Pramipexole Normon 0.7 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pramipexole Normon 0.7 mg tablets EFG

pramipexole

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Pramipexole Normon is and what it is used for
2. What you need to know before taking Pramipexole Normon
3. How to take Pramipexole Normon
4. Possible adverse effects
5. How to store Pramipexole Normon
6. Contents of the pack and other information

1. What is Pramipexole Normon and what is it used for?

Pramipexole 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 body movements.

Pramipexole is used to:

• treat symptoms of idiopathic Parkinson's disease in adults. It may be used alone or in combination with levodopa (another medicine for Parkinson's disease).

• treat moderate to severe idiopathic Restless Legs Syndrome in adults.

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

Do not take Pramipexole Normon

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

Warnings and precautions

Talk to your doctor before starting to take pramipexole. Inform your doctor if you have or have had any illness 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 taking levodopa, you may experience dyskinesia during the gradual increase in pramipexole dose.

• Dystonia. Inability to keep the trunk and neck straight and upright (axial dystonia). Specifically, you may experience forward bending of the head and neck (also known as antecollis), forward curvature of the lumbar region (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome). In such cases, your doctor may decide to modify your treatment.

• Somnolence and sudden sleep episodes.

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

• Psychosis (e.g., symptoms resembling schizophrenia).

• Vision disturbances. You should undergo periodic eye examinations during treatment with pramipexole.

• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the beginning of treatment, to prevent postural hypotension (a drop in blood pressure upon standing).

• Worsening of restless legs syndrome. If you notice that symptoms start earlier than usual in the evening (or even in the afternoon), are more intense, affect larger areas of the affected limbs, or affect other limbs. Your doctor may reduce your dose or discontinue treatment.

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in an unusual way and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is called impulse control disorder and may include behaviors such as compulsive gambling, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings. Your doctor may need to adjust or discontinue your dose.

Inform your doctor if you, your family, or caregivers notice symptoms of mania (agitation, feeling elated or overexcited) or delirium (reduced consciousness, confusion, or loss of touch with reality). Your doctor may need to adjust or discontinue your dose.

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

Inform your doctor if you experience difficulty maintaining an upright posture of the trunk and neck (axial dystonia). In such cases, your doctor may decide to adjust or modify your treatment.

Children and adolescents

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

Other medicines and Pramipexole Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines, herbal remedies, natural foods, or nutritional supplements obtained without a prescription.

You should avoid using pramipexole together with antipsychotic medicines.

Be cautious if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and stomach ulcers),
• amantadine (which may be used in the treatment of Parkinson's disease),
• mexiletine (used to treat 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 (used to treat 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 falciparum malaria (malignant malaria)),
• procainamide (used to treat irregular heartbeat).

If you are taking levodopa, it is recommended to reduce the levodopa dose when starting treatment with pramipexole.

Be cautious if you are taking sedative medicines (with sedative effect) or drinking alcohol. In these cases, pramipexole may affect your ability to drive or operate machinery.

Taking Pramipexole Normon with food, drinks, and alcohol

Be cautious if you drink alcohol during treatment with pramipexole.

You may take pramipexole with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will advise you whether you should continue treatment with pramipexole.

The effect of pramipexole on the fetus is unknown. Therefore, do not take pramipexole if you are pregnant unless your doctor specifically instructs you to do so.

Pramipexole should not be used during breastfeeding. Pramipexole may reduce breast milk production. It may also pass into breast milk and reach your baby. If pramipexole use is essential, breastfeeding must be discontinued.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Pramipexole has been associated with somnolence and sudden episodes of falling asleep, especially in patients with Parkinson's disease. If you experience these adverse effects, you must not drive or operate machinery. Inform your doctor if this happens.

Pramipexole Normon contains sodium

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

3. How to take Pramipexole Normon

Follow exactly the administration instructions for Pramipexole Normon given by your doctor. If in doubt, consult your doctor again. Your doctor will determine the correct dosage for you.

You may take pramipexole with or without food. The tablets should be swallowed with water.

Parkinson's disease:

The daily dose should be taken in three 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 pramipexole 0.18 mg three times daily or 2 tablets of 0.088 mg three times daily (equivalent to 0.54 mg daily); during the third week, the dose is half a tablet of pramipexole 0.7 mg three times daily or 2 tablets of pramipexole 0.18 mg three times daily (equivalent to 1.1 mg daily).

The usual maintenance dose is 1.1 mg per day. However, your dose may need to be increased further. If necessary, your doctor could increase your tablet dose up to a maximum of 3.3 mg of pramipexole 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 renal 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 impairment, the usual starting dose is 0.088 mg twice daily. If you have severe renal impairment, the usual starting dose is 0.088 mg once daily.

Restless Legs Syndrome:

The dose is usually taken once daily, in the evening, 2-3 hours before going to bed.

During the first week, the usual dose is 0.088 mg once daily (equivalent to 0.088 mg per day).

