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PRAMIPEXOLE TEVA 3.15 MG PROLONGED-RELEASE TABLETS

Active substance(s): PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

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PRAMIPEXOLE TEVA
0.26 mg, 0.52 mg, 1.05 mg,
1.57 mg, 2.1 mg, 2.62 mg AND 3.15 mg
PROLONGED-RELEASE TABLETS

If you are taking levodopa, the dose of levodopa is
recommended to be reduced when you start
treatment with Pramipexole Teva.

Take care if you are using any medicines that calm
you down (have a sedative effect) or if you are
PACKAGE LEAFLET: INFORMATION FOR THE USER
drinking alcohol. In these cases Pramipexole Teva
Read all of this leaflet carefully before you start
may affect your ability to drive and operate
taking this medicine because it contains important machinery.
information for you.
• Keep this leaflet. You may need to read it again. Pramipexole Teva with food, drink and alcohol
You should be cautious while drinking alcohol
• If you have any further questions, ask your
during treatment with Pramipexole Teva.
doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Pramipexole Teva can be taken with or without
food.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
Pregnancy, breast-feeding and fertility
yours.
If you are pregnant or breast-feeding, think you
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
side effects not listed in this leaflet. See
taking this medicine. Your doctor will then discuss
section 4.
with you if you should continue to take
WHAT IS IN THIS LEAFLET:
Pramipexole Teva.
1. What Pramipexole Teva is and what it is used for
The effect of Pramipexole Teva on the unborn child
2. What you need to know before you take
is not known. Therefore, do not take Pramipexole
Pramipexole Teva
Teva if you are pregnant unless your doctor tells
3. How to take Pramipexole Teva
you to do so.
4. Possible side effects
5. How to store Pramipexole Teva
Pramipexole Teva should not be used during
6. Contents of the pack and other information
breast-feeding. Pramipexole Teva can reduce the
of breast milk. Also, it can pass into the
1 What Pramipexole Teva is and what it production
breast
milk
and can reach your baby. If use of
is used for
Pramipexole Teva is unavoidable, breast-feeding
Pramipexole Teva belongs to a group of medicines should be stopped.
known as dopamine agonists, which stimulate
dopamine receptors in the brain. Stimulation of the Ask your doctor or pharmacist for advice before
dopamine receptors triggers nerve impulses in the taking any medicine.
brain that help to control body movements.
Driving and using machines
Pramipexole Teva is used to treat the symptoms of Pramipexole Teva can cause hallucinations (seeing,
primary Parkinson’s disease in adults. It can be used hearing or feeling things that are not there). If
affected, do not drive or use machines.
alone or in combination with levodopa (another
medicine for Parkinson’s disease).
Pramipexole Teva has been associated with
sleepiness and episodes of suddenly falling asleep,
2 What you need to know before you
particularly in patients with Parkinson’s disease. If
take Pramipexole Teva
you experience these side effects, you must not
drive or operate machinery. You should tell your
Do not take Pramipexole Teva
doctor if this occurs.
• 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 Teva.
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 Teva
• 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 Teva
• 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).
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, loss of reality). Your doctor
may need to adjust or stop your dose.
Children and adolescents
Pramipexole Teva is not recommended for use in
children or adolescents under 18 years.
Other medicines and Pramipexole Teva
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.

3 How to take Pramipexole Teva
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure. The doctor will
advise you on the right dosing.
Take Pramipexole Teva Prolonged-release Tablets
only once a day and each day at about the same
time.
You can take Pramipexole Teva
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 danger you
could overdose, because the
medicine may be released into
your body too quickly.
During the first week, the usual daily dose is 0.26
mg pramipexole. The dose will be increased every
5-7 days as directed by your doctor until your
symptoms are controlled (maintenance dose).
Ascending dose schedule of Pramipexole Teva
Prolonged-release Tablets
Week

Daily dose
(mg)

Number of tablets

1

0.26

One Pramipexole Teva
0.26 mg Prolonged-release
Tablet.

