Pramipexole Mylan Pharma

Package leaflet: Information for the user

Pramipexole Mylan 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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pramipexole Mylan Pharma contains the active substance pramipexole and belongs to a group of
medicines known as dopaminergic agonists that stimulate dopamine receptors located in the
brain. Stimulation of dopamine receptors in the brain triggers nerve impulses that help control
body movements.
Pramipexole Mylan Pharma is used to treat the symptoms of primary Parkinson's disease in adults. It may be used alone or in combination with levodopa (another medicine for Parkinson's disease).

2. What you need to know before taking Pramipexole Mylan Pharma

Do not take Pramipexole Mylan 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 or pharmacist before taking Pramipexole Mylan Pharma.
Inform your doctor if you have or have had any medical condition, especially the following:

• kidney problems.
• Psychosis (e.g. symptoms similar to schizophrenia).
• 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 upon standing up, which may cause dizziness or fainting).

You should also inform your doctor if you develop any of the above-mentioned conditions during treatment with Pramipexole Mylan Pharma, such as:

• Hallucinations (seeing, hearing or sensing things that do not exist). 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 Mylan Pharma.
• Dystonia (inability to maintain an 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 these symptoms occur, your doctor may decide to modify your treatment.
• Drowsiness and sudden onset of sleep episodes (see also “Driving and use of machines” in this section).
• Visual disturbances. Regular eye examinations are recommended during treatment with Pramipexole Mylan Pharma.

Inform your doctor if you, your family members or caregivers notice that you are developing an urge or desire to behave in unusual ways and are unable to resist the impulse, drive 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, binge eating, excessive spending, abnormally increased sexual desire or preoccupation with sexual thoughts or sensations. Your doctor may need to adjust the dose or discontinue treatment.
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 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 Mylan Pharma. If symptoms persist for more than a few weeks, your doctor may need to adjust your treatment.
Pramipexole Mylan Pharma prolonged-release tablets are specially designed to gradually release the active substance after ingestion. It is possible that parts of the tablet may be expelled and seen in the stool, appearing as intact tablets. Inform your doctor if you notice tablet fragments in your stool.
Children and adolescents
The use of Pramipexole Mylan Pharma is not recommended in children or adolescents under 18 years of age.
Other medicines and Pramipexole Mylan Pharma
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 Mylan Pharma together with antipsychotic medicines (used to treat certain mental health conditions).
Be cautious if you are taking any of 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 (used to treat HIV infection)
• cisplatin (used to treat various types of cancer)
• quinine (which may be used to prevent painful nocturnal cramps and to treat falciparum malaria (malignant malaria))
• procainamide (used to treat irregular heartbeats)
• any sedative medicine (with a calming or sedative effect)

If you are taking levodopa, a reduction in its dose is recommended when starting treatment with Pramipexole Mylan Pharma.
Pramipexole Mylan Pharma with food, drinks and alcohol
Be cautious if you consume alcohol during treatment with Pramipexole Mylan Pharma, as alcohol may increase the risk of drowsiness and sudden sleep episodes. Pramipexole Mylan Pharma can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine. Your doctor will discuss with you whether to continue taking Pramipexole Mylan Pharma.
Pregnancy
The effect of pramipexole on unborn babies is not known. Therefore, do not take Pramipexole Mylan Pharma during pregnancy unless your doctor specifically tells you to do so.
Breastfeeding
Pramipexole Mylan Pharma should not be taken during breastfeeding. Pramipexole may reduce milk production and may pass into breast milk, potentially affecting the infant. If taking Pramipexole Mylan Pharma cannot be avoided, breastfeeding must be discontinued.
Consult your doctor or pharmacist before taking any medicine.
Driving and use of machines
Pramipexole Mylan Pharma may cause hallucinations (seeing, hearing or sensing things that do not exist). If this occurs, do not drive or operate machinery.
Pramipexole Mylan Pharma has been associated with drowsiness and sudden onset of sleep episodes, particularly when taken with alcohol or other sedative medicines. If you experience these side effects, avoid driving and do not operate machinery. Inform your doctor if this occurs.

3. How to take Pramipexole Mylan 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 Mylan Pharma prolonged-release tablets once daily, at approximately the same time each day.
Pramipexole Mylan Pharma 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 result in 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 Mylan Pharma 0.26 mg prolonged-release tablet per day.

Patients with kidney disease
If you have kidney disease, your doctor may instruct you to take the usual initial dose of prolonged-release 0.26 mg tablets only on alternate days 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 in increments of 0.26 mg of pramipexole, up to a maximum of 1.57 mg daily.
If you have severe kidney problems, your doctor may consider it necessary to prescribe a different pramipexole-containing medicine. If your kidney problems worsen during treatment, you must contact your doctor as soon as possible.

If you are switching from immediate-release pramipexole tablets
Your doctor will determine the dose of Pramipexole Mylan Pharma prolonged-release tablets based on the dose of immediate-release pramipexole tablets you were previously taking.
Continue taking your immediate-release tablets as usual the day before switching. Then, take Pramipexole Mylan Pharma prolonged-release tablets the following morning and do not take any more immediate-release pramipexole tablets.

If you take more Pramipexole Mylan Pharma 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 nausea or vomiting, restlessness or agitation, low blood pressure, hallucinations, or any of the adverse effects listed in section 4, “Possible side effects.”

