PRAMIPEXOLO 0.18 MG Коированная таблетка

Содержание инструкции

1. Pramipexolo Aurobindo 0.088 mg tablets, 0.18 mg tablets, 0.35 mg tablets, 0.7 mg tablets
   1. What is Pramipexolo Aurobindo and what it is used for
   2. What you need to know before taking Pramipexolo Aurobindo
   3. How to take Pramipexolo Aurobindo
   4. Possible side effects
   5. How to store Pramipexolo Aurobindo
   6. Package contents and other information

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

Generic medicine
Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pramipexolo Aurobindo contains the active substance pramipexole and belongs to a group of
medicines known as dopamine agonists which stimulate the dopamine receptors located in the
brain. The stimulation of dopamine receptors in the brain triggers nerve impulses that
help to control body movements.

Pramipexolo 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 idiopathic moderate to severe Restless Legs Syndrome (RLS) in adults.

2. What you need to know before taking Pramipexolo Aurobindo

Do not take Pramipexolo 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 Pramipexolo Aurobindo. Tell your doctor if you have (have had) or
develop any medical condition or symptom, especially if it is one of the following:

• Kidney disease
• Hallucinations (seeing, hearing or perceiving things that are not there). Most hallucinations are visual.
• Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you suffer from advanced Parkinson's disease and are also taking levodopa, you may develop dyskinesia during the titration of Pramipexolo Aurobindo.
• Dystonia (inability to keep the body and neck upright (axial dystonia)). In particular, you may experience forward flexion of the head and neck (also known as anterior torticollis), forward flexion of the lower back (also known as camptocormia) or lateral curvature of the spine (also known as pleurototonia or Pisa syndrome). If the above symptoms occur, your doctor may decide to modify the treatment.
• Sleepiness and sudden onset of sleep episodes.
• Psychosis (e.g. comparable to symptoms of schizophrenia).
• Impairment of vision. During treatment with Pramipexolo Aurobindo, you should undergo regular eye checks.
• Severe heart or blood vessel disease. Especially at the beginning of treatment, your blood pressure will need to be checked regularly. This is to avoid postural hypotension (a drop in blood pressure when standing up).
• Worsening. You may find that symptoms appear sooner than usual, are more intense and involve other limbs.

Tell your doctor if you or your family members/caregivers notice that you are
developing impulses or desires to behave in ways that are unusual for you and that you cannot resist
the urge or temptation to carry out certain activities that could harm yourself
or others. These are called impulse control disorders and can include
behaviours such as gambling, overeating or overspending, an abnormal,
excessive sexual urge or an increase in sexual thoughts or feelings. Your doctor may consider
adjusting the dose or stopping therapy.
Tell your doctor if you or a family member/caregiver notices that you are developing
mania (agitation, feeling of euphoria or excitement) or delirium (reduced awareness,
confusion, loss of perception of reality). Your doctor may consider adjusting the
dose or stopping therapy.
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, feeling of fatigue,
sweating or pain after stopping treatment or reducing the dose of Pramipexolo
Aurobindo. If the symptoms persist for more than a few weeks, your doctor may
need to adjust the therapy.

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

Other medicines and Pramipexolo Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines, herbal preparations, dietary products or
supplements obtained without a prescription.
You should avoid taking Pramipexolo Aurobindo in combination with antipsychotic medicines.
Be careful if you are taking the following medicines:

• cimetidine (to treat excess acid in the stomach and gastric ulcers);
• amantadine (which can be used to treat Parkinson's disease);
• mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia);
• zidovudine (which can be used to treat acquired immunodeficiency syndrome (AIDS), a disease of the human immune system);
• cisplatin (to treat various types of cancer);
• quinine (which can be used for the prevention of painful night cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria));
• procainamide (to treat irregular heartbeats).

If you are taking levodopa, it is recommended to reduce the dose when starting treatment with
Pramipexolo Aurobindo.
Be careful if you are taking any calming medicine (sedative effect) or if you are
drinking alcohol. In these cases, Pramipexolo Aurobindo may impair your ability to
drive or operate machinery.

Pramipexolo Aurobindo with food, beverages and alcohol
You should be cautious if you drink alcohol while taking Pramipexolo Aurobindo.
Pramipexolo Aurobindo can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The doctor will discuss with you whether to continue taking Pramipexolo Aurobindo.
The effect of Pramipexolo Aurobindo on fetuses is not known. Therefore, do not take Pramipexolo
Aurobindo if you are pregnant unless your doctor tells you to do so.
Pramipexolo Aurobindo should not be taken during breastfeeding. Pramipexolo Aurobindo
may reduce milk production. It can also pass into the milk and reach the baby. If
taking Pramipexolo Aurobindo is unavoidable, breastfeeding should be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Pramipexolo Aurobindo can cause hallucinations (seeing, hearing or perceiving things that are not there). If
this happens, do not drive or operate machinery.
Pramipexolo Aurobindo has been associated with sleepiness and sudden onset of sleep
episodes, particularly in patients with Parkinson's disease. If these effects
occur, avoid driving and do not operate machinery. Tell your doctor if this happens.

3. How to take Pramipexolo Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor. The doctor will indicate the correct dosage.
Pramipexolo Aurobindo can be taken with or without food. The tablets must be swallowed
with water.

Parkinson's Disease
The daily dose should be taken divided into 3 equal doses.
During the first week, the usual dose is 1 tablet of Pramipexolo 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 the symptoms
are controlled (maintenance dose).

The usual maintenance dose is 1.1 mg per day. However, your dose may also be
further increased. If necessary, the doctor may increase the number of tablets up to a
maximum of 3.3 mg per day of pramipexole. A lower maintenance dose is also possible
equal to three tablets of Pramipexolo Aurobindo 0.088 mg per day.

Patients with kidney disease
If you suffer from moderate or severe kidney disease, your doctor will prescribe a lower dosage. In
this case, you will have to take the tablets only once or twice a day. If you suffer from moderate
kidney disease, the usual starting dose is 1 tablet of Pramipexolo Aurobindo 0.088 mg twice a
day. In case of severe kidney disease, the usual starting dose is only 1 tablet of
Pramipexolo Aurobindo 0.088 mg per day.

Restless Legs Syndrome
The dose is usually taken once a day in the evening, 2 – 3 hours before going to bed.
During the first week, the usual dose is 1 tablet of Pramipexolo Aurobindo 0.088 mg
once a day (equivalent to 0.088 mg per day):

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

The daily dose should not exceed 6 tablets of Pramipexolo Aurobindo 0.088 mg or a dose
of 0.54 mg (0.75 mg of pramipexole salt).
If you stop taking it for a period longer than a few days and intend to resume
treatment, you must start again from the lowest dosage. You can then return to your dose
as you did the first time.
Ask your doctor for advice.
The doctor will review your treatment after 3 months to decide whether to continue it or not.

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

If you take more Pramipexolo Aurobindo than you should
If you accidentally take too many tablets,

• contact your doctor immediately or go to the emergency room of the nearest hospital, for advice.
• you may experience vomiting, a feeling of restlessness or any of the undesirable effects described in section 4 “Possible side effects”.

If you forget to take Pramipexolo Aurobindo
Do not worry. Simply skip the dose completely and then take the next dose at the usual
time.
Do not take a double dose to make up for a missed dose.

If you stop taking Pramipexolo Aurobindo
Do not stop taking Pramipexolo Aurobindo without first talking to your doctor.
If you need to stop treatment with this medicine, the doctor will gradually reduce the dose.
This reduces the risk of worsening symptoms.
If you suffer from Parkinson's disease, you should not stop treatment with Pramipexolo Aurobindo
abruptly.
Sudden discontinuation may induce the development of a medical condition called neuroleptic
malignant syndrome, which may pose a greater risk to your health. Symptoms include:

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

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you suffer from Parkinson's disease, you may develop the following side effects:

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

• Dyskinesia (e.g. involuntary, abnormal movements of the limbs)
• Drowsiness
• Dizziness
• Nausea (feeling unwell)

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

• Urge to behave unusually
• Hallucinations (seeing, hearing or perceiving things that are not there)
• Confusion
• Fatigue (feeling tired)
• Sleeplessness (insomnia)
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision changes
• 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 well-being)
• Delusions
• Excessive daytime sleepiness and sudden onset of sleep
• Amnesia (memory disorders)
• Hyperkinesia (increased movements and inability to remain calm)
• Weight gain
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that can cause shortness of breath or swelling of the ankles)*
• Inappropriate secretion of antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the urge, drive or temptation to perform an action that may 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 worrying behaviour for yourself or others, for example, an increased sexual drive.
• Compulsive shopping or an uncontrollable urge to spend too much.
• Uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than is 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 excitement)

Not known(frequency cannot be estimated based on available data) :

• After stopping or reducing the dosage of Pramipexolo Aurobindo, depression, apathy, anxiety, feeling tired, sweating or pain (dopaminergic agonist withdrawal syndrome or DAWS) may occur.