2

0.52

One Pramipexole Teva
0.52 mg Prolonged-release
Tablet,
OR
two Pramipexole Teva
0.26 mg Prolonged-release
Tablets.

3

1.05

One Pramipexole Teva
1.05 mg Prolonged-release
Tablet,
OR
two Pramipexole Teva
0.52 mg Prolonged-release
Tablets,
OR
four Pramipexole Teva
0.26 mg Prolonged-release
Tablets.

The usual maintenance dose is 1.05 mg per day.
You should avoid taking Pramipexole Teva together However, your dose may have to be increased
even further. If necessary, your doctor may
with antipsychotic medicines.
increase your dose up to a maximum of 3.15 mg of
Take care if you are taking the following medicines: pramipexole a day. A lower maintenance dose of
one Pramipexole Teva 0.26 mg Prolonged-release
• cimetidine (to treat excess stomach acid and
Tablet a day is also possible.
stomach ulcers)
• amantadine (which can be used to treat
Patients with kidney disease
Parkinson’s disease)
If you have kidney disease, your doctor may advise
• mexiletine (to treat irregular heartbeats, a
you to take the usual starting dose of 0.26 mg
condition known as ventricular arrhythmia)
prolonged-release tablets only every other day for
• zidovudine (which can be used to treat the
acquired immune deficiency syndrome (AIDS), the first week. After that, your doctor may increase
the dosing frequency to one 0.26 mg
a disease of the human immune system)
prolonged-release tablet every day. If a further dose
• cisplatin (to treat various types of cancers)
increase is necessary, your doctor may adjust it in
• quinine (which can be used for the prevention
steps of 0.26 mg pramipexole.
of painful night-time leg cramps and for the
If you have serious kidney problems, your doctor
treatment of a type of malaria known as
may need to switch you to a different pramipexole
falciparum malaria (malignant malaria))
medicine. If during treatment your kidney
• procainamide (to treat irregular heart beat).
problems get worse, you should contact your
doctor as soon as possible.

If you are switching from pramipexole (immediate
release) tablets
Your doctor will base your dose of pramipexole
prolonged-release tablets on the dose of
pramipexole (immediate release) tablets you were
taking.



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).


Take your pramipexole (immediate release) tablets
as normal the day before you switch. Then take
Rare:
your pramipexole prolonged-release tablets next
• mania (agitation, feeling elated or over-excited).
morning and do not take any more pramipexole
(immediate release) tablets.
Tell your doctor if you experience any of these
If you take more Pramipexole Teva than you should behaviors; he will discuss ways of managing or
reducing the symptoms.
If you accidentally take too many tablets,
• Contact your doctor or nearest hospital casualty
For the side effects marked with * a precise
department immediately for advice.
• You may experience vomiting, restlessness, or frequency estimation is not possible, since these
any of the side effects as described in Section 4 side effects were not observed in clinical studies
among 2,762 patients treated with pramipexole.
“Possible side effects”.
The frequency category is probably not greater
than “uncommon”.
If you forget to take Pramipexole Teva
If you forget to take a dose of Pramipexole Teva,
but remember within 12 hours of your usual time, Reporting of side effects
If you get any side effects, talk to your doctor,
take your tablet straightaway and then take your
pharmacist or nurse. This includes any possible
next tablet at the usual time.
side effects not listed in this leaflet.
If you forget for more than 12 hours, simply take
the next single dose at the usual time. Do not take
a double dose to make up for a forgotten tablet
dose.
If you stop taking Pramipexole Teva
Do not stop taking Pramipexole Teva 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 Teva 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, pharmacist or nurse.

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

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 Teva
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 medicine 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 Teva Prolonged-release Tablets
contain
The active substance 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 pramipexole
as 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg,
3.75 mg, or 4.5 mg pramipexole dihydrochloride
monohydrate, respectively.
The other excipient(s) are hypromellose,
anhydrous calcium hydrogen phosphate,
magnesium stearate and colloidal anhydrous silica.

