Pramipexole Aurobindo

Package leaflet: Information for the user

Pramipexole Aurobindo 0.088 mg tablets, 0.18 mg tablets, 0.35 mg tablets, 0.7 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Pramipexole Aurobindo is and what it is used for

Pramipexole Aurobindo 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 Aurobindo 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 for 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 Aurobindo

Do not take Pramipexole Aurobindo

• 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 Aurobindo. Inform your doctor if you have (had) or
develop any medical condition or symptom, especially if it is one of the following:

• 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 dose titration of Pramipexole Aurobindo.
• 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 these symptoms occur, your doctor may decide to modify your treatment.
• Drowsiness and sudden onset of sleep episodes.
• Psychosis (e.g., symptoms comparable to schizophrenia).
• Vision disturbances. During treatment with Pramipexole Aurobindo, 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).
• Worsening of symptoms. You may notice that symptoms occur earlier than usual, are more intense, and affect additional limbs.

Inform your doctor if you or your family members/caregivers notice that you are developing
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 behaviors such as gambling addiction, excessive
eating or spending, abnormally increased sexual desire, or an increase in sexual thoughts or
feelings. Your doctor may consider it necessary to adjust the dose or discontinue therapy.
Inform your doctor if you or a family member/caregiver notices the development of mania (agitation,
feelings of euphoria or excitement) or delirium (reduced awareness, confusion, loss of touch with
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 dosage of Pramipexole Aurobindo. If symptoms
persist for longer than a few weeks, your doctor may need to adjust your treatment.

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

Other medicines and Pramipexole Aurobindo
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 Aurobindo together with antipsychotic medicines.
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 (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 nocturnal cramps and to treat falciparum malaria (malignant malaria));
• procainamide (to treat irregular heartbeats).

If you are taking levodopa, a reduction in dose is recommended when starting treatment with
Pramipexole Aurobindo.
Be cautious if you are taking any sedative medicine or consuming alcohol. In such cases, Pramipexole
Aurobindo may impair your ability to drive or operate machinery.

Pramipexole Aurobindo with food, drinks and alcohol
You should be cautious if consuming alcohol during treatment with Pramipexole Aurobindo.
Pramipexole Aurobindo may 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 or pharmacist before taking this medicine.
Your doctor will discuss with you whether to continue taking Pramipexole Aurobindo.
The effect of Pramipexole Aurobindo on the fetus is unknown. Therefore, do not take Pramipexole
Aurobindo during pregnancy unless your doctor specifically instructs you to do so.
Pramipexole Aurobindo must not be taken during breastfeeding. Pramipexole Aurobindo may reduce
milk production and may pass into breast milk and reach the infant. If taking Pramipexole Aurobindo
is unavoidable, breastfeeding must be discontinued.
Consult your doctor or pharmacist before taking any medicine.

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

3. How to take Pramipexole Aurobindo

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor. Your doctor will determine the correct dosage for you.
Pramipexole Aurobindo may be taken with or without food. The tablets should be swallowed with water.
Parkinson's disease
The daily dose should be taken in three equal doses.
During the first week, the usual dose is 1 tablet of Pramipexole Aurobindo 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 per day. A lower maintenance dose may also be possible, equivalent to three tablets of Pramipexole Aurobindo 0.088 mg daily.

Patients with renal disease
If you have moderate or severe renal disease, your doctor will prescribe a lower dosage. In such
cases, 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 Aurobindo 0.088 mg twice daily. In case of severe
renal disease, the usual starting dose is only 1 tablet of Pramipexole Aurobindo 0.088 mg per day.
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 Aurobindo 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 Aurobindo 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 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 to continue it or not.

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

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

• contact your doctor immediately or go to the nearest hospital emergency department for advice.
• symptoms such as vomiting, restlessness, or any of the side effects listed in section 4 "Possible side effects" may occur.

If you forget to take Pramipexole Aurobindo
Do not worry. Simply miss out the forgotten dose and take the next dose at your usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Pramipexole Aurobindo
Do not stop taking Pramipexole Aurobindo 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 Aurobindo 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 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.
The assessment of these side effects is based on the following frequency categories:
If you suffer from 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 limb movements)
• Somnolence
• Dizziness
• Nausea (feeling unwell)

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

• Impulse to behave in an unusual way
• Hallucinations (seeing, hearing or sensing things that are not there)
• Confusion
• Fatigue (feeling tired)
• Insomnia (difficulty sleeping)
• 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 loss of appetite

