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PRAMIPEXOLE 700 MICROGRAMS TABLETS

Active substance(s): PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

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Package leaflet: Information for the user
Pramipexole 88 micrograms Tablets
Pramipexole 180 micrograms Tablets
Pramipexole 350 micrograms Tablets
Pramipexole 700 micrograms Tablets
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:
Pregnancy and breast-feeding
1. What Pramipexole Tablets are and what they
If you are pregnant or breast-feeding, think you
are used for
may be pregnant or are planning to have a baby,
2. What you need to know before you take
ask your doctor for advice before taking this
Pramipexole Tablets
medicine. Your doctor will then discuss with you if
3. How to take Pramipexole Tablets
you should continue to take Pramipexole Tablets.
4. Possible side effects
The effect of Pramipexole Tablets on the unborn
5. How to store Pramipexole Tablets
child is not known. Therefore, do not take
6. Contents of the pack and other information
Pramipexole Tablets if you are pregnant unless
your doctor tells you to do so.
1. What Pramipexole Tablets are and what
Pramipexole Tablets should not be used during
they are used for
breast-feeding. Pramipexole Tablets can reduce
the production of breast milk. Also, they can
Pramipexole Tablets contains the active
pass into the breast milk and can reach your
substance pramipexole and belong to a group
baby. If use of Pramipexole Tablets is
of medicines known as dopamine agonists,
unavoidable, breast-feeding should be stopped.
which stimulate dopamine receptors in the
brain. Stimulation of the dopamine receptors
Ask your doctor or pharmacist for advice before
triggers nerve impulses in the brain that help to
taking any medicine.
control body movements.
Driving and using machines
Pramipexole Tablets are used to:
Pramipexole Tablets can cause hallucinations
• treat the symptoms of primary Parkinson’s
(seeing, hearing or feeling things that are not
disease in adults. They can be used alone or in there). If affected, do not drive or use machines.
combination with levodopa (another
Pramipexole Tablets have been associated with
medicine for Parkinson’s disease).
sleepiness and episodes of suddenly falling
asleep, particularly in patients with Parkinson’s
Pramipexole which is contained in Pramipexole
disease. If you experience these side effects, you
Tablets may also be authorised to treat other
must not drive or operate machinery. You
conditions which are not mentioned in this
should tell your doctor if this occurs.
leaflet. Ask your doctor or pharmacist if you
have further questions.
3. How to take Pramipexole Tablets
2. What you need to know before you take
Always take this medicine exactly as your doctor
Pramipexole Tablets
has told you. Check with your doctor if you are
not sure. The doctor will advise you on the right
Do not take Pramipexole Tablets
dosing.
• if you are allergic to pramipexole or to any of
the other ingredients of this medicine (listed
You can take Pramipexole Tablets with or
in section 6).
without food. Swallow the tablets with water.
Warnings and precautions
Parkinson’s disease
Talk to your doctor before taking Pramipexole
The daily dose is to be taken divided into three
Tablets. Tell your doctor if you have (had) or
equal doses.
develop any medical conditions or symptoms,
During the first week, the usual dose is one
especially any of the following:
Pramipexole 88 micrograms Tablet three times a
• kidney disease
day (equivalent to 264 micrograms daily):
• hallucinations (seeing, hearing or feeling
things that are not there). Most hallucinations
1st week
are visual
Number of tablets One Pramipexole
• dyskinesia (e.g. abnormal, uncontrolled
88 micrograms Tablet
movements of the limbs). If you have
three times a day
advanced Parkinson’s disease and are also
Total
daily
dose
taking levodopa, you might develop
(micrograms)
264
dyskinesia during the up-titration of
Pramipexole Tablets
This will be increased every 5-7 days as directed
• sleepiness and episodes of suddenly falling
by your doctor until your symptoms are
asleep
controlled (maintenance dose).
