Pramipexole Accord

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  • Pramipexole Accord
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Staðsetning

  • Fáanlegt í:
  • Pramipexole Accord
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  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Anti Parkinson drugs
  • Lækningarsvæði:
  • Parkinson Disease, Restless Legs Syndrome
  • Ábendingar:
  • Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).
  • Vörulýsing:
  • Revision: 8

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/002291
  • Leyfisdagur:
  • 28-09-2011
  • EMEA númer:
  • EMEA/H/C/002291
  • Síðasta uppfærsla:
  • 25-05-2019

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/403892/2016

EMEA/H/C/002291

EPAR summary for the public

Pramipexole Accord

pramipexole

This is a summary of the European public assessment report (EPAR) for Pramipexole Accord. It

explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to

reach its opinion in favour of granting a marketing authorisation and its recommendations on the

conditions of use for Pramipexole Accord.

What is Pramipexole Accord?

Pramipexole Accord is a medicine that contains the active substance pramipexole. It is available as

tablets (0.088, 0.18, 0.35, 0.7 and 1.1 mg).

Pramipexole Accord is a ‘generic medicine’. This means that Pramipexole Accord is similar to a

‘reference medicine’ already authorised in the European Union (EU) called Mirapexin. For more

information on generic medicines, see the question-and-answer document here

What is Pramipexole Accord used for?

Pramipexole Accord is used to treat the symptoms of Parkinson’s disease, a progressive brain disorder

that causes shaking, slow movement and muscle stiffness. Pramipexole Accord can be used either on

its own or in combination with levodopa (another medicine for Parkinson’s disease), at any stage of

disease including the later stages when levodopa starts becoming less effective.

The medicine can only be obtained with a prescription.

How is Pramipexole Accord used?

The starting dose is one 0.088 mg tablet three times a day. The dose should be increased every five to

seven days until symptoms are controlled without causing side effects that cannot be tolerated. The

maximum daily dose is three 1.1 mg tablets. Pramipexole Accord must be given less often in patients

who have problems with their kidneys. If treatment is stopped for any reason, the dose should be

decreased gradually.

Pramipexole Accord

EMA/403892/2016

Page 2/2

How does Pramipexole Accord work?

The active substance in Pramipexole Accord, pramipexole, is a dopamine agonist (a substance that

imitates the action of dopamine). Dopamine is a messenger substance in the parts of the brain that

control movement and co-ordination. In patients with Parkinson’s disease, the cells that produce

dopamine begin to die and the amount of dopamine in the brain decreases. The patients then lose their

ability to control their movements reliably. Pramipexole stimulates the brain as dopamine would, so

that patients can control their movement and have fewer of the signs and symptoms of Parkinson’s

disease, such as shaking, stiffness and slowness of movement.

How has Pramipexole Accord been studied?

Because Pramipexole Accord is a generic medicine, studies in people have been limited to tests to

determine that it is bioequivalent to the reference medicine, Mirapexin. Two medicines are

bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Pramipexole Accord?

Because Pramipexole Accord is a generic medicine and is bioequivalent to the reference medicine, its

benefits and risks are taken as being the same as the reference medicine’s.

Why has Pramipexole Accord been approved?

The CHMP concluded that, in accordance with EU requirements, Pramipexole Accord has been shown to

have comparable quality and to be bioequivalent to Mirapexin. Therefore, the CHMP’s view was that, as

for Mirapexin, the benefit outweighs the identified risk. The Committee recommended that Pramipexole

Accord be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of

Pramipexole Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Pramipexole Accord have been included in the summary of product characteristics

and the package leaflet.

Other information about Pramipexole Accord

The European Commission granted a marketing authorisation valid throughout the European Union for

Pramipexole Accord on 30 September 2011.

The full EPAR for Pramipexole Accord can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European Public Assessment Reports. For more information about

treatment with Pramipexole Accord, read the package leaflet (also part of the EPAR) or contact your

doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency’s website.

This summary was last updated in 06-2016.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Pramipexole Accord 0.088 mg tablets

Pramipexole Accord 0.18 mg tablets

Pramipexole Accord 0.35 mg tablets

Pramipexole Accord 0.7 mg tablets

Pramipexole Accord 1.1 mg tablets

Pramipexole

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 further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet. See section 4

What is in this leaflet:

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

2. What you need to know before you take Pramipexole Accord

3. How to take Pramipexole Accord

4. Possible side effects

5. How to store Pramipexole Accord

6. Contents of the pack and other information

1.

