Pramipexole Normon 0.26 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pramipexole NORMON 0.26 mg prolonged-release tablets EFG

Read all of this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects 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 side 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 taking 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 or pharmacist before starting to take Pramipexole NORMON. Inform your doctor if you have or have had any illness 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 taking levodopa, you may develop dyskinesia during the gradual dose increase 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 lower back (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.
• Behavioral changes (e.g., gambling disorder, compulsive buying), increased libido (e.g., increased sexual appetite), binge eating.
• Psychosis (e.g., symptoms resembling schizophrenia).
• Vision disorders. You should undergo regular eye examinations during treatment with Pramipexole NORMON.
• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the beginning of treatment, to prevent orthostatic 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 behaviors such as gambling addiction, excessive eating or spending, abnormally high sex 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 currently using, have recently used, or might need to use any other medicines. This includes medicines, herbal remedies, natural health products, or nutritional supplements obtained without a prescription.

You should avoid using Pramipexole NORMON together with antipsychotic medications.

Use caution 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 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 NORMON.

Use caution 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

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, 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 breast milk production. In addition, it 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 onset of sleep, especially in patients with Parkinson's disease. If you experience these adverse effects, you should not drive or operate machinery. Inform your doctor if this happens to you.

3. How to take Pramipexol NORMON

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

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

You may take Pramipexol NORMON with or without food. The tablets must be swallowed whole with water.

Do not chew, divide, or crush the prolonged-release tablets. Doing so may lead to 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 pramipexol.

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

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 on alternate days during the first week.

Afterwards, your doctor may increase the frequency to one 0.26 mg prolonged-release tablet 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 it necessary to switch 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 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 the 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 remember more than 12 hours after your usual time, simply take the next dose at your regular time. Do not take a double dose to make up for a missed dose.

If you stop taking Pramipexole NORMON

Do not stop your treatment with Pramipexole NORMON without first consulting your doctor. If you need to discontinue 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 known as 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 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 disturbance
• Vomiting (feeling sick)
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g., excessive concern about health)
• Delirium
• Excessive daytime sleepiness and sudden episodes of falling asleep
• 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
• 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 yourself or others, which may include:
• 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.*
• Uncontrollable excessive shopping 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 necessary to satisfy hunger)*

Frequency not known:

• After discontinuing or reducing treatment with pramipexole: 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; he or she will explain how to manage or reduce the symptoms.

For adverse effects marked with *, an accurate estimation of frequency 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".

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pramipexole NORMON

The active substance is pramipexole. Each tablet contains 0.26 mg of pramipexole as 0.375 mg of pramipexole dihydrochloride monohydrate.

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

Appearance of the product and contents of the pack

Pramipexole NORMON 0.26 mg are prolonged-release tablets, white or almost white, cylindrical, flat and bevelled, marked with "026" on one side. Each pack contains 30 tablets.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

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

Manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PACK SIZES

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 review of this leaflet: December 2021

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