Pramipexole Sandoz A/S

Package leaflet: Information for the user

Pramipexole Sandoz A/S 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

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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Pramipexole Sandoz A/S is and what it is used for

Pramipexole Sandoz A/S 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 Sandoz A/S 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 must know before taking Pramipexole Sandoz A/S

Do not take Pramipexole Sandoz A/S

• 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 Sandoz A/S. Inform your doctor if you have (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 of Pramipexole Sandoz A/S.
• Dystonia (inability to maintain upright posture of body and neck (axial dystonia)). In particular, forward bending of head and neck (also known as antecollis), forward bending of the lumbar spine (also known as camptocormia), or lateral curvature of the spine (also known as pleurothotonus or Pisa syndrome) may occur. If any of these symptoms occur, your doctor may decide to modify your treatment.
• Drowsiness and sudden onset of sleep episodes.
• Psychosis (e.g. symptoms similar to schizophrenia).
• Visual disturbances. During treatment with Pramipexole Sandoz A/S, 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 (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 called impulse control disorders and may include behaviours such as gambling addiction, binge 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 notice that you are developing 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 Pramipexole Sandoz A/S. If symptoms persist for more than a few weeks, your doctor may need to adjust your therapy.
Pramipexole Sandoz A/S prolonged-release tablets are specially designed tablets from which the active ingredient is released gradually once the tablet has been swallowed. Parts of the tablet may occasionally pass through and be observed in the faeces and may appear as intact tablets. Inform your doctor if you find pieces of tablet in your faeces.
Children and adolescents
The use of Pramipexole Sandoz A/S is not recommended in children or adolescents under 18 years of age.
Other medicines and Pramipexole Sandoz A/S
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines, dietary products or supplements obtained without a prescription.
You must avoid taking Pramipexole Sandoz A/S together with antipsychotic medicines.
Be cautious 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 (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 (to treat various types of cancer);
• quinine (which may be used to prevent painful nocturnal leg cramps and to treat falciparum malaria (malignant malaria));
• procainamide (to treat irregular heartbeat).

If you are taking levodopa, it is recommended to reduce the levodopa dose when starting treatment with
Pramipexole Sandoz A/S.
Be cautious if you are taking any sedative (sleep-inducing) medicine or consuming alcohol. In these cases, Pramipexole Sandoz A/S may impair your ability to drive or operate machinery.
Pramipexole Sandoz A/S with food, drinks and alcohol
Be cautious if you consume alcohol during treatment with Pramipexole Sandoz A/S.
Pramipexole Sandoz A/S can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will discuss with you whether to continue taking Pramipexole Sandoz A/S.
It is not known whether Pramipexole Sandoz A/S has any effect on the unborn baby. Therefore, do not take Pramipexole Sandoz A/S during pregnancy unless your doctor specifically tells you to do so.
Pramipexole Sandoz A/S must not be taken during breastfeeding. Pramipexole Sandoz A/S may reduce breast milk production. It may also pass into breast milk and reach the infant. If taking Pramipexole Sandoz A/S is unavoidable, breastfeeding must be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Pramipexole Sandoz A/S may cause hallucinations (seeing, hearing or sensing things that are not real). If this occurs, do not drive or operate machinery.
Pramipexole Sandoz A/S 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 Sandoz A/S

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor. Your doctor will determine the correct dosage for you.
Take Pramipexole Sandoz A/S prolonged-release tablets once daily, at approximately the same time each day.
Pramipexole Sandoz A/S may be taken with or without food. Swallow the tablets whole with water.

Do not chew, divide, or crush the prolonged-release tablets. Doing so may result in overdose,
as the medicine could 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 of one tablet daily of Pramipexole Sandoz A/S 0.26 mg prolonged-release tablets is also possible.

Patients with renal disease
If you have renal disease, your doctor may advise you to take the usual initial dose of 0.26 mg prolonged-release tablets only every other day during the first week. Afterwards, 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 renal problems, your doctor may consider it necessary to prescribe a different pramipexole-containing medicine. If your renal problems worsen during treatment, you must contact your doctor as soon as possible.

If you are switching from pramipexole tablets (immediate-release)
Your doctor will base the choice of dose of Pramipexole Sandoz A/S prolonged-release tablets on the dose of pramipexole tablets (immediate-release) you were taking.

Take your pramipexole tablets (immediate-release) as usual the day before the switch. Then take Pramipexole Sandoz A/S prolonged-release tablets the following morning and do not take pramipexole tablets (immediate-release) anymore.

If you take more Pramipexole Sandoz A/S 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 reactions listed in section 4 “Possible side effects” may occur.

If you forget to take Pramipexole Sandoz A/S
If you forget to take a dose of Pramipexole Sandoz A/S 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 regular time. Do not take a double dose to make up for the missed dose.

If you stop taking Pramipexole Sandoz A/S
Do not stop taking Pramipexole Sandoz A/S 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 worsening symptoms.

