Pramipexole Pensapharma

Package leaflet: Information for the user

Pramipexole Pensa Pharma 0.26 mg prolonged-release tablets, 0.52 mg prolonged-release tablets, 1.05 mg prolonged-release tablets, 2.1 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 Pensa Pharma is and what it is used for
2. What you need to know before taking Pramipexole Pensa Pharma
3. How to take Pramipexole Pensa Pharma
4. Possible side effects
5. How to store Pramipexole Pensa Pharma
6. Contents of the pack and other information

1. What Pramipexole Pensa Pharma is and what it is used for

Pramipexole Pensa Pharma 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 Pensa Pharma 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 should know before taking Pramipexole Pensa Pharma

Do not take Pramipexole Pensa Pharma

• 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 Pensa Pharma. Inform your doctor if you 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, 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 Pensa Pharma;
• 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 antecollis), forward bending of the lumbar spine (also known as camptocormia), or lateral curvature of the back (also known as pleurothotonus or Pisa syndrome). In such cases, your doctor may decide to modify your treatment;
• drowsiness and sudden onset of sleep episodes;
• psychosis (e.g. symptoms comparable to schizophrenia);
• vision disorders. During treatment with Pramipexole Pensa Pharma, 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 may harm yourself or others. These phenomena are called impulse control disorders and may include behaviours 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, a family member or caregiver notice that you are developing mania (agitation, feeling 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 Pensa Pharma. If symptoms persist for more than a few weeks, your doctor may need to adjust your treatment.

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

Other medicines and Pramipexole Pensa Pharma
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 Pensa Pharma 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 (used 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 leg cramps and to treat falciparum malaria (malignant malaria));
• procainamide (used to treat irregular heartbeats).
  If you are taking levodopa, it is recommended to reduce its dose when starting treatment with Pramipexole Pensa Pharma.
  Be cautious if you are taking any sedative (sedating) medicine or alcohol. In such cases, Pramipexole Pensa Pharma may impair your ability to drive or operate machinery.

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

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

Driving and using machines
Pramipexole Pensa Pharma may cause hallucinations (seeing, hearing or sensing things that are not real). If this occurs, do not drive or operate machinery.
Pramipexole Pensa Pharma 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 and must not operate machinery. Inform your doctor if this happens.

3. How to take Pramipexole Pensa Pharma

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Your doctor will determine the correct dosage for you.
Take Pramipexole Pensa Pharma prolonged-release tablets only once daily, and every day
approximately at the same time. Pramipexole Pensa Pharma may 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 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 may also be used, consisting of one tablet daily of Pramipexole Pensa Pharma 0.26 mg prolonged-release tablets.

Patients with renal disease
If you have renal disease, your doctor may instruct you to take the usual initial dose of 0.26 mg prolonged-release tablets only on alternate days during the first week. Afterwards, your doctor may increase the dosing frequency to one 0.26 mg prolonged-release tablet daily. If further dose increases are needed, your doctor may increase the dose by increments of 0.26 mg of pramipexole at a time.

If you have severe renal problems, your doctor may consider it necessary to switch you to 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 Pensa tablets (immediate-release)
Your doctor will determine the appropriate dose of Pramipexole Pensa Pharma prolonged-release tablets based on the dose of Pramipexole Pensa tablets (immediate-release) you were previously taking.

Take your Pramipexole Pensa tablets (immediate-release) as usual the day before switching, then take Pramipexole Pensa Pharma prolonged-release tablets the following morning and do not take any more Pramipexole Pensa tablets (immediate-release).

If you take more Pramipexole Pensa Pharma than you should
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.

Symptoms may include vomiting, restlessness, or any of the adverse effects described in section 4, “Possible side effects”.

If you forget to take Pramipexole Pensa Pharma
If you forget to take a dose of Pramipexole Pensa Pharma 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 Pensa Pharma
Do not stop taking Pramipexole Pensa Pharma 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 have Parkinson’s disease, you must not abruptly stop treatment with Pramipexole Pensa Pharma.

