PRAMIPEXOLO 0.26 mg Таблетки с пролонгированным высвобождением

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

Pramipexolo 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

Pramipexolo Sandoz A/S 2.62 mg prolonged-release tablets
Pramipexolo Sandoz A/S 3.15 mg prolonged-release tablets
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Pramipexolo Sandoz A/S 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 to control body movements.
Pramipexolo Sandoz A/S is used in adults for the treatment of 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 need to know before you take Pramipexolo Sandoz A/S

Do not take Pramipexolo Sandoz A/S

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

Warnings and precautions
Talk to your doctor before taking Pramipexolo Sandoz A/S. Tell your doctor if you have (have had) or
develop any medical condition or symptom, especially if you belong to the following list:

• Kidney disease.
• Hallucinations (seeing, hearing or perceiving things that are not there). Most hallucinations are visual.
• Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you suffer from advanced Parkinson's disease and are also taking levodopa, you may develop dyskinesia during the titration of Pramipexolo Sandoz A/S.
• Dystonia (inability to keep the body and neck upright (axial dystonia)). In particular, you may experience forward flexion of the head and neck (also known as anterior torticollis), forward flexion of the lower back (also known as camptocormia) or lateral curvature of the spine (also known as pleurototonia or Pisa syndrome). If these symptoms occur, your doctor may decide to modify the treatment.
• Sleepiness and sudden onset of sleep episodes.
• Psychosis (e.g. comparable to symptoms of schizophrenia).
• Impaired vision. During treatment with Pramipexolo Sandoz A/S, you should undergo regular eye checks.
• Severe heart or blood vessel disease. Especially at the beginning of treatment, your blood pressure will need to be checked regularly. This is to avoid postural hypotension (a drop in blood pressure when getting up).

Tell your doctor if you, your family members or your caregiver notice that you are developing a
urge or desire to behave in ways that are unusual for you and that you are unable to 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,
excessive eating or spending, unusually high sexual drive or preoccupation
with increased sexual thoughts or sensations. Your doctor may need to adjust the dose or
stop therapy.
Tell your doctor if you or a family member or anyone who cares for you notices that you are developing mania (agitation,
feeling of euphoria or overexcitement) or delirium (reduced awareness, confusion, loss of sense
of reality). Your doctor may need to adjust the dose or stop therapy.
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, feeling tired, sweating or
pain after stopping treatment or reducing the dosagewith/of Pramipexolo Sandoz A/S. If the
symptoms persist for more than a few weeks, your doctor may need to adjust the therapy.
Pramipexolo Sandoz A/S extended-release tablets are tablets specially designed from which the
active ingredient is released gradually, once the tablet has been swallowed. Parts of tablets
may occasionally pass through and be observed in the stool and may appear as whole
tablets. Tell your doctor if you find pieces of tablet in your stool.

Children and adolescents
The use of Pramipexolo Sandoz A/S is not recommended in children or adolescents under the age of 18 years.

Other medicines and Pramipexolo Sandoz A/S
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines, herbal preparations, dietary products or supplements
obtained without a prescription.
You should avoid taking Pramipexolo Sandoz A/S in combination with antipsychotic medicines.
Be careful if you are taking the following medicines:

• cimetidine (to treat excess acid in the stomach and stomach ulcers);
• amantadine (which can be used to treat Parkinson's disease);
• mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia);
• zidovudine (which can be used to treat acquired immunodeficiency syndrome (AIDS), a disease of the human immune system);
• cisplatin (to treat various types of cancer);
• quinine (which can be used for the prevention of painful leg cramps at night and for the treatment of a type of malaria known as falciparum malaria (malignant malaria));
• procainamide (to treat irregular heartbeats). If you are taking levodopa, it is recommended to reduce the dose of levodopa when starting treatment with Pramipexolo Sandoz A/S.

Be careful if you are taking any sedative medicine (sedative effect) or if you are drinking
alcohol. In these cases Pramipexolo Sandoz A/S may impair your ability to drive or operate
machinery.