This dose will be increased every 4 to 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 pramipexole 0.18 mg daily or 2 doses of 0.088 mg daily (equivalent to 0.18 mg daily); during the third week, the dose is half a tablet of pramipexole 0.7 mg daily or 2 tablets of pramipexole 0.18 mg daily or 4 doses of 0.088 mg daily (equivalent to 0.35 mg daily); during the fourth week, the dose is half a tablet of pramipexole 0.7 mg plus 1 tablet of pramipexole 0.18 mg daily or 3 tablets of pramipexole 0.18 mg daily or 6 doses of 0.088 mg daily (equivalent to 0.54 mg daily).

The daily dose for the treatment of restless legs syndrome must not exceed 0.54 mg (0.75 mg of pramipexole salt).

If you stop taking your tablets for a few days and wish to restart treatment, you must begin again with the lowest 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 discontinue therapy.

Patients with renal disease

If you have severe kidney disease, pramipexole 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:

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

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

If you forget to take Pramipexol Normon

Do not worry. Skip that dose entirely and take the next dose at the correct time. Do not take a double dose to make up for a missed dose.

If you interrupt treatment with Pramipexol Normon

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

If you have Parkinson's disease, you should not abruptly interrupt your treatment with pramipexole. Sudden discontinuation may cause a disorder called neuroleptic malignant syndrome, which may pose a serious health risk. 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 interrupt treatment or reduce the dose of pramipexole, you may also develop a medical condition called dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you should contact your doctor.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, pramipexole may have adverse effects, although not everyone experiences 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 limbs).
• Somnolence.
• Dizziness.
• Nausea.

Common:

• Urge to behave in an unusual manner.
• Hallucinations (seeing, hearing, or feeling things that are not present).
• Confusion.
• Tiredness (fatigue).
• Insomnia.
• Fluid retention, usually in the legs (peripheral edema).
• Headache.
• Hypotension (low blood pressure).
• Abnormal dreams.
• Constipation.
• Vision disturbance.
• Vomiting (feeling sick).
• Weight loss including loss of appetite.

Uncommon:

• Paranoia (e.g., excessive concern about your health).

• Delusion.

• Excessive daytime sleepiness and sudden episodes of sleep.

• Amnesia (memory impairment).

• Hyperkinesia (increased movements and inability to remain still).

• Weight gain.

• Allergic reactions (e.g., skin rash, itching, hypersensitivity).

• Fainting.

• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles).*

• Inappropriate antidiuretic hormone secretion.*

• Restlessness.

• Hiccups.

• Dyspnea (difficulty breathing).

• Pneumonia (lung infection).

• Inability to resist the impulse, urge, or temptation to carry out an action that could be harmful to you or others, which may include:

  • Strong urge to gamble excessively despite serious personal or family consequences.
  • Altered or increased sexual interest and behavior that is concerning to you or others, for example, increased libido.
  • Compulsive buying or spending.
  • Binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).*

• Delirium (reduced awareness, confusion, loss of contact with reality).

Rare:

• Mania (agitation, feeling elated or overexcited).

Frequency not known:

• After stopping or reducing pramipexole treatment: 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 or she will explain how to manage or reduce the symptoms.

For adverse effects marked with *, a precise frequency estimate is not available, as these adverse effects were not observed in clinical trials involving 2,762 patients treated with pramipexole. The frequency category is likely no higher than "uncommon."

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

Very common:

• Nausea.
• Symptoms starting earlier than usual, becoming more intense, or affecting other limbs (worsening of Restless Legs Syndrome).

Common:

• Changes in sleep patterns, such as insomnia and somnolence.
• Tiredness (fatigue).
• Headache.
• Abnormal dreams.
• Constipation.
• Dizziness.
• Vomiting (feeling sick).

Uncommon:

• Urge to behave in an unusual manner.*

• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles).*

• Inappropriate antidiuretic hormone secretion.*

• Dyskinesia (e.g., abnormal involuntary movements of limbs).

• Hyperkinesia (increased movements 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 sleepiness and sudden episodes of sleep.

• Weight gain.

• Hypotension (low blood pressure).

• Fluid retention, usually in the legs (peripheral edema).

• Allergic reactions (e.g., skin rash, itching, hypersensitivity).

• Fainting.

• Restlessness.

• Vision disturbance.

• Weight loss including loss of appetite.

• Dyspnea (difficulty breathing).

• Hiccups.

• Pneumonia (lung infection).*

• Inability to resist the impulse, urge, or temptation to carry out an action that could be harmful to you or others, including:

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

• Altered or increased sexual interest and behavior that is concerning to you or others, for example, increased libido.*

• Compulsive buying or spending.*

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

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

• Delirium (reduced awareness, confusion, loss of contact with reality).*

Frequency not known:

• After stopping or reducing pramipexole treatment, 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 or she will explain how to manage or reduce the symptoms.

For adverse effects marked with *, a precise frequency estimate is not available, as these adverse effects were not observed in clinical trials involving 1,395 patients treated with pramipexole. The frequency category is likely no higher than "uncommon."

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of containers and unused medicines. This helps protect the environment.

6. Contents of the container and other information

Composition of Pramipexol Normon

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

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

Appearance of the product and contents of the container

Pramipexol Normon 0.7 mg are white or almost white, round, biconvex, scored tablets with the imprint “P 0.70”. The tablet can be divided into equal halves. It is available in packs 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 most recent review of this leaflet: February 2024

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