Pramipexole Aurovitas 0.18 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pramipexole Aurovitas 0.18 mg tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Pramipexole 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 dopaminergic receptors triggers nerve impulses in the brain that help control body movements.

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

2. What you need to know before taking Pramipexole Aurovitas

Do not take Pramipexole Aurovitas

• 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 before starting pramipexole.

Talk to your doctor if you have or have had, or develop 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 increase in pramipexole dose.
• Dystonia (inability to maintain an upright posture of the trunk and neck (axial dystonia)). Specifically, you may experience forward bending of the head and neck (also known as antecollis), forward curvature of the lumbar spine (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome). In such cases, your doctor may consider modifying your treatment.
• Somnolence and sudden episodes of sleep.
• Psychosis (e.g., symptoms resembling schizophrenia).
• Vision disturbances. You should undergo periodic eye examinations during treatment with pramipexole.
• 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).
• Worsening of restless legs syndrome. If you notice that symptoms start earlier than usual in the evening (or even in the afternoon), are more intense, affect larger areas of the affected limbs, or affect other limbs. Your doctor may reduce your dose or discontinue treatment.

Inform your doctor if you or your family members/caregivers notice that you are developing urges or cravings to behave in ways that are unusual for you and that you 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 gambling addiction, binge eating, compulsive spending, abnormally increased sex drive, or increased sexual thoughts or feelings. Your doctor may need to adjust or discontinue your dose.

Inform your doctor if you or your family members/caregivers report that you are developing mania (agitation, feelings of euphoria or overexcitement) or delirium (reduced consciousness, confusion, or loss of sense of reality). Your doctor may need to adjust or discontinue 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.

Inform your doctor if you experience difficulty maintaining an upright posture of the trunk and neck (axial dystonia). In such cases, 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 Pramipexole Aurovitas with other medicines

Tell 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 health products, or nutritional supplements obtained without a prescription.

You must avoid using pramipexole together with antipsychotic medicines.

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 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 pramipexole.

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

Taking Pramipexole Aurovitas with food, drinks, and alcohol

Be cautious if you drink alcohol during treatment with pramipexole.

You may take pramipexole with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Your doctor will advise you whether you should continue treatment with pramipexole.

The effect of pramipexole on the fetus is unknown. Therefore, do not take pramipexole during pregnancy unless your doctor specifically instructs you to do so.

Pramipexole must not be used during breastfeeding. Pramipexole may reduce the production of breast milk. It may also pass into breast milk and reach your baby. If pramipexole use is essential, breastfeeding must be discontinued.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Pramipexole may cause somnolence and sudden episodes of sleep, especially in patients with Parkinson’s disease. If this occurs, you must not drive or engage in activities where reduced attention could place you or others at risk of death or serious injury (e.g., operating machinery) until these episodes and/or somnolence have resolved.

3. How to take Pramipexole Aurovitas

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

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

Parkinson's Disease

The daily dose should be taken in three equal doses.

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

	Week 1
Number of tablets	1 tablet of pramipexole 0.088 mg three times daily
Total daily dose (mg)	0.264

This dose will be increased every 5–7 days according to your doctor's instructions, until your symptoms are controlled (maintenance dose).

	Week 2	Week 3
Number of tablets	1 tablet of pramipexole 0.18 mg three times a day or 2 tablets of pramipexole 0.088 three times a day	1 tablet of pramipexole 0.35 mg three times a day or 2 tablets of pramipexole 0.18 mg three times a day
Total daily dose (mg)	0.54	1.1

The usual maintenance dose is 1.1 mg daily. However, your dose may need to be increased further. If necessary, your doctor could 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 pramipexole 0.088 mg tablets per day.

	Minimum maintenance dose	Maximum maintenance dose
Number of tablets	1 tablet of pramipexole 0.088 mg three times daily	1 tablet of pramipexole 0.7 mg and 1 tablet of pramipexole 0.35 mg three times daily
Total daily dose (mg)	0.264	3.15

Patients 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 renal impairment, the usual starting dose is 1 tablet of pramipexole 0.088 mg twice daily. If you have severe renal impairment, the usual starting dose is 1 tablet of pramipexole 0.088 mg once daily.

