Pramipexole Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRAMIPEXOLE ZENTIVA 0.088 mg tablets, 0.18 mg tablets, 0.35 mg tablets, 0.7 mg tablets, 1.1 mg 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 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, because it could be harmful.
• If you experience any side effect, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PRAMIPEXOLE ZENTIVA is and what it is used for

PRAMIPEXOLE ZENTIVA belongs to a group of medicines known as dopaminergic agonists which
stimulate dopamine receptors located in the brain. Stimulation of dopamine receptors in the
brain triggers nerve impulses that help control body movements.
PRAMIPEXOLE ZENTIVA is used for:

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

2. What you need to know before taking Pramipexole Zentiva

Do not take PRAMIPEXOLE ZENTIVA

• 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 ZENTIVA. 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 PRAMIPEXOLE ZENTIVA;
• 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 those seen in schizophrenia);
• visual disturbances. During treatment with PRAMIPEXOLE ZENTIVA, regular eye examinations are required;
• severe heart or blood vessel diseases. Especially at the beginning of treatment, your blood pressure should be monitored regularly to avoid postural hypotension (a drop in blood pressure when standing up);
• worsening symptoms. You may notice that symptoms appear earlier than usual, are more intense, and involve other limbs. Inform your doctor if you or someone in your family or caregiver notices that you are developing urges or desires to behave in ways that are unusual for you and that you cannot resist the impulse or temptation to carry out certain activities that could harm yourself or others. These phenomena are known as impulse control disorders and may include behaviours such as gambling addiction, excessive eating or spending, abnormally increased sexual desire, or increased sexual thoughts or sensations. Your doctor may consider it necessary to adjust the dose or discontinue therapy.

Inform your doctor if you or a family member or caregiver notices 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.
Children and adolescents
The use of PRAMIPEXOLE ZENTIVA is not recommended in children or adolescents under 18 years of age.
Other medicines and PRAMIPEXOLE ZENTIVA
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 PRAMIPEXOLE ZENTIVA 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 heartbeats, a condition known as ventricular arrhythmia);
• zidovudine [used to treat acquired immunodeficiency syndrome (AIDS), a disease of the human immune system];
• cisplatin (used to treat various types of cancer);
• quinine [used to prevent painful nighttime leg cramps and to treat a type of malaria known as falciparum malaria (malignant malaria)];
• procainamide (to treat irregular heartbeat).

If you are taking levodopa, a reduction of its dose is recommended when starting treatment with
PRAMIPEXOLE ZENTIVA.
Be cautious if you are taking any sedative (sleep-inducing) medicine or consuming alcohol. In such cases,
PRAMIPEXOLE ZENTIVA may impair your ability to drive or operate machinery.
PRAMIPEXOLE ZENTIVA with food, drinks and alcohol
You should be cautious if consuming alcohol during treatment with PRAMIPEXOLE ZENTIVA.
PRAMIPEXOLE may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult
your doctor or pharmacist before taking this medicine. Your doctor will discuss with you whether to continue
taking PRAMIPEXOLE ZENTIVA.
The effect of PRAMIPEXOLE ZENTIVA on unborn babies is unknown. Therefore, do not take
PRAMIPEXOLE ZENTIVA during pregnancy unless your doctor specifically tells you to do so.
PRAMIPEXOLE ZENTIVA must not be taken during breastfeeding.
PRAMIPEXOLE ZENTIVA may reduce milk production. It may also pass into breast milk and reach the baby.
If taking PRAMIPEXOLE ZENTIVA cannot be avoided, breastfeeding must be discontinued.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
PRAMIPEXOLE ZENTIVA may cause hallucinations (seeing, hearing or sensing things that are not real). If
this occurs, do not drive or use machinery.
PRAMIPEXOLE ZENTIVA 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 use
machinery. Inform your doctor if this happens.

3. How to take PRAMIPEXOLE ZENTIVA

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Your doctor will indicate the correct dosage.
PRAMIPEXOLE ZENTIVA may be taken 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 ZENTIVA 0.088 mg three
times a day (equivalent to 0.264 mg per day):

This dose will be increased every 5–7 days according to the doctor's instructions until symptoms are controlled (maintenance dose).

The usual maintenance dose is 1.1 mg daily. However, your dose may be further increased. If necessary, your doctor may increase the tablet dose up to a maximum of 3.3 mg of pramipexole daily. A lower maintenance dose, equivalent to three tablets of PRAMIPEXOLE ZENTIVA 0.088 mg daily, is also possible.

