Pramipexole Eg

Package leaflet: Information for the user

PRAMIPEXOLE EG 0.18 mg tablets, 0.7 mg tablets

Equivalent medicine
Please read all of this leaflet carefully before you take 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 effect, including those not listed in this leaflet,
please contact your doctor or pharmacist. See section 4.
Contents of this leaflet

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

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

PRAMIPEXOLE EG 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.
PRAMIPEXOLE EG 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);
treat moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults.

2. What you need to know before taking PRAMIPEXOLE EG

DO NOT take PRAMIPEXOLE EG
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 EG. Inform your doctor if you have or have had any medical conditions or symptoms, especially the following:

• kidney problems;
• hallucinations (seeing, hearing or sensing things that are not real). Most hallucinations are visual;
• dyskinesia (e.g. abnormal, uncontrollable movements of limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you may develop dyskinesia during the titration phase of PRAMIPEXOLE EG;
• dystonia;
• inability to maintain an upright posture of the body and neck (axial dystonia). In particular, forward bending of the 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 adjust your treatment;
• somnolence and sudden onset of sleep episodes;
• psychosis (e.g. symptoms similar to schizophrenia);
• visual disturbances. You should undergo regular eye examinations during treatment with PRAMIPEXOLE EG;
• severe heart or vascular disease. Your blood pressure should be monitored regularly, especially at the beginning of treatment, to prevent postural hypotension (a drop in blood pressure upon standing).
• worsening of symptoms. You may notice that symptoms occur earlier than usual, are more intense, or involve additional limbs.

Inform your doctor if you, a family member, or caregiver notice the development of impulses or urges 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 are called impulse control disorders and may include behaviours such as gambling addiction, compulsive shopping or excessive spending, abnormally increased sexual desire, or increased sexual thoughts or feelings. Your doctor may consider it necessary to adjust the dose or discontinue treatment.

Inform your doctor if you, a family member, or caregiver notice signs of mania (agitation, feelings of euphoria or over-excitement) or delirium (reduced awareness, confusion, 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 EG. If symptoms persist for more than a few weeks, your doctor may need to adjust your treatment.

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

Other medicines and PRAMIPEXOLE EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines, herbal preparations, dietary products, or supplements obtained without a prescription.
You must avoid taking PRAMIPEXOLE EG together with antipsychotic medicines.

Pay special attention 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 (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 nocturnal cramps and to treat a type of malaria known as falciparum malaria (malignant malaria));
• procainamide (to treat irregular heartbeats).

If you are taking levodopa, a dose reduction is recommended when starting treatment with PRAMIPEXOLE EG.

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

PRAMIPEXOLE EG with food, drinks and alcohol
Exercise caution if you consume alcohol during treatment with PRAMIPEXOLE EG.
PRAMIPEXOLE EG 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 with you whether you should continue taking PRAMIPEXOLE EG.
The effect of PRAMIPEXOLE EG on unborn babies is unknown. Therefore, do not take PRAMIPEXOLE EG during pregnancy unless your doctor specifically instructs you to do so.
PRAMIPEXOLE EG must not be taken during breastfeeding. PRAMIPEXOLE EG may reduce milk production.
It may also pass into breast milk and reach the infant. If taking PRAMIPEXOLE EG is unavoidable, breastfeeding must be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.

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

3. How to take PRAMIPEXOLE EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Your doctor will tell you the correct dosage.
PRAMIPEXOLE EG 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 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 may also be used, equivalent to three pramipexole 0.088 mg tablets daily.

Patients with renal disease
If you have moderate or severe renal disease, your doctor will prescribe you a reduced dose. In this
case, you will need to take the tablets only once or twice a day. If you have moderate renal disease,
the usual starting dose is 1 tablet of pramipexole 0.088 mg twice daily. In case of severe renal disease,
the usual starting dose is only 1 tablet of pramipexole 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 0.088 mg once daily (equivalent to 0.088 mg daily):

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

The daily dose must not exceed 6 tablets of pramipexole 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexole salt).
If you stop taking the medication for more than a few days and wish to restart treatment, you must begin again with the lowest dose. You may then return to your previous dose as you did the first time. Ask your doctor for advice.
Your doctor will review your treatment after 3 months to decide whether it should continue or not.