Sudden discontinuation may lead to the development of a medical condition called neuroleptic malignant syndrome, which could pose a serious 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 have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. 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 (sleepiness)
• Dizziness
• Nausea (feeling unwell)

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

• Impulse to behave in an unusual way
• Hallucinations (seeing, hearing or feeling 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
• Visual disturbances
• Vomiting (feeling unwell)
• Weight loss accompanied by decreased appetite

Uncommon (may affect up to 1 in 100 people):

• Paranoia (e.g. excessive fear about 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 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 spending or shopping
  • 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 1,000 people):

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

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

• After stopping or reducing the dose of Pramipexole Pensa Pharma, symptoms such as depression, apathy, anxiety, feeling of 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 *, it is not possible to estimate frequency precisely, as these side effects were not observed in clinical trials among the 2,762 patients treated with pramipexole. The frequency category is likely no greater than "uncommon".
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
Reporting of side effects
If you experience any side effect, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pramipexole Pensa Pharma

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 conditions.
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 Pensa Pharma prolonged-release tablets contain

• The active substance is pramipexole. Each tablet contains 0.26 mg, 0.52 mg, 1.05 mg, 2.1 mg, or 3.15 mg of pramipexole, corresponding to 0.375 mg, 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg of pramipexole dihydrochloride monohydrate, respectively.
• The other components are hypromellose, anhydrous calcium hydrogen phosphate, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Pramipexole Pensa Pharma prolonged-release tablets and contents of the
pack
Pramipexole Pensa Pharma 0.26 mg prolonged-release tablets: white or almost white, cylindrical, flat tablets with bevelled edges, 9 mm in diameter, marked with "026" on one side.
Pramipexole Pensa Pharma 0.52 mg prolonged-release tablets: white or almost white, cylindrical, biconvex tablets, 10 mm in diameter, marked with "052" on one side.
Pramipexole Pensa Pharma 1.05 mg prolonged-release tablets: white or almost white, cylindrical, biconvex tablets, 10 mm in diameter, marked with "105" on one side.
Pramipexole Pensa Pharma 2.1 mg prolonged-release tablets: white or almost white, cylindrical, biconvex tablets, 10 mm in diameter, marked with "21" on one side.
Pramipexole Pensa Pharma 3.15 mg prolonged-release tablets: white or almost white, cylindrical, flat tablets with bevelled edges, 11 mm in diameter, marked with "315" on one side.
Aluminium/OPA-aluminium-PVC blisters:
0.26 mg: 10 and 30 prolonged-release tablets
0.52 mg: 10 prolonged-release tablets
1.05 mg: 30 prolonged-release tablets
2.1 mg: 30 prolonged-release tablets
3.15 mg: 30 prolonged-release tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano, Italy

Manufacturers responsible for batch release
Ferrer Internacional, S.A.
Joan Buscallà, 1-9, 08173
Sant Cugat del Vallés (Barcelona), Spain
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6,
Tres Cantos, 28760 Madrid, Spain

Italy: Pramipexole Pensa Pharma 0.26 mg prolonged-release tablets.
Pramipexole Pensa Pharma 0.52 mg prolonged-release tablets.
Pramipexole Pensa Pharma 1.05 mg prolonged-release tablets.
Pramipexole Pensa Pharma 2.1 mg prolonged-release tablets.
Pramipexole Pensa Pharma 3.15 mg prolonged-release tablets.

Spain: Pramipexol Pensa 0.26 mg prolonged-release tablets (EU/EEA reference number: EFG)
Pramipexol Pensa 1.05 mg prolonged-release tablets (EU/EEA reference number: EFG)
Pramipexol Pensa 2.1 mg prolonged-release tablets (EU/EEA reference number: EFG)

Sweden: Pramipexol Pensa

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco).