PRAMIPEXOL NORMON 0.52 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Pramipexole NORMON

Do not take Pramipexole NORMON

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 or pharmacist before starting treatment with Pramipexole NORMON. 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 the dose of Pramipexole NORMON.
• 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 bending to the sides (also called pleurototonos or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• Somnolence and sudden episodes of sleep.
• Behavioral changes (e.g., gambling, compulsive shopping), increased libido (e.g., increased sexual appetite), binge eating.
• Psychosis (e.g., similar to symptoms of schizophrenia).
• Visual impairment. You should undergo regular eye examinations during treatment with Pramipexole NORMON.
• Severe heart or blood vessel disease. You should undergo 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 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 addiction to gambling, 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 stop the 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.

Children and adolescents

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

Taking Pramipexole NORMON with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use 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 NORMON 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 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 dose of levodopa when starting treatment with Pramipexole NORMON.

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

Taking Pramipexole NORMON with food and drinks

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

You can take Pramipexole NORMON with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will indicate if you should continue treatment with Pramipexole NORMON.

The effect of pramipexole on the fetus is not known. Therefore, do not take Pramipexole NORMON if you are pregnant unless your doctor indicates it.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Pramipexole NORMON 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 sudden episodes of 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 to you.

3. How to take Pramipexole NORMON

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

Take Pramipexole NORMON prolonged-release tablets once a day at the same time every day.

You can take Pramipexole NORMON 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 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 1 prolonged-release tablet of Pramipexole NORMON 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.

Then, your doctor may increase the frequency of administration to 1 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 NORMON immediate-release tablets

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

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

If you take more Pramipexole NORMON than you should

If you accidentally take too many tablets, 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 medicine and the amount ingested.

If you forget to take Pramipexole NORMON

If you forget to take your dose of Pramipexole NORMON, 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 the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Pramipexole NORMON

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

If you have Parkinson's disease, do not stop your treatment with Pramipexole NORMON abruptly. 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 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 Pramipexole NORMON, 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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)
• Delirium
• 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 you or others, which may include:
• Strong impulse to gamble excessively despite serious personal or family consequences.*
• Altered or increased sexual interest and worrisome behavior for you or others, for example, increased sexual appetite.*
• Uncontrolled shopping 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)*

Frequency not known

• After stopping or reducing treatment with pramipexole: 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 have an accurate estimate of the frequency, as these side effects were not observed in clinical trials involving 2,762 patients treated with pramipexole. The frequency category is likely not higher than "uncommon".

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pramipexole NORMON

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

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for proper disposal. If you have any further questions, ask your pharmacist. This will help protect the environment.

6. Package Contents and Additional Information

Pramipexol NORMON Composition

The active ingredient is pramipexol. Each tablet contains 0.52 mg of pramipexol as 0.75 mg of pramipexol dihydrochloride monohydrate.

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

Product Appearance and Package Contents

Pramipexol NORMON 0.52 mg are prolonged-release tablets, white or almost white in color, cylindrical, flat, and beveled, marked with 052 on one face. Each package contains 30 tablets.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

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

Manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Pramipexol NORMON 0.52 mg prolonged-release tablets EFG.

Pramipexol NORMON 1.05 mg prolonged-release tablets EFG.

Pramipexol NORMON 1.57 mg prolonged-release tablets EFG.

Pramipexol NORMON 2.1 mg prolonged-release tablets EFG.

Pramipexol NORMON 2.62 mg prolonged-release tablets EFG.

Pramipexol NORMON 3.15 mg prolonged-release tablets EFG.

Date of the Last Revision of this Leaflet:December 2021

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