Package Leaflet: Information for the User

Pramipexole Cinfa 0.18 mg Tablets

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Pramipexol cinfa contains the active ingredient pramipexol andbelongs 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 the body's movements.

pramipexol cinfa 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 cinfa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take pramipexol cinfa.

Inform your doctor if you have or have had any disease or symptom, especially any of the following:

• Renal 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: Inability to maintain 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 pleurototonus or Pisa syndrome). In this case, your doctor may decide to modify your treatment.
• Drowsiness and sudden episodes of sleep.
• Psychosis (e.g., similar to schizophrenia symptoms).
• 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).
• Increased 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 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 an unusual way in you and you cannot resist the impulse, instinct or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as excessive gaming, excessive eating or spending, abnormally high sexual appetite or excessive concern about an increase in sexual thoughts and feelings.Your doctor may need to adjust or discontinue your dose.

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 or loss of contact with reality).Your doctor may need to adjust or discontinue your dose.

Inform your doctor if you notice 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 few weeks, your doctor may need to adjust your treatment.

Inform your doctor if you are noticing inability to maintain 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.

Other medicines and pramipexol cinfa

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

This includes medicines, herbal remedies, natural foods or nutritional supplements that you have obtained without a prescription. You should avoid using pramipexol 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 immunodeficiency syndrome (AIDS), a human immunological disease)
• cisplatin (to treat 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 (to treat irregular heartbeats).

If you are using levodopa, it is recommended to reduce the levodopa dose 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 cinfa with food, drinks and alcohol

You should 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, consult your doctor or pharmacist before using this medicine. Your doctor will tell you if you should continue treatment with pramipexol.

Pramipexol has not been shown to have an effect on the fetus. 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 necessary, breastfeeding should be discontinued.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Pramipexol may cause drowsiness and sudden episodes of sleep. If this happens, you should not drive vehicles or perform activities in which a lack of attention may put you or others at risk of death or serious harm (e.g., operating machinery), until the episodes and/or drowsiness have disappeared.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will indicate the correct dosage.

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

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 doses 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 0.088 mg twice a day. If you have severe renal insufficiency, the usual starting dose is 0.088 mg per day.

Restless Legs Syndrome

The dose is usually administered once a day, at night, 2-3 hours before bedtime.

During the first week, the usual dose of pramipexol is 0.088 mgonce 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 doses of pramipexol 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexol salt).

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 not with the 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 cinfa than you should

If you accidentally take too many tablets,

• 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 your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take pramipexol cinfa

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 cinfa

Do not stop your treatment with pramipexol without consulting your doctor first. If you need to stop your treatment with this medication, your doctor will gradually reduce your dose. This reduces the risk of worsening your symptoms.

If you have Parkinson's disease, you should not stop your treatment with pramipexol abruptly. Sudden discontinuation 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 stop 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 medicines, this medicine may cause side effects, although not everyone will experience them. The classification of side effects is based on the following frequencies:

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

Very common:

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

Common:

• Need to behave in an unusual way.
• Hallucinations (seeing, hearing, or feeling things that are not there).
• Confusion.
• Fatigue (tiredness).
• Insomnia.
• Excess fluid, usually in the legs (peripheral edema).
• Headache.
• Low blood pressure.
• Abnormal dreams.
• Constipation.
• Visual disturbances.
• Vomiting (urge to vomit).
• Weight loss including loss of appetite.

Uncommon:

• Paranoia (e.g., excessive concern about your health).
• Delusion.
• Excessive daytime somnolence and sudden onset of sleep.
• Amnesia (memory disturbance).
• Hypokinesia (increase in 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*.
• Restlessness.
• Dyspnea (difficulty breathing).
• Hypophonia (soft voice).
• Pneumonia (lung infection)*.
• Inability to resist the impulse, instinct, 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 concerning behavior for you or others, for example, increased sexual appetite*.

-Uncontrollable excessive spending*.

-Binge eating (ingestion of large amounts of food in a short period of time) or compulsive eating (ingestion of more food than normal and more than needed to satisfy hunger)*.

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

Rare:

• Mania (agitation, feeling elated or overexcited).

Frequency not known:

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

Inform your doctor if you experience any of these behaviors; he 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:

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

Common:

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

Uncommon:

• Need to behave in an unusual way*.
• 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 limbs).
• Hypokinesia (increase in movement and inability to remain still)*.
• Paranoia (e.g., excessive concern about your health)*.
• Delusion*.
• Amnesia (memory disturbance)*.
• Hallucinations (seeing, hearing, or feeling things that are not there).
• Confusion.
• Excessive daytime somnolence and sudden onset of sleep.
• Weight gain.
• Low blood pressure.
• Excess fluid, usually in the legs (peripheral edema).
• Allergic reactions (e.g., skin rash, itching, hypersensitivity).
• Syncope (fainting).
• Restlessness.
• Visual disturbances.
• Weight loss including loss of appetite.
• Dyspnea (difficulty breathing).
• Hypophonia (soft voice).
• Pneumonia (lung infection)*.
• Inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you or others, which may include:

• Fuerte impulso de jugar excesivamente a pesar de las serias consecuencias personales o familiares*.
• Interés sexual alterado o aumentado y comportamiento preocupante para usted o para otros, por ejemplo, aumento del apetito sexual*.
• Compra o gasto excesivo incontrolable*.
• Atracón (ingesta de grandes cantidades de comida en un corto periodo de tiempo) o ingesta compulsiva (ingesta de más comida de lo normal y más de la necesaria para satisfacer el hambre)*.

• Manía (agitación, sentirse exaltado o sobreexcitado)*.
• Delirio (disminución de la conciencia, confusión, pérdida de contacto con la realidad)*.

Frequency not known:

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

Inform your doctor if you experience any of these behaviors; he 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box, after CAD. 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 thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Pramipexole cinfa composition

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

Appearance of the product and contents of the packaging

Pramipexole cinfa 0.18 mg tablets are white, oval, and scored.

Pramipexole cinfa is presented in aluminum/aluminum blisters.

Each package contains 30 or 100 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer

Laboratorios Salvat, S.A.

C/ Gall 30-36

08950 Esplugues de Llobregat

Barcelona

SPAIN

Last review date of this leaflet: February 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. 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