PRAMIPEXOL AUROVITAS 0.18 mg TABLETS

Introduction

Package Leaflet: Information for the User

Pramipexol Aurovitas 0.18 mg 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 and what is it used for
2. What you need to know before you take Pramipexol Aurovitas
3. How to take Pramipexol Aurovitas
4. Possible side effects
5. Storage of Pramipexol Aurovitas
6. Contents of the pack and other information

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

Pramipexol Aurovitas contains the active substance pramipexole 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.

Pramipexole 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).
• treat symptoms of moderate to severe idiopathic Restless Legs Syndrome in adults.

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

Do not take Pramipexol Aurovitas

• if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take pramipexole.

Consult 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 pramipexole dose.
• 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 sideways curvature of the back (also called pleurothotonus or Pisa syndrome). In this case, your doctor may decide to adjust your treatment.
• Somnolence and sudden episodes of sleep.
• Psychosis (e.g. similar to symptoms of schizophrenia).
• Visual impairment. You should have regular eye examinations during treatment with pramipexole.
• 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).
• Increased Restless Legs Syndrome. If you experience that symptoms start earlier than usual at night (or even in the afternoon), are more intense or affect larger parts of the affected limbs or affect other limbs. Your doctor may reduce your dose or stop treatment.

Tell your doctor if you or your family members/caregivers notice that you are developing cravings or urges to behave in an unusual way for you and cannot resist the impulse, urge or temptation to carry out certain activities that could be harmful to you or others. This is known as impulse control disorders and may include behaviors such as addiction to gambling, eating or spending excessively, an abnormally high desire for sex or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Tell your doctor if you or your family members/caregivers notice that you are developing mania (agitation, feeling of euphoria or overexcitement) or delirium (decreased consciousness, confusion or loss of sense of reality). Your doctor may need to adjust or stop your dose.

Tell your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating or pain when stopping or reducing treatment with pramipexole. If problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Tell your doctor if you notice inability to keep the trunk and neck straight and upright (axial dystonia). In this case, your doctor may decide to adjust or modify your treatment.

Children and adolescents

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

Taking Pramipexol Aurovitas with other medicines

Tell 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 pramipexole 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 condition 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 levodopa dose when starting treatment with pramipexole.

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

Taking Pramipexol Aurovitas with food, drinks and alcohol

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

You can take pramipexole with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Your doctor will tell you if you should continue treatment with pramipexole.

The effect of pramipexole on the fetus is not known. Therefore, do not take pramipexole if you are pregnant unless your doctor tells you to.

Pramipexole should not be used during breast-feeding. Pramipexole may decrease milk production. Also, pramipexole may pass into breast milk and reach your baby. If the use of pramipexole is essential, breast-feeding should be discontinued.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Pramipexole may cause somnolence and sudden episodes of sleep, especially in patients with Parkinson's disease. If this happens, you should not drive vehicles or perform activities where a lack of attention may put you or others at risk of death or serious injury (e.g. using machines), until such episodes and/or somnolence have resolved.

3. How to take Pramipexol Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Your doctor will tell you the correct dose.

You can take pramipexole with or without food. The tablets should be swallowed with water.

Parkinson's disease

The daily dose should be taken divided into 3 equal doses.

During the first week, the usual dose is 1 tablet of pramipexole 0.088 mg three times a day (equivalent to 0.264 mg daily):

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 1.1 mg per day. However, it may be necessary to increase your dose further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole per day. It is also possible to reduce the maintenance dose to three tablets of pramipexole 0.088 mg per day.

Patient with kidney disease

If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you should take the tablets only once or twice a day. If you have moderate kidney impairment, the usual starting dose is 1 tablet of pramipexole 0.088 mg twice a day. If you have severe kidney impairment, the usual starting dose is 1 tablet of pramipexole 0.088 mg per day.

Restless Legs Syndrome

The dose is usually taken once a day, in the evening, 2-3 hours before bedtime. During the first week, the usual dose is 1 tablet of pramipexole 0.088 mg once a day (equivalent to 0.088 mg per day):

This dose will be increased every 4-7 days according to your doctor's instructions, until your symptoms are controlled (maintenance dose).

The daily dose for the treatment of Restless Legs Syndrome should not exceed 6 tablets of pramipexole 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexole salt).

If you stop taking your tablets for a few days and want to restart treatment, you should start again with the smallest dose and then gradually increase the dose as you did the first time. Consult your doctor if you have any doubts.

Your doctor will assess your treatment after 3 months to decide whether to continue or not with the treatment.

Patient with kidney disease:

If you have severe kidney disease, pramipexole may not be a suitable treatment.

If you take more Pramipexol Aurovitas 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 side effects described in section 4 (“Possible side effects”).

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

If you forget to take Pramipexol Aurovitas

Do not worry. Omit that dose completely and take the next dose at the correct time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Pramipexol Aurovitas

Do not stop your treatment with pramipexole without 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 pramipexole abruptly. Sudden withdrawal may cause a condition called neuroleptic malignant syndrome, which can be 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 Pramipexol Aurovitas, 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The classification of adverse effects is based on the following frequencies:

If you have Parkinson's disease, you may experience the following adverse effects:

Very Common(may affect more than 1 in 10 people):

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

Common(may affect up to 1 in 10 people):

• 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 disturbance.
• Vomiting (nausea).
• Weight loss, including loss of appetite.

