PRAMIPEXOL CINFA 0.7 mg TABLETS

2. What you need to know before you take pramipexol cinfa

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.

Tell 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 gradual increase in pramipexol dose.
• Dystonia: Inability to keep the trunk and neck straight and upright (axial dystonia). In particular, you may experience forward flexion of the head and neck (also called antecollis), forward curvature of the lumbar region (also called camptocormia), or sideways curvature of the back (also called pleurothotonus or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• Somnolence and sudden episodes of sleep.
• Psychosis (e.g., similar to symptoms of schizophrenia).
• Visual impairment.
• You should have regular eye examinations during treatment with pramipexol.
• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the start of treatment, to avoid postural hypotension (a drop in blood pressure when standing up).
• Increased Restless Legs Syndrome. If you experience that symptoms start earlier than usual at night (or even in the afternoon), are more intense, or affect more extensive parts of the affected limbs or affect other limbs. Your doctor may reduce your dose or interrupt treatment.

Tell your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave abnormally and cannot resist the impulse, instinct, or temptation to perform certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sexual desire, or increased thoughts and feelings of sex. Your doctor may need to adjust or interrupt your dose.

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

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

Tell your doctor if you notice inability to keep the trunk and neck straight and upright (axial dystonia). In this case, your doctor may choose to adjust or modify your treatment.

Children and adolescents

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

Other medicines and pramipexol cinfa

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

This includes medicines, herbal remedies, natural products, 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 immune deficiency syndrome (AIDS), a disease of the human immune system)
• cisplatin (for the treatment of 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 the treatment of irregular heartbeat).

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 medicines 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you should continue treatment with pramipexol.

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Pramipexol may cause somnolence and sudden episodes of sleep. If this happens, do not drive vehicles or perform activities where a lack of attention may put you or others at risk of death or serious harm (e.g., using machines), until such episodes and/or somnolence have disappeared.

3. How to take pramipexol cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 0.088 mg tablet 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 per day. However, it may be necessary to increase your dose further. If necessary, your doctor may increase your tablet dose 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.

Patient 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 kidney failure, the usual starting dose is 0.088 mg twice a day. If you have severe kidney failure, the usual starting dose is 0.088 mg once a day.

Restless Legs Syndrome

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

During the first week, the usual dose of pramipexol is 0.088 mg once a day (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 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 restart 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 doubts.

Your doctor will assess your treatment after 3 months to decide whether to continue or not with the treatment.

Patient with kidney disease:

If you have severe kidney disease, pramipexol may not be a suitable treatment for your Restless Legs Syndrome.

If you take more pramipexol cinfa than you should

If you accidentally take too many tablets,

• contact your doctor or the nearest hospital emergency department immediately,
• you may experience vomiting, restlessness, or any of the adverse effects described in section 4 “Possible side 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 medicine and the amount taken.

If you forget to take pramipexol cinfa

Do not worry. Omit that dose completely 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 cinfa

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

If you have Parkinson's disease, do not stop your treatment with pramipexol abruptly. Sudden interruption can cause a disorder called neuroleptic malignant syndrome, which can be a 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 suffer from a medical disorder 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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 the limbs).
• Somnolence.
• Dizziness.
• Nausea.

Common:

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

Uncommon:

• Paranoia (e.g., excessive concern for one's health).
• Delusion.
• Excessive daytime somnolence and sudden episodes of sleep.
• Amnesia (memory impairment).
• Hyperkinesia (increased movement and inability to remain still).
• Weight gain.
• Allergic reactions (e.g., skin rash, itching, hypersensitivity).
• Fainting.
• Heart failure (heart problems that can cause shortness of breath or swelling of the ankles)*.
• Inadequate secretion of antidiuretic hormone*.
• Restlessness.
• Dyspnea (difficulty breathing).
• Hiccup.
• Pneumonia (lung infection).
• Inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, including:

• Strong impulse to gamble excessively despite serious personal or family consequences*.
• Altered or increased sexual interest and disturbing behavior for you or others, for example, increased sexual appetite*.
• Uncontrolled excessive shopping or spending*.
• Binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming more food than normal and more than necessary 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 pramipexole: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS) may occur.

Tell your doctor if you experience any of these behaviors; he will explain how to manage or reduce the symptoms.

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

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

Very Common:

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

Common:

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

Uncommon:

• Need to behave in an unusual way*.
• Heart failure (heart problems that can cause shortness of breath or swelling of the ankles)*.
• Inadequate secretion of antidiuretic hormone*.
• Dyskinesia (e.g., abnormal involuntary movements of the limbs).
• Hyperkinesia (increased movement and inability to remain still)*.
• Paranoia (e.g., excessive concern for one's health)*.
• Delusion*.
• Amnesia (memory impairment)*.
• Hallucinations (seeing, hearing, or feeling things that are not present).
• Confusion.
• Excessive daytime somnolence and sudden episodes of sleep.
• Weight gain.
• Hypotension (low blood pressure).
• Excess fluid, usually in the legs (peripheral edema).
• Allergic reactions (e.g., skin rash, itching, hypersensitivity).
• Fainting.
• Restlessness.
• Visual disturbance.
• Weight loss, including loss of appetite.
• Dyspnea (difficulty breathing).
• Hiccup.
• Pneumonia (lung infection)*.
• Inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, including:
• • Strong impulse to gamble excessively despite serious personal or family consequences*.
  • Altered or increased sexual interest and disturbing behavior for you or others, for example, increased sexual appetite*.
  • Uncontrolled excessive shopping or spending*.
  • Binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming more food than normal and more than necessary to satisfy hunger)*.

• Mania (agitation, feeling elated or overexcited)*.
• Delirium (decreased consciousness, confusion, loss of contact with reality)*.

Frequency Not Known:

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

Tell your doctor if you experience any of these behaviors; he will explain how to manage or reduce the symptoms.

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

Reporting of Adverse Effects

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

Medicines should not be thrown away through the drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Pramipexole Cinfa

• The active ingredient is pramipexole. Each Pramipexole Cinfa 0.7 mg tablet contains 0.7 mg of pramipexole base (as 1.0 mg of pramipexole dihydrochloride monohydrate).
• The other components are: mannitol (E-421), cornstarch, colloidal anhydrous silica, povidone (E-1201), magnesium stearate (E-470b).

Appearance of the Product and Package Contents

Pramipexole Cinfa 0.7 mg tablets are white and cylindrical with the code "PA" in relief. The tablets are scored.

Pramipexole Cinfa is presented in aluminum/aluminum blisters.

Each package 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 Last Revision of this Prospectus:February 2024

Detailed information about 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 updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72270/P_72270.html

QR code to: https://cima.aemps.es/cima/dochtml/p/72270/P_72270.html