Pramipexolo Sandoz A/S with food, drinks and alcohol
You should be cautious if you drink alcohol during treatment with Pramipexolo Sandoz A/S.
Pramipexolo Sandoz A/S can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Your doctor will discuss with you whether to continue taking Pramipexolo Sandoz A/S.
The effect of Pramipexolo Sandoz A/S on the fetus is unknown. Therefore, do not take Pramipexolo Sandoz A/S if you
are pregnant unless your doctor tells you to do so.
Pramipexolo Sandoz A/S should not be taken during breastfeeding. Pramipexolo Sandoz A/S may
reduce milk production. It can also pass into breast milk and reach the baby. If
taking Pramipexolo Sandoz A/S is unavoidable, breastfeeding must be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Pramipexolo Sandoz A/S can cause hallucinations (seeing, hearing or perceiving things that are not there). If this should
happen, do not drive or use machines.
Pramipexolo Sandoz A/S has been associated with sleepiness and sudden onset of sleep episodes,
particularly in patients with Parkinson's disease. If these side effects occur, avoid
driving and do not use machines. Tell your doctor if this happens.

3. How to take Pramipexolo Sandoz A/S

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor. Your doctor will tell you the correct dosage.
Take Pramipexolo Sandoz A/S prolonged-release tablets only once a day and at approximately the same time each day.
Pramipexolo Sandoz A/S can be taken with or without food. Swallow the tablets whole with water.
Do not chew, divide or crush the prolonged-release tablets. If you do, there is a risk of overdose,
because the medicine may be released too
quickly inside 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 as directed by your doctor until your symptoms are controlled (maintenance dose).

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

Patients with kidney disease
If you have kidney disease, your doctor may tell you to take the usual starting dose of prolonged-release tablets of 0.26 mg only on alternate days for the first week. Subsequently your doctor may
increase the frequency of the dose to one 0.26 mg prolonged-release tablet every day. If a
further increase in the dose is necessary, your doctor may increase it by 0.26 mg of pramipexole.
If you have severe kidney problems, your doctor may consider it necessary to give you a different medicine also
based on pramipexole. If your kidney problems worsen during treatment, you should 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 Pramipexolo Sandoz A/S prolonged-release tablets on the dose
of pramipexole tablets (immediate-release) that you were taking.
Take the pramipexole tablets (immediate-release) as usual the day before switching.
Then take Pramipexolo Sandoz A/S prolonged-release tablets the following morning and do not take
any more pramipexole tablets (immediate-release).

If you take more Pramipexolo Sandoz A/S than you should
If you accidentally take too many tablets,

• contact your doctor immediately or go to the emergency room of the nearest hospital.
• You may experience vomiting, a feeling of restlessness or any of the undesirable effects described in section 4 “Possible undesirable effects”.

If you forget to take Pramipexolo Sandoz A/S
If you forget to take a dose of Pramipexolo Sandoz A/S, but remember within 12 hours
of your usual time of taking it, take the tablet immediately and then the next one at your usual time.
If more than 12 hours have passed, simply take the next dose at your usual time. Do not take
a double dose to make up for a forgotten dose.

If you stop taking Pramipexolo Sandoz A/S
Do not stop taking Pramipexolo Sandoz A/S without first talking to your doctor. If you need
to stop treatment with this medicine, your doctor will gradually reduce the dose. This reduces the risk
of worsening of symptoms.
If you suffer from Parkinson's disease, you should not suddenly stop treatment with Pramipexolo Sandoz
A/S. An abrupt discontinuation could induce the development of a medical condition called malignant neuroleptic syndrome, which can pose a serious health risk. The 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 have any questions about using 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 frequencies indicated below.
The following side effects may occur:

Very common (may affect more than 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

• Impulse to behave unusually
• Hallucinations (seeing, hearing or perceiving things that are not there)
• Confusion
• Fatigue (feeling tired)
• Insomnia
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision changes
• 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 well-being)
• Delirium
• Excessive daytime sleepiness and sudden onset 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 can 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 urge, drive or temptation to perform an action that may be harmful to you or others, which may include:
• Strong urge to gamble despite serious personal or family consequences.
• Altered or increased sexual interest and behavior that causes significant concern to you or others, for example an increased sexual drive.
• Excessive and uncontrollable shopping or 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 your appetite)*
• Delirium (reduced awareness, confusion, loss of sense of reality)

Rare (may affect up to 1 in 1,000):
Mania (agitation, feeling of euphoria or overexcitement)

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

• After stopping or reducing therapy with Pramipexolo Sandoz A/S, depression, apathy, anxiety, feeling tired, sweating or pain (dopamine agonist withdrawal syndrome or DAWS) may occur.