What Pramipexole Accord is and what it is used for

Pramipexole Accord contains the active substance pramipexole and belongs to a group of medicines

known as dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of the

dopamine receptors triggers nerve impulses in the brain that help to control body movements.

Pramipexole Accord 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 need to know before you take Pramipexole Accord

Do not take Pramipexole Accord:

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 Accord. Tell your doctor if you have (had) or develop

any medical conditions or symptoms, especially any of the following:

Kidney disease.

Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are

visual.

Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you have advanced

Parkinson’s disease and are also taking levodopa, you might develop dyskinesia during the up-

titration of Pramipexole Accord.

Dystonia

Inability of keeping your body and neck straight and upright (axial dystonia). In particular, you

may experience forward flexion of the head and neck (also called antecollis), forward bending

of the lower back (also called camptocormia) or sidewards bending of the back (also called

pleurothotonus or Pisa Syndrome). If this happens, your doctor may want to change your

medication.

Sleepiness and episodes of suddenly falling asleep.

Psychosis (e.g. comparable with symptoms of schizophrenia).

Vision impairment. You should have regular eye examinations during treatment with

Pramipexole Accord.

Severe heart or blood vessels disease. You will need to have your blood pressure checked

regularly, especially at the beginning of treatment. This is to avoid postural hypotension (a fall

in blood pressure on standing up).

Augmentation. You may experience that symptoms start earlier than usual, be more intense and

involve other limbs.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to

behave in ways that are unusual for you and you cannot resist the impulse, drive 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 addictive gambling, excessive eating or spending, an abnormally

high sex drive or preoccupation with an increase in sexual thoughts or feelings. Your doctor may need

to adjust or stop your dose.

Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling

elated or over-excited) or delirium (decreased awareness, confusion or loss of reality). Your doctor

may need to adjust or stop your dose.

Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or

pain after stopping or reducing your Pramipexole Accord treatment. If the problems persist more than

a few weeks, your doctor may need to adjust your treatment.

Children and adolescents

Pramipexole Accord is not recommended for use in children or adolescents under 18 years.

Other medicines and Pramipexole Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This includes medicines, herbal remedies, health foods or supplements that you have

obtained without a prescription.

You should avoid taking Pramipexole Accord together with antipsychotic medicines.

Take care if you are taking the following medicines:

cimetidine (to treat excess stomach acid and stomach 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 the acquired immune deficiency syndrome (AIDS), a

disease of the human immune system)

cisplatin (to treat various types of cancers)

quinine (which can be used for the prevention of painful night-time leg cramps and for the

treatment of a type of malaria known as falciparum malaria (malignant malaria))

procainamide (to treat irregular heart beat)

If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start

treatment with Pramipexole Accord.

Take care if you are using any medicines that calm you down (have a sedative effect) or if you are

drinking alcohol. In these cases Pramipexole Accord may affect your ability to drive and operate

machinery.

Pramipexole Accord with food, drink and alcohol

You should be cautious while drinking alcohol during treatment with Pramipexole Accord.

Pramipexole Accord can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor for advice before taking this medicine. Your doctor will then discuss with you if you

should continue to take Pramipexole Accord.

The effect of Pramipexole Accord on the unborn child is not known. Therefore, do not take

Pramipexole Accord if you are pregnant unless your doctor tells you to do so.

Pramipexole Accord should not be used during breast-feeding. Pramipexole Accord can reduce the

production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of

Pramipexole Accord is unavoidable, breast-feeding should be stopped.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Pramipexole Accord can cause hallucinations (seeing, hearing or feeling things that are not there). If

affected, do not drive or use machines.

Pramipexole Accord has been associated with sleepiness and episodes of suddenly falling asleep,

particularly in patients with Parkinson’s disease. If you experience these side effects, you must not

drive or operate machinery. You should tell your doctor if this occurs.

3.

How to take Pramipexole Accord

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not

sure. The doctor will advise you on the right dosing.

You can take Pramipexole Accord with or without food. Swallow the tablets with water.

Parkinson’s disease

The daily dose is to be taken divided into 3 equal doses.

