Pramipexole CINFA 0.18 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

pramipexole cinfa 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, as 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, and you should not give it to others, even if they have the same symptoms as you, because 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.

Leaflet contents

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

1. What pramipexole cinfa is and what it is used for

Pramipexole cinfa contains the active substance pramipexole and belongs to a group of medicines called dopaminergic agonists, which stimulate dopamine receptors in the brain. Stimulation of dopaminergic receptors triggers nerve impulses in the brain that help control body movements.

pramipexole cinfa is used for:

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

2. What you need to know before taking pramipexole cinfa

Do not take pramipexole cinfa

• 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 or pharmacist before starting to take pramipexole cinfa.

Inform your doctor if you have or have had 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 dose increase of pramipexole.
• Dystonia: Inability to keep the trunk and neck straight and 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). In such cases, your doctor may consider modifying your treatment.
• Somnolence and sudden episodes of falling asleep.
• Psychosis (e.g., symptoms resembling schizophrenia).
• Vision disturbances.
• You should undergo regular eye examinations during treatment with pramipexole.
• Severe heart or blood vessel disease. You should have periodic 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 begin 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, your family, or caregivers notice that you are developing impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, instinct, 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 symptoms of mania (agitation, feeling elated or overexcited) or delirium (reduced awareness, confusion, or loss of touch with reality). Your doctor may need to adjust or stop 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 notice an inability to keep your trunk and neck straight and 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.

Other medicines and pramipexole cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This includes herbal remedies, natural foods, or nutritional supplements obtained without a prescription. You should 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 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 or drinking alcohol. In these cases, pramipexole may affect your ability to drive or operate machinery.

Taking pramipexole cinfa with food, drinks, and alcohol

Exercise caution 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 or pharmacist 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 instructs you to do so.

Pramipexole should not be used during breastfeeding. Pramipexole may reduce the production of breast milk and may pass into breast milk, reaching 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 drowsiness and sudden episodes of falling asleep. If this occurs, you must not drive or engage in activities where lack of attention could place you or others at risk of death or serious injury (e.g., operating machinery) until these episodes and/or drowsiness have resolved.

3. How to take pramipexole cinfa

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

You may take pramipexole with or without food. The tablets should be swallowed with water. The tablet may be divided into equal doses.

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 daily doses of pramipexole 0.088 mg.

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 0.088 mg twice daily. If you have severe renal impairment, the usual starting dose is 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 of pramipexole is 0.088 mg once daily (equivalent to 0.088 mg daily):

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 doses of 0.088 mg pramipexole or 1 dose of 0.54 mg (0.75 mg 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 for your restless legs syndrome.

If you take more pramipexole cinfa than you should

If you accidentally take too many tablets:

• consult 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 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 pramipexole cinfa

Do not worry. Skip that dose entirely 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 pramipexole cinfa

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, do not stop treatment with pramipexole abruptly. Sudden discontinuation may lead to 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 discontinue treatment or reduce the dose of pramipexole, you may also experience 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 may 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:

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

Common:

• Urge to behave in an unusual manner.
• 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 disturbances.
• Vomiting (feeling of vomiting).
• Weight loss including loss of appetite.

Uncommon:

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

• Delusion.

• Excessive daytime sleepiness and sudden episodes of falling asleep.

• Amnesia (memory impairment).

• Hyperkinesia (increased movements and inability to stay 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 secretion of antidiuretic hormone*.

• Restlessness.

• Dyspnea (difficulty breathing).

• Hiccups.

• Pneumonia (lung infection).

• Inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you or others, possibly 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 libido*.

• Compulsive buying or uncontrolled excessive 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:

• Mania (agitation, feeling elated or overexcited).

Frequency not known:

• After stopping or reducing pramipexole treatment: 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 behaviors; he/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 2,762 patients treated with pramipexole. The frequency category is likely no higher than "uncommon".

If you haveRestless Legs Syndrome**, you may experience the following adverse effects:

Very common:

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

Common:

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

Uncommon:

• Urge to behave in an unusual manner*.

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

• Inappropriate secretion of antidiuretic hormone*.

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

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

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

• Delusion*.

• Amnesia (memory impairment)*.

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

• Confusion.

• Excessive daytime sleepiness and sudden episodes of falling asleep.

• 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 disturbances.

• Weight loss including loss of appetite.

• Dyspnea (difficulty breathing).

• Hiccups.

• Pneumonia (lung infection)*.

• Inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you or others, possibly 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 libido*.
  • Compulsive buying or uncontrolled excessive 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)*.

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

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

Frequency not known:

• After stopping or reducing pramipexole treatment: 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 behaviors; he/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 reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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 reactions, you can help provide more information on the safety of this medicine.

5. Storage of pramipexole cinfa

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

Do not use this medicine after the expiry date stated on the carton, after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of pramipexol cinfa

• The active substance is pramipexole. Each pramipexol cinfa 0.18 mg tablet contains 0.18 mg of pramipexole base (as 0.25 mg of pramipexole dihydrochloride monohydrate).
• The other components are: mannitol (E-421), corn starch, colloidal anhydrous silica, povidone (E-1201), magnesium stearate (E-470b).

Appearance of the product and contents of the pack

pramipexol cinfa 0.18 mg tablets are white, oblong, and scored.

pramipexol cinfa is available in aluminum/aluminum blisters.

Each pack contains 30 or 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Salvat, S.A.

C/ Gall 30-36

08950 Esplugues de Llobregat

Barcelona

SPAIN

Date of the most recent review of this summary: February 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/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72269/P_72269.html

QR code to: https://cima.aemps.es/cima/dochtml/p/72269/P_72269.html