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

• Paranoia (e.g. excessive fear for one's own well-being)
• Delirium
• Excessive daytime sleepiness and sudden onset sleep episodes
• Amnesia (memory disturbances)
• 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 ankle swelling)*
• Inappropriate antidiuretic hormone secretion*
• Restlessness
• Dyspnoea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, urge or temptation to perform an action that could be harmful to you or others, which may include:
• Strong urge to gamble excessively despite serious personal or family consequences.
• Abnormal or increased sexual desire and behaviour that is concerning to you or others, for example, increased sexual drive.
• Compulsive shopping or uncontrolled impulse to spend too much money.
• 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)*
• Delirium (reduced awareness, confusion, loss of perception 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 Aurobindo, 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 *, 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".
If you suffer from 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 somnolence
• Fatigue (feeling tired)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (feeling unwell)

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

• Impulse to behave in an unusual way*
• Heart failure (heart problems that may cause shortness of breath or ankle swelling)*
• 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 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 rash, itching, hypersensitivity)
• Fainting
• Restlessness
• Visual impairment
• Weight loss accompanied by loss of appetite
• Dyspnoea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)*
• Inability to resist the impulse, urge or temptation to perform an action that could be harmful to you or others, which may include:
• Strong urge to gamble excessively despite serious personal or family consequences.*
• Abnormal or increased sexual desire and behaviour that is concerning to you or others, for example, increased sexual drive.*
• Compulsive shopping or uncontrolled impulse to spend too much money.*
• 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)*
• Mania (agitation, feeling of euphoria or over-excitement)*
• Delirium (reduced awareness, confusion, loss of perception of reality).*

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

• After stopping or reducing the dose of Pramipexole Aurobindo, 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 *, a precise frequency estimate cannot be made since these side effects were not observed in clinical studies 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
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 Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Pramipexolo Aurobindo contains

• The active substance is pramipexole. Each tablet contains 0.125 mg of pramipexole dihydrochloride monohydrate, equivalent to 0.088 mg of pramipexole. Each tablet contains 0.25 mg of pramipexole dihydrochloride monohydrate, equivalent to 0.18 mg of pramipexole. Each tablet contains 0.5 mg of pramipexole dihydrochloride monohydrate, equivalent to 0.35 mg of pramipexole. Each tablet contains 1.0 mg of pramipexole dihydrochloride monohydrate, equivalent to 0.7 mg of pramipexole.
• The other components are: mannitol (E421), maize starch, povidone K30, povidone K90, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Pramipexolo Aurobindo and contents of the pack
Tablet.
Pramipexolo Aurobindo 0.088 mg Tablets:
Uncoated tablets, white to off-white, round, flat, with bevelled edges, engraved with 'Y' on one side and '41' on the other side.
Pramipexolo Aurobindo 0.18 mg Tablets:
Film-coated uncoated tablets, white to off-white, oval, biconvex, with bevelled edges, engraved with 'Y' and '42' separated by a breakline on one side and plain with a breakline on the other side.
The tablet may be divided into equal parts.
Pramipexolo Aurobindo 0.35 mg Tablets:
Uncoated tablets, white to off-white, oval, biconvex, with bevelled edges, engraved with 'Y' and '43' separated by a breakline on one side and plain with a breakline on the other side.
The tablets may be divided in half.
Pramipexolo Aurobindo 0.7 mg Tablets:
Film-coated uncoated tablets, white to off-white, round, flat, with bevelled edges, engraved with 'Y' and '45' separated by a breakline on one side and plain with a breakline on the other side.
The tablet may be divided into equal parts.
Pramipexolo Aurobindo tablets are available in blister packs made of Polyamide/Aluminium foil/PVC – Aluminium foil and in HDPE bottles with polypropylene cap containing cotton.
Pack sizes
Blister packs: 10, 20, 30, 50, 60, 90, 100 and 200 tablets
HDPE bottles: 90, 100 and 1000 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l.
via San Giuseppe, 102
21047 Saronno (VA)
Italy
Manufacturers:
APL Swift Services (Malta) Limited,
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG3000
Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD.
United Kingdom
This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark Pramipexol "Aurobindo"
France Pramipexole ARROW LAB 0.18 mg /0.7 mg/1.1 mg
Germany Pramipexol Aurobindo 0.088 mg/0.18 mg/0.35 mg/0.7 mg Tabletten
Italy Pramipexolo Aurobindo
Malta Pramipexole Aurobindo 0.088 mg/0.18 mg/0.35 mg/0.7 mg/1.1 mg Tablets
Netherlands Pramipexol Aurobindo 0.088 mg/0.7 mg/ tabletten
Poland Pramipexol Aurobindo
Portugal Pramipexol Aurobindo, 0.088 mg/0.18 mg/0.35 mg/0.7 mg/1.1 mg, Comprimidos
Romania Pramipexol Aurobindo 0.18 mg/0.7 mg comprimat
Spain PRAMIPEXOL AUROBINDO 0.18 mg/0.7 mg/1.1 mg comprimidos
Sweden Pramipexol Aurobindo 0.088 mg/0.18 mg/0.35 mg/0.7 mg tabletter
United Kingdom Pramipexole 0.088 mg/0.18 mg/0.7 mg tablets