During the first week, the usual dose is 1 tablet Pramipexole Accord 0.088 mg three times a day

(equivalent to 0.264 mg daily):

week

Number of tablets

1 Pramipexole Accord tablet 0.088 mg three times a day

Total daily dose (mg)

0.264

This will be increased every 5-7 days as directed by your doctor until your symptoms are controlled

(maintenance dose).

week

week

Number of tablets

1 Pramipexole Accord tablet 0.18

mg three times a day

2 Pramipexole Accord tablets

0.088 mg three times a day

1 Pramipexole Accord tablet 0.35

mg three times a day

2 Pramipexole Accord tablets

0.18 mg three times a day

Total daily dose (mg)

0.54

The usual maintenance dose is 1.1 mg per day. However, your dose may have to be increased even

further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of

pramipexole a day. A lower maintenance dose of three Pramipexole Accord 0.088 mg tablets a day is

also possible.

Lowest maintenance dose

Highest maintenance dose

Number of tablets

1 Pramipexole Accord tablet

0.088 mg three times a day

1 Pramipexole Accord tablet 1.1

mg three times a day

Total daily dose (mg)

0.264

Patients with kidney disease

If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case,

you will have to take the tablets only once or twice a day. If you have moderate kidney disease, the

usual starting dose is 1 Pramipexole Accord tablet 0.088 mg twice a day. In severe kidney disease, the

usual starting dose is just 1 Pramipexole Accord tablet 0.088 mg a day.

If you take more Pramipexole Accord than you should

If you accidentally take too many tablets,

Contact your doctor or nearest hospital casualty department immediately for advice.

You may experience vomiting, restlessness, or any of the side effects as described in chapter 4

“Possible side effects”.

If you forget to take Pramipexole Accord

Do not worry. Simply leave out that dose completely and then take your next dose at the right time.

Do not try to make up for the missed dose.

If you stop taking Pramipexole Accord

Do not stop taking Pramipexole Accord without first talking to your doctor. If you have to stop taking

this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening

symptoms.

If you suffer from Parkinson’s disease you should not stop treatment with Pramipexole Accord

abruptly. A sudden stop could cause you to develop a medical condition called neuroleptic malignant

syndrome which may represent a major health risk. The symptoms include:

akinesia (loss of muscle movement)

rigid muscles

fever

unstable blood pressure

tachycardia (increased heart rate)

confusion

depressed level of consciousness (e.g. coma)

If you have any further questions on 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.

Evaluation of these side effects is based on the following frequencies:

Very common

may affect more than 1 in 10 people

Common

may affect up to 1 in 10 people

Uncommon

may affect up to 1 in 100 people

Rare

may affect up to 1 in 1,000 people

Very rare

may affect up to 1 in 10,000 people

Not known

Frequency cannot be estimated from the available data

If you suffer from Parkinson’s disease, you may experience the following side effects:

Very common:

Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)

Sleepiness

Dizziness

Nausea (sickness)

Common:

Urge to behave in an unusual way

Hallucinations (seeing, hearing or feeling things that are not there)

Confusion

Tiredness (fatigue)

Sleeplessness (insomnia)

Excess of fluid, usually in the legs (peripheral oedema)

Headache

Hypotension (low blood pressure)

Abnormal dreams

Constipation

Visual impairment

Vomiting (being sick)

Weight loss including decreased appetite

Uncommon:

Paranoia (e.g. excessive fear for one’s own well-being)

Delusion

Excessive daytime sleepiness and suddenly falling asleep

Amnesia (memory disturbance)

Hyperkinesia (increased movements and inability to keep still)

Weight increase

Allergic reactions (e.g. rash, itching, hypersensitivity)

Fainting

Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*

Inappropriate antidiuretic hormone secretion*

Restlessness

Dyspnoea (difficulties to breathe)

Hiccups

Pneumonia (infection of the lungs)

Inability to resist the impulse, drive or temptation to perform an action that could be harmful to

you or others, which may include:

Strong impulse to gamble excessively despite serious personal or family consequences.

Altered or increased sexual interest and behaviour of significant concern to you or to

others, for example, an increased sexual drive.

