Pramipexole Teva Italia

Patient Information Leaflet: Instructions for the User

Pramipexole Teva Italia 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 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Pramipexole Teva Italia is and what it is used for

Pramipexole Teva Italia 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 Teva Italia 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 Teva Italia

Do not take Pramipexole Teva Italia

• 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 Teva Italia. 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 perceiving things that do not exist). Most hallucinations are visual.
• Dyskinesia (e.g., abnormal, uncontrolled movements of limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you may develop dyskinesia during dose adjustment of Pramipexole Teva Italia.
• Dystonia (inability to maintain 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 curvature of the spine (also known as pleurothotonus or Pisa syndrome). If you experience any of these symptoms, your doctor may decide to modify your treatment.
• Drowsiness and sudden onset of sleep episodes.
• Drug overuse and drug craving.
• Psychosis (e.g., comparable to symptoms of schizophrenia).
• Visual disturbances. During treatment with Pramipexole Teva Italia, 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 avoid 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 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 decide to adjust the dose or discontinue therapy.
Inform your doctor if you or a family member or caregiver notice symptoms of 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 Teva Italia. If symptoms persist for more than a few weeks, your doctor may need to adapt your treatment.

Children and adolescents
The use of Pramipexole Teva Italia is not recommended in children or adolescents under 18 years of age.

Other medicines and Pramipexole Teva Italia
Inform 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 Teva Italia in combination 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 (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 nighttime leg 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 Teva Italia.
  Be cautious if you are taking any sedative (sleep-inducing) medicine or consuming alcohol. In these cases, Pramipexole Teva Italia may impair your ability to drive or operate machinery.

Pramipexole Teva Italia with food, drinks, and alcohol
You should be cautious if consuming alcohol during treatment with Pramipexole Teva Italia.
Pramipexole Teva Italia may be taken with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will discuss with you whether to continue taking Pramipexole Teva Italia.
The effect of Pramipexole Teva Italia on the fetus is unknown. Therefore, do not take Pramipexole Teva Italia during pregnancy unless your doctor tells you to do so.
Pramipexole Teva Italia should not be taken during breastfeeding. Pramipexole Teva Italia may reduce the production of breast milk and may pass into breast milk and reach the infant. If taking Pramipexole Teva Italia is unavoidable, breastfeeding must be discontinued.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Pramipexole Teva Italia may cause hallucinations (seeing, hearing, or perceiving things that do not exist). If this occurs, do not drive or operate machinery.
Pramipexole Teva Italia has been associated with drowsiness and sudden onset of sleep episodes, particularly in patients with Parkinson’s disease. If these side effects occur, you must not drive or operate machinery. Inform your doctor if this happens.

3. How to take Pramipexole Teva Italia

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist. Your doctor will determine the correct dosage for you.
Take Pramipexole Teva Italia prolonged-release tablets once daily, and every day approximately at the same time. Pramipexole Teva Italia 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 lead to an 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 daily. A lower maintenance dose may also be possible, equal to one Pramipexole Teva Italia 0.26 mg prolonged-release tablet daily.

Patients with renal disease
If you have renal disease, your doctor may instruct you to take the usual initial dose of prolonged-release 0.26 mg tablets only every other day during the first week. Subsequently, your doctor may increase the dosing frequency to one prolonged-release 0.26 mg tablet daily. If a further dose increase is needed, your doctor may increase it by 0.26 mg of pramipexole at a time.

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.

Switching from Pramipexole Teva tablets (immediate-release)
Your doctor will base the choice of dose of Pramipexole Teva Italia prolonged-release tablets on the dose of Pramipexole Teva tablets (immediate-release) you were previously taking. Take Pramipexole Teva tablets (immediate-release) as usual the day before switching. Then take Pramipexole Teva Italia prolonged-release tablets the following morning and no longer take Pramipexole Teva tablets (immediate-release).

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

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

If you forget to take Pramipexole Teva Italia
If you forget to take a dose of Pramipexole Teva Italia 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 usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Pramipexole Teva Italia
Do not stop taking Pramipexole Teva Italia 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 stop treatment with Pramipexole Teva Italia abruptly.
Sudden discontinuation may lead to the development of a medical condition called neuroleptic malignant syndrome, which could pose a greater health risk. 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 stop or reduce treatment with Pramipexole Teva Italia, 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 doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. The assessment of these adverse reactions is based on the following frequencies:

The following undesirable effects may occur:
Very common:

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

Common:

