Pramipexole Eg Stada

Package leaflet: Information for the user

Pramipexole Eurogenerics 0.26 mg prolonged-release tablets

Pramipexole Eurogenerics 0.52 mg prolonged-release tablets
Pramipexole Eurogenerics 1.05 mg prolonged-release tablets
Pramipexole Eurogenerics 2.10 mg prolonged-release tablets
Pramipexole Eurogenerics 3.15 mg prolonged-release tablets
Generic medicinal product
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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet
  1. What Pramipexole Eurogenerics is and what it is used for
  2. What you need to know before taking Pramipexole Eurogenerics
  3. How to take Pramipexole Eurogenerics
  4. Possible side effects
  5. How to store Pramipexole Eurogenerics
  6. Contents of the pack and other information

1. What Pramipexole Eurogenerics is and what it is used for

Pramipexole Eurogenerics contains the active substance pramipexole and belongs to a group of
medicines known as dopaminergic agonists that stimulate dopamine receptors located in the
brain. Stimulation of dopamine receptors in the brain triggers nerve impulses that help control
body movements.
Pramipexole Eurogenerics is used to treat the symptoms of primary Parkinson's disease in adults. It
can be used alone or in combination with levodopa (another medicine for Parkinson's disease).

2. What you need to know before taking Pramipexole Eurogenerici

DO NOT take Pramipexole Eurogenerici

• 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 Pramipexole Eurogenerici. Inform your doctor if you 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 gradual dose escalation of Pramipexole Eurogenerici.
• Dystonia (inability to maintain an upright posture of body and neck (axial dystonia)). In particular, you may experience forward bending of head and neck (also known as anterocollis), forward bending of the lumbar spine (also known as camptocormia), or lateral flexion and rotation of the trunk (also known as pleurothotonus or Pisa syndrome).
• Drowsiness and sudden onset of sleep episodes.
• Psychosis (e.g., symptoms comparable to schizophrenia).
• Visual disturbances. During treatment with Pramipexole Eurogenerici, 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 when standing up).

Tell your doctor if you, your family members, or your caregiver 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 may harm yourself or others. These phenomena are called impulse control disorders and may include behaviors such as gambling addiction, binge eating, compulsive spending, abnormally increased sexual desire, or preoccupation due to increased sexual thoughts or sensations. Your doctor may need to adjust the dose or discontinue treatment.

Inform your doctor if you or a family member or caregiver notice the development of mania (agitation, feelings of euphoria or overexcitement) or delirium (reduced awareness, confusion, or loss of sense of reality). Your doctor may need to adjust the dose or stop treatment.

Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of Pramipexole Eurogenerici. If symptoms persist for more than a few weeks, your doctor may need to adjust treatment.

Inform your doctor if you experience inability to maintain an upright posture of body and neck (axial dystonia). If these symptoms occur, your doctor may decide to adjust or change treatment.

Pramipexole Eurogenerici prolonged-release tablets are specially designed to gradually release the active substance after the tablet has been swallowed. Occasionally, parts of the tablet may pass through and be found in the stool, resembling whole tablets. Inform your doctor if you find pieces of tablets in your stool.

Children and adolescents

Pramipexole Eurogenerici is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Pramipexole Eurogenerici

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes prescription and non-prescription medicines, herbal remedies, dietary products, or supplements.

You must avoid taking Pramipexole Eurogenerici together with antipsychotic medicines.

Inform your doctor if you are taking 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 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 (used to treat various types of cancer);
• quinine (which may be used to prevent painful nighttime leg cramps and to treat a type of malaria known as falciparum malaria (malignant malaria));
• procainamide (used to treat irregular heartbeats).

If you are taking levodopa, it is recommended to reduce its dose when starting treatment with Pramipexole Eurogenerici.

Be cautious if you are taking any sedative (sedating) medicine or consuming alcohol. In such cases, Pramipexole Eurogenerici may impair your ability to drive or operate machinery.

Pramipexole Eurogenerici with food, drinks, and alcohol

Be cautious if you consume alcohol during treatment with Pramipexole Eurogenerici.

Pramipexole Eurogenerici 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 evaluate whether you should continue taking Pramipexole Eurogenerici.

It is not known what effect Pramipexole Eurogenerici may have on the fetus. Therefore, do not take Pramipexole Eurogenerici during pregnancy unless specifically instructed by your doctor.

