Pramipexole Kern Pharma 0.18 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pramipexole Kern Pharma 0.18 mg tablets EFG

Pramipexole

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

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

Contents of the leaflet:

1. What Pramipexole Kern Pharma is and what it is used for
2. What you need to know before taking Pramipexole Kern Pharma
3. How to take Pramipexole Kern Pharma
4. Possible side effects
5. How to store Pramipexole Kern Pharma
6. Contents of the pack and other information

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

Pramipexole Kern Pharma contains pramipexole as the active substance and belongs to a group of medicines called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopaminergic receptors triggers nerve impulses in the brain that help control body movements.

Pramipexole Kern Pharma is used for:

• treating the symptoms of idiopathic Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson's disease),
• treating moderate to severe idiopathic Restless Legs Syndrome.

2. What you need to know before starting to take Pramipexole Kern Pharma

Do not take Pramipexole Kern Pharma

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

Warnings and precautions

Talk to your doctor before starting to take Pramipexole Kern Pharma. Inform your doctor if you have or have had any illness 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 taking levodopa, you may experience dyskinesia during the gradual dose increase of Pramipexole Kern Pharma.

• Dystonia (inability to keep the trunk and neck straight and upright (axial dystonia)). Specifically, you may experience forward bending of the head and neck (also known as antecollis), forward curvature of the lumbar region (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome). In such cases, your doctor may consider modifying your treatment.

• Somnolence and sudden episodes of falling asleep.

• Psychosis (e.g., symptoms resembling schizophrenia).

• Vision disturbances.

You should undergo regular eye examinations during treatment with Pramipexole Kern Pharma.

• Severe heart or blood vessel disease.

You should have regular blood pressure checks, especially at the beginning of treatment, to prevent postural hypotension (a drop in blood pressure upon standing).

• Worsening of restless legs syndrome. If you notice that symptoms start earlier than usual at night (or even in the afternoon), are more intense, affect larger areas of the affected limbs, or affect other limbs, your doctor may reduce your dose or discontinue treatment.

Inform your doctor if you, a family member, or caregiver notice that you are developing impulses or urges to behave in an unusual way or are unable to resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviors such as pathological gambling, compulsive shopping, compulsive eating, abnormally increased sex drive, or preoccupation with increased 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 elated or overexcited) or delirium (reduced awareness, confusion, loss of contact with reality). Your doctor may need to adjust or discontinue your dose.

Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with pramipexole. If these problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Children and adolescents

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

Taking Pramipexole Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines, herbal remedies, natural food products, or nutritional supplements obtained without a prescription.

You should avoid using Pramipexole Kern Pharma together with antipsychotic medicines.

Use caution if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and stomach ulcers),
• amantadine (which may be used to treat Parkinson's disease),
• mexiletine (used to treat irregular heartbeat, a condition known as ventricular arrhythmia),
• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a human immune system disease),
• cisplatin (used to treat various types of cancer),
• quinine (which may be used to prevent painful leg cramps occurring at night and to treat a type of malaria known as falciparum malaria (malignant malaria)),
• procainamide (used to treat irregular heartbeat).

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

Use caution if you are taking sedative medicines (with sedative effects) or drinking alcohol. In such cases, Pramipexole Kern Pharma may affect your ability to drive or operate machinery.

Taking Pramipexole Kern Pharma with food, drink, and alcohol

Be cautious if you drink alcohol during treatment with Pramipexole Kern Pharma.

You may take Pramipexole Kern Pharma with or without food.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will advise you whether you should continue treatment with Pramipexole Kern Pharma.

The effect of Pramipexole Kern Pharma on the fetus is unknown. Therefore, do not take Pramipexole Kern Pharma during pregnancy unless your doctor specifically instructs you to do so.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Pramipexole Kern Pharma has been associated with somnolence and sudden episodes of falling asleep, especially in patients with Parkinson's disease. If you experience these adverse effects, you must not drive or operate machinery. Inform your doctor if this happens.

3. How to take Pramipexole Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again. Your doctor will determine the correct dosage for you.

You may take Pramipexole Kern Pharma with or without food. The tablets should be swallowed with water.

Parkinson's Disease

The daily dose should be divided into 3 equal doses.

During the first week, the usual dose is 1 tablet of Pramipexole 0.088 mg three times daily (equivalent to 0.264 mg daily):

This dose will be increased every 5–7 days as directed by your doctor, until your symptoms are controlled (maintenance dose).

The usual maintenance dose is 1.1 mg daily. However, your dose may need to be increased further. If necessary, your doctor could increase your tablet dose up to a maximum of 3.3 mg of pramipexole per day. It is also possible to reduce the maintenance dose to three Pramipexole 0.088 mg tablets daily.

