PRAMIPEXOL CINFA 0.52 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Pramipexol Cinfa

Do not take Pramipexol Cinfa

• If you are allergic to pramipexol or any of the other components of this medication (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:

• 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 bending of the head and neck (also called antecollis), forward bending of the lumbar region (also called camptocormia), or sideways curvature of the back (also called pleurototonus or Pisa syndrome).
• Somnolence and sudden sleep episodes.
• Psychosis (e.g., similar to symptoms of schizophrenia).
• Visual impairment. You should have regular eye exams 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).

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in an unusual way for you and that you 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 appetite, or increased concern about an increase in sexual thoughts and feelings. Your doctor may need to adjust or interrupt your dose.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling elated or overexcited) or delirium (decreased consciousness, confusion, loss of contact with reality). Your doctor may need to adjust or interrupt 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 notice an inability to keep your 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 to release the active substance gradually once the tablet is ingested. Occasionally, parts of the tablets may be excreted and seen in the feces, which may appear to be whole tablets. Inform your doctor if you find tablet fragments in your feces.

Children and adolescents

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

Taking Pramipexol Cinfa with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes medications, herbal remedies, natural foods, or nutritional supplements that you have obtained without a prescription.

You should avoid using pramipexol with antipsychotic medications.

Be cautious if you are using the following medications:

• 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 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 medications 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 plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will indicate if 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 do so.

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 interrupted.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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 somnolence and sudden sleep episodes. If this happens, you should not drive vehicles or perform activities where a lack of attention may pose a risk, putting you or others in danger of death or serious harm (e.g., using machines), until such episodes and/or somnolence have disappeared.

3. How to take Pramipexol Cinfa

Follow the administration instructions for this medication exactly as 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 at the same time every day.

You can take pramipexol with or without food. The tablets should be swallowed whole with water.

Do not chew, divide, 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 pramipexol tablets up to a maximum of 3.15 mg of pramipexol per day. It is also possible to reduce the maintenance dose to one prolonged-release tablet of pramipexol 0.26 mg per day.

Patient 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 on alternate days during the first week.

After that, your doctor may increase the frequency of administration to one prolonged-release tablet of 0.26 mg per day. If it is necessary 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 to a different pramipexol medication. If your kidney problems worsen during treatment, contact your doctor as soon as possible.

If you are switching from Pramipexol immediate-release tablets

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

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

If you take more Pramipexol Cinfa than you should

• consult your doctor or the nearest hospital emergency department immediately.
• you may experience vomiting, restlessness, or any of the side 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, telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take 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 the usual time.

If you forget to take your dose and more than 12 hours have passed, simply take the next dose at your usual 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 need to stop your treatment with this medication, your doctor will gradually reduce your dose. This reduces the risk of worsening symptoms.

If you have Parkinson's disease, you should not stop your treatment with pramipexol abruptly. Sudden interruption can cause 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).

If you stop or reduce treatment with 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can 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)
• 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 impairment
• Vomiting (nausea)
• Weight loss, including loss of appetite

Uncommon:

• Paranoia (e.g., excessive concern about your health)
• Delusion
• Excessive daytime somnolence and sudden sleep episodes
• 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 you or others, which may include:
• • Strong impulse to gamble excessively despite serious personal or family consequences.*
  • Altered or increased sexual interest and behavior that is concerning for you or others, for example, increased sexual appetite.*
  • Uncontrolled buying or spending.*
  • Binge eating (eating large amounts of food in a short period) or compulsive eating (eating 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: depression, apathy, anxiety, fatigue, sweating, or pain may occur (known as dopamine agonist withdrawal syndrome or DAWS).

Tell 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 an accurate 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".

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pramipexol Cinfa

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

Do not use this medication after the expiration date stated 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 wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pramipexol cinfa

• The active ingredient is pramipexole. Each prolonged-release tablet contains 0.52 mg of pramipexole as 0.75 mg of pramipexole dihydrochloride monohydrate.

• The other components are: hypromellose, calcium hydrogen phosphate, magnesium stearate, and anhydrous colloidal silica.

Appearance of the Product and Package Contents

Pramipexol cinfa 0.52 mg prolonged-release tablets are 10 mm, white or almost white, cylindrical, biconvex tablets with 052 embossed on one side. Each package contains 30 tablets in Alu/Alu-PVC-OPA blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Poligono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Normon, S.A.

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

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Poligono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Prospectus: April 2020

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products http://www.aemps.gob.es

You can access detailed and updated information about this medication 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/80052/P_80052.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80052/P_80052.html