Package Insert: Information for the User

Pramipexol NORMON 2.1 mg Extended-Release Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.This information is important for your health.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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 NORMON 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).

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

Consult your doctor or pharmacist before starting to take Pramipexol NORMON. 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 there). 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 NORMON dose.
• 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 (also known as pleurototonos or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• Drowsiness and sudden episodes of sleep.
• Changesinbehavior(e.g.,pathological gambling,compulsive buying),increasedlibido(e.g.,increasedsexual appetite),binge eating.
• Psychosis (e.g., symptoms similar to those of schizophrenia).
• Visual disturbances. You should undergo regular eye examinations during treatment with Pramipexol NORMON.
• Severe heart or blood vessel disease. You should undergo regular blood pressure checks, especially at the start of treatment, to avoid postural hypotension (a drop in blood pressure when standing up).

Inform your doctor if you, your family or carers notice that you are developing unusual impulses or urges to behave in a way that may harm you or others. This is known as impulse control disorder and may include behaviors such as pathological gambling, compulsive buying, abnormally high sexual appetite or excessive concern about increased thoughts and feelings of sex. It may be necessary for your doctor to adjust or stop your treatment.It may be necessary for your doctor to adjust or stop your treatment.

Inform your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating or pain when stopping or reducing pramipexol treatment. If these problems persist for more than a few weeks, it may be necessary for your doctor to adjust your treatment.

Children and adolescents

Pramipexol NORMON is not recommended for use in children or adolescents under 18 years.

Taking Pramipexol NORMON with other medicines

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

Avoid using Pramipexol NORMON 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 human immunodeficiency disease);
• cisplatin (for treating 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 malignant malaria (malaria falciparum))
• procainamide (for treating irregular heartbeats).

If you are using levodopa, it is recommended to reduce the levodopa dose when starting treatment with Pramipexol NORMON.

Be cautious if you are using sedative tranquilizers or if you drink alcohol. In these cases, Pramipexol NORMON may affect your ability to drive and operate machinery.

Taking Pramipexol NORMON with food and drink

Be cautious if you drink alcohol during treatment with Pramipexol NORMON.

You can take Pramipexol NORMON with or without food.

Pregnancy,breastfeedingandfertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will tell you if you should continue taking Pramipexol NORMON.

Pramipexol has not been shown to have an effect on the fetus. Therefore, do not take Pramipexol NORMON if you are pregnant, unless your doctor tells you to.

Pramipexol NORMON should not be used during breastfeeding. Pramipexol may decrease milk production. It may also pass into breast milk and reach your baby. If the use of Pramipexol NORMON is necessary, breastfeeding should be stopped.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Pramipexol NORMON may cause hallucinations (seeing, hearing or feeling things that are not there). 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 side effects, do not drive or operate machinery. Inform your doctor if this happens.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Your doctor will indicate the correct dosage.

Take Pramipexol NORMON prolonged-release tablets once a day and at the same hour every day.

Pramipexol NORMON can be taken with or without food. The tablets should be swallowed whole with water.

Do not chew, divide, or crush the prolonged-release tablets. If you do, there is a risk of overdose, as the medication may be released in your body too quickly.

The usual daily dose for the first week is 0.26 mg of pramipexol.

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. If necessary, your doctor may increase your dose up to a maximum of 3.15 mg of pramipexol per day. It is also possible to reduce the maintenance dose to 1 prolonged-release Pramipexol NORMON 0.26 mg tablet per day.

Patients with kidney 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.

After that, your doctor may increase the frequency of doses to 1 prolonged-release Pramipexol NORMON 0.26 mg tablet per day. If necessary, your doctor may adjust your dose in increments of 0.26 mg of pramipexol.

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

If you are changingfromPramipexol NORMON tablets (immediate-release)
Your doctor will base your Pramipexol NORMON prolonged-release tablets dose on the Pramipexol NORMON tablets dose you were taking.

The day before the change, take your Pramipexol NORMON tablets as you normally would. The next morning, take your Pramipexol NORMON prolonged-release tablet and do not take any more Pramipexol NORMON tablets.

If you take more Pramipexol NORMON than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pramipexol NORMON

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

If you forget to take the 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 compensate for the missed doses.

If you interrupt treatment with Pramipexol NORMON

Do not stop your treatment with Pramipexol NORMON 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, do not stop your treatment with Pramipexol NORMON abruptly. Sudden discontinuation may cause the appearance of a condition called neuroleptic malignant syndrome, which can pose a significant 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 NORMON, 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, contact your doctor.

If you have any other questions about the use of this medication, 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:

You may experience the following side effects:

Very common:

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

Common:

• Need to behave in an abnormal way
• Hallucinations (seeing, hearing or feeling things that are not present)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Excess fluid, usually in the legs (peripheral edema)
• Headache
• Low blood pressure
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (urge to vomit)
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g. excessive concern about your health)
• Delirium
• Excessive daytime somnolence and sudden sleep episodes
• Amnesia (memory alteration)
• Hypokinesia (increase in movements and inability to remain still)
• Weight gain
• Allergic reactions (e.g. skin rashes, itching, hypersensitivity)
• Syncope (fainting)
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)
• Inadequate secretion of the antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hypophonia (low voice)
• 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 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)*

Unknown frequency

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

Inform 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 provide a precise estimate of the frequency, as these side effects were not observed in clinical trials between 2,762 patients treated with pramipexol. The frequency category is likely to be no 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 the Spanish System for the 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 sight and reach of children.

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.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Pramipexol NORMON

The active ingredient is pramipexol. Each tablet contains 2.1 mg of pramipexol as 3 mg of dihydrochloride monohydrate of pramipexol.

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

Appearance of the product and content of the packaging

Pramipexol NORMON 2.1 mg are prolonged-release tablets, white or almost white, cylindrical, flat, and beveled, marked with 210 on one side. Each package contains 30 tablets.

Holder of the marketing authorization

LABORATORIOS NORMON, S.A.

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

Responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

or

Ferrer Internacional, S.A.

Joan Buscallà, 1-9, 08173 Sant Cugat del Vallés, Barcelona (SPAIN)

OTHER PRESENTATIONS

Pramipexol NORMON 0.52 mg prolonged-release tablets EFG.

Pramipexol NORMON 1.05 mg prolonged-release tablets EFG.

Pramipexol NORMON 1.57 mg prolonged-release tablets EFG.

Pramipexol NORMON 2.1 mg prolonged-release tablets EFG.

Pramipexol NORMON 2.62 mg prolonged-release tablets EFG.

Pramipexol NORMON 3.15 mg prolonged-release tablets EFG.

Date of the last review of this prospectus:December 2021

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