Patients with renal disease
If you have moderate or severe renal disease, your doctor will prescribe a lower dosage. In this case,
you will need to take the tablets only once or twice a day. If you have moderate renal disease, the
usual initial dose is 1 tablet of PRAMIPEXOLE ZENTIVA 0.088 mg twice daily. In case of
severe renal disease, the usual initial dose is only 1 tablet of PRAMIPEXOLE ZENTIVA 0.088 mg
once daily.

Restless Legs Syndrome
The dose is usually taken once daily in the evening, 2–3 hours before going to bed.
During the first week, the usual dose is 1 tablet of Pramipexole Zentiva 0.088 mg once daily (equivalent to 0.088 mg daily):

1st week
Number of tablets: 1 tablet of Pramipexole Zentiva 0.088 mg
Total daily dose: 0.088 (mg)

This dose will be increased every 4–7 days according to your doctor's instructions until symptoms are controlled (maintenance dose).

2nd week
Number of tablets: 1 tablet of Pramipexole Zentiva 0.18 mg or 2 tablets of Pramipexole Zentiva 0.088 mg
Total daily dose: 0.18 (mg)

3rd week
Number of tablets: 1 tablet of Pramipexole Zentiva 0.35 mg or 2 tablets of Pramipexole Zentiva 0.18 mg or 4 tablets of Pramipexole Zentiva 0.088 mg
Total daily dose: 0.35 (mg)

4th week
Number of tablets: 1 tablet of Pramipexole Zentiva 0.35 mg and 1 tablet of Pramipexole Zentiva 0.18 mg or 3 tablets of Pramipexole Zentiva 0.18 mg or 6 tablets of Pramipexole Zentiva 0.088 mg
Total daily dose: 0.54 (mg)

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

If you stop taking the medicine for more than a few days and wish to restart treatment, you must begin again with the lowest dose. You may then gradually return to your previous dose as done initially.
Consult your doctor for advice.

Your doctor will review your treatment after 3 months to decide whether it should be continued.

Patients with renal disease
If you have severe renal disease, treatment with Pramipexole Zentiva may not be suitable for you.

If you take more PRAMIPEXOLE ZENTIVA 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 described in section 4 “Possible side effects” may occur.

If you forget to take PRAMIPEXOLE ZENTIVA
Do not worry. Simply miss the forgotten dose completely and 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 PRAMIPEXOLE ZENTIVA
Do not stop taking PRAMIPEXOLE ZENTIVA without first discussing it with 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 suffer from Parkinson’s disease, you must not stop treatment with PRAMIPEXOLE ZENTIVA abruptly. Sudden discontinuation may lead to the development of a medical condition called neuroleptic malignant syndrome, which may pose a greater 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 have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The classification of these side effects is based on the following frequencies:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people

If you have Parkinson's disease, you may experience the following side effects:
Very common:

• Dyskinesia (e.g. involuntary, abnormal limb movements)
• Somnolence (sleepiness)
• 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 tired)
• Difficulty sleeping (insomnia)
• Fluid retention, usually in the legs (peripheral oedema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (feeling unwell)
• Weight loss including decreased appetite

Uncommon:

• Paranoia (e.g. excessive fear for one's own well-being)

• Delirium

• Excessive daytime sleepiness and sudden onset sleep episodes

• Amnesia (memory disorders)

• 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 antidiuretic hormone secretion*

• Restlessness

• Dyspnoea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)

• Inability to resist the impulse to carry out behaviours that could be harmful to you or others, which may include:

• Strong urge to gamble excessively, despite serious personal or family consequences

• Increased or altered interest in sex and behaviour causing significant concern to you or others, for example, increased sexual desire

• Uncontrollable shopping or excessive spending

• Compulsive eating (eating large amounts of food in a short period of time) or bulimia (eating more food than normal and more than needed to satisfy your appetite)*

• Delirium (reduced awareness, confusion, loss of sense of reality)

Rare:

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

Not known:

• After stopping or reducing the dose of Pramipexole Zentiva, 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, so that he or she can decide how to
intervene to manage or reduce your symptoms.
For side effects marked with *, it is not possible to estimate frequency precisely, as these side effects were not observed in clinical studies involving 2,762 patients treated with pramipexole. The frequency category is likely no higher than "uncommon".