Tell your doctor if you experience any of these behaviours; they will explain how to manage or
reduce the symptoms.
For the side effects marked with * it is not possible to make a precise estimate of the frequency
because these side effects have not been 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 develop 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 falling asleep (insomnia) and drowsiness
• Fatigue (feeling tired)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (feeling unwell)

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

• Urge to behave unusually*
• Heart failure (heart problems that can cause shortness of breath or swelling of the ankles)*
• Inappropriate secretion of antidiuretic hormone*
• Dyskinesia (e.g. involuntary, abnormal movements of the limbs)
• Hyperkinesia (increased movements and inability to remain calm)*
• Paranoia (e.g. excessive fear for one's well-being)*
• Delusions*
• Amnesia (memory disorders)*
• Hallucinations (seeing, hearing or perceiving things that are not there)
• Confusion
• Excessive daytime sleepiness and sudden onset of sleep
• Weight gain
• Hypotension (low blood pressure)
• Fluid retention, usually in the legs (peripheral edema)
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Fainting
• Restlessness
• Impaired vision
• Weight loss accompanied by decreased appetite
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)*
• Inability to resist the urge, drive or temptation to perform an action that may 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 worrying behaviour for yourself or others, for example, an increased sexual drive.*
• Compulsive shopping or an uncontrollable urge to spend too much.*
• Uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than is needed to satisfy your appetite)*
• Mania (agitation, feeling of euphoria or overexcitement)*
• Delirium (reduced awareness, confusion, loss of perception of reality).*

Not known(frequency cannot be established based on available data) :

• After stopping or reducing the dosage of Pramipexolo Aurobindo, depression, apathy, anxiety, feeling tired, sweating or pain (dopaminergic agonist withdrawal syndrome or DAWS) may occur.

Tell your doctor if you experience any of these behaviours; they will explain how to manage or
reduce the symptoms.
For the side effects marked with * it is not possible to make a precise estimate of the frequency
because these side effects have not been 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through 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 Pramipexolo Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the box and blister after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 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 ingredients are: mannitol (E421), corn starch, povidone K30, povidone K90, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Pramipexolo Aurobindo and package contents
Tablet.

Pramipexolo Aurobindo 0.088 mg Tablets:
Uncoated tablets, from white to off-white, round, flat, with beveled edges, with ‘Y’
engraved on one side and ‘41’ on the other side.

Pramipexolo Aurobindo 0.18 mg Tablets:
Film-coated tablets, from white to off-white, oval, biconcave, with beveled edges,
with ‘Y’ and ‘42’ separated by a fracture line on one side and plain with fracture line
on the other side.
The tablet can be divided into equal parts.

Pramipexolo Aurobindo 0.35 mg Tablets:
Uncoated tablets, from white to off-white, oval, biconcave, with beveled edges, with engraved
‘Y’ and ‘43’ separated by a fracture line on one side and plain with fracture line on the other side.
The tablets can be halved.

Pramipexolo Aurobindo 0.7 mg Tablets:
Film-coated tablets, from white to off-white, round, flat, with beveled edges, with
engraved ‘Y’ and ‘45’ separated by a fracture line on one side and plain with fracture line on the other
side.
The tablet can be divided into equal parts.
Pramipexolo Aurobindo tablets are available in blister packs in
Polyamide/Aluminum foil/PVC – Aluminum foil and HDPE bottles with a
polypropylene cap containing cotton.

Package sizes
Blisters: 10, 20, 30, 50, 60, 90, 100 and 200 tablets
HDPE bottles: 90, 100 and 1000 tablets
Not all package 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 Member States of the European Economic Area with the
following denominations:
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 Tablets
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/ tablets
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