PRAMIPEXOL KERN PHARMA 0.18 mg TABLETS

2. What you need to know before you take Pramipexol Kern Pharma

Do not take Pramipexol Kern Pharma

• if you are allergic to pramipexol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before you start taking Pramipexol Kern Pharma. 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 gradual increase in the dose of Pramipexol Kern Pharma.

• 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 pleurototonos 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 Kern Pharma.

• 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 the 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 the dose or interrupt treatment.

Tell your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave abnormally or if 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, shopping, or compulsive eating, abnormally high sexual appetite, or concern about an increase in sexual thoughts and feelings. Your doctor may need to adjust or interrupt the 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, loss of contact with reality). Your doctor may need to adjust or interrupt the 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 the problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Children and adolescents

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

Using Pramipexol Kern Pharma with other medicines

Tell 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 Pramipexol Kern Pharma with antipsychotic medicines.

Be cautious if you are using the following medicines:

• cimetidine (for the treatment of excess acid and stomach ulcers),
• amantadine (which can be used to treat Parkinson's disease),
• mexiletine (for the treatment of irregular heartbeats, a condition known as ventricular arrhythmia),
• zidovudine (which can 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 can 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 Pramipexol Kern Pharma.

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

Using Pramipexol Kern Pharma with food, drink, and alcohol

You should be cautious if you drink alcohol during treatment with Pramipexol Kern Pharma.

You can take Pramipexol Kern Pharma with or without food.

Pregnancy and breastfeeding

If you are pregnant, or think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will tell you if you should continue treatment with Pramipexol Kern Pharma.

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

Pramipexol Kern Pharma should not be used during breastfeeding. Pramipexol Kern Pharma may reduce milk production. Additionally, it may pass into breast milk and reach your baby. If the use of Pramipexol Kern Pharma is essential, breastfeeding should be discontinued.

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

Driving and using machines

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

Pramipexol Kern Pharma 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. Tell your doctor if this happens to you.

3. How to take Pramipexol Kern Pharma

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor again. Your doctor will tell you the correct dosage.

You can take Pramipexol Kern Pharma with or without food. The tablets should be swallowed with water.

Parkinson's disease

The daily dose should be taken divided into 3 equal doses.

During the first week, the usual dose is 1 tablet of Pramipexol 0.088 mg 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 dose of tablets up to a maximum of 3.3 mg of pramipexol per day. It is also possible to reduce the maintenance dose to three tablets 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 1 tablet of Pramipexol 0.088 mg twice a day. If you have severe kidney failure, the usual starting dose is 1 tablet of Pramipexol 0.088 mg per day.

Restless Legs Syndrome

The dose is usually given once a day, in the evening, 2-3 hours before bedtime.

During the first week, the usual dose is 1 tablet of Pramipexol 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 tablets 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 any 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 Kern Pharma than you should

If you accidentally take too many tablets, consult your doctor or the emergency department of the nearest hospital or call the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken.

You may experience vomiting, restlessness, or any of the side effects described in section 4. Possible side effects.

If you forget to take Pramipexol Kern Pharma

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 Kern Pharma

Do not stop your treatment with Pramipexol Kern Pharma without consulting your doctor first. If you need to 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, you should not stop your treatment with Pramipexol Kern Pharma 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 stiffness
• fever
• unstable blood pressure
• tachycardia (increased heart rate)
• confusion
• decreased level of consciousness (e.g., coma)

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

If you stop treatment or reduce the dose of [name of medicine], 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.

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 about your 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 harm you or others, which may include:
• Strong impulses to gamble excessively despite serious personal and family consequences.*
• Alterations or increased sexual desire and disturbing behavior for you or others, for example, an increased sexual appetite.
• Uncontrollable and compulsive shopping.
• Binge eating (ingesting large amounts of food in a short period) or compulsive eating (ingesting more food than normal and more than necessary to satisfy your appetite)*
• 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.

If you have Restless 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 (worsening of 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 about your health)*
• Delirium*
• 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 harm you or others, which may include:

• Strong impulses to gamble excessively despite serious personal and family consequences.*
• Alterations or increased sexual desire and disturbing behavior for you or others, for example, an increased sexual appetite.*
• Uncontrollable and compulsive shopping.*
• Excessive eating (ingesting large amounts of food in a short period) or compulsive eating (ingesting more food than normal and more than necessary to satisfy your appetite)*

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 the effects marked with * it is not possible to have 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 probably no higher than "uncommon".

Tell 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 have 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 no 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 Pramipexol Kern Pharma

Keep out of sight and reach of children.

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

This medicine does not require special storage precautions.

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

6. Package Contents and Additional Information

Composition of Pramipexol Kern Pharma

• The active ingredient is pramipexole. Each Pramipexol Kern Pharma 0.18 mg tablet contains 0.18 mg of pramipexole base (as 0.25 mg of pramipexole dihydrochloride monohydrate).
• The other ingredients are pregelatinized cornstarch, mannitol, microcrystalline cellulose, povidone (27.0-32.4), talc, and magnesium stearate.

Appearance of the Product and Package Contents

Pramipexol Kern Pharma 0.18 mg are white, round tablets, marked with a "1" (one) on one side, scored on the other side, without defects, and with dimensions of 6.0 ± 0.1 mm in diameter and 3.0 mm ± 0.2 mm in thickness.

Pramipexol Kern Pharma is presented in aluminum/aluminum blister strips of 10 tablets per strip, in boxes with 3 or 10 blister strips (30 or 100 tablets).

Only some package sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Pharmathen S.A.

Dervenakion 6,

153 51 Pallini Attiki,

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Prospectus: February 2024.

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