Uncommon(may affect up to 1 in 100 people):

• Paranoia (e.g., excessive concern about one's health).
• Thought disorder.
• 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.
• Cardiac 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, desire, or temptation to perform an action that may be harmful to oneself or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences.
• altered or increased sexual interest and disturbing behavior for oneself or others, for example, increased sexual desire.
• uncontrollable urge to spend or buy excessively.
• binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming more food than normal and more than necessary to satisfy hunger).

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

Rare(may affect up to 1 in 1,000 people):

• Mania (agitation, feeling elated or overexcited).
• Spontaneous erection of the penis.

Frequency Not Known(cannot be estimated from the available data):

• After stopping or reducing treatment with pramipexole, depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS) may occur.

Inform your doctor if you experience any of these behaviors; he will assess how to control or reduce the symptoms.

For the adverse effects marked with *, it is not possible to provide a precise estimate of the frequency, as these adverse effects were not observed in clinical trials among 2,762 patients treated with pramipexole. The frequency category is likely not higher than "uncommon".

If you have Restless Legs Syndrome, you may experience the following adverse effects:

Very Common(may affect more than 1 in 10 people):

• Nausea.
• Symptoms that start earlier than usual, are more intense, or affect other limbs (increase in Restless Legs Syndrome).

Common(may affect up to 1 in 10 people):

• Changes in sleep patterns, such as insomnia and somnolence.
• Fatigue.
• Headache.
• Abnormal dreams.
• Constipation.
• Dizziness.
• Vomiting (nausea).

Uncommon(may affect up to 1 in 100 people):

• Need to behave in an unusual way*.
• Cardiac failure (heart problems that can cause shortness of breath or swelling of the ankles)*.
• Inadequate secretion of antidiuretic hormone*.
• Dyskinesia (e.g., abnormal involuntary movements of the limbs).
• Hyperkinesia (increased movement and inability to remain still)*.
• Paranoia (e.g., excessive concern about one's health)*.
• Delirium*.
• Amnesia (memory impairment)*.
• Hallucinations (seeing, hearing, or feeling things that are not present).
• Confusion.
• Excessive daytime somnolence and sudden sleep episodes.
• Weight gain.
• Hypotension (low blood pressure).
• Excess fluid, usually in the legs (peripheral edema).
• Allergic reactions (e.g., skin rash, itching, hypersensitivity).
• Fainting.
• Restlessness.
• Visual disturbance.
• Weight loss, including loss of appetite.
• Dyspnea (difficulty breathing).
• Hiccup.
• Pneumonia (lung infection)*.
• Inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to oneself or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences*.
• altered or increased sexual interest and disturbing behavior for oneself or others, for example, increased sexual desire*.
• uncontrollable urge to spend or buy excessively*.
• binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming more food than normal and more than necessary to satisfy hunger)*.

• Mania (agitation, feeling elated or overexcited)*.
• Delirium (reduced consciousness, confusion, loss of contact with reality)*.

Rare(may affect up to 1 in 1,000 people):

• Spontaneous erection of the penis.

Frequency Not Known(cannot be estimated from the available data):

• After stopping or reducing treatment with pramipexole, depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS) may occur.

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

For the adverse effects marked with *, it is not possible to provide a precise estimate of the frequency, as these adverse effects were not observed in clinical trials among 1,395 patients treated with pramipexole. The frequency category is likely not higher than "uncommon".

Reporting of Adverse Effects

If you experience any 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 through the Spanish Pharmacovigilance System of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Pramipexol Aurovitas

Keep out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date shown on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pramipexol Aurovitas

• The active substance is pramipexole.

Each tablet contains 0.25 mg of pramipexole dihydrochloride monohydrate, equivalent to 0.18 mg of pramipexole.

• The other ingredients (excipients) are: mannitol (E 421), cornstarch, povidone K30, povidone K90, colloidal anhydrous silica, and magnesium stearate.

Appearance and Package Contents

Tablet.

White to off-white, oval, biconvex, uncoated tablets with beveled edges, marked with "Y" and "42" separated by a score line on one side and smooth with a score line on the other side.

The tablet can be divided into equal doses.

Pramipexol Aurovitas tablets are available in Polyamide/Aluminum/PVC-aluminum blister packs and high-density polyethylene (HDPE) bottles with a polypropylene cap containing cotton.

Package Sizes:

Blister packs: 10, 20, 30, 50, 60, 90, 100, and 200 tablets.

HDPE bottles: 90, 100, and 1,000 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark Pramipexol "Aurobindo"

France Pramipexole ARROW LAB 0.18 mg comprimé sécable

Germany Pramipexol Aurobindo 0.18 mg Tabletten

Italy Pramipexole Aurobindo

Malta Pramipexole Aurobindo 0.18 mg Tablets

Portugal Pramipexol Aurobindo, 0.18 mg, Comprimidos

Spain Pramipexol Aurovitas 0.18 mg comprimidos EFG

Sweden Pramipexol Aurobindo 0.18 mg tabletter

Date of the Last Revision of this Leaflet:July 2024

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