If you have Restless Legs Syndrome, you may experience the following side effects:
Very common:

• Nausea (feeling unwell)

Common:

• Sleep disturbances, such as difficulty sleeping (insomnia) and somnolence (sleepiness)
• Fatigue (feeling tired)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (feeling unwell)

Uncommon:

• Impulse to behave in an unusual way*
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inappropriate antidiuretic hormone secretion*
• Dyskinesia (e.g. involuntary, abnormal limb movements)
• Hyperkinesia (increased movements and inability to stay still)
• Paranoia (e.g. excessive fear for one's own well-being)
• Delirium
• Amnesia (memory disorders)
• Hallucinations (seeing, hearing or sensing things that are not there)
• Confusion
• Excessive daytime sleepiness and sudden onset sleep episodes
• Weight gain
• Hypotension (low blood pressure)
• Fluid retention, usually in the legs (peripheral oedema)
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Fainting
• Restlessness
• Visual disturbances
• Weight loss including decreased appetite
• Dyspnoea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse to carry out behaviours that could be harmful to you or others, which may include:
• Strong urge to gamble excessively, despite serious personal or family consequences*
• Altered or increased interest in sex and behaviour causing significant concern to you or others, for example, increased sexual desire*
• Uncontrollable shopping or excessive spending*
• Compulsive eating (eating large amounts of food in a short period of time) or bulimia (eating more food than normal and more than needed to satisfy your appetite)*
• Mania (agitation, feeling of euphoria or over-excitement)*
• Delirium (reduced awareness, confusion, loss of sense of reality)*

Not known:

• After stopping or reducing the dose of Pramipexole Zentiva, 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, so that he or she can decide how
intervene to manage or reduce your symptoms.
For side effects marked with *, it is not possible to estimate frequency precisely, as these side effects were not observed in clinical studies involving 1,395 patients treated with pramipexole. The frequency category is likely no higher than "uncommon".

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. 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 PRAMIPIXOLE ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
Do not dispose of this 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 ZENTIVA contains
The active substance is pramipexole.
0.088 mg tablet: each tablet contains 0.088 mg of pramipexole base as 0.125 mg of
pramipexole dihydrochloride monohydrate; 0.18 mg tablet: each tablet contains 0.18 mg of
pramipexole base as 0.25 mg of pramipexole dihydrochloride monohydrate; 0.35 mg tablet: each
tablet contains 0.35 mg of pramipexole base as 0.5 mg of pramipexole dihydrochloride monohydrate;
0.7 mg tablet: each tablet contains 0.7 mg of pramipexole base as 1.0 mg of pramipexole
dihydrochloride monohydrate; 1.1 mg tablet: each tablet contains 1.1 mg of pramipexole base as
1.5 mg of pramipexole dihydrochloride monohydrate.
The excipients are: mannitol, maize starch, hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of PRAMIPEXOLE ZENTIVA and package contents
0.088 mg tablets: white, round, flat tablets with a diameter of approximately 6.5 mm.
0.18 mg tablets: white, biconvex, oblong tablets, scored on both sides, approximately 8 mm x 4 mm in size.
0.35 mg tablets: white, biconvex, oblong tablets, scored on both sides, approximately 11.1 mm x 5.6 mm in size.
0.7 mg tablets: white, round, flat tablets with a score on one side and a diameter of approximately 9 mm.
1.1 mg tablets: white, round, flat tablets with a score on one side, with two parallel lines imprinted on both sides of the score line, and a diameter of approximately 9 mm.
PRAMIPEXOLE ZENTIVA 0.18 mg, 0.35 mg, 0.7 mg, 1.1 mg tablets:
The tablet may be divided into two equal doses.
1.1 mg tablet: the two parallel lines are not intended for breaking the tablet.
PRAMIPEXOLE ZENTIVA is available in OPA/Aluminum/PVC/Aluminum blisters containing 10
tablets each, packed in cardboard cartons containing 1, 3, 6, 10 or 20 blisters.
Pack sizes: 10, 30, 60, 100 and 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale L. Bodio, 37/b
20158 Milano, Italy

Responsible manufacturers for batch release:
Saneca Pharmaceuticals a.s.
Nitrianská 100,
920 27 Hlohovec (Slovak Republic)

This medicinal product is authorized in the European Economic Area member states under the following names:
Italy: Pramipexolo Zentiva
Germany: Pramipexol Winthrop
France: Pramipexole Zentiva

This Patient Information Leaflet was last updated on: