Pramipexole Stada 0.7 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pramipexole Stada 0.7 mg tablets EFG

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Pramipexole Stada

3. How to take Pramipexole Stada

4. Possible side effects

5. How to store Pramipexole Stada

6. Contents of the pack and other information

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

Pramipexol Stada 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 can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
• treat moderate to severe symptoms of idiopathic Restless Legs Syndrome in adults.

2. What you need to know before taking Pramipexol Stada

Do not take Pramipexol Stada

• 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 to take Pramipexol Stada. Inform your doctor if you have or have had any illness 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 taking levodopa, you may develop dyskinesia during the gradual dose increase of pramipexole.

• Dystonia

• Inability to keep your trunk and neck upright (axial dystonia). Specifically, you may experience forward bending of the head and neck (also known as antecollis), forward curvature of the lumbar region (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome).

• Somnolence and sudden episodes of falling asleep.

• Psychosis (e.g. symptoms similar to schizophrenia).

• Vision disorders.

• 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 postural hypotension (a drop in blood pressure upon standing).

• Worsening of restless legs syndrome. If you notice that symptoms start earlier than usual at night (or even in the afternoon), are more intense, affect larger areas of the affected limbs, or affect other limbs. Your doctor may need to reduce your dose or stop treatment.

Inform your doctor if you, your family, or caregivers notice that you are developing urges or impulses to behave in ways that are unusual for you and that you cannot resist the urge, drive, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally increased sex drive, or preoccupation with increased sexual thoughts and feelings. Your doctor may need to adjust or stop your dose.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling elated or overexcited) or delirium (reduced awareness, confusion, loss of touch with 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 an inability to keep your trunk and neck upright (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.

Use of Pramipexol Stada 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 foods, 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 Pramipexol Stada 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 tells you to do so.

Pramipexole must not be used during breastfeeding. Pramipexole may reduce breast milk production. 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 has been associated with somnolence and sudden episodes of falling asleep, especially in patients with Parkinson's disease. If you experience these adverse effects, you must not drive or operate machinery.

Inform your doctor if this happens.

3. How to take Pramipexole Stada

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, ask your doctor. 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 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 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 daily.

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, 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 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 must not exceed 6 tablets of pramipexole 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).

If you stop taking your tablets for several 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 or not to continue the treatment.

Patients with renal disease

If you have severe kidney disease, pramipexole 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:

• 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 adverse effects).

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone (91) 562 04 20.

If you forget to take Pramipexol Stada

Do not worry. Completely skip the missed dose 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 Stada

Do not stop your treatment with pramipexole without 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 interruption 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 pramipexole, you may also experience a medical condition called 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. 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 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 oedema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision disturbances
• Vomiting (feeling sick)
• 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 sleepiness and sudden sleep episodes

• Amnesia (memory impairment)

• Hyperkinesia (increased movements and inability to remain still)

• Weight gain

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

• Fainting

• Heart failure (heart problems that may cause breathlessness or ankle swelling)*

• Inappropriate antidiuretic hormone secretion*

• Restlessness

• Dyspnoea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)

• Inability to resist the impulse, instinct, 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 behaviour concerning to you or others, for example, increased libido.*

• Compulsive buying or spending.*

• 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 hunger)*

• Delirium (reduced consciousness, confusion, loss of touch 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 with pramipexole: depression, apathy, anxiety, fatigue, sweating, or pain may occur (known as dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviours; they 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 among 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, becoming 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 breathlessness or ankle swelling)*
• Inappropriate antidiuretic hormone secretion*
• Dyskinesia (e.g., abnormal involuntary movements of limbs)
• Hyperkinesia (increased movements and inability to remain still)
• Paranoia (e.g., excessive concern about health)
• Delirium
• Amnesia (memory impairment)
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Excessive daytime sleepiness and sudden sleep episodes
• Weight gain
• Hypotension (low blood pressure)
• Fluid retention, usually in the legs (peripheral oedema)
• Allergic reactions (e.g., skin rash, itching, hypersensitivity)
• Fainting
• Restlessness
• Vision disturbances
• Weight loss including loss of appetite
• Dyspnoea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)*
• Inability to resist the impulse, desire, or temptation to perform an action that could be harmful to you or others, which may include:
• Strong urge to gamble despite serious personal or family consequences.
• Altered or increased sexual interest and behaviour that may concern you or others, for example, increased libido.*
• Excessive and uncontrolled buying or spending.*
• Overeating (large amounts of food in a short period of time) or compulsive eating (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)*

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).

Inform your doctor if you experience any of these behaviours; they will advise you on ways to control 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 among 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Stada

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

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

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point located at pharmacies. If you are unsure, ask your pharmacist how to properly discard unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pramipexol Stada

The active substance is pramipexole.

Each tablet of Pramipexol Stada contains 0.7 mg of pramipexole (as pramipexole dihydrochloride monohydrate).

The other components are:

Betadex
Corn starch
Povidone K 30
Microcrystalline cellulose
Anhydrous colloidal silica
Magnesium stearate

Appearance of the product and contents of the pack

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

Pramipexol Stada 0.7 mg tablets are available in blister packs of 10 tablets per strip, in boxes containing 3, 6, 10 or 2 x 10 blister strips (30, 60, 100 or 200 (2 x 100) tablets).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

STADA Arzneimittel AG
Stadastraße 2 – 18
D-61118 Bad Vilbel
Germany

or

Clonmel Healthcare 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 under the following names:

DE: Pramipexol Stada 0.7 mg Tabletten
DK: Pramipexol Stada 0,7 mg tabletter
FI: Pramipexol Stada 0,7 mg tabletti
FR: PRAMIPEXOLE EG 0,7 mg comprimé
HU: Pramipexol Stada 0,7 mg tabletta
IE: Miramel 0.7 mg tablets
IT: Pramipexolo EG 0,7 mg compresse
LU: Pramipexole EG 0,7 mg comprimés
PL: Pramipexol Stada 0,7 mg tabletki
RO: Pramipexol Stada 0,7 mg comprimate
SK: Pramipexol Stada 0,7 mg tablety
ES: Pramipexol Stada 0,7 mg comprimidos EFG
SE: Pramipexol Stada 0,7 mg tabletter
NL: Pramipexol CF 0,7 mg tabletten

Date of the most recent revision of this leaflet: March 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/