PRAMIPEXOL SANDOZ FARMACEUTICA 2.1 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Pramipexole Sandoz Pharmaceutical

Do not take Pramipexole Sandoz Pharmaceutical

If you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before taking Pramipexole Sandoz Pharmaceutical. 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.
• 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 pleurotonus or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• Discinesia (e.g., abnormal involuntary movements of the limbs).

If you have advanced Parkinson's disease and are also using levodopa, you may experience discinesia during the gradual increase in the dose of Pramipexole Sandoz Pharmaceutical.

• Somnolence and episodes of sudden sleep.

• Psychosis (e.g., similar to symptoms of schizophrenia).
• Visual impairment.

You should undergo regular eye examinations during treatment with Pramipexole Sandoz Pharmaceutical.

• Severe heart or blood vessel disease.

You should undergo regular blood pressure checks, especially at the beginning of treatment, in order 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 abnormally and that you cannot resist the impulse, instinct, or temptation to carry out 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 preoccupation with an increase in sexual thoughts and feelings. Your doctor may need to adjust or stop the 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 pramipexole. If the problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Pramipexole prolonged-release tablets are specially designed tablets from which the active substance is gradually released 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

Pramipexole Sandoz Pharmaceutical is not recommended for use in children or adolescents under 18 years of age.

Other medicines and Pramipexole Sandoz

Inform 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 pramipexole 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 disease of the human immune system),
• cisplatin (for the treatment of various types of cancer),
• quinine (which may be used for the prevention of painful leg cramps that occur at night and for the treatment of 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 dose of levodopa when starting treatment with Pramipexole Sandoz Pharmaceutical.

Be cautious if you are using sedative medicines (with a sedative effect) or if you drink alcohol. In these cases, pramipexole may affect your ability to drive and operate machinery.

Taking Pramipexole Sandoz Pharmaceutical with food, drinks, and alcohol

You should be cautious if you drink alcohol during treatment with pramipexole.

You can take pramipexole with or without food.

Pregnancy, breastfeeding, and fertility

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 pramipexole.

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

Pramipexole should not be used during breastfeeding. Pramipexole may decrease milk production. Additionally, pramipexole may pass into breast milk and reach your baby. If the use of pramipexole is essential, breastfeeding should be discontinued.

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

Driving and using machines

Pramipexole may cause hallucinations (seeing, hearing, or feeling things that are not present). If this happens, do not drive or operate machinery.

Pramipexole has been associated with somnolence and episodes of sudden sleep, especially in patients with Parkinson's disease. If you experience these side effects, do not drive or operate machinery. Inform your doctor if this happens.

3. How to take Pramipexole Sandoz Pharmaceutical

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will tell you the correct dosage.

Take Pramipexole Sandoz Pharmaceutical prolonged-release tablets once a day at the same time each day.

You can take pramipexole 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 overdosing, as the medicine may be released in your body too quickly.

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

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 1.05 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 pramipexole per day. It is also possible to reduce the maintenance dose to one prolonged-release tablet of Pramipexole Sandoz Pharmaceutical 0.26 mg per day.

Patient with renal disease

If you have kidney disease, your doctor may advise you to take the usual 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 every day. If it is necessary to increase your dose further, your doctor may adjust your dose in levels of 0.26 mg of pramipexole.

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

If you are switching from Pramipexole immediate-release tablets

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

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

If you take more Pramipexole Sandoz Pharmaceutical than you should

If you accidentally ingest too many tablets,

• contact 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).

If you have taken more Pramipexole Sandoz Pharmaceutical than you should, contact your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Pramipexole Sandoz Pharmaceutical

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

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

If you stop taking Pramipexole Sandoz Pharmaceutical

Do not stop taking Pramipexole Sandoz Pharmaceutical without consulting your doctor first. If you need to stop taking this medicine, your doctor will reduce your dose gradually. This reduces the risk of worsening symptoms.

If you have Parkinson's disease, you should not stop taking pramipexole suddenly. Sudden interruption can cause a condition called neuroleptic malignant syndrome, which can be a serious risk to your health. These symptoms include:

• akinesia (loss of muscle movement),
• muscle stiffness,
• fever,
• unstable blood pressure,
• tachycardia (increased heart rate),
• confusion,
• decreased level of consciousness (e.g., coma).

If you stop taking Pramipexole Sandoz Pharmaceutical or reduce the dose, 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 further questions on the use of this medicine, 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:

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
• Restlessness
• Amnesia (memory impairment)
• 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 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 yourself or others, which may include:
• • Strong impulse to gamble excessively despite serious personal or family consequences.*
  • Altered or increased sexual interest and behavior that may be concerning to 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 needed to satisfy hunger).*
• Delirium (decreased consciousness, confusion, loss of contact with reality).

Rare:

• Mania (agitation, feeling elated or overexcited)
• Spontaneous erection of the penis.

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.

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

For the 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 probably 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. Conservation of Pramipexol Sandoz Farmacéutica

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

Do not use this medicine after the expiration date that appears on the packaging after "CAD/EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

6. Content of the Packaging and Additional Information

Composition of Pramipexol Sandoz Farmacéutica 0.26 mg

• The active ingredient is pramipexole. Each tablet contains 0.26 mg of pramipexole as 0.375 mg of pramipexole dihydrochloride monohydrate.
• The other ingredients are: hypromellose, calcium phosphate dibasic, magnesium stearate, and anhydrous colloidal silica.

Composition of Pramipexol Sandoz Farmacéutica 1.05 mg

• The active ingredient is pramipexole. Each tablet contains 1.05 mg of pramipexole as 1.5 mg of pramipexole dihydrochloride monohydrate.
• The other ingredients are: hypromellose, calcium phosphate dibasic, magnesium stearate, and anhydrous colloidal silica.

Composition of Pramipexol Sandoz Farmacéutica 2.1 mg

• The active ingredient is pramipexole. Each tablet contains 2.1 mg of pramipexole as 3 mg of pramipexole dihydrochloride monohydrate.
• The other ingredients are: hypromellose, calcium phosphate dibasic, magnesium stearate, and anhydrous colloidal silica.

Appearance of the Product and Content of the Packaging

Pramipexol Sandoz Farmacéutica 0.26 mg are prolonged-release tablets, white or almost white, cylindrical, flat and beveled, marked with 026 on one face. Each packaging contains 30 tablets.

Pramipexol Sandoz Farmacéutica 1.05 mg are prolonged-release tablets, white or almost white, cylindrical and biconvex, marked with 105 on one face. Each packaging contains 30 tablets.

Pramipexol Sandoz Farmacéutica 2.1 mg are prolonged-release tablets, white or almost white, cylindrical and biconvex, marked with 210 on one face. Each packaging contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

LABORATORIOS NORMON, 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)

Date of the Last Revision of this Prospectus: January 2025

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/