Leaflet: information for the user

Pramipexol Kern Pharma 0.7 mg tablets EFG

Pramipexol

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Pramipexol Kern Pharma is and what it is used for

2. What you need to know before you start taking Pramipexol Kern Pharma

3. How to take Pramipexol Kern Pharma

4. Possible side effects

5. Storage of Pramipexol Kern Pharma

6. Contents of the pack and additional information

Pramipexol Kern Pharma contains pramipexol as the active ingredient and belongs to a group of medications called dopaminergic agonists that stimulate dopamine receptors in the brain. Stimulation of dopaminergic receptors triggers nerve impulses in the brain that help control the body's movements.

Pramipexol Kern Pharma is used for:

- treating the symptoms of idiopathic Parkinson's disease in adults. It may be used alone or in combination with levodopa (another medication for Parkinson's disease),

-treating the symptoms of moderate to severe idiopathic Restless Legs Syndrome..

Do not take Pramipexol Kern Pharma

• 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 before starting to take 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.
• 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 progressive increase in Pramipexol Kern Pharma dosage.

• distonía (inability to maintain the trunk and neck straight and upright (axial distonía)). Specifically, you may experience forward flexion of the head and neck (also known as antecolis), forward curvature of the lumbar region (also known as camptocormia) or lateral curvature of the back (also known as pleurototonos or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• drowsiness and sudden episodes of sleep.
• psychosis (e.g. similar to symptoms of schizophrenia).
• vision alteration.

You must undergo periodic eye examinations during treatment with Pramipexol Kern Pharma.

• severe heart or blood vessel disease.

You must undergo periodic blood pressure checks, especially at the beginning of treatment, in order to avoid postural hypotension (a drop in blood pressure when standing up).

• Increased restless legs syndrome. If you experience symptoms starting earlier than usual in the evening (or even in the afternoon), are more intense, or affect larger areas of the affected limbs or other limbs.Your doctor may reduce your dose or discontinue treatment.

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in an unusual way or if you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as compulsive buying, compulsive eating, abnormally high sexual appetite, or excessive concern about an increase in sexual thoughts and feelings.Your doctor may need to adjust or discontinue your dose.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling overexcited or overstimulated) or delirium (diminished consciousness, confusion, loss of contact with reality). Your doctor may need to adjust or discontinue 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.

Children and adolescents

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

Use of Pramipexol Kern Pharma with other medications

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

Avoid using Pramipexol Kern Pharma 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 to treat 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 human immunological disease),
• 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 malignant malaria),
• procainamide (for the treatment of irregular heartbeats).

If you are using levodopa, it is recommended to reduce the levodopa dose when starting treatment with Pramipexol Kern Pharma.

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

Use of Pramipexol Kern Pharma with food, drink, and alcohol

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 breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medication. Your doctor will tell you if you should continue treatment with Pramipexol Kern Pharma.

The effect of Pramipexol Kern Pharma on the fetus is unknown. 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 necessary, breastfeeding should be discontinued.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again. Your doctor will indicate 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 in 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 per day):

This dose will be increased every 5-7 days as indicated by your doctor, 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.

Patients 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 renal insufficiency, the usual starting dose is 1 tablet of Pramipexol 0.088 mg twice a day. If you have severe renal insufficiency, the usual starting dose is 1 tablet of Pramipexol 0.088 mg per day.

Restless Legs Syndrome

The dose is usually administered once a day, at night, 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 as indicated by your doctor, 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 base).

If you stop taking your tablets for a few days and want to resume 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 evaluate your treatment after 3 months to decide whether to continue or not with the treatment.

Patients with kidney disease:

If you have severe kidney disease, it is possible that Pramipexol may not be an appropriate 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 nearest hospital emergency service immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount taken.

You may experience vomiting, restlessness, or any of the adverse effects described in section 4. Possible adverse 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 compensate for the missed doses.

If you interrupt treatment with 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 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 Kern Pharma abruptly. Sudden discontinuation may cause the appearance of a condition called neuroleptic malignant syndrome, which can represent a very 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 have any other doubts about the use of this medication, ask your doctor or pharmacist.

If you stop treatment or reduce the dose of [medication name] you may also suffer from 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.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The classification of side effects is based on the following frequencies:

If you haveParkinson's disease, you may experience the following side effects:

Very common:

• Discinesia (e.g., abnormal involuntary movements of the limbs)
• Drowsiness
• Dizziness
• Nausea

Common:

• Need to behave in an unusual way
• Alucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Excess fluid, usually in the legs (peripheral edema)
• Headache
• Low blood pressure
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (urge to vomit)
• 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 alteration)
• Hypokinesia (increase in movement and inability to remain still)
• Weight gain
• Allergic reactions (e.g., skin rashes, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of the antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hypophonia
• 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 severe consequences at a personal and family level.*
• Alterations or increase in sexual desire and concerning behavior for you or others, for example, an increase in sexual appetite.*
• Compulsive and uncontrolled purchases.*
• Binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite)*
• Delirium (diminished consciousness, confusion, loss of contact with reality)

Rare:

• Mania (agitation, feeling elated or overexcited)

Unknown frequency:

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

Inform 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 a precise 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".

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

Very common:

-Nausea

- Symptoms that start earlier than usual, are more intense, or affect other limbs (increased restless legs syndrome)

Common:

• Changes in sleep patterns, such as insomnia and somnolence
• Fatigue (tiredness)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (urge to vomit)

Uncommon:

• Need to behave in an unusual way*
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of the antidiuretic hormone*
• Discinesia (e.g., abnormal involuntary movements of the limbs)
• Hypokinesia (increase in movement and inability to remain still)*
• Paranoia (e.g., excessive concern about your health)*
• Delirium*
• Amnesia (memory alteration)*
• Alucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Excessive daytime somnolence and sudden sleep episodes
• Weight gain
• Low blood pressure
• Excess fluid, usually in the legs (peripheral edema)
• Allergic reactions (e.g., skin rashes, itching, hypersensitivity)
• Fainting
• Restlessness
• Visual disturbances
• Weight loss including loss of appetite
• Dyspnea (difficulty breathing)
• Hypophonia
• Pneumonia (lung infection)*
• Inability to resist the impulse, instinct, or temptation to perform an action that may harm you or others, and which may include:

• Strong impulses to gamble excessively despite severe consequences at a personal and family level.*
• Alterations or increase in sexual desire and concerning behavior for you or others, for example, an increase in sexual appetite.*
• Compulsive and uncontrolled purchases.*
• Binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite)*

Unknown frequency:

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

Inform 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 a precise estimate of the frequency, as these side effects were not observed in clinical trials involving 1,395 patients treated with pramipexol. The frequency category is likely not higher than "uncommon".

Reporting of side effects

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

Keep out of the sight and reach of children.

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

This medication does not require special storage precautions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE pharmacy drop-off point. If in doubt, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

Composition of Pramipexol Kern Pharma

• The active ingredient is pramipexol. Each Pramipexol Kern Pharma 0.7 mg tablet contains 0.7 mg of pramipexol base (as 1.0 mg of pramipexol 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 contents of the packaging

Pramipexol Kern Pharma 0.70 mg are white, round, tablets marked on one side with a “3” (three), 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 strips of blister (30 or 100 tablets).

Only some packaging sizes may be commercially marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for Manufacturing

Pharmathen S.A.

Dervenakion 6,

153 51 Pallini Attiki,

Greece

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: February 2024.

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