If you forget to take Pramipexole Mylan Pharma
If you forget to take a dose of Pramipexole Mylan Pharma but remember within 12 hours of your usual dosing time, take the tablet immediately and then take the next dose at your 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 Mylan Pharma
Do not stop taking Pramipexole Mylan 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.
You must not abruptly stop treatment with Pramipexole Mylan Pharma. Sudden discontinuation may lead to the development of a medical condition called neuroleptic malignant syndrome, which may pose a greater health risk. Symptoms include:

• loss of muscle movement (akinesia)
• muscle rigidity
• fever
• unstable blood pressure
• increased heart rate (tachycardia)
• confusion
• reduced level of consciousness (e.g., coma)

If you have any questions 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.
CONTACT A DOCTOR IMMEDIATELY IF YOU EXPERIENCE ANY OF THE FOLLOWING SIDE EFFECTS:

• Signs of a severe allergic reaction, including sudden shortness of breath, rash, itching or hives, swelling of the lips, tongue, face or throat causing difficulty in swallowing or breathing (uncommon side effect).
• Pneumonia, a lung infection that may cause fever, chills, sweating, difficulty breathing, chest pain and a general feeling of being unwell (uncommon side effect).
• Heart failure, which may cause shortness of breath or persistent cough, extreme tiredness and swelling in the ankles * (uncommon side effect).
• Low sodium levels in the blood, which may make you feel weak and confused with muscle pain. This could be due to inappropriate antidiuretic hormone secretion (ASH), a hormone causing the body to retain water and dilute the blood, thereby reducing sodium levels * (uncommon side effect).
• Fainting (uncommon side effect).

Inform your doctor if any of these occur, so that he or she can decide how to manage or reduce the symptoms.
Other possible side effects:
Very common (may affect more than 1 in 10 people):

• Involuntary, abnormal limb movements (dyskinesia)
• Sleepiness
• Dizziness
• Feeling unwell (nausea)

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

• Seeing, hearing or sensing things that are not real (hallucinations)
• Confusion
• Tiredness (fatigue)
• Difficulty sleeping (insomnia)
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision disorders such as blurred or double vision, or reduced visual acuity
• Feeling unwell (vomiting)
• Weight loss accompanied by reduced appetite

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

• Excessive fear about one's well-being (paranoia)
• Delirium
• Sudden onset of sleep episodes
• Memory disorders (amnesia)
• Increased movements and inability to stay still (hyperkinesia)
• Weight gain
• Rash
• Itching
• Restlessness
• Difficulty breathing (dyspnea)
• Hiccups
• Inability to resist the impulse, urge or temptation to carry out an action that may be harmful to you or others, which may include:
• Strong urge to gamble excessively despite serious personal or family consequences.
• Altered or increased sexual interest and behaviour causing significant concern to you 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 your appetite)
• Reduced awareness, confusion, loss of sense of reality (delirium)

Rare (may affect up to 1 in 1,000 people):

• Agitation, feeling of euphoria or overexcitement (mania)

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

• After stopping or reducing the dose of Pramipexole Mylan Pharma, 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; he or she will explain how to manage or reduce the symptoms.
For side effects marked with *, a precise frequency estimate cannot be made since these side effects were not observed in clinical studies involving 2,762 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 http://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 Mylan 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. Store in the original packaging to protect the medicine from moisture.
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 Pramipexole Mylan Pharma contains
The active substance is pramipexole.
Each tablet contains 0.375 mg of pramipexole dihydrochloride monohydrate, equivalent to 0.26 mg
of pramipexole.
Each tablet contains 0.75 mg of pramipexole dihydrochloride monohydrate, equivalent to 0.52 mg
of pramipexole.
Each tablet contains 1.5 mg of pramipexole dihydrochloride monohydrate, equivalent to 1.05 mg
of pramipexole.
Each tablet contains 3 mg of pramipexole dihydrochloride monohydrate, equivalent to 2.1 mg
of pramipexole.
Each tablet contains 4.5 mg of pramipexole dihydrochloride monohydrate, equivalent to 3.15 mg
of pramipexole.
The other ingredients are hypromellose 2208 (E464), pregelatinized starch (maize),
anhydrous colloidal silica, magnesium stearate (E470b).
Description of the appearance of Pramipexole Mylan Pharma and contents of the pack

Pramipexole Mylan Pharma is available in blisters containing 7, 10, 30, 90 and 100 prolonged-release tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan, Italy
Manufacturer
Generics [UK] Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
McDermott Laboratories Ltd. t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary
This medicinal product is authorized in the EEA Member States under the following names:
Czech Republic: Pramipexol Mylan
Germany: Pramipexol Mylan 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg &
3.15 mg Retardtabletten
Hungary: Pramipexol Mylan 0.26 mg, 0.52 mg, 1.05 mg & 2.1 mg, retard tabletta
Italy: Pramipexolo Mylan Pharma
Netherlands: Pramipexol Mylan 0,26 mg, 0,52 mg, 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg and
3,15 mg tabletten met verlengde afgifte.
Poland: Pramipexole Mylan
Romania: Pramipexol Mylan 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg &
tablete cu eliberare prelungita
United Kingdom: Pramipexole Mylan 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg,
3.15 mg prolonged-release tablets