Restless Legs Syndrome

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

	Week 1
Number of tablets	1 tablet of pramipexole 0.088 mg
Total daily dose (mg)	0.088

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

	2nd week	3rd week	4th week
Number of tablets	tablet of pramipexole 0.18 mg or tablets of pramipexole 0.088 mg	tablet of pramipexole 0.35 mg or tablets of pramipexole 0.18 mg or 4 tablets of pramipexole 0.088 mg	1 tablet of pramipexole 0.35 mg and 1 tablet of pramipexole 0.18 mg or 3 tablets of pramipexole 0.18 mg or 6 tablets of pramipexole 0.088 mg
Total daily dose (mg)	0.18	0.35	0.54

The daily dose for the treatment of restless legs syndrome must 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 wish to restart treatment, you must begin 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 evaluate your treatment after 3 months to decide whether to continue or discontinue therapy.

Patients with renal disease:

If you have severe kidney disease, pramipexole may not be an appropriate 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, agitation, 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 telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pramipexol Aurovitas

Do not worry. Skip 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 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 abruptly stop your treatment with pramipexole. 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 Pramipexol Aurovitas, you may also develop 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 can cause adverse effects, although not everyone will experience 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):

• Urge to behave in an unusual way.
• Hallucinations (seeing, hearing, or feeling things that are not present).
• Confusion.
• Tiredness (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 (may affect up to 1 in 100 people):

• Paranoia (e.g., excessive concern about your health).
• Thought disorder.
• Excessive daytime sleepiness and sudden sleep attacks.
• Amnesia (memory impairment).
• Hyperkinesia (increased movements and inability to remain still).
• Weight gain.
• Allergic reactions (e.g., skin rashes, 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, desire, or temptation to carry out an action that may be harmful to you 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, exaggerated sexual behavior.
  • Uncontrollable urge to spend or shop excessively.
  • Binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite).
• Delirium (disturbance of consciousness, confusion, or loss of sense of reality).

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

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

Frequency not known (cannot be estimated from available data):

• 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 or she will assess how to manage or reduce the symptoms.

For adverse effects marked with *, a precise frequency estimate 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".

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 starting earlier than usual, being more intense, or affecting other limbs (worsening of restless legs syndrome).

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

• Changes in sleep pattern, such as insomnia and somnolence.
• Tiredness (fatigue).
• Headache.
• Abnormal dreams.
• Constipation.
• Dizziness.
• Vomiting (feeling sick).

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

• Urge to behave in an unusual way*.

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

• Inappropriate antidiuretic hormone secretion*.

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

• Hyperkinesia (increased movements and inability to remain still)*.

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

• Delirium*.

• Amnesia (memory impairment)*.

• Hallucinations (seeing, hearing, or feeling things that are not present).

• Confusion.

• Excessive daytime sleepiness and sudden sleep attacks.

• Weight gain.

• Hypotension (low blood pressure).

• Fluid retention, usually in the legs (peripheral edema).

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

• Fainting.

• Restlessness.

• Visual disturbance.

• Weight loss including loss of appetite.

• 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 you or others, including:

  • 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 sexual appetite.*
  • Uncontrollable excessive shopping or spending.*
  • Binge eating (consuming large amounts of food in a short period of time) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger)*

• Mania (agitation, feeling elated or overexcited)*.

• Delirium (reduced consciousness, confusion, loss of touch with reality)*

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

• Spontaneous penile erection.

Frequency not known (cannot be estimated from available data):

• 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 or she will explain how to manage or reduce the symptoms.

For adverse effects marked with *, a precise frequency estimate is not available, as these adverse effects were not observed in clinical trials involving 1,395 patients treated with pramipexole. The frequency category is likely no 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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

Keep out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 components (excipients) are: mannitol (E 421), maize starch, povidone K30, povidone K90, colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and contents of the container

Tablet.

Uncoated white to off-white oval biconvex tablets with bevelled edges, marked on one side with "Y" and "42" separated by a score line, 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 blisters and high-density polyethylene (HDPE) bottles with a polypropylene cap containing cotton.

Pack sizes:

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area (EEA) under the following names:

Denmark Pramipexol "Aurobindo"

France Pramipexole ARROW LAB 0.18 mg tablets

Germany Pramipexol Aurobindo 0.18 mg Tablets

Italy Pramipexole Aurobindo

Malta Pramipexole Aurobindo 0.18 mg Tablets

Portugal Pramipexol Aurobindo, 0.18 mg, Tablets

Spain Pramipexol Aurovitas 0.18 mg tablets EFG

Sweden Pramipexol Aurobindo 0.18 mg tablets

Date of the latest 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/)