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PRAMIPEXOLE ZENTIVA 1.05 MG PROLONGED-RELEASE TABLETS

Active substance(s): PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

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CODES

Pramipexole 0.26 mg prolonged-release tablets
Pramipexole 0.52 mg prolonged-release tablets
Pramipexole 1.05 mg prolonged-release tablets
Pramipexole 1.57 mg prolonged-release tablets
Pramipexole 2.10 mg prolonged-release tablets
Pramipexole 2.62 mg prolonged-release tablets
Pramipexole 3.15 mg prolonged-release tablets

CODES

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, or 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, or pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Pramipexole is and what it is used for
2. What you need to know before you take
Pramipexole
3. How to take Pramipexole
4. Possible side effects
5. How to store Pramipexole
6. Contents of the pack and other information
1. What Pramipexole is and what it is used for
Pramipexole 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 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

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.
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 may
affect your ability to drive and operate machinery.

Do not take Pramipexole
- if you are allergic to pramipexole or any of the other Pramipexole with food, drink and alcohol
You should be cautious while drinking alcohol
ingredients of this medicine (listed in section 6).
during treatment with Pramipexole.
Warnings and precautions
Pramipexole can be taken with or without food.
Talk to your doctor before taking Pramipexole. Tell
your doctor if you have (had) or develop any Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you
medical conditions or symptoms, especially any
may be pregnant or are planning to have a baby,
of the following:
ask your doctor or pharmacist for advice before
- Kidney disease.
taking this medicine.
- Hallucinations (seeing, hearing or feeling things Your doctor will then discuss with you if you
that are not there). Most hallucinations are visual. should continue to take Pramipexole.
- Dyskinesia (e.g. abnormal, uncontrolled The effect of Pramipexole on the unborn child is
movements of the limbs). If you have advanced not known. Therefore, do not take Pramipexole if
Parkinson’s disease and are also taking you are pregnant unless your doctor tells you to
levodopa, you might develop dyskinesia during do so.
the up titration of Pramipexole.
Pramipexole should not be used during
- Dystonia (inability of keeping your body and breast-feeding. Pramipexole can reduce the
neck straight and upright (axial dystonia)). In production of breast milk. Also, it can pass into
particular, you may experience forward flexion the breast milk and can reach your baby. If use of
of the head and neck (also called antecollis), Pramipexole is unavoidable, breast-feeding
forward bending of the lower back (also called should be stopped.
camptocormia) or sidewards bending of the Ask your doctor or pharmacist for advice before
back (also called pleurothotonus or Pisa taking any medicine.
Syndrome). If this happens, your doctor may
Driving and using machines
want to change your medication.
Pramipexole can cause hallucinations (seeing,
- Sleepiness and episodes of suddenly falling
hearing or feeling things that are not there). If
asleep.
affected, do not drive or use machines.
- Excessive use and craving for the product.
- Psychosis (e.g. comparable with symptoms of Pramipexole has been associated with sleepiness
and episodes of suddenly falling asleep,
schizophrenia).
- Vision impairment. You should have regular eye particularly in patients with Parkinson’s disease. If
examinations during treatment with Pramipexole. you experience these side effects, you must not
- Severe heart or blood vessels disease. You will drive or operate machinery. You should tell your
need to have your blood pressure checked doctor if this occurs.
regularly, especially at the beginning of 3. How to take Pramipexole
treatment. This is to avoid postural hypotension
Always take this medicine exactly as your doctor
(a fall in blood pressure on standing up).
Tell your doctor if you or your family/carer or pharmacist has told you. Check with your
notices that you are developing urges or doctor or pharmacist if you are not sure. The
cravings to behave in ways that are unusual for doctor will advise you on the right dosing.
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.

Pramipexole All Strengths m1-3-2-leaflet-mock-up UK
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Date:
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One Pramipexole 1.05 mg
prolonged-release tablet,
OR
two Pramipexole 0.52 mg
prolonged-release tablets,
OR
four Pramipexole 0.26 mg
prolonged-release tablets.

000000

N/A

Signature:

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.

1.05

No

THESE
SIGNATURES
ARE
Head
of Regulatory
Approved: Yes
No
N/A
Date:
FOR
Signature:
HEAD
OFFICE USE
Other
- as required
Approved: Yes
No
ONLY
Date:

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Take Pramipexole prolonged-release tablets only
once a day and each day at about the same time.
You can take Pramipexole with or without food.
Swallow the tablets whole with water.

Tell your doctor if you experience symptoms such
as depression, apathy, anxiety, fatigue, sweating
or pain after stopping or reducing your
Pramipexol treatment. If the problems persist During the first week, the usual daily dose is 0.26 mg
more than a few weeks, your doctor may need to pramipexole. The dose will be increased every
adjust your treatment.
5-7 days as directed by your doctor until your
Pramipexol prolonged-release tablets is a symptoms are controlled (maintenance dose).
specially designed tablet from which the active Ascending dose schedule of Pramipexole
ingredient is gradually released, once the tablet prolonged-release tablets
has been ingested. Parts of tablets may Week Daily dose (mg) Number of tablets
occasionally be passed and seen in the stool 1
0.26
One Pramipexole 0.26 mg
(faeces) and may look like whole tablets. Inform
prolonged-release tablet.
your doctor if you find tablet pieces in your faeces. 2
0.52
One Pramipexole 0.52 mg
prolonged-release tablet,
Children and adolescents
OR
Pramipexole is not recommended for use in
two Pramipexole 0.26 mg
children or adolescents under 18 years.
prolonged-release tablets.
Other medicines and Pramipexole
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 together
with antipsychotic medicines.

