Leaflet: information for the user

Pramipexol cinfa 1.57 mg prolonged-release tablets EFG

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.

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

2.What you need to know before starting to take Pramipexol cinfa

3.How to take Pramipexol cinfa

4.Possible side effects

5.Storage of Pramipexol cinfa

6.Contents of the pack and additional information

Pramipexol cinfa contains the active ingredient pramipexol and belongs 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 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).

Do not take Pramipexol cinfa

• If you are allergic to pramipexol or 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 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 dose.
• 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 antecollis), forward curvature of the lumbar region (also known as camptocormia), or lateral curvature of the back (also known as pleurototonus or Pisa syndrome).
• 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).

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in an unusual way and that 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, eating, or spending, abnormally high sexual appetite, or excessive concern about increased 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 (diminished consciousness, confusion, 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 experiencing difficulty maintaining the trunk and neck straight and upright (axial dystonia). In this case, your doctor may decide to adjust or modify your treatment.

Pramipexol cinfa prolonged-release tablets are specially designed tablets that release the active ingredient gradually once the tablet is ingested. Occasionally, parts of the tablets may be excreted and appear in the stool, which may resemble intact tablets. Inform your doctor if you find fragments of tablets in your stool.

Children and adolescents

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

Taking Pramipexol cinfa with other medicines

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.

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 immunodeficiency 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 falciparum malaria (malignant malaria))
• procainamide (for treating 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 tranquilizers (sedative effect) 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

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 or plan to become pregnant, consult your doctor or pharmacist before using this medicine. 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, pramipexol 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 hallucinations (seeing, hearing, or feeling things that are not present). If this happens, do not drive or operate machinery.

Pramipexol may cause drowsiness and sudden episodes of sleep. If this happens, do not drive vehicles or perform activities that require attention, as they may pose a risk to you or others.

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.

Take pramipexol prolonged-release tablets once a day and at the same hour every day.

Pramipexol can be taken with or without food. The tablets should be swallowed whole with water.

Do not chew, break, or crush the prolonged-release tablets. If you do, there is a risk of overdose, as the medication may be released in your body too quickly.

During the first week, the usual daily dose is 0.26 mg of pramipexol.

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

The recommended maintenance dose is 1.05 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 3.15 mg of pramipexol per day. It is also possible to reduce the maintenance dose to 1 prolonged-release pramipexol 0.26 mg tablet per day.

Patients with kidney disease

If you have kidney disease, your doctor may advise you to take the recommended starting dose of 0.26 mg prolonged-release tablets every other day during the first week.

After that, your doctor may increase the frequency of doses to 1 prolonged-release pramipexol 0.26 mg tablet per day. If you need to increase your dose further, your doctor may adjust your dose in increments of 0.26 mg of pramipexol.

If you have severe kidney disease, your doctor may consider it necessary to switch you to a different pramipexol medication. If your kidney problems worsen during treatment, contact your doctor as soon as possible.

Switching from Pramipexol immediate-release tablets

Your doctor will base your pramipexol prolonged-release tablet dose on the dose of pramipexol immediate-release tablets you were taking.

The day before switching, take your pramipexol immediate-release tablets as you normally would. The next morning, take your pramipexol prolonged-release tablet and do not take any additional pramipexol immediate-release tablets.

Accidental overdose of Pramipexol cinfa

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.

Missing a dose of Pramipexol cinfa

If you forget to take your pramipexol dose, but remember to take it within 12 hours of your usual time, take your tablet and continue with the next tablet at your usual time.

If you forget to take your dose more than 12 hours after your usual time, simply take the next dose at your usual time. Do not take a double dose to make up for the missed doses.

Stopping 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, do not stop your treatment with pramipexol abruptly. Sudden discontinuation may cause the onset of a condition called neuroleptic malignant syndrome, which can pose a significant 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).

Stopping treatment or reducing the dose of pramipexol cinfa may also cause a medical condition called dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, contact your doctor.

If you have any other questions about using 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:

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 present)
• Confusion
• Fatigue (tiredness)
• 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:

• Paranoia (e.g. excessive concern about your health)
• Delusion
• Excessive daytime somnolence and sudden onset of sleep
• Amnesia (memory alteration)
• Hypokinesia (increase in movements 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 the antidiuretic hormone*
• Anxiety
• Dyspnea (difficulty breathing)
• Hypophonia (low 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 or compulsive buying.*
  • 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 interrupting 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 between 2,762 patients treated with pramipexol. The frequency category is likely to be no 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 Pharmacovigilance 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 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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Pramipexol cinfa Composition

• The active ingredient is pramipexol. Each prolonged-release tablet contains 1.57 mg of pramipexol as 2.25 mg of dihydrochloride monohydrate of pramipexol.
• The other components are: hypromellose, calcium hydrogen phosphate, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and content of the packaging

Pramipexol cinfa 1.57 mg prolonged-release tablets are 10 mm, white or almost white, cylindrical, biconvex tablets with "157" written in relief on one face. Each package contains 30 tablets in an Alu/Alu-PVC-OPA blister.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

or

Ferrer Internacional, S.A.

Joan Buscallà, 1-9, 08173 Sant Cugat del Vallés, Barcelona (SPAIN)

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: April 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Deviceshttp://www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/80054/P_80054.html

QR code to:https://cima.aemps.es/cima/dochtml/p/80054/P_80054.html