).
• Restlessness.
• Visual disturbances.
• Weight loss including loss of appetite.
• Dyspnea (difficulty breathing).
• Hypophonia (soft voice).
• Pneumonia (lung infection).*
• Inability to resist the impulse, instinct or temptation to perform an action that may be harmful to you or others, including:

• 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.*
• Uncontrolled excessive spending.*
• Binge eating (ingestion of large amounts of food in a short period of time) or compulsive eating (ingestion of more food than normal and more than needed to satisfy hunger).*

• Mania (agitation, feeling elated or overexcited).*
• Delirium (diminished consciousness, confusion, loss of contact with reality).*

Frequency unknown:

• After stopping or reducing treatment with pramipexol: 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 side effects marked with * it is not possible to provide a precise estimate of the frequency, as these side effects were not observed in clinical trials involving 1,395 patients treated with pramipexol. The frequency category is probably not higher than "uncommon".

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at your local SIGRE collection point.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Pramipexol Normon Composition

The active ingredient is pramipexol. Each tablet contains 0.18 mg of pramipexol, equivalent to 0.25 mg of dihydrochloride monohydrate of pramipexol.

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

Product appearance and packaging contents

Pramipexol Normon 0.18 mg are white or almost white, round, biconvex, scored, and with the serigraphy “P 0.18”. The tablet can be divided into two equal halves. It is presented in packs of 30 and 100 tablets.

Marketing authorization holder and manufacturer responsible

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet:February 2024

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es