What Pramipexole Teva Prolonged-release Tablets
looks like and contents of the pack
Pramipexole Teva 0.26 mg Prolonged-release Tablets:
The round tablets of 9 mm diameter are white or
nearly white, have a flat surface with bevelled
You may experience the following side effects:
edges and are marked with 026 on one side.
Very common:
Pramipexole Teva 0.52 mg Prolonged-release Tablets:
• dyskinesia (e.g. abnormal, uncontrolled
The round tablets of 10 mm diameter are white or
movements of the limbs)
nearly white, biconvex and are marked with 052 on
• sleepiness
one side.
• dizziness
Pramipexole Teva 1.05 mg Prolonged-release Tablets:
• nausea (sickness).
The round tablets of 10 mm diameter are white or
nearly white, biconvex and are marked with 105 on
Common:
one side.
• urge to behave in an unusual way
Pramipexole Teva 1.57 mg Prolonged-release Tablets:
• hallucinations (seeing, hearing or feeling things
The round tablets of 10 mm diameter are white or
that are not there)
nearly white, biconvex and are marked with 157 on
• confusion
one side.
• tiredness (fatigue)
Pramipexole Teva 2.1 mg Prolonged-release Tablets:
• sleeplessness (insomnia)
The round tablets of 10 mm diameter are white or
• excess of fluid, usually in the legs (peripheral
nearly white, biconvex and are marked with 210 on
oedema)
one side.
• headache
Pramipexole Teva 2.62 mg Prolonged-release Tablets:
• hypotension (low blood pressure)
The round tablets of 10 mm diameter are white or
• abnormal dreams
nearly white, biconvex and are marked with 262 on
• constipation
one side.
• visual impairment
Pramipexole Teva 3.15 mg Prolonged-release Tablets:
• vomiting (being sick)
The round tablets of 11 mm diameter are white or
• weight loss including decreased appetite.
nearly white, have a flat surface with bevelled
edges and are marked with 315 on one side.
Uncommon:
Rare

















may affect up to
1 in 1,000 people

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

Pramipexole Teva is available in packs containing
10, 30 and 100 prolonged-release tablets in
aluminium blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6, Tres Cantos, Madrid,
28760, Spain
This leaflet was last revised in 12/2014.
PL 00289/1873
PL 00289/1874
PL 00289/1875
PL 00289/1876
PL 00289/1877
PL 00289/1878
PL 00289/1879

53020-A
255493.01-GB

550 x 200

PRAMIPEXOLE TEVA
0.26 mg, 0.52 mg,
1.05 mg, 1.57 mg, 2.1 mg,
2.62 mg AND 3.15 mg
PROLONGED-RELEASE TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER

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, pharmacist or nurse.
• 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 side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.

If you are taking levodopa, the dose of
levodopa is recommended to be reduced
when you start treatment with Pramipexole
Teva.
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 Teva may affect
your ability to drive and operate machinery.
Pramipexole Teva with food, drink and
alcohol
You should be cautious while drinking
alcohol during treatment with Pramipexole
Teva.
Pramipexole Teva can be taken with or
without food.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine. Your
WHAT IS IN THIS LEAFLET:
doctor will then discuss with you if you
1. What Pramipexole Teva is and what it is should continue to take Pramipexole Teva.
used for
The effect of Pramipexole Teva on the
2. What you need to know before you
unborn child is not known. Therefore, do not
take Pramipexole Teva
take Pramipexole Teva if you are pregnant
3. How to take Pramipexole Teva
unless your doctor tells you to do so.
4. Possible side effects
5. How to store Pramipexole Teva
Pramipexole Teva should not be used
6. Contents of the pack and other
during breast-feeding. Pramipexole Teva
information
can reduce the production of breast milk.
Also, it can pass into the breast milk and
1 What Pramipexole Teva is and can reach your baby. If use of Pramipexole
what it is used for
Teva is unavoidable, breast-feeding should
be stopped.
Pramipexole Teva 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 Teva 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 Teva

Do not take Pramipexole Teva
• 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 Teva. 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 Teva
• 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 Teva
• 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).
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,
loss of reality). Your doctor may need to
adjust or stop your dose.
Children and adolescents
Pramipexole Teva is not recommended for
use in children or adolescents under 18
years.
Other medicines and Pramipexole Teva
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 Teva
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).

Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Pramipexole Teva can cause hallucinations
(seeing, hearing or feeling things that are
not there). If affected, do not drive or use
machines.
Pramipexole Teva 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 Teva
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure. The doctor will advise you on the
right dosing.
Take Pramipexole Teva Prolonged-release
Tablets only once a day and each day at
about the same time.
You can take Pramipexole Teva 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 danger you could
overdose, because the
medicine may be
released into your body
too quickly.
During the first week, the usual daily dose
is 0.26 mg pramipexole. The dose will be
increased every 5-7 days as directed by
your doctor until your symptoms are
controlled (maintenance dose).
Ascending dose schedule of Pramipexole
Teva Prolonged-release Tablets
Week Daily dose Number of tablets
(mg)
1

0.26

One Pramipexole Teva
0.26 mg Prolonged-release
Tablet.

2

0.52

One Pramipexole Teva
0.52 mg Prolonged-release
Tablet,
OR
two Pramipexole Teva
0.26 mg Prolonged-release
Tablets.

3

1.05

One Pramipexole Teva
1.05 mg Prolonged-release
Tablet,
OR
two Pramipexole Teva
0.52 mg Prolonged-release
Tablets,
OR
four Pramipexole Teva
0.26 mg Prolonged-release
Tablets.

The usual maintenance dose is 1.05 mg per
day. However, your dose may have to be
increased even further. If necessary, your
doctor may increase your dose up to a
maximum of 3.15 mg of pramipexole a
day. A lower maintenance dose of one
Pramipexole Teva 0.26 mg
Prolonged-release Tablet a day is also
possible.
Patients with kidney disease
If you have kidney disease, your doctor
may advise you to take the usual starting
dose of 0.26 mg prolonged-release tablets
only every other day for the first week.
After that, your doctor may increase the
dosing frequency to one 0.26 mg
prolonged-release tablet every day. If a
further dose increase is necessary, your
doctor may adjust it in steps of 0.26 mg
pramipexole.
If you have serious kidney problems, your
doctor may need to switch you to a
different pramipexole medicine. If during
treatment your kidney problems get
worse, you should contact your doctor as
soon as possible.

If you are switching from pramipexole
(immediate release) tablets
Your doctor will base your dose of
pramipexole prolonged-release tablets on
the dose of pramipexole (immediate
release) tablets you were taking.
Take your pramipexole (immediate
release) tablets as normal the day before
you switch. Then take your pramipexole
prolonged-release tablets next morning
and do not take any more pramipexole
(immediate release) tablets.
If you take more Pramipexole Teva 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 Section 4 “Possible side
effects”.
If you forget to take Pramipexole Teva
If you forget to take a dose of Pramipexole
Teva, but remember within 12 hours of
your usual time, take your tablet
straightaway and then take your next
tablet at the usual time.
If you forget for more than 12 hours,
simply take the next single dose at the
usual time. Do not take a double dose to
make up for a forgotten tablet dose.
If you stop taking Pramipexole Teva
Do not stop taking Pramipexole Teva
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 Teva 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,
pharmacist or nurse.

4 Possible side effects

Rare:
• mania (agitation, feeling elated or
over-excited).
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 2,762 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 Teva
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 medicine 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 Teva Prolonged-release
Tablets contain
The active substance 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 pramipexole as 0.375 mg,
0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg,
or 4.5 mg pramipexole dihydrochloride
monohydrate, respectively.