Uncontrollable excessive shopping or spending

Binge eating (eating large amounts of food in a short time period) or compulsive eating

(eating more food than normal and more than is needed to satisfy your hunger)*

Delirium (decreased awareness, confusion, loss of reality)

Rare:

Mania (agitation, feeling elated or over excited)

Not known:

After stopping or reducing your Pramipexole Accord treatment: Depression, apathy, anxiety,

fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviours; he will discuss ways of managing or

reducing the symptoms.

For the side effects marked with * a precise frequency estimation is not possible, since these side

effects were not observed in clinical studies among 2,762 patients treated with pramipexole. The

frequency category is probably not greater than “uncommon”.

If you suffer from other indication, you may experience the following side effects:

Very common:

Nausea (sickness)

Common:

Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness

Tiredness (fatigue)

Headache

Abnormal dreams

Constipation

Dizziness

Vomiting (being sick)

Uncommon:

Urge to behave in an unusual way*

Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*

Inappropriate antidiuretic hormone secretion*

Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)

Hyperkinesia (increased movements and inability to keep still)*

Paranoia (e.g. excessive fear for one’s own well-being)*

Delusion*

Amnesia (memory disturbance)*

Hallucinations (seeing, hearing or feeling things that are not there)

Confusion

Excessive daytime sleepiness and suddenly falling asleep

Weight increase

Hypotension (low blood pressure)

Excess of fluid, usually in the legs (peripheral oedema)

Allergic reactions (e.g. rash, itching, hypersensitivity)

Fainting

Restlessness

Visual impairment

Weight loss including decreased appetite

Dyspnoea (difficulties to breathe)

Hiccups

Pneumonia (infection of the lungs)*

Inability to resist the impulse, drive or temptation to perform an action that could be harmful to

you or others, which may include:

Strong impulse to gamble excessively despite serious personal or family consequences.

Altered or increased sexual interest and behaviour of significant concern to you or to

others, for example, an increased sexual drive.

Uncontrollable excessive shopping or spending

Binge eating (eating large amounts of food in a short time period) or compulsive eating

(eating more food than normal and more than is needed to satisfy your hunger)*

Mania (agitation, feeling elated or over excited)*

Delirium (decreased awareness, confusion, loss of reality)*

Not known:

After stopping or reducing your Pramipexole Accord treatment: Depression, apathy, anxiety,

fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviors; he will discuss ways of managing or

reducing the symptoms.

For the side effects marked with * a precise frequency estimation is not possible, since these side

effects were not observed in clinical studies among 1,395 patients treated with pramipexole. The

frequency category is probably not greater than “uncommon”.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store Pramipexole Accord

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 carton after EXP. The

expiry date refers to the last day of that month.

Store below 30°C. Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help to protect the

environment.

6.

Contents of the pack and other information

What Pramipexole Accord tablet contains:

The active ingredient is pramipexole.

Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg

pramipexole.

Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg

pramipexole.

Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg

pramipexole.

Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg

pramipexole.

Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.1 mg

pramipexole.

The other ingredients are mannitol, cellulose microcrystalline, maize starch, silica colloidal

anhydrous, povidone K 30 and magnesium stearate.

What Pramipexole Accord tablet looks like and contents of the pack

Pramipexole Accord 0.088 mg tablets are white to off-white, round, flat faced, bevel edged, with

inscription ‘I1’ on one side and plain on the other side.

Pramipexole Accord 0.18 mg tablets are white to off-white, round, flat faced, bevel edged, with

inscription ‘I’ and ‘2’ on either side of the breakline on one side and breakline on the other side.

Pramipexole Accord 0.35 mg tablets are white to off-white, round, flat faced, bevel edged, with

inscription ‘I’ and ‘3’ on either side of the breakline on one side and breakline on the other side.

Pramipexole Accord 0.7 mg tablets are white to off-white, round, flat faced, bevel edged, with

inscription ‘I’ and ‘4’ on either side of the breakline on one side and breakline on the other side..

Pramipexole Accord 1.1 mg tablets are white to off-white, round, flat faced, bevel edged, with

inscription ‘I’ and ‘5’ on either side of the breakline on one side and breakline on other side.

All the strengths of Pramipexole Accord tablets are available in alu-alu blisters of 10 tablets per strip,

in cartons containing 3 or 10 blister strips (30 or 100 tablets).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Limited,

Sage house, 319 Pinner road,

North Harrow

HA1 4HF, Middlesex,

United Kingdom

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

The leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.