PRAMIPERAL 0.26 MG Extended-release tablet

Зміст інструкції

1. Pramiperal 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
   1. What is Pramiperal and what is it used for
   2. What you need to know before taking Pramiperal
   3. How to take Pramiperal
   4. Possible side effects
   5. How to store Pramiperal
   6. Package Contents and Other Information

Pramiperal 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

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

1. What is Pramiperal and what is it used for

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

2. What you need to know before taking Pramiperal

Do not take Pramiperal

• if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking Pramiperal. Tell your doctor if you have (have had) or develop any
medical condition or symptom, especially if you belong to the following list:

• 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 Pramiperal
• 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 flexion and lateral rotation
of the trunk (also known as pleurototonia or Pisa syndrome).

• Sleepiness and sudden onset of sleep episodes
• Psychosis (e.g. comparable to symptoms of schizophrenia)
• Impaired vision. During treatment with Pramiperal, you should undergo regular eye examinations.
• Severe heart or blood vessel diseases. Especially at the beginning of treatment, your blood pressure should be checked regularly. This is to avoid postural hypotension (a drop in blood pressure when standing up)

Tell your doctor if you, your family members or your caregiver notice that you are developing
a craving or desire to behave in ways that are unusual for you and that you are unable to resist the impulse,
urge or temptation to perform certain activities that may harm yourself or others.
These phenomena are called impulse control disorders and may include behaviors
such as gambling, overeating or excessive shopping, unusually high sexual drive or preoccupation with
increased sexual thoughts or sensations. Your doctor may need to adjust the dose or stop therapy.
Tell your doctor if you or a family member or anyone caring for you notices that you are developing mania
(agitation, feeling of euphoria or overexcitement) or delirium (reduced awareness,
confusion, loss of sense of reality). Your doctor may need to adjust the dose or
stop 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 Pramiperal. If the
symptoms persist for more than a few weeks, your doctor may need to adjust the
therapy.
Tell your doctor if you experience an inability to keep your body and neck upright (axial dystonia).
If the above symptoms occur, your doctor may decide to adjust or change
treatment.
Pramiperal prolonged-release tablets are a tablet specially designed for the gradual release of the active substance,
once the tablet has been swallowed. It is possible that parts of the
tablets are expelled and observed in the stool and have the appearance of whole tablets. Tell
your doctor if you should find pieces of tablet in your stool.

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

Other medicines and Pramiperal
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 Pramiperal in combination with antipsychotic medicines.
Be careful if you are taking the following medicines:

• cimetidine (to treat excess acid in the stomach and stomach ulcers)
• amantadine (which can be used to treat Parkinson's disease)
• mexiletine (for treating 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 nocturnal cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria))
• procainamide (for treating irregular heartbeats).

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

Pramiperal with food, beverages and alcohol
You should be cautious if you drink alcohol while taking Pramiperal.
Pramiperal 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, ask your doctor for advice before taking this medicine.
The doctor will discuss with you whether to continue taking Pramiperal.
The effect of Pramiperal on the fetus is unknown. Therefore, do not take Pramiperal if you are pregnant unless
your doctor tells you to do so.
Pramiperal should not be taken during breastfeeding. Pramiperal may reduce milk production.
It can also pass into the milk and reach the baby. If taking Pramiperal is unavoidable,
breastfeeding must be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.

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

3. How to take Pramiperal

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor.
Your doctor will tell you the correct dosage.
Take Pramiperal prolonged-release tablets only once a day and every day at approximately the same
time.
Pramiperal can 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
inside 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 as directed by your doctor until your symptoms are controlled
(maintenance dose).
The usual maintenance dose is 1.05 mg per day. However, your dose may also be
further increased. If necessary, your doctor may increase the dose of tablets up to a
maximum of 3.15 mg per day of pramipexole. A lower maintenance dose of one Pramiperal 0.26 mg
prolonged-release tablet per day is also possible.

Patients with kidney disease
If you have kidney disease, your doctor may tell you to take the usual starting dose of
prolonged-release tablets of 0.26 mg only on alternate days for the first week.
Subsequently, your doctor may increase the frequency of the dose to one prolonged-release
tablet of 0.26 mg every day. If a further dose increase is necessary, your doctor may
increase it by 0.26 mg of pramipexole.
If you have severe kidney problems, your doctor may consider it necessary to give you a different
medicine also based on pramipexole. If your kidney problems worsen during treatment, you should
contact your doctor as soon as possible.

If you are switching from pramipexole tablets (immediate-release)
Your doctor will base the choice of dose of Pramiperal prolonged-release tablets on the dose of
pramipexole tablets (immediate-release) that you were taking.
Take pramipexole tablets (immediate-release) as usual the day before switching.
Then take Pramiperal prolonged-release tablets the following morning and no longer take
pramipexole tablets (immediate-release).

If you take more Pramiperal than you should
If you accidentally take too many tablets,

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

If you forget to take Pramiperal
If you forget to take a dose of Pramiperal, but remember within 12 hours of your usual time
of taking it, take the tablet immediately and then the next one at your usual time.
If more than 12 hours have passed, simply take the next dose at your usual time. Do not take
a double dose to make up for a missed dose.

If more than 12 hours have already passed, simply take the next dose at the usual time. Do not take
a double dose to compensate for forgetting a dose.

If you stop taking Pramiperal
Do not stop taking Pramiperal without first talking to your doctor. If you need to
stop treatment with this medicine, your doctor will reduce the dose gradually. This reduces the
risk of worsening of symptoms.
If you have Parkinson's disease, you should not stop treatment with Pramiperal abruptly.
Sudden discontinuation could induce the development of a medical condition called neuroleptic malignant syndrome, which may represent a greater risk to your health. 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 treatment with Pramiperal or reduce it, you may also develop a medical condition
called dopamine agonist withdrawal syndrome. Symptoms include depression,
apathy, anxiety, feeling tired, sweating or pain. If you experience these symptoms, you should
contact your doctor.
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 everybody gets them.

You may experience the following side effects:

Very common:

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

Common:

• Urge to behave unusually
• Hallucinations (seeing, hearing or perceiving things that are not there)
• Confusion
• Fatigue (feeling tired)
• Difficulty sleeping (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 reduced 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 remain still)
• Weight gain
• Allergic reactions (e.g. 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:
• A strong urge to gamble excessively despite serious personal or family consequences.
• Altered or increased sexual interest and behaviour that causes significant distress to you or others, for example an increased sexual impulse.
• Excessive and uncontrollable shopping or spending
• Uncontrollable 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 sense of reality)

Rare:

• Mania (agitation, feeling of euphoria or overexcitement)
• Spontaneous penile erection

Not known:

• After stopping or reducing the dosage of Pramiperal, 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 the side effects marked with * it is not possible to make a precise estimate of the frequency as
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”.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Pramiperal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after SCAD. The expiry
date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
This medicine does not require any particular storage temperature.
Do not dispose of any medicine in 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 Pramiperal prolonged-release tablets contain

• The active ingredient 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 ingredients are hypromellose, calcium hydrogen phosphate, magnesium stearate, anhydrous colloidal silicon dioxide.

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

Marketing Authorisation Holder
Ralpharma S.r.l.
Via Vicolo Duomo 2

• 20900 – Monza

Manufacturer
Ferrer Internacional, S.A.
Joan Buscallà 1-9
E-08190 Sant Cugat del Vallès (Barcelona)
Laboratorios Normon, S.A
Ronda de Valdecarrizo, 6, Tres Cantos, 28760 Madrid