The other excipient(s) are hypromellose,
Like all medicines, this medicine can cause anhydrous calcium hydrogen phosphate,
side effects, although not everybody gets magnesium stearate and colloidal
them. Evaluation of these side effects is
anhydrous silica.
based on the following frequencies:
What Pramipexole Teva Prolonged-release
Very common
may affect more than
Tablets looks like and contents of the pack
1 in 10 people
Pramipexole Teva 0.26 mg
Prolonged-release Tablets: The round
Common
may affect up to
tablets of 9 mm diameter are white or
1 in 10 people
nearly white, have a flat surface with
bevelled edges and are marked with 026
Uncommon
may affect up to
on one side.
1 in 100 people
Pramipexole Teva 0.52 mg
Rare
may affect up to
Prolonged-release Tablets: The round
1 in 1,000 people
tablets of 10 mm diameter are white or
nearly white, biconvex and are marked
You may experience the following side
with 052 on one side.
effects:
Pramipexole Teva 1.05 mg
Prolonged-release Tablets: The round
Very common:
• dyskinesia (e.g. abnormal, uncontrolled tablets of 10 mm diameter are white or
nearly white, biconvex and are marked
movements of the limbs)
with 105 on one side.
• sleepiness
Pramipexole Teva 1.57 mg
• dizziness
Prolonged-release Tablets: The round
• nausea (sickness).
tablets of 10 mm diameter are white or
nearly white, biconvex and are marked
Common:
with 157 on one side.
• urge to behave in an unusual way
Pramipexole Teva 2.1 mg
• hallucinations (seeing, hearing or
Prolonged-release Tablets: The round
feeling things that are not there)
tablets of 10 mm diameter are white or
• confusion
nearly white, biconvex and are marked
• tiredness (fatigue)
with 210 on one side.
• sleeplessness (insomnia)
Pramipexole Teva 2.62 mg
• excess of fluid, usually in the legs
Prolonged-release Tablets: The round
(peripheral oedema)
tablets of 10 mm diameter are white or
• headache
nearly white, biconvex and are marked
• hypotension (low blood pressure)
with 262 on one side.
• abnormal dreams
Pramipexole Teva 3.15 mg
• constipation
Prolonged-release Tablets: The round
• visual impairment
tablets of 11 mm diameter are white or
• vomiting (being sick)
nearly white, have a flat surface with
• weight loss including decreased
bevelled edges and are marked with 315
appetite.
on one side.
Uncommon:
Pramipexole Teva is available in packs
• paranoia (e.g. excessive fear for one’s
containing 10, 30 and 100
own well-being)
prolonged-release tablets in aluminium
• delusion
blisters.
• excessive daytime sleepiness and
suddenly falling asleep
Not all pack sizes may be marketed.
• amnesia (memory disturbance)
• hyperkinesia (increased movements
Marketing Authorisation Holder
and inability to keep still)
TEVA UK Limited,
• weight increase
Eastbourne,
• allergic reactions (e.g. rash, itching,
BN22 9AG,
hypersensitivity)
UK
• fainting
• cardiac failure (heart problems which
can cause shortness of breath or ankle Manufacturer
Laboratorios Normon, S.A.
swelling)*
Ronda de Valdecarrizo, 6, Tres Cantos,
• inappropriate antidiuretic hormone
Madrid, 28760, Spain
secretion*
• restlessness
This leaflet was last revised in 12/2014.
• dyspnoea (difficulties to breathe)
PL 00289/1873
• hiccups
PL 00289/1874
• pneumonia (infection of the lungs)
PL 00289/1875
• inability to resist the impulse, drive or
PL 00289/1876
temptation to perform an action that
PL 00289/1877
could be harmful to you or others,
PL 00289/1878
which may include:
PL 00289/1879
• 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).

53021-A

255492.01-GB
660 x 170

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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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