• psychosis (e.g. comparable with symptoms of
2nd week
3rd week
schizophrenia)
Number of
One
One
• vision impairment. You should have regular
tablets
Pramipexole
Pramipexole
eye examinations during treatment with
180 micrograms 350 micrograms
Pramipexole Tablets
Tablet three
Tablet three
• severe heart or blood vessels disease. You will
times a day
times a day
need to have your blood pressure checked
OR
OR
regularly, especially at the beginning of
Two
Two
treatment. This is to avoid postural
hypotension (a fall in blood pressure on
Pramipexole
Pramipexole
standing up)
88 micrograms 180 micrograms
• augmentation. You may experience that
Tablets three
Tablets three
symptoms start earlier than usual, be more
times a day
times a day
intense and involve other limbs.
Total daily
dose
Tell your doctor if you or your family/carer
(micrograms) 540
1,100
notices that you are developing urges or
cravings to behave in ways that are unusual for
The usual maintenance dose is 1,100 micrograms
you and you cannot resist the impulse, drive or
per day. However, your dose may have to be
temptation to carry out certain activities that
increased even further. If necessary, your doctor
could harm yourself or others. These are called
may increase your tablet dose up to a maximum
impulse control disorders and can include
of 3,300 micrograms of pramipexole a day. A
behaviours such as addictive gambling,
lower maintenance dose of three Pramipexole 88
excessive eating or spending, an abnormally
micrograms Tablets a day is also possible.
high sex drive or an increase in sexual thoughts
Lowest
Highest
or feelings. Your doctor may need to adjust or
maintenance maintenance
stop your dose.
dose
dose
Children and adolescents
Number of
One
One
Pramipexole Tablets are not recommended for
tablets
Pramipexole
Pramipexole
use in children or adolescents under 18 years.
88 micrograms 350 micrograms
Tablet three
Tablet and one
Other medicines and Pramipexole Tablets
times a day
Pramipexole
Tell your doctor or pharmacist if you are taking,
700 micrograms
have recently taken or might take any other
Tablet three
medicines. This includes medicines, herbal
times a day
remedies, health foods or supplements that you
have obtained without a prescription.
Total daily
dose
You should avoid taking Pramipexole Tablets
(micrograms) 264
3,150
together with antipsychotic medicines.
Take care if you are taking the following medicines: Patients with kidney disease
• cimetidine (to treat excess stomach acid and
If you have moderate or severe kidney disease,
stomach ulcers)
your doctor will prescribe a lower dose. In this
• amantadine (which can be used to treat
case, you will have to take the tablets only once
Parkinson’s disease)
or twice a day. If you have moderate kidney
• mexiletine (to treat irregular heartbeats, a
disease, the usual starting dose is one
condition known as ventricular arrhythmia)
Pramipexole 88 micrograms Tablet twice a day. In
• zidovudine (which can be used to treat the
severe kidney disease, the usual starting dose is
acquired immune deficiency syndrome (AIDS), just one Pramipexole 88 micrograms Tablet a day.
a disease of the human immune system)
If you take more Pramipexole Tablets than
• cisplatin (to treat various types of cancers)
should
• quinine (which can be used for the prevention you
If you accidentally take too many tablets,
of painful night-time leg cramps and for the
• contact your doctor or nearest hospital
treatment of a type of malaria known as
casualty department immediately for advice
falciparum malaria (malignant malaria))
• you may experience vomiting, restlessness, or
• procainamide (to treat irregular heart beat).
any of the side effects as described in chapter
If you are taking levodopa, the dose of levodopa
4 “Possible side effects”.
is recommended to be reduced when you start
If
you
forget to take Pramipexole Tablets
treatment with Pramipexole Tablets.
Do not worry. Simply leave out that dose
Take care if you are using any medicines that
completely and then take your next dose at the
calm you down (have a sedative effect) or if you
right time.
are drinking alcohol. In these cases Pramipexole
Do not try to make up for the missed dose.
Tablets may affect your ability to drive and
If you stop taking Pramipexole Tablets
operate machinery.