Patients with kidney disease
If you suffer from severe kidney disease, treatment with PRAMIPEXOLE EG may not be suitable for you.

If you take more PRAMIPEXOLE EG than you should
If you accidentally take too many tablets:
contact your doctor or go immediately to the nearest hospital emergency department.
Symptoms such as vomiting, restlessness, or any of the adverse reactions described in section 4 (Possible side effects) may occur.

If you forget to take PRAMIPEXOLE EG
Do not worry. Simply miss the forgotten dose 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 EG
Do not stop taking PRAMIPEXOLE EG 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 suffer from Parkinson's disease, you must not stop treatment with PRAMIPEXOLE EG abruptly. Sudden withdrawal 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 have any questions about the use of 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.

If you have Parkinson’s disease, you may experience the following side effects:

Very common (may affect more than 1 in 10 people):
Dyskinesia (e.g. involuntary, abnormal movements of limbs)
Somnolence (drowsiness)
Dizziness
Nausea (feeling unwell)

Common (may affect up to 1 in 10 people):
Urge to behave in an unusual way
Hallucinations (seeing, hearing or sensing things that are not there)
Confusion
Tiredness (feeling fatigued)
Sleeplessness (insomnia)
Fluid retention, usually in the legs (peripheral oedema)
Headache
Hypotension (low blood pressure)
Abnormal dreams
Constipation
Vision disorders
Vomiting (feeling unwell)
Weight loss accompanied by loss of appetite

Uncommon (may affect up to 1 in 100 people):
Paranoia (e.g. excessive fear for one’s own wellbeing)
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 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 oneself or others, which may include:

  • Strong urge to gamble excessively, despite serious personal or family consequences
  • Altered or increased sexual interest and behaviour causing considerable concern to the patient or others, e.g. increased libido
  • Compulsive 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 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)

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

• After stopping or reducing the dose of PRAMIPEXOLE EG, symptoms such as depression, apathy, anxiety, feeling fatigued, sweating, or pain may occur (dopamine agonist withdrawal syndrome or DAWS).
  Inform your doctor if any of these behaviours occur, so that he/she can decide how to intervene to manage or reduce the symptoms.

For side effects marked with *, a precise frequency estimate is not possible, as these side effects were not observed in clinical trials involving 2,762 patients treated with pramipexole. The frequency category is likely no greater than "uncommon".

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

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

Common (may affect up to 1 in 10 people):
Sleep disturbances, such as difficulty sleeping (insomnia) and drowsiness
Tiredness (asthenia)
Headache
Abnormal dreams
Constipation
Dizziness
Vomiting (feeling unwell)

Uncommon (may affect up to 1 in 100 people):
Urge 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 movements of limbs)
Hyperkinesia (increased movements and inability to remain still)*
Paranoia (e.g. excessive fear for one’s own wellbeing)*
Delirium*
Amnesia (memory disturbances)*
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 rashes, itching, hypersensitivity)
Fainting
Restlessness
Vision disorders
Weight loss accompanied by loss of appetite
Dyspnoea (difficulty breathing)
Hiccups
Pneumonia (lung infection)*

• Inability to resist the impulse to carry out behaviours that could 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 behaviour causing considerable concern to the patient or others, e.g. increased libido*
  • Compulsive 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 hunger)*
• Mania (agitation, feeling of euphoria or over-excitement)*
• Delirium (reduced awareness, confusion, loss of sense of reality)*

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

• After stopping or reducing the dose of PRAMIPEXOLE EG, symptoms such as depression, apathy, anxiety, feeling fatigued, sweating, or pain may occur (dopamine agonist withdrawal syndrome or DAWS).
  Inform your doctor if any of these behaviours occur, so that he/she can decide how to intervene to manage or reduce the symptoms.

