Package Insert: Information for the Patient

Pramipexol Stada 0.18 mg Tablets EFG

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What you need to know before starting to take Pramipexol Stada
2. How to take Pramipexol Stada

1. Possible adverse effects

1. Storage of Pramipexol Stada

1. Contents of the package and additional information

Pramipexol Stada contains the active substance pramipexol and belongs to a group of medicines called dopamine agonists that stimulate dopamine receptors in the brain. Stimulation of dopamine receptors triggers nerve impulses in the brain that help control the body's movements.

Pramipexol 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).

- treating the symptoms of moderate to severe idiopathic Restless Legs Syndrome in adults.

Do not take Pramipexol Stada

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

Warnings and precautions

Consult your doctor before starting to take Pramipexol Stada. 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 using levodopa, you may experience dyskinesia during the progressive increase in pramipexol dosage.
• Dystonia
• Difficulty maintaining the trunk and neck straight and upright (axial dystonia). Specifically, you may experience forward flexion of the head and neck (also known as antecolis), forward curvature of the lumbar region (also known as camptocormia) or lateral curvature of the back (also known as pleurototonos or Pisa syndrome).

• Drowsiness and sudden episodes of sleep.
• Psychosis (e.g. similar to symptoms of schizophrenia).
• Visual disturbances.
• You should undergo periodic eye examinations during treatment with pramipexol.
• Severe heart or blood vessel disease. You should undergo periodic blood pressure checks, especially at the beginning of treatment, to avoid postural hypotension (a drop in blood pressure when standing up).
• Worsening of restless legs syndrome. If you experience symptoms starting earlier than usual in the evening (or even in the afternoon), are more intense, or affect larger areas of the affected limbs or other limbs, your doctor may reduce your dosage or discontinue treatment.

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in an unusual way that you cannot resist, which may harm you or others. This is known as impulse control disorder and may include behaviors such as excessive gaming, eating, or spending, abnormal high sex drive, or excessive concern about increased thoughts and feelings of sex. Your doctor may need to adjust or discontinue your dosage.

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

Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with pramipexol. If the problems persist for more than a week, your doctor may need to adjust your treatment.

Inform your doctor if you notice difficulty maintaining 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

Pramipexol is not recommended for use in children or adolescents under 18 years old.

Use of Pramipexol Stada with other medications

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

Avoid using pramipexol 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 to treat Parkinson's disease);
• mexiletine (for the treatment of irregular heartbeats, a condition known as ventricular arrhythmia);
• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a human immunological disease);
• cisplatin (for treating 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 malignant malaria);
• procainamide (for treating irregular heartbeats).

If you are using levodopa, it is recommended to reduce the levodopa dosage when starting treatment with pramipexol.

Be cautious if you are using sedative tranquilizers or if you drink alcohol. In these cases, pramipexol may affect your ability to drive and operate machinery.

Taking Pramipexol Stada with food, drinks, and alcohol

Be cautious if you drink alcohol during treatment with pramipexol. You can take pramipexol with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.Your doctor will tell you if you should continue treatment with pramipexol.

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

Pramipexol should not be used during breastfeeding. Pramipexol may decrease milk production. Additionally, it may pass into breast milk and reach your baby. If the use of pramipexol is essential, breastfeeding should be discontinued.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Pramipexol 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 drowsiness and sudden episodes of sleep, especially in patients with Parkinson's disease. If you experience these adverse effects, do not drive or operate machinery.

Inform your doctor if this happens.

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, ask your doctor. Your doctor will indicate the correct dosage.

You can take pramipexol 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 pramipexol tablet 0.088 mg three times a day (equivalent to 0.264 mg per day):

This dose will be increased every 5-7 days as indicated by your doctor, 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 dose of tablets up to a maximum of 3.3 mg of pramipexol per day. It is also possible to reduce the maintenance dose to three tablets of pramipexol 0.088 mg per day.

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 insufficiency, the usual starting dose is 1 tablet of pramipexol 0.088 mg twice a day. If you have severe renal insufficiency, the usual starting dose is 1 tablet of pramipexol 0.088 mg per day.

Restless Legs Syndrome

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

This dose will be increased every 4-7 days as indicated by your doctor, until your symptoms are controlled (maintenance dose).

The daily dose for the treatment of restless legs syndrome should not exceed 6 tablets of pramipexol 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexol base).

If you stop taking your tablets for a few days and want to resume 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 evaluate your treatment after 3 months to decide whether to continue or discontinue treatment.

Patients with kidney disease

If you have severe kidney disease, pramipexol may not be an appropriate treatment for your restless legs syndrome.

If you take more Pramipexol Stada than you should

If you accidentally take too many tablets, consult your doctor or the nearest hospital emergency service immediately.

• Consult your doctor or the nearest hospital emergency service immediately.
• You may experience vomiting, restlessness, or any of the adverse effects described in section 4 (Possible adverse effects).

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone (91) 562 04 20.

If you forgot to take Pramipexol Stada

Don't worry. Omit that dose completely and take the next dose at the correct time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pramipexol Stada

Do not stop your treatment with pramipexol without consulting your doctor. 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 pramipexol abruptly.