Tell your doctor if you experience any of these behaviors; they will explain how to manage or reduce the
symptoms.
For the side effects marked with * it is not possible to make a precise estimate of the frequency as these
side effects have not been observed in clinical studies in 2,762 patients treated with pramipexole. The
frequency category is probably no greater than “uncommon”.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through 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 Pramipexolo 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 pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pramipexolo 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 equivalent to 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 ingredients are: hypromellose, dibasic calcium phosphate anhydrous, magnesium stearate, anhydrous colloidal silicon dioxide.

Description of the appearance of Pramipexolo Sandoz A/S and contents of the pack
Pramipexolo Sandoz A/S 0.26 mg prolonged-release tablets: the 9 mm tablets are white or almost white in colour, cylindrical in shape, flat, with bevelled edges and marked with 026 on one side.
Pramipexolo Sandoz A/S 0.52 mg prolonged-release tablets: the 10 mm tablets are white or almost white in colour, cylindrical in shape, biconvex and marked with 052 on one side.
Pramipexolo Sandoz A/S 1.05 mg prolonged-release tablets: the 10 mm tablets are white or almost white in colour, cylindrical in shape, biconvex, and marked with 105 on one side.
Pramipexolo Sandoz A/S 1.57 mg prolonged-release tablets: the 10 mm tablets are white or almost white in colour, cylindrical in shape, biconvex and marked with 157 on one side.
Pramipexolo Sandoz A/S 2.1 mg prolonged-release tablets: the 10 mm tablets are white or almost white in colour, cylindrical in shape, biconvex and marked with 210 on one side.
Pramipexolo Sandoz A/S 2.62 mg prolonged-release tablets: the 10 mm tablets are white or almost white in colour, cylindrical in shape, biconvex and marked with 262 on one side.
Pramipexolo Sandoz A/S 3.15 mg prolonged-release tablets: the 11 mm tablets are white or almost white in colour, cylindrical in shape, flat, with bevelled edges and marked with 315 on one side.
OPA-Al-PVC/Al blisters: 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 for Italy: Sandoz SpA, Largo U. Boccioni 1, 21040 Origgio (VA)

Manufacturers
Ferrer Internacional, S.A.
Joan Buscallà, 1-9, Sant Cugat del Vallès (Barcelona), 08173
Spain
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 – Retardtablets
Pramipexol 1A Pharma 0.52 mg – Retardtablets
Pramipexol 1A Pharma 1.05 mg – Retardtablets
Pramipexol 1A Pharma 1.57 mg – Retardtablets
Pramipexol 1A Pharma 2.1 mg – Retardtablets
Pramipexol 1A Pharma 2.62 mg – Retardtablets
Pramipexol 1A Pharma 3.15 mg – Retardtablets
Germany Pramipexol Lageman 0.26 mg Retardtablets
Pramipexol Lageman 0.52 mg Retardtablets
Pramipexol Lageman 1.05 mg Retardtablets
Pramipexol Lageman 1.57 mg Retardtablets
Pramipexol Lageman 2.1 mg Retardtablets
Pramipexol Lageman 2.62 mg Retardtablets
Pramipexol Lageman 3.15 mg Retardtablets
Italy Pramipexolo Sandoz A/S
Romania
Slovenia
Pramipexol Lageman 0.52 mg prolonged-release tablets
Pramipexol Lageman 2.1 mg prolonged-release tablets
Pramipexol Lageman 3.15 mg prolonged-release tablets
Pramipeksol Sandoz 0.26 mg tablets with prolonged release
Pramipeksol Sandoz 0.52 mg tablets with prolonged release
Pramipeksol Sandoz 1.05 mg tablets with prolonged release
Pramipeksol Sandoz 1.57 mg tablets with prolonged release
Pramipeksol Sandoz 2.1 mg tablets with prolonged release
Pramipeksol Sandoz 2.62 mg tablets with prolonged release
Sweden Pramipexole Lageman