PRAMIPEXOL AUROVITAS SPAIN 0.26 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Pramipexol 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, you may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pramipexol Aurovitas Spain and what is it used for
2. What you need to know before you take Pramipexol Aurovitas Spain
3. How to take Pramipexol Aurovitas Spain
4. Possible side effects
5. Storage of Pramipexol Aurovitas Spain
6. Contents of the pack and other information

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

Pramipexol contains the active substance pramipexol and 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.

Pramipexol Aurovitas Spain is used to:

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

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

Do not take Pramipexol Aurovitas Spain

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 taking Pramipexol Aurovitas Spain. 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 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 the dose of Pramipexol Aurovitas Spain
• Dystonia (inability to keep the trunk and neck straight and upright [axial dystonia]). In particular, you may experience forward bending of the head and neck (also called antecollis), forward bending of the lumbar region (also called camptocormia), or sideways bending of the back (also called pleurothotonus or Pisa syndrome)
• Somnolence and sudden sleep episodes
• Psychosis (e.g., similar to symptoms of schizophrenia)
• Visual impairment. You should have regular eye examinations during treatment with Pramipexol Aurovitas Spain
• Severe heart or blood vessel disease. You should have 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 caregivers notice that you are developing impulses or cravings to behave in an unusual way for you and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as addiction to gambling, excessive eating or spending, or abnormally high sexual interest or drive. Your doctor may need to adjust your dose or stop treatment

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling elated or overexcited) or delirium (decreased consciousness, confusion, or loss of contact with reality). Your doctor may need to adjust your dose or stop treatment

Inform your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with pramipexol. If 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 this case, your doctor may decide to adjust or modify your treatment

Pramipexol Aurovitas Spainprolonged-release tablets are specially designed to release the active substance gradually once the tablet is swallowed. Sometimes, parts of the tablets may be excreted and seen in the stool, which may look like whole tablets. Inform your doctor if you find tablet fragments in your stool

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 take any other medicines. This includes medicines, herbal remedies, natural products, or nutritional supplements that you have obtained without a prescription

You should avoid using Pramipexol Aurovitas Spain 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 disorder known as ventricular arrhythmia)
• zidovudine (which may be used to treat acquired immune deficiency syndrome [AIDS], a disease of the human immune system)
• cisplatin (for the treatment of 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 falciparum malaria [malignant malaria])
• procainamide (for the treatment of irregular heartbeat)

If you are using levodopa, it is recommended to reduce the dose of levodopa when starting treatment with Pramipexol Aurovitas Spain

Be cautious if you are using sedative medicines (with a sedative effect) or if you drink alcohol. In these cases, Pramipexol Aurovitas Spain may affect your ability to drive and operate machinery

Taking Pramipexol Aurovitas Spain with food, drinks, and alcohol

You should be cautious if you drink alcohol during treatment with Pramipexol Aurovitas Spain

You can take Pramipexol Aurovitas Spain with or without food

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you should continue treatment with Pramipexol Aurovitas Spain

The effect of pramipexol on the fetus is not known. Therefore, do not take Pramipexol Aurovitas Spain if you are pregnant unless your doctor advises you to

Pramipexol Aurovitas Spain should not be used during breast-feeding. Pramipexol may decrease milk production. Additionally, it may pass into breast milk and reach your baby. If the use of Pramipexol Aurovitas Spain is essential, breast-feeding should be discontinued. Consult your doctor or pharmacist before taking any medicine

Driving and using machines

Pramipexol Aurovitas Spain may cause hallucinations (seeing, hearing, or feeling things that are not present). If this happens, do not drive or operate machinery

Pramipexol has been associated with somnolence and sudden sleep episodes, 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 to you

3. How to take Pramipexol Aurovitas Spain

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor again. Your doctor will tell you the correct dosage

Take Pramipexol Aurovitas Spain prolonged-release tablets once a day at the same time every day

You can take Pramipexol Aurovitas Spain 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 overdosing, as the medicine may 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, it may be necessary to increase your dose further. If necessary, your doctor may increase your dose of tablets 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 tablet of Pramipexol Aurovitas Spain 0.26 mg per day

Patient 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. Then, your doctor may increase the frequency of administration to 1 prolonged-release tablet of 0.26 mg every day. If it is necessary to increase your dose further, your doctor may adjust your dose in levels of 0.26 mg of pramipexol

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

If you are switching from Pramipexol Aurovitas Spain immediate-release tablets

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

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

If you take more Pramipexol Aurovitas Spain than you should

If you accidentally swallow too many tablets:

• contact your doctor or the nearest hospital emergency department immediately
• you may experience vomiting, restlessness, or any of the side effects described in section 4, “Possible side effects”

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested

If you forget to take Pramipexol Aurovitas Spain

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

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

If you stop taking Pramipexol Aurovitas Spain

Do not stop your treatment with Pramipexol Aurovitas Spainwithout consulting your doctor first. If you need to stop your treatment with this medicine, your doctor will reduce your dose gradually. This reduces the risk of worsening symptoms

If you have Parkinson's disease, you should not stop your treatment with Pramipexol Aurovitas Spain abruptly. Sudden interruption can cause a condition called neuroleptic malignant syndrome, which can be a serious risk to your health. These symptoms include:

• akinesia (loss of muscle movement)
• muscle rigidity
• fever
• unstable blood pressure
• rapid heart rate
• confusion
• decreased level of consciousness (e.g., coma)

If you stop treatment or reduce the dose of Pramipexol Aurovitas Spain, you may also experience a medical condition called dopamine agonist withdrawal syndrome. The 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 on the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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)
• Somnolence
• Dizziness
• Nausea

Common:

• Need to behave in an unusual way
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Fatigue
• Insomnia
• Excess fluid, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual impairment
• Vomiting (nausea)
• Weight loss, including loss of appetite

Uncommon:

• Paranoia (e.g., excessive concern for your health)
• Delusion
• Excessive daytime somnolence and sudden sleep episodes
• Amnesia (memory impairment)
• Hyperkinesia (increased movement and inability to remain still)
• Weight gain
• Allergic reactions (e.g., skin rash, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that can cause shortness of breath or swelling of the ankles) *
• Inadequate secretion of antidiuretic hormone *
• Restlessness
• Shortness of breath
• Hiccup
• 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 behavior that is worrisome to you or others, for example, increased sexual appetite
• Uncontrolled buying or spending
• Binge eating (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than needed to satisfy hunger) *

• Delirium (decreased consciousness, confusion, or loss of contact with reality)

Rare:

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

Frequency not known:

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

For the side effects marked with *, it is not possible to have an exact estimate of the frequency, as these side effects were not observed in clinical trials among 2,762 patients treated with pramipexol. The frequency category is likely not higher than “uncommon”

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine

5. Storage of Pramipexol Aurovitas Spain

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after "CAD". The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pramipexol Aurovitas Spain

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

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

Appearance of the Product and Package Contents

Pramipexol Aurovitas Spain 0.26 mg are prolonged-release tablets, white or almost white in color, cylindrical, flat, and beveled, marked with 026 on one face. Each package contains 30 tablets.

Marketing Authorization 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)

or

Ferrer Internacional, S.A.

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

OTHER PRESENTATIONS

Pramipexol Aurovitas Spain 1.05 mg prolonged-release tablets EFG.

Pramipexol Aurovitas Spain 2.1 mg prolonged-release tablets EFG.

Date of the Last Revision of this Leaflet: February 2025

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