Patients with renal disease:

If you have moderate or severe kidney disease, your doctor will prescribe you a lower dose. In this case, you should take the tablets only once or twice a day. If you have moderate renal impairment, the usual starting dose is 1 tablet of Pramipexole 0.088 mg twice daily. If you have severe renal impairment, the usual starting dose is 1 tablet of Pramipexole 0.088 mg once daily.

Restless Legs Syndrome

The dose is usually taken once daily, in the evening, 2–3 hours before bedtime.

During the first week, the usual dose is 1 tablet of Pramipexole 0.088 mg once daily (equivalent to 0.088 mg daily):

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 must not exceed 6 tablets of Pramipexole 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexole salt).

If you stop taking your tablets for a few days and wish to restart treatment, you must begin 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 discontinue therapy.

Patients with renal disease:

If you have severe kidney disease, Pramipexole may not be an appropriate treatment for your restless legs syndrome.

If you take more Pramipexole Kern Pharma than you should

If you accidentally take too many tablets, contact your doctor or the nearest hospital emergency department immediately, or call the Toxicology Information Service at 915 620 420, indicating the medication and the amount ingested.

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

If you forget to take Pramipexole Kern Pharma

Do not worry. Completely skip the missed dose and take your next dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you stop taking Pramipexole Kern Pharma

Do not stop treatment with Pramipexole Kern Pharma without first consulting your doctor. If you need to discontinue 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 treatment with Pramipexole Kern Pharma abruptly. Sudden discontinuation may cause a condition called neuroleptic malignant syndrome, which may pose a serious health risk. 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 further 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. 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 have side effects, although not everyone experiences 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 limbs)
• Somnolence
• Dizziness
• Nausea

Common:

• Urge to behave in an unusual way
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Tiredness (fatigue)
• Insomnia
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (feeling sick)
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g., excessive concern about your health)
• Delusion
• Excessive daytime sleepiness and sudden episodes of falling asleep
• Amnesia (memory impairment)
• Hyperkinesia (increased movements and inability to stay still)
• Weight gain
• Allergic reactions (e.g., skin rash, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inappropriate secretion of antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, urge, or temptation to perform an action that could harm you or others, which may include:
• Strong urges to gamble excessively despite serious personal and family consequences.*
• Changes or increase in sexual desire and behavior that is concerning to you or others, for example, increased sex drive.
• Compulsive and uncontrollable shopping.
• 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 (reduced 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 may occur (known as dopamine agonist withdrawal syndrome or DAWS).

If you have Restless Legs Syndrome, you may experience the following adverse effects:

Very common:

• Nausea
• Symptoms starting earlier than usual, being more intense, or affecting other limbs (worsening of restless legs syndrome)

Common:

• Changes in sleep patterns, such as insomnia and somnolence
• Tiredness (fatigue)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (feeling sick)

Uncommon:

• Urge to behave in an unusual way*

• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*

• Inappropriate secretion of antidiuretic hormone*

• Dyskinesia (e.g., abnormal involuntary movements of limbs)

• Hyperkinesia (increased movements and inability to stay 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 sleepiness and sudden episodes of falling asleep

• Weight gain

• Hypotension (low blood pressure)

• Fluid retention, usually in the legs (peripheral edema)

• Allergic reactions (e.g., skin rash, itching, hypersensitivity)

• Fainting

• Restlessness

• Visual disturbances

• Weight loss including loss of appetite

• Dyspnea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)*

• Inability to resist the impulse, urge, or temptation to perform an action that could harm you or others, including:

• Strong urges to gamble excessively despite serious personal and family consequences.*

• Changes or increase in sexual desire and behavior that is concerning to you or others, for example, increased sex drive.*

• Compulsive and uncontrollable shopping.*

• 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)*

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 or she will explain how to manage or reduce the symptoms.

For the effects marked with *, a precise estimation of frequency cannot be provided, as these adverse effects were not observed in clinical trials involving 1,395 patients treated with pramipexole. The frequency category is likely no higher than "uncommon."

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

For the adverse effects marked with *, a precise estimation of frequency cannot be provided, as these adverse effects were not observed in clinical trials involving 2,762 patients treated with pramipexole. The frequency category is likely 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pramipexole Kern Pharma

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, following “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage precautions.

Medicines must not be disposed of via wastewater drains or household waste. Instead, dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pramipexole Kern Pharma

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

Appearance of the product and contents of the pack

Pramipexole Kern Pharma 0.18 mg are white, round tablets, marked on one side with a "1" (one), scored on the other side, free from defects, with dimensions of 6.0 ± 0.1 mm in diameter and 3.0 mm ± 0.2 mm in thickness.

Pramipexole Kern Pharma is available in aluminum/aluminum blisters containing 10 tablets per strip, in boxes containing 3 or 10 blister strips (30 or 100 tablets).

Only certain pack 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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the last revision of this leaflet: February 2024.

Updated and detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/