Pramipexole Normon 1.05 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pramipexole NORMON 1.05 mg prolonged-release tablets EFG

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

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

Contents of the leaflet

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 Pramipexole NORMON is and what it is used for

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

Pramipexole 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).

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 components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pramipexole NORMON. 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 develop dyskinesia during the gradual increase in dose of Pramipexole NORMON.
• Dystonia. Inability to keep the trunk and neck straight and upright (axial dystonia). Specifically, you might 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 (also known as pleurothotonus or Pisa syndrome). In such cases, your doctor may consider modifying your treatment.
• Drowsiness and sudden sleep episodes.
• Changes in behaviour (e.g. gambling, compulsive shopping), increased libido (e.g. increased sexual appetite), binge eating.
• Psychosis (e.g. symptoms similar to schizophrenia).
• Vision disturbances. You should undergo periodic eye examinations during treatment with Pramipexole NORMON.
• Severe heart or blood vessel disease. You should have periodic blood pressure checks, especially at the beginning of treatment, to prevent postural hypotension (a drop in blood pressure upon standing).

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviours such as gambling addiction, excessive eating or spending, abnormally high sexual drive, or preoccupation with increased sexual thoughts and feelings. Your doctor may need to adjust or stop 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. If these problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Children and adolescents

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

Taking Pramipexole NORMON with other medicines

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 NORMON 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 occurring 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 dose of levodopa when starting treatment with Pramipexole NORMON.

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

Taking Pramipexole NORMON with food and drink

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

You may take Pramipexole NORMON with or without food.

Pregnancy, breastfeeding, and fertility

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

The effect of pramipexole on the fetus is unknown. Therefore, do not take Pramipexole NORMON during pregnancy unless instructed by your doctor.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Pramipexole NORMON 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 drowsiness and sudden episodes of sleep, 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 to you.

3. How to take Pramipexole NORMON

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the correct dosage for you.

Take Pramipexole NORMON prolonged-release tablets once daily, at the same time each day.

You may take Pramipexole NORMON with or without food. The tablets should be swallowed whole with water.

Do not chew, divide, or crush the prolonged-release tablets. Doing so may result in overdose, as the medicine could be released into your body too quickly.

During the first week, the usual daily dose is 0.26 mg of pramipexole.

This dose will be increased every 5–7 days as directed by your doctor, until your symptoms are controlled (maintenance dose).

The usual maintenance dose is 1.05 mg daily. However, your dose may need to be increased further. If necessary, your doctor may increase your dose of tablets up to a maximum of 3.15 mg of pramipexole per day. It may also be possible to reduce the maintenance dose to one prolonged-release tablet of Pramipexole Normon 0.26 mg daily.

Patients with renal 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.

Afterwards, your doctor may increase the frequency to one prolonged-release tablet of 0.26 mg daily. If further dose increases are needed, your doctor may adjust your dose in increments of 0.26 mg of pramipexole.

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

If you are switching from Pramipexole Normon tablets (immediate-release)
Your doctor will base your dose of Pramipexole Normon prolonged-release tablets on the dose of Pramipexole Normon tablets you were previously taking.

On the day before the switch, take your Pramipexole Normon tablets as usual. On the following morning, take your Pramipexole Normon prolonged-release tablet and do not take any further Pramipexole Normon tablets.

If you take more Pramipexole Normon than you should

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

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

If you forget to take Pramipexole Normon

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

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

If you stop taking Pramipexole Normon

Do not stop your treatment with Pramipexole Normon 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 must not stop treatment with Pramipexole Normon abruptly. Sudden discontinuation may cause a condition 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 stop treatment or reduce the dose of Pramipexole 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, you should contact your doctor.

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

4. Possible adverse effects

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

You may experience the following adverse effects:

Very common:

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

Common:

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

Uncommon:

• Paranoia (e.g., excessive concern about your health)
• Delirium
• Excessive daytime sleepiness and sudden sleep episodes
• 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 swollen ankles)*
• Inappropriate antidiuretic hormone secretion*
• Restlessness
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, instinct, or temptation to carry out an action that may be harmful to you or others, possibly including:
• Strong urge to gamble excessively despite serious personal or family consequences.*
• Altered or increased sexual interest and behavior concerning to you or others, for example, increased libido.*
• Compulsive or uncontrolled excessive spending or buying.*
• 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)*

Frequency not known:

• After discontinuation or reduction of pramipexole treatment: depression, apathy, anxiety, fatigue, sweating, or pain may occur (known as dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

For the adverse effects marked with *, an accurate estimation of frequency is not possible, 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".

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 not listed in this leaflet. You can 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and additional information

Composition of Pramipexole NORMON

The active substance is pramipexole. Each tablet contains 1.05 mg of pramipexole as 1.5 mg of pramipexole dihydrochloride monohydrate.

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

Appearance of the medicinal product and contents of the pack

Pramipexole NORMON 1.05 mg are prolonged-release tablets, white or almost white, cylindrical, flat and bevelled, marked with "105" on one side. Each pack contains 30 tablets.

Marketing Authorisation Holder

LABORATORIOS NORMON, S.A.

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

Manufacturer responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Pramipexole NORMON 0.52 mg prolonged-release tablets EFG.

Pramipexole NORMON 1.05 mg prolonged-release tablets EFG.

Pramipexole NORMON 1.57 mg prolonged-release tablets EFG.

Pramipexole NORMON 2.1 mg prolonged-release tablets EFG.

Pramipexole NORMON 2.62 mg prolonged-release tablets EFG.

Pramipexole NORMON 3.15 mg prolonged-release tablets EFG.

Date of the most recent revision of this leaflet: December 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/