If you have Parkinson’s disease, you must not abruptly stop treatment with Pramipexole Sandoz A/S. Sudden discontinuation may lead to the development of a medical condition called neuroleptic malignant syndrome, which can pose a serious health risk. Symptoms include:

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

If you stop or reduce treatment with [product name], 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 everyone gets them. The assessment of these side effects is based on the following frequency categories.
The following side effects may occur:
Very common (may affect more than 1 in 10 people):

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

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 real)
• Confusion
• Fatigue (feeling tired)
• Difficulty sleeping (insomnia)
• Fluid retention, usually in the legs (peripheral oedema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision disturbances
• Vomiting (feeling unwell)
• Weight loss accompanied by decreased 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 sleep episodes
• Amnesia (memory disturbances)
• 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
• Dyspnoea (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 despite serious personal or family consequences.
  • Altered or increased sexual interest and behaviour causing significant concern to oneself or others, for example increased sexual drive.
  • Excessive and uncontrollable shopping or spending
  • 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 appetite)*
• Delirium (reduced awareness, confusion, loss of sense of reality)

Rare (may affect up to 1 in 1000 people):

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

Not known (frequency cannot be estimated from the available data):

• After stopping or reducing treatment with Pramipexole Sandoz A/S, symptoms such as depression, apathy, anxiety, fatigue, sweating or pain may occur (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 *, an accurate 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 no greater than "uncommon".
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at 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 Sandoz A/S

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Pramipexole Sandoz A/S contains

• 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 Pramipexole Sandoz A/S and pack contents
Pramipexole Sandoz A/S 0.26 mg prolonged-release tablets: 9 mm white or almost white, cylindrical, flat tablets with bevelled edges, marked with "026" on one side.
Pramipexole Sandoz A/S 0.52 mg prolonged-release tablets: 10 mm white or almost white, cylindrical, biconvex tablets marked with "052" on one side.
Pramipexole Sandoz A/S 1.05 mg prolonged-release tablets: 10 mm white or almost white, cylindrical, biconvex tablets marked with "105" on one side.
Pramipexole Sandoz A/S 1.57 mg prolonged-release tablets: 10 mm white or almost white, cylindrical, biconvex tablets marked with "157" on one side.
Pramipexole Sandoz A/S 2.1 mg prolonged-release tablets: 10 mm white or almost white, cylindrical, biconvex tablets marked with "210" on one side.
Pramipexole Sandoz A/S 2.62 mg prolonged-release tablets: 10 mm white or almost white, cylindrical, biconvex tablets marked with "262" on one side.
Pramipexole Sandoz A/S 3.15 mg prolonged-release tablets: 11 mm white or almost white, cylindrical, flat tablets with bevelled edges, marked with "315" on one side.
Blister OPA-Al-PVC/Al: 10, 30 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Representative in Italy: Sandoz S.p.A., Viale Luigi Sturzo, 43 - 20154, Milan

Manufacturers
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6, Tres Cantos, 28760 Madrid
Spain

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben
Germany

Austria
Pramipexol 1A Pharma 0.26 mg – Retardtabletten
Pramipexol 1A Pharma 0.52 mg – Retardtabletten
Pramipexol 1A Pharma 1.05 mg – Retardtabletten
Pramipexol 1A Pharma 1.57 mg – Retardtabletten
Pramipexol 1A Pharma 2.1 mg – Retardtabletten
Pramipexol 1A Pharma 2.62 mg – Retardtabletten
Pramipexol 1A Pharma 3.15 mg – Retardtabletten

Germany
Pramipexol Lageman 0.26 mg Retardtabletten
Pramipexol Lageman 0.52 mg Retardtabletten
Pramipexol Lageman 1.05 mg Retardtabletten
Pramipexol Lageman 1.57 mg Retardtabletten
Pramipexol Lageman 2.1 mg Retardtabletten
Pramipexol Lageman 2.62 mg Retardtabletten
Pramipexol Lageman 3.15 mg Retardtabletten

Italy
Pramipexolo Sandoz A/S

Romania
Pramipexol Lageman 0.52 mg comprimate cu eliberare prelungită
Pramipexol Lageman 2.1 mg comprimate cu eliberare prelungită
Pramipexol Lageman 3.15 mg comprimate cu eliberare prelungită

Slovenia
Pramipeksol Sandoz 0.26 mg tablete s podaljšanim sproščanjem
Pramipeksol Sandoz 0.52 mg tablete s podaljšanim sproščanjem
Pramipeksol Sandoz 1.05 mg tablete s podaljšanim sproščanjem
Pramipeksol Sandoz 1.57 mg tablete s podaljšanim sproščanjem
Pramipeksol Sandoz 2.1 mg tablete s podaljšanim sproščanjem
Pramipeksol Sandoz 2.62 mg tablete s podaljšanim sproščanjem

Sweden
Pramipexole Lageman