Pramiperal

Patient Information Leaflet: Information for the User

Pramiperal 0.26 mg prolonged-release tablets, 0.52 mg prolonged-release tablets, 1.05 mg prolonged-release tablets, 1.57 mg prolonged-release tablets, 2.1 mg prolonged-release tablets, 2.62 mg prolonged-release tablets, 3.15 mg prolonged-release tablets

Pramipexole
“Generic medicine”
Please read all of this 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Pramiperal is and what it is used for

Pramiperal contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors located in the brain. Stimulation of dopamine receptors in the brain triggers nerve impulses that help control body movements.
Pramiperal is used to treat 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).

2. What you should know before taking Pramiperal

Do not take Pramiperal

• 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 taking Pramiperal. Inform your doctor if you have (or have had) or develop any medical condition or symptom, especially if it belongs to the following list:

• Kidney disease
• Hallucinations (seeing, hearing, or sensing things that are not real). Most hallucinations are visual
• Dyskinesia (e.g., abnormal, uncontrollable movements of limbs). If you suffer from advanced Parkinson’s disease and are also taking levodopa, you may develop dyskinesia during the titration phase of Pramiperal
• Dystonia (inability to maintain body and neck in an upright position (axial dystonia)). In particular, forward bending of the head and neck (also known as anterocollis),

forward bending of the lumbar spine (also known as camptocormia), or bending and lateral rotation of the trunk (also known as pleurothotonus or Pisa syndrome) may occur.

• Drowsiness and sudden onset of sleep episodes
• Psychosis (e.g., symptoms similar to schizophrenia)
• Vision changes. During treatment with Pramiperal, you should undergo regular eye examinations.
• Severe heart or blood vessel diseases. Especially at the beginning of treatment, your blood pressure should be monitored regularly to prevent postural hypotension (a drop in blood pressure upon standing)

Inform your doctor if you, your family members, or caregivers notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others.
These phenomena are known as impulse control disorders and may include behaviors such as gambling addiction, compulsive eating, excessive spending, abnormally increased sexual desire, or preoccupation due to increased sexual thoughts or sensations. Your doctor may need to adjust the dose or discontinue therapy.
Inform your doctor if you or a family member or caregiver notices symptoms of mania (agitation, feelings of euphoria or overexcitement) or delirium (reduced awareness, confusion, loss of sense of reality). Your doctor may consider it necessary to adjust the dose or discontinue therapy.
Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of Pramiperal. If symptoms persist for more than a few weeks, your doctor may need to adapt your treatment.
Inform your doctor if you experience inability to maintain body and neck in an upright position (axial dystonia). If these symptoms occur, your doctor may decide to adjust or change your treatment.
Pramiperal prolonged-release tablets are specially designed to gradually release the active ingredient after ingestion. It is possible that parts of the tablets may be expelled and observed in the feces, appearing as intact tablets. Inform your doctor if you find tablet fragments in your stool.

Children and adolescents
The use of Pramiperal is not recommended in children or adolescents under 18 years of age.

Other medicines and Pramiperal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal remedies, dietary products, or supplements obtained without a prescription.
You must avoid taking Pramiperal together with antipsychotic medicines.
Be cautious if you are taking any of the following medicines:

• cimetidine (used to treat excess stomach acid and gastric 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 disease of the human immune system)
• cisplatin (used to treat various types of cancer)
• quinine (which may be used to prevent painful nighttime cramps and to treat falciparum malaria (malignant malaria))
• procainamide (used to treat irregular heartbeat)

If you are taking levodopa, it is recommended to reduce its dose when starting treatment with Pramiperal.
Be cautious if you are taking any sedative medicine (sedative effect) or consuming alcohol. In such cases, Pramiperal may impair your ability to drive or operate machinery.

Pramiperal with food, drinks, and alcohol
Be cautious if you consume alcohol during treatment with Pramiperal.
Pramiperal can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Your doctor will discuss with you whether to continue taking Pramiperal.
The effect of Pramiperal on the fetus is unknown. Therefore, do not take Pramiperal during pregnancy unless your doctor specifically instructs you to do so.
Pramiperal should not be taken during breastfeeding. Pramiperal may reduce milk production and can pass into breast milk, potentially reaching the infant. If taking Pramiperal is unavoidable, breastfeeding must be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Pramiperal may cause hallucinations (seeing, hearing, or perceiving things that are not real). If this occurs, do not drive or operate machinery.
Pramiperal has been associated with drowsiness and sudden onset of sleep episodes, particularly in patients with Parkinson’s disease. If these side effects occur, avoid driving and do not operate machinery. Inform your doctor if this happens.

3. How to take Pramiperal

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor. Your doctor will determine the correct dosage for you.
Take Pramiperal prolonged-release tablets only once daily and every day, approximately at the same time.
Pramiperal can be taken with or without food. Swallow the tablets whole with water.
Do not chew, split, or crush the prolonged-release tablets.
If you do, there is a risk of overdose, as the medicine may be released too quickly into your body.

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 symptoms are controlled (maintenance dose).

The usual maintenance dose is 1.05 mg daily. However, your dose may be further increased. If necessary, your doctor may increase the tablet dose up to a maximum of 3.15 mg of pramipexole per day. A lower maintenance dose may also be possible, equal to one Pramiperal 0.26 mg prolonged-release tablet per day.