• Impulse to behave in an unusual way
• Hallucinations (seeing, hearing or sensing things that are not there)
• Confusion
• Fatigue (feeling of tiredness)
• Difficulty sleeping (insomnia)
• Fluid retention, usually in the legs (peripheral oedema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision disturbances
• Vomiting (sickness)
• Weight loss accompanied by decreased appetite

Uncommon:

• 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 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, 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
• 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 hunger)* 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 Teva Italia, symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating or pain (dopamine agonist withdrawal syndrome or DAWS) may occur.
Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.
For adverse effects marked with *, a precise frequency estimate cannot be made, as these adverse effects have not been observed in clinical studies among the 2,762 patients treated with pramipexole. The frequency category is likely not higher than "uncommon".
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the website
www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Pramipexole Teva Italia

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
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 Teva Italia prolonged-release tablets contain

• 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, anhydrous calcium hydrogen phosphate, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Pramipexole Teva Italia prolonged-release tablets and package contents
Pramipexole Teva Italia 0.26 mg prolonged-release tablets: The 9 mm tablets are white or almost white, cylindrical in shape, flat, with bevelled edges, and marked with "026" on one side.
Pramipexole Teva Italia 0.52 mg prolonged-release tablets: The 10 mm tablets are white or almost white, cylindrical in shape, biconvex, and marked with "052" on one side.
Pramipexole Teva Italia 1.05 mg prolonged-release tablets: The 10 mm tablets are white or almost white, cylindrical in shape, biconvex, and marked with "105" on one side.
Pramipexole Teva Italia 1.57 mg prolonged-release tablets: The 10 mm tablets are white or almost white, cylindrical in shape, biconvex, and marked with "157" on one side.
Pramipexole Teva Italia 2.1 mg prolonged-release tablets: The 10 mm tablets are white or almost white, cylindrical in shape, biconvex, and marked with "210" on one side.
Pramipexole Teva Italia 2.62 mg prolonged-release tablets: The 10 mm tablets are white or almost white, cylindrical in shape, biconvex, and marked with "262" on one side.
Pramipexole Teva Italia 3.15 mg prolonged-release tablets: The 11 mm tablets are white or almost white, cylindrical in shape, flat, with bevelled edges, and marked with "315" on one side.
Aluminum/OPA-aluminum-PVC blisters: 10, 30, or 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4, 20123 – Milan, Italy

Manufacturer
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
Teva Pharma B.V.
Swensweg 5, Haarlem
2031 GA
The Netherlands
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren
Germany
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211, 8054 Graz
Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Pramipexol Genericon 0.26 mg Retardtabletten
Pramipexol Genericon 0.52 mg Retardtabletten
Pramipexol Genericon 1.05 mg Retardtabletten
Pramipexol Genericon 2.1 mg Retardtabletten
Pramipexol Genericon 3.15 mg Retardtabletten

Germany: Pramipexol Ferrer 0.26 mg Retardtabletten
Pramipexol Ferrer 0.52 mg Retardtabletten
Pramipexol Ferrer 1.05 mg Retardtabletten
Pramipexol Ferrer 1.57 mg Retardtabletten
Pramipexol Ferrer 2.1 mg Retardtabletten
Pramipexol Ferrer 2.62 mg Retardtabletten
Pramipexol Ferrer 3.15 mg Retardtabletten

Hungary: Pramipexol Meditop 0.26 mg retard tabletta
Pramipexol Meditop 0.52 mg retard tabletta
Pramipexol Meditop 1.05 mg retard tabletta
Pramipexol Meditop 2.1 mg retard tabletta

Italy: Pramipexolo Teva Italia 0.26 mg compresse a rilascio prolungato
Pramipexolo Teva Italia 0.52 mg compresse a rilascio prolungato
Pramipexolo Teva Italia 1.05 mg compresse a rilascio prolungato
Pramipexolo Teva Italia 1.57 mg compresse a rilascio prolungato
Pramipexolo Teva Italia 2.1 mg compresse a rilascio prolungato
Pramipexolo Teva Italia 2.62 mg compresse a rilascio prolungato
Pramipexolo Teva Italia 3.15 mg compresse a rilascio prolungato

Spain: Pramipexol Ferrer 0.26 mg comprimidos de liberación prolongada EFG
Pramipexol Ferrer 0.52 mg comprimidos de liberación prolongada EFG
Pramipexol Ferrer 1.05 mg comprimidos de liberación prolongada EFG
Pramipexol Ferrer 2.1 mg comprimidos de liberación prolongada EFG
Pramipexol Ferrer 3.15 mg comprimidos de liberación prolongada EFG

Sweden: Pramipexol Ferrer

Other sources of information
More detailed information on this medicinal product is available on the website