Pramipexole Aurovitas Spain 0.26 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pramipexole Aurovitas Spain 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 you should not give it to other people, even if they have the same symptoms as you, because it may 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 Aurovitas Spain is and what it is used for
2. What you need to know before taking Pramipexole Aurovitas Spain
3. How to take Pramipexole Aurovitas Spain
4. Possible side effects
5. How to store Pramipexole Aurovitas Spain
6. Contents of the pack and other information

1. What Pramipexole Aurovitas Spain is and what it is used for

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

Pramipexole Aurovitas Spain 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).

2. What you need to know before taking Pramipexol Aurovitas Spain

Do not take Pramipexol Aurovitas Spain

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 Pramipexol Aurovitas Spain. 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 Pramipexol Aurovitas Spain.
• 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).
• Drowsiness and sudden episodes of falling asleep.
• Psychosis (e.g., symptoms similar to schizophrenia).
• Vision disturbances. You should undergo periodic eye examinations during treatment with Pramipexol Aurovitas Spain.
• Severe heart or blood vessel disease. You should have periodic 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 urges or impulses 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 called impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, or abnormally increased sexual appetite or interest with increased sexual thoughts and feelings. Your doctor may need to adjust the dose or discontinue treatment.

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

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.

Inform your doctor if you notice an inability to keep your trunk and neck straight and upright (axial dystonia). In such cases, your doctor may decide to adjust or modify your treatment.

Pramipexol Aurovitas Spain prolonged-release tablets are specially designed tablets from which the active ingredient is gradually released after ingestion. Occasionally, parts of the tablets may be excreted and seen in the stools, which may resemble intact tablets. Inform your doctor if you find tablet fragments in your stools.

Children and adolescents

Pramipexol Aurovitas Spain is not recommended for use in children or adolescents under 18 years of age.

Other medicines and Pramipexol Aurovitas Spain

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 must avoid using Pramipexol Aurovitas Spain together with antipsychotic medications.

Use caution if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and 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 levodopa dose when starting treatment with Pramipexol Aurovitas Spain.

Use caution if you are taking sedative medicines (with sedative effects) or drinking alcohol. In these cases, Pramipexol Aurovitas Spain may affect your ability to drive or operate machinery.

Taking Pramipexol Aurovitas Spain with food, drinks, and alcohol

Exercise caution if you drink alcohol during treatment with Pramipexol Aurovitas Spain.

You may take Pramipexol Aurovitas Spain with or without food.

Pregnancy, breastfeeding, and fertility

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

The effect of pramipexole on the fetus is unknown. Therefore, do not take Pramipexol Aurovitas Spain if you are pregnant unless instructed by your doctor.

Pramipexol Aurovitas Spain must 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 Pramipexol Aurovitas Spain is essential, breastfeeding must be discontinued. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Pramipexol Aurovitas Spain 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 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.

3. How to take Pramipexol Aurovitas Spain

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again. Your doctor will tell you the correct dosage.

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

You may take Pramipexol Aurovitas Spain 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 according to your doctor's instructions 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 may increase your tablet dose 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 Aurovitas Spain 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 Aurovitas Spain immediate-release tablets

Your doctor will base your dose of Pramipexole Aurovitas Spain prolonged-release tablets on the dose of Pramipexole Aurovitas Spain immediate-release tablets you were taking.

On the day before switching, take your pramipexole immediate-release tablets as you normally would. On the following morning, take your pramipexole prolonged-release tablet and do not take any further pramipexole immediate-release tablets.

If you take more Pramipexole Aurovitas Spain than you should

If you accidentally take too many tablets:

• contact your doctor or the nearest hospital emergency department immediately
• 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 Aurovitas Spain

If you forget to take your dose of pramipexole 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 a missed dose.

If you stop taking Pramipexole Aurovitas Spain

Do not stop your treatment with Pramipexole Aurovitas Spain without consulting your doctor first. 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 abruptly stop your treatment with Pramipexole Aurovitas Spain. 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 stop treatment or reduce the dose of Pramipexole Aurovitas Spain, 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 way
• 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 sick)
• Weight loss including loss of appetite

Uncommon:

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

• Delusion

• Excessive daytime sleepiness and sudden sleep episodes

• Amnesia (memory impairment)

• Hyperkinesia (increased movements and inability to stay still)

• Weight gain

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

• Fainting

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

• Inappropriate antidiuretic hormone secretion *

• Restlessness

• Dyspnea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)

• Inability to resist the impulse, urge 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 that is troubling to you or others, e.g. 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 touch with reality)

Rare:

• Mania (agitation, feeling elated or overexcited)
• Spontaneous penile erection

Frequency not known:

• After stopping 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 the adverse effects marked with *, a precise estimation of frequency cannot be provided, 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 Aurovitas Spain

Keep this medicine out of 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 a SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pramipexol Aurovitas Spain

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, calcium hydrogen phosphate, magnesium stearate and colloidal anhydrous silica.

Appearance of the medicinal product and contents of the pack

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

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PACK SIZES

Pramipexol Aurovitas Spain 1.05 mg prolonged-release tablets EFG.

Pramipexol Aurovitas Spain 2.1 mg prolonged-release tablets EFG.

Date of the most recent revision of this summary: February 2025

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