Patients with kidney disease
If you have kidney disease, your doctor may instruct you to take the usual initial dose of 0.26 mg prolonged-release tablets only every other day during the first week. Subsequently, your doctor may increase the dosing frequency to one 0.26 mg prolonged-release tablet daily. If a further dose increase is needed, your doctor may increase it by 0.26 mg of pramipexole.
If you have severe kidney problems, your doctor may consider it necessary to prescribe a different pramipexole-containing medicine. If your kidney problems worsen during treatment, you must contact your doctor as soon as possible.

Switching from pramipexole tablets (immediate-release)
Your doctor will base the choice of dose of Pramiperal prolonged-release tablets on the dose of pramipexole tablets (immediate-release) you were previously taking.
Continue taking pramipexole tablets (immediate-release) as usual on the day before switching. Then take Pramiperal prolonged-release tablets the following morning and no longer take pramipexole tablets (immediate-release).

If you take more Pramiperal than you should
If you accidentally take too many tablets:

• contact your doctor immediately or go to the nearest hospital emergency department.
• you may experience vomiting, restlessness, or any of the adverse effects described in section 4 “Possible side effects”.

If you forget to take Pramiperal
If you forget to take a dose of Pramiperal but remember within 12 hours of your usual dosing time, take the tablet immediately and then take the next dose at the usual time.
If 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 the missed dose.

If you stop taking Pramiperal
Do not stop taking Pramiperal without first talking to your doctor. If you need to discontinue treatment with this medicine, your doctor will gradually reduce the dose. This reduces the risk of symptom worsening.
If you have Parkinson’s disease, you must not stop treatment with Pramiperal abruptly. Sudden discontinuation could lead to the development of a medical condition called neuroleptic malignant syndrome, which may pose a greater health risk. Symptoms include:

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

If you stop or reduce treatment with Pramiperal, you may also develop a medical condition called dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you must contact your doctor.

If you have any 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 assessment of these side effects is based on the following frequencies:

May experience the following side effects:
Very common:

• Dyskinesia (e.g., involuntary, abnormal limb movements)
• Somnolence
• Dizziness
• Nausea (feeling unwell)

Common:

• Impulse to behave in an unusual way
• Hallucinations (seeing, hearing or sensing things that are not there)
• Confusion
• Fatigue (feeling of tiredness)
• Sleeplessness (insomnia)
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision disturbances
• Vomiting (feeling unwell)
• Weight loss accompanied by reduced appetite

Uncommon:

• Paranoia (e.g., excessive fear for one's well-being)
• Delirium
• Excessive daytime sleepiness and sudden onset of sleep episodes
• Amnesia (memory disorders)
• Hyperkinesia (increased movements and inability to remain still)
• Weight gain
• Allergic reactions (e.g., skin rash, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that may cause shortness of breath or ankle swelling)*
• Inappropriate antidiuretic hormone secretion*
• Restlessness
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, urge or temptation to carry out an action that may be harmful to oneself or others, which may include:
• Strong urge to gamble excessively despite serious personal or family consequences.
• Altered or increased sexual interest and behavior causing significant concern to oneself or others, for example increased sexual drive.
• Compulsive shopping or uncontrolled spending
• Uncontrolled 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 appetite)*
• Delirium (reduced awareness, confusion, loss of sense of reality)

Rare:

• Mania (agitation, feeling of euphoria or overexcitement)
• Spontaneous penile erection

Not known:

• After stopping or reducing the dose of Pramipexole, symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating, or pain may occur (dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviors; they will explain how to manage or
reduce the symptoms.
For side effects marked with *, it is not possible to estimate the frequency precisely, as these side effects were not observed in clinical studies 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pramiperal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pramiperal prolonged-release tablets contain

• The active substance is pramipexole. Each tablet contains 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg or 3.15 mg of pramipexole, respectively as 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg or 4.5 mg of pramipexole dihydrochloride monohydrate.
• The other components are hypromellose, calcium hydrogen phosphate, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Pramiperal prolonged-release tablets and contents of the
packaging
Pramiperal 0.26 mg prolonged-release tablets: The 9 mm tablets are white or almost white, cylindrical in shape, flat, with bevelled edges and marked with "026" on one side.
Pramiperal 0.52 mg prolonged-release tablets: The 10 mm tablets are white or almost white, cylindrical in shape, biconvex and marked with "052" on one side.
Pramiperal 1.05 mg prolonged-release tablets: The 10 mm tablets are white or almost white, cylindrical in shape, biconvex and marked with "105" on one side.
Pramiperal 1.57 mg prolonged-release tablets: The 10 mm tablets are white or almost white, cylindrical in shape, biconvex and marked with "157" on one side.
Pramiperal 2.1 mg prolonged-release tablets: The 10 mm tablets are white or almost white, cylindrical in shape, biconvex and marked with "210" on one side.
Pramiperal 2.62 mg prolonged-release tablets: The 10 mm tablets are white or almost white, cylindrical in shape, biconvex and marked with "262" on one side.
Pramiperal 3.15 mg prolonged-release tablets: The 11 mm tablets are white or almost white, cylindrical in shape, flat, with bevelled edges and marked with "315" on one side.
Al/OPA-Al-PVC blister packs: 10, 30 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Ralpharma S.r.l.
Via Vicolo Duomo 2
20900 – Monza

Manufacturer
Ferrer Internacional, S.A.
Joan Buscallà 1-9
E-08190 Sant Cugat del Vallès (Barcelona)
Laboratorios Normon, S.A
Ronda de Valdecarrizo, 6, Tres Cantos, 28760 Madrid