Pramipexole Eurogenerici must not be used during breastfeeding. Pramipexole Eurogenerici may reduce milk production and can pass into breast milk, thereby reaching your baby. If the use of Pramipexole Eurogenerici is unavoidable, breastfeeding must be discontinued.

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

Driving and using machines

Pramipexole Eurogenerici may cause hallucinations (seeing, hearing, or sensing things that are not real). If this occurs, do not drive or operate machinery.

Pramipexole Eurogenerici 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 Pramipexole Eurogenerics

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist. Your doctor will determine the correct dosage for you.
How and when to take Pramipexole Eurogenerics
Take Pramipexole Eurogenerics prolonged-release tablets only once daily, and at approximately the same time each day.
You may take Pramipexole Eurogenerics with or without food. Swallow the tablets whole with water.
Do not chew, split, or crush the prolonged-release tablets.
Doing so may lead to overdose, as the medicine could be released into your body too quickly.

Dosage
During the first week, the usual dose is 0.26 mg of pramipexole. The dose will be increased every 5–7 days according to your doctor's instructions until symptoms are controlled (maintenance dose).

Dose escalation schedule for Pramipexole Eurogenerics prolonged-release tablets:

| Week | Daily dose (mg) | Number of tablets | |------|------------------|-------------------| | 1 | 0.26 | 1 prolonged-release tablet containing 0.26 mg of pramipexole Eurogenerics | | 2 | 0.52 | 1 prolonged-release tablet containing 0.52 mg of pramipexole Eurogenerics
or
2 prolonged-release tablets containing 0.26 mg of pramipexole Eurogenerics | | 3 | 1.05 | 1 prolonged-release tablet containing 1.05 mg of pramipexole Eurogenerics
or
2 prolonged-release tablets containing 0.52 mg of pramipexole Eurogenerics
or
4 prolonged-release tablets containing 0.26 mg of pramipexole Eurogenerics |

The usual maintenance dose is 1.05 mg/day. However, your dose may be further increased if needed. If necessary, your doctor may increase the dose up to a maximum of 3.15 mg of pramipexole per day. A lower maintenance dose may also be used, such as one prolonged-release tablet of Pramipexole Eurogenerics 0.26 mg/day.

Patients with kidney disease
If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg of prolonged-release tablets every other day during the first week.
Thereafter, your doctor may increase the frequency to one 0.26 mg prolonged-release tablet daily. If a further dose increase is needed, your doctor may adjust it in increments of 0.26 mg of pramipexole.
In case of severe kidney problems, your doctor may decide to prescribe you another pramipexole-containing medicine. If your kidney problems worsen during treatment, contact your doctor as soon as possible.

Switching from pramipexole tablets (immediate-release)
Your doctor will determine the dose of Pramipexole Eurogenerics prolonged-release tablets based on the dose of pramipexole immediate-release tablets you were previously taking.
Take your pramipexole immediate-release tablets as usual the day before switching. Then, take Pramipexole Eurogenerics prolonged-release tablets the following morning and do not take any further pramipexole immediate-release tablets.

If you take more Pramipexole Eurogenerics than you should
If you accidentally take too many tablets:

• Contact your doctor immediately or go to the nearest hospital emergency department.
• Symptoms such as vomiting, restlessness, or any of the adverse effects listed in section 4 “Possible side effects” may occur.

If you forget to take Pramipexole Eurogenerics
If you forget to take a dose of Pramipexole Eurogenerics but remember within 12 hours of your usual time, take one tablet immediately and then take the next dose at your usual time.
If more than 12 hours have passed, simply take your next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Pramipexole Eurogenerics
Do not stop taking Pramipexole Eurogenerics 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 symptom worsening.
If you have Parkinson’s disease, do not stop treatment with Pramipexole Eurogenerics abruptly. Sudden discontinuation may lead to 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 (rapid heartbeat)
• confusion
• reduced level of consciousness (e.g., coma)

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The assessment of these side effects is based on the following frequency data:
The following side effects may occur:
Very common (may affect more than 1 in 10 people)

• Dyskinesia (e.g. abnormal, uncontrollable movements of limbs)
• Drowsiness
• Dizziness
• Nausea (feeling of sickness)

Common (may affect up to 1 in 10 people)

