PRAMIPEXOL AUROVITAS SPAIN 2.1 mg PROLONGED-RELEASE TABLETS

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

Do not take Pramipexole Aurovitas Spain

If you are allergic to pramipexole or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pramipexole Aurovitas Spain. Inform your doctor if you have or have had any disease 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 using levodopa, you may experience dyskinesia during the gradual increase in the dose of Pramipexole Aurovitas Spain.
• Dystonia (inability to keep the trunk and neck straight and upright [axial dystonia]). In particular, you may experience forward flexion of the head and neck (also called antecollis), forward flexion of the lumbar region (also called camptocormia), or curvature of the back to the sides (also called pleurototonos or Pisa syndrome).
• Somnolence and sudden sleep episodes.
• Psychosis (e.g., similar to symptoms of schizophrenia).
• Visual impairment. You should undergo regular eye examinations during treatment with Pramipexole Aurovitas Spain.
• Severe heart or blood vessel disease. You should undergo regular blood pressure checks, especially at the beginning 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 gambling addiction, excessive eating or spending, or abnormally high sexual interest or drive. Your doctor may need to adjust your dose or interrupt 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 interrupt treatment.

Inform your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with pramipexole. If the 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.

Pramipexole Aurovitas Spainprolonged-release tablets are specially designed to release the active substance gradually once the tablet is ingested. Occasionally, parts of the tablets may be excreted and visible in the stool, which may appear to be whole tablets. Inform your doctor if you find tablet fragments in your stool.

Children and adolescents

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

Other medications and Pramipexole Aurovitas Spain

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

You should avoid using Pramipexole Aurovitas Spain with antipsychotic medications.

Be cautious if you are using the following medications:

• 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 Pramipexole Aurovitas Spain.

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

Taking Pramipexole Aurovitas Spain with food, drinks, and alcohol

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

You can take Pramipexole Aurovitas Spain with or without food.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will indicate whether you should continue treatment with Pramipexole Aurovitas Spain.

The effect of pramipexole on the fetus is not known. Therefore, do not take Pramipexole Aurovitas Spain if you are pregnant unless your doctor indicates it.

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

Driving and using machines

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

Pramipexole 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 Pramipexole Aurovitas Spain

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor again. Your doctor will indicate the correct dosage.

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

You can take Pramipexole Aurovitas Spainwith 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 medication may 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 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 pramipexole per day. It is also possible to reduce the maintenance dose to 1 prolonged-release tablet of Pramipexole 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 increments of 0.26 mg of pramipexole.

If you have severe kidney disease, your doctor may consider it necessary to switch to a different pramipexole medication. If your kidney problems worsen during treatment, 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.

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

If you take more Pramipexole Aurovitas Spain than you should

If you accidentally ingest too many tablets:

• consult your doctor or the emergency department of the nearest hospital 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 medication and the amount ingested.

If you forget to take Pramipexole Aurovitas Spain

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

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

If you stop taking Pramipexole Aurovitas Spain

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

If you have Parkinson's disease, do not stop your treatment with Pramipexole Aurovitas Spainabruptly. Sudden interruption can cause a disorder 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
• tachycardia (increased heart rate)
• confusion
• decreased level of consciousness (e.g., coma).

If you stop or reduce treatment with Pramipexole Aurovitas Spain, you may also experience a medical disorder called dopamine agonist withdrawal syndrome (DAWS).

The symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you should contact your doctor.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences 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
• Dyspnea (difficulty breathing)
• 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 concerning for 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 pramipexole: 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 provide an accurate estimate of the frequency, as these side effects were not observed in clinical trials among 2,762 patients treated with pramipexole. The frequency category is likely not higher than "uncommon".

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pramipexol Aurovitas Spain

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

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration 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 at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging contents and additional information

Composition of Pramipexol Aurovitas Spain

The active ingredient is pramipexol. Each tablet contains 2.1 mg of pramipexol as 3 mg of pramipexol dihydrochloride monohydrate.

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

Appearance of the product and packaging contents

Pramipexol Aurovitas Spain 2.1 mg are prolonged-release tablets, white or almost white in color, cylindrical and biconvex, marked with 210 on one side. 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 0.26 mg prolonged-release tablets EFG.

Pramipexol Aurovitas Spain 1.05 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/