Do not stop taking Pramipexole Tablets without
Pramipexole Tablets with food, drink and alcohol first talking to your doctor. If you have to stop
You should be cautious while drinking alcohol
taking this medicine, your doctor will reduce the
during treatment with Pramipexole Tablets.
dose gradually. This reduces the risk of
Pramipexole Tablets can be taken with or
worsening symptoms.
without food.
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If you suffer from Parkinson’s disease you should
not stop treatment with Pramipexole Tablets
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
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:
• 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:
• inability to resist the impulse, drive or
temptation to perform an action that could
be harmful to you or others, which may include:
º strong impulse to gamble excessively despite
serious personal or family consequences.
º altered or increased sexual interest and
behaviour of significant concern to you or to
others, for example, an increased sexual drive.
º uncontrollable excessive shopping or spending
º 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)
Tell your doctor if you experience any of
these behaviours; they will discuss ways
of managing or reducing the symptoms.
• 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)
• delirium (decreased awareness, confusion,
loss of reality).
Rare:
• Mania (agitation, feeling elated or over-excited).
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 another 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:
• inability to resist the impulse, drive or
temptation to perform an action that could be
harmful to you or others, which may include:
º strong impulse to gamble excessively despite
serious personal or family consequences.
º altered or increased sexual interest and
behaviour of significant concern to you or to
others, for example, an increased sexual drive.
º uncontrollable excessive shopping or spending
º 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)
Tell your doctor if you experience any of
these behaviours; they will discuss ways
of managing or reducing the symptoms.
• 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)*
• delirium (decreased awareness, confusion,
loss of reality
• mania (agitation, feeling elated or over-excited).
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 Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Pramipexole Tablets
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.
This medicinal product does not require any
special storage conditions.
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 protect the environment.
6. Contents of the pack and other information
What Pramipexole Tablets contain
The active substance is pramipexole.
Each tablet contains 88 micrograms,
180 micrograms, 350 micrograms or
700 micrograms pramipexole as
125 micrograms, 250 micrograms,
500 micrograms or 1,000 micrograms
pramipexole dihydrochloride monohydrate,
respectively.
The other ingredients are mannitol, maize starch,
citric acid monohydrate, colloidal anhydrous
silica, povidone K 30 and magnesium stearate.
What Pramipexole Tablets look like and
contents of the pack
Pramipexole 88 micrograms Tablets are white
to off white, round uncoated tablets, debossed
“ WII6 ” on one side and plain on the other.
Pramipexole 180 micrograms Tablets are white
to off white, oval shaped uncoated tablets,
debossed “W” on one side and “II7” on the other
side of score line and plain on either side of the
score line on the reverse side.
Pramipexole 350 micrograms Tablets are white
to off white, oval shaped uncoated tablets,
debossed “W” on one side and “II8” on the other
side of score line and plain on either side of the
score line on the reverse side.
Pramipexole 700 micrograms Tablets are white
to off white, round shaped uncoated tablets,
debossed “W” on one side and “II9” on the other
side of score line and plain on either side of the
score line on the reverse side.
The 180 micrograms, 350 micrograms and
700 micrograms tablets can be divided into
equal halves.
Pramipexole Tablets are available in Alu/Alu
blister packs of ten tablets per strip.
Pramipexole 88 micrograms Tablets are
available in cartons containing three blister
strips (30 tablets) and Pramipexole 180
micrograms, 350 micrograms and 700
micrograms Tablets are available in cartons
containing three or ten blister strips (30 or 100
tablets). Not all pack sizes may be marketed.
Other formats:
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name
Reference
Number
Pramipexole 88 micrograms PL 29831/0472
Tablets
Pramipexole 180 micrograms PL 29831/0473
Tablets
Pramipexole 350 micrograms PL 29831/0474
Tablets
Pramipexole 700 micrograms PL 29831/0475
Tablets
This is a service provided by the Royal National
Institute of Blind People.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Wockhardt UK Limited, Ash Road North,
Wrexham, LL13 9UF, UK.
Manufacturer
CP Pharmaceuticals Limited, Ash Road North,
Wrexham, LL13 9UF, UK.
This leaflet was last revised in 03/2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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