• Impulse to behave in an unusual way
• Hallucinations (seeing, hearing or sensing things that are not there)
• Confusion
• Tiredness (fatigue)
• Difficulty sleeping (insomnia)
• Fluid retention, usually in the legs (peripheral oedema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Blurred vision
• Vomiting (sickness)
• Weight loss accompanied by reduced appetite

Uncommon (may affect up to 1 in 100 people)

• Paranoia (e.g. excessive fear for one's own well-being)
• Delirium
• Excessive daytime sleepiness and sudden onset of sleep episodes
• Amnesia (memory disturbances)
• 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)*
• Syndrome of inappropriate antidiuretic hormone secretion*
• Restlessness
• Dyspnoea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, drive or temptation to carry out an action that may be harmful to oneself or others, which may include:
  o Strong impulse to gamble excessively despite serious personal or family consequences.
  o Altered or increased sexual interest and behaviour causing significant concern to oneself or others, e.g. increased sexual drive.
  o Excessive and uncontrollable shopping or spending.
  o 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 hunger)*
• Delirium (reduced awareness, confusion, loss of sense of reality)

Rare (may affect up to 1 in 1,000 people)

• Mania (agitation, feeling of euphoria or over-excitement)

Frequency not known (frequency cannot be estimated from the available data)
After stopping or reducing the dose of Pramipexole Eurogenerici, symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating, or pain may occur (known as dopamine agonist withdrawal syndrome or DAWS).
Tell your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.
For side effects marked with *, a precise frequency estimate cannot be provided, 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 can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pramipexole Eurogenerici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack or blister after the words “EXP.” The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store the medicine in the original packaging to protect it from moisture.
Do not dispose of any medicine 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 Pramipexole Eurogenerici contains
The active substance is: pramipexole.
Each tablet contains 0.26 mg of pramipexole as 0.375 mg of pramipexole dihydrochloride monohydrate.
Each tablet contains 0.52 mg of pramipexole as 0.75 mg of pramipexole dihydrochloride monohydrate.
Each tablet contains 1.05 mg of pramipexole as 1.5 mg of pramipexole dihydrochloride monohydrate.
Each tablet contains 2.10 mg of pramipexole as 3 mg of pramipexole dihydrochloride monohydrate.
Each tablet contains 3.15 mg of pramipexole as 4.5 mg of pramipexole dihydrochloride monohydrate.

The excipients are hypromellose, dibasic calcium phosphate anhydrous, magnesium stearate, colloidal anhydrous silica.

Description of the appearance of Pramipexole Eurogenerici and package contents
The 9 mm tablets are white or almost white, cylindrical, flat, with bevelled edges and engraved with "026" on one side.
The 10 mm tablets are white or almost white, cylindrical, biconvex, with "052" engraved on one side.
The 10 mm tablets are white or almost white, cylindrical, biconvex, with "105" engraved on one side.
The 10 mm tablets are white or almost white, cylindrical, biconvex, with "210" engraved on one side.
The 11 mm tablets are white or almost white, cylindrical, flat, with bevelled edges and engraved with "315" on one side.

Al/OPA-Al-PVC blisters: 10, 30 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milano, Italy

Manufacturers
Ferrer Internacional, S.A., Joan Buscallà 1-9, 08173 Sant Cugat del Vallès (Barcelona), Spain
Laboratorios NORMON, S.A., Ronda de Valdecarrizo, 6, 28760 – Tres Cantos – Madrid, Spain
STADA Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel, Germany
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien, Austria

This medicinal product is authorised in the European Economic Area countries under the following names:
AT Pramipexol STADA 0.26/0.52/1.05/1.57/2.10/2.62/3.15 mg Retardtabletten
BE Pramipexol EG 0.26/0.52/1.05/1.57/2.10/2.62/3.15 mg tabletten met verlengde afgifte
DE Pramipexol AL 0.26/0.52/1.05/1.57/2.10/2.62/3.15 mg Retardtabletten
DK Pramipexol STADA
FI Pramipexol STADA 0.26/0.52/1.05/1.57/2.10/2.62/3.15 mg depottabletti
IT PRAMIPEXOLO EUROGENERICI
IS Pramipexol STADA 0.26/0.52/1.05/1.57/2.10/2.62/3.15 mg forðatöflur
LU Pramipexol EG 0.26/0.52/1.05/1.57/2.10/2.62/3.15 mg comprimés à libération prolongée
SE Pramipexol STADA 0.26/0.52/1.05/1.57/2.10/2.62/3.15 mg depottabletter