For side effects marked with *, a precise frequency estimate is not possible, as these side effects were not observed in clinical trials involving 1,395 patients treated with pramipexole. The frequency category is likely no greater 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: 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 EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the tablets from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What PRAMIPEXOLO EG contains
The active substance is: pramipexole
PRAMIPEXOLO EG 0.18 mg tablets
One tablet contains 0.18 mg of pramipexole (as pramipexole dihydrochloride monohydrate).
PRAMIPEXOLO EG 0.7 mg tablets
One tablet contains 0.7 mg of pramipexole (as pramipexole dihydrochloride monohydrate).

The other components are:
Betadex
Maize starch
Povidone (K30)
Microcrystalline cellulose
Anhydrous colloidal silica
Magnesium stearate

Description of the appearance of PRAMIPEXOLO EG and contents of the pack
The tablets in PRAMIPEXOLO EG 0.18 mg tablets are oval, white to off-white in colour, with a score line on both sides. The tablet can be divided into equal halves.
The tablets in PRAMIPEXOLO EG 0.7 mg tablets are round, white to off-white in colour, with a score line on both sides. The tablet can be divided into equal halves.
Each blister contains 10 tablets.
PRAMIPEXOLO EG 0.18 mg tablets: Packs containing 1, 3, 6, 10 or 2 x 10 blisters (10, 30, 60, 100 or 200 (2 x 100) tablets).
PRAMIPEXOLO EG 0.7 mg tablets: Packs containing 3, 6, 10 or 2 x 10 blisters (30, 60, 100 or 200 (2 x 100) tablets).
Not all pack sizes may be marketed.

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

Manufacturers
Stada Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel (Germany)
Centrafarm Services B.V., Nieuwe Donk 9 – 4879 AC Etten Leur (The Netherlands)
Clonmel Healthcare Ltd., Waterford Road, Clonmel Co Tipperary (Ireland)
Lamp San Prospero S.p.A., Via della Pace, 25/A 41030 San Prospero, Modena (Italy)
PharmaCoDane ApS., Marielundvej 46 DK-2730 Herlev (Denmark)

This medicinal product is authorised in the European Economic Area countries under the following names:
BE: Pramipexole EG 0.18 mg tabletten
CZ: Pramipexol STADA 0.18 mg tablety
DE: Pramipexol STADA 0.18 mg Tabletten
DK: Pramipexol STADA 0.18 mg tabletter
FI: Pramipexol STADA 0.18 mg tabletti
FR: PRAMIPEXOLE EG 0.18 mg comprimé
HU: Pramipexol STADA 0.18 mg tabletta
IE: Miramel 0.18 mg tablets
IT: Pramipexolo EG 0.18 mg compresse
LU: Pramipexole EG 0.18 mg comprimés
RO: Pramipexol STADA 0.18 mg comprimate
SK: Pramipexol STADA 0.18 mg tablety
ES: Pramipexol STADA 0.18 mg comprimidos EFG
SE: Pramipexol STADA 0.18 mg tabletter

BE: Pramipexole EG 0.7 mg tabletten
CZ: Pramipexol STADA 0.7 mg tablety
DE: Pramipexol STADA 0.7 mg Tabletten
DK: Pramipexol STADA 0.7 mg tabletter
FI: Pramipexol STADA 0.7 mg tabletti
FR: PRAMIPEXOLE EG 0.7 mg comprimé
HU: Pramipexol STADA 0.7 mg tabletta
IE: Miramel 0.7 mg tablets
IT: Pramipexolo EG 0.7 mg compresse
LU: Pramipexole EG 0.7 mg comprimés
RO: Pramipexol STADA 0.7 mg comprimate
SK: Pramipexol STADA 0.7 mg tablety
ES: Pramipexol STADA 0.7 mg comprimidos EFG
SE: Pramipexol STADA 0.7 mg tabletter