A sudden interruption may cause the appearance of a condition called neuroleptic malignant syndrome, which can represent a very 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 interrupt treatment or reduce the dose of pramipexol, 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 other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them. If you have Parkinson's disease, you may experience the following side effects:

Very common(may affect more than 1 in 10 people)

• Dyskinesia (e.g., abnormal involuntary movements of the extremities)
• Drowsiness
• Dizziness
• Nausea

Common(may affect up to 1 in 10 people)

• Unusual behavior
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Fatigue
• Insomnia
• Peripheral edema (excess fluid, usually in the legs)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (urge to vomit)
• Weight loss, including loss of appetite

Uncommon(may affect up to 1 in 100 people)

• Paranoia (e.g., excessive concern about health)
• Delirium
• Excessive daytime somnolence and sudden sleep episodes
• Amnesia (memory alteration)
• Hypokinesia (decreased movement and inability to remain still)
• Weight gain
• Allergic reactions (e.g., skin rash, itching, hypersensitivity)
• Syncope (fainting)
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of antidiuretic hormone*
• Anxiety
• Dyspnea (difficulty breathing)
• Hypophonia (low voice)
• Pneumonia (lung infection)*
• Inability to resist the impulse, desire, 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 may concern you or others, for example, increased sexual desire.*
• Uncontrolled excessive 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 (diminished consciousness, confusion, loss of contact with reality)

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

• Mania (agitation, feeling elated or overexcited)

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

• After stopping or reducing treatment withpramipexol: 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; they will explain how to manage or reduce the symptoms.

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

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

Very common(may affect more than 1 in 10 people)

• Nausea
• Symptoms that start earlier than usual, are more intense, or affect other extremities (increased restless legs syndrome).

Common(may affect up to 1 in 10 people)

• Change in sleep pattern, such as insomnia and somnolence
• Fatigue
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (urge to vomit)

Uncommon(may affect up to 1 in 100 people)

• Unusual behavior*
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of antidiuretic hormone*
• Dyskinesia (e.g., abnormal involuntary movements of the extremities)
• Hypokinesia (decreased movement and inability to remain still)
• Paranoia (e.g., excessive concern about health)
• Delirium
• Amnesia (memory alteration)
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Excessive daytime somnolence and sudden sleep episodes
• Weight gain
• Hypotension (low blood pressure)
• Peripheral edema (excess fluid, usually in the legs)
• Allergic reactions (e.g., skin rash, itching, hypersensitivity)
• Syncope (fainting)
• Anxiety
• Visual disturbances
• Weight loss, including loss of appetite
• Dyspnea (difficulty breathing)
• Hypophonia (low voice)
• Pneumonia (lung infection)*
• Impossibility of resisting the impulse, desire, or temptation to perform an action that could 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 may concern you or others, for example, increased sexual desire.*
• Uncontrolled excessive 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)*
• Mania (agitation, feeling elated or overexcited)*
• Delirium (diminished consciousness, confusion, loss of contact with reality)*

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

• After stopping or reducing treatment withpramipexol: 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; they will explain how to manage or reduce the symptoms.

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pramipexol Stada

The active ingredient is pramipexol.

Each Pramipexol Stada tablet contains 0.18 mg of pramipexol (as dihydrochloride monohydrate of pramipexol).

The other components are:

Betadex

Maize starch

Povidone K 30

Microcrystalline cellulose

Anhydrous colloidal silica

Magnesium stearate

Appearance of the product and contents of the package

White to off-white, oval, scored on both sides. The tablet can be divided into two equal halves.

Pramipexol Stada 0.18 mg tablets are presented in blisters of 10 tablets per strip, in boxes containing 3, 6, 10 or 2 x 10 strips of blisters (30, 60, 100 or 200 (2 x 100) tablets).

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastraße 2 – 18

D-61118 Bad Vilbel

Germany

or

Clonmel Healtcare Ltd.

Waterford Road, Clonmel,

Co. Tipperary

Ireland

or

LAMP SANPROSPERO S.p.A

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

This medicinal product has been authorized in the Member States of the EEA with the following names:

BE:Pramipexole EG0.18 mgtablets

DE:Pramipexol Stada 0.18 mg Tabletten

DK:Pramipexol Stada 0,18 mg tabletter

FI:Pramipexol Stada 0,18 mg tabletti

FR:PRAMIPEXOLE EG 0,18 mg comprimé

HU:Pramipexol Stada 0,18 mg tabletta

IE:Miramel 0.18 mg tablets

IT:Pramipexolo EG 0,18 mg compresse

LU:Pramipexole EG 0,18 mg comprimés

PL:Pramipexol Stada 0,18 mg tabletki

RO:Pramipexol Stada 0,18 mg comprimate

SK:Pramipexol Stada 0,18 mg tablety

ES:Pramipexol Stada 0,18 mg comprimidos EFG

SE:Pramipexol Stada 0,18 mg tabletter

Last review date of this leaflet:March 2024

The detailed and updated information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

/