Sanofi

HelveticaLTStd-BoldCond
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Smallest point sized used:

Average Text Size (Body Text):
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CODES

CODES

The usual maintenance dose is 1.05 mg per day. - Hiccups
However, your dose may have to be increased - Pneumonia (infection of the lungs)
even further. If necessary, your doctor may - Inability to resist the impulse, drive or
temptation to perform an action that could be
increase your dose up to a maximum of 3.15 mg
harmful to you or others, which may include:
of pramipexole a day. A lower maintenance dose
Strong impulse to gamble excessively
of one Pramipexole 0.26 mg prolonged-release
despite serious personal or family
tablet a day is also possible.
consequences.
Patients with kidney disease
- Altered or increased sexual interest and
If you have kidney disease, your doctor may
behaviour of significant concern to you or to
advise you to take the usual starting dose of
others, for example, an increased sexual
0.26 mg prolonged-release tablets only every
drive.
other day for the first week. After that, your doctor
- Uncontrollable excessive shopping or
may increase the dosing frequency to one 0.26 mg
spending
prolonged-release tablet every day. If a further
- Binge eating (eating large amounts of food in
dose increase is necessary, your doctor may
a short time period) or compulsive eating
adjust it in steps of 0.26 mg pramipexole.
(eating more food than normal and more than
If you have serious kidney problems, your doctor
is needed to satisfy your hunger)*
may need to switch you to a different pramipexole - Delirium (decreased awareness, confusion,
medicine. If during treatment your kidney
loss of reality)
problems get worse, you should contact your
Rare:
doctor as soon as possible.
- Mania (agitation, feeling elated or over-excited)
If you are switching from Pramipexole (immediate
Not Known:
release) tablets
Your doctor will base your dose of Pramipexole After stopping or reducing your Pramipexol treatment:
prolonged-release tablets on the dose of Depression, apathy, anxiety, fatigue, sweating or pain
Pramipexole (immediate release) tablets you were may occur (called dopamine agonist withdrawal
syndrome or DAWS).
taking.
Take your Pramipexole (immediate release) tablets Tell your doctor if you experience any of
as normal the day before you switch. Then take these behaviors; he will discuss ways of
your Pramipexole prolonged-release tablets next managing or reducing the symptoms.
morning and do not take any more Pramipexole For the side effects marked with * a precise
(immediate release) tablets.
frequency estimation is not possible, since these
If you take more Pramipexole than you side effects were not observed in clinical studies
among 2,762 patients treated with pramipexole.
should
The frequency category is probably not greater
If you accidentally take too many tablets,
- Contact your doctor or nearest hospital than “uncommon”.
casualty department immediately for advice.
- You may experience vomiting, restlessness, or
any of the side effects as described in chapter 4
“Possible side effects”.

Reporting of side effects
If you get any side effects, talk to your doctor or,
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:
If you forget to take Pramipexole
If you forget to take a dose of Pramipexole, but www.mhra.gov.uk/yellowcard or search for MHRA
remember within 12 hours of your usual time, take Yellow Card in the Google Play or Apple App Store.
your tablet straightaway and then take your next By reporting side effects you can help provide more
information on the safety of this medicine.
tablet at the usual time.
If you forget for more than 12 hours, simply take 5. How to store Pramipexole
the next single dose at the usual time. Do not take
a double dose to make up for a forgotten tablet Keep this medicine out of the sight and reach of
children.
dose.
Do not use this medicine after the expiry date
If you stop taking Pramipexole
Do not stop taking Pramipexole without first which is stated on the carton after {EXP}.The
talking to your doctor. If you have to stop taking expiry date refers to the last day of that month.
this medicine, your doctor will reduce the dose This medicinal product does not require any
gradually. This reduces the risk of worsening special temperature storage conditions, but store
symptoms.
in the original package in order to protect from
If you suffer from Parkinson’s disease you moisture.
should not stop treatment with Pramipexole
Do not throw away any medicines via wastewater
abruptly. A sudden stop could cause you to
or household waste. Ask your pharmacist how to
develop a medical condition called neuroleptic
throw away medicines you no longer use. These
malignant syndrome which may represent a major
measures will help protect the environment.
health risk. The symptoms include:
- akinesia (loss of muscle movement),
6. Contents of the pack and other
- rigid muscles,
information
- fever,
What Pramipexole 0.26mg, 0.52mg, 1.05mg,
- unstable blood pressure,
1.57mg, 2.10mg, 2.62mg and 3.15mg
- tachycardia (increased heart rate),
prolonged-release tablets contains
- confusion,
- depressed level of consciousness (e.g. coma). - The active substance(s) is pramipexole.
If you have any further questions on the use of this Each tablet contains 0.26 mg, 0.52 mg, 1.05 mg,
medicine, ask your doctor or pharmacist or nurse. 1.57 mg, 2.10 mg, 2.62 mg and 3.15 mg
pramipexole as 0.375 mg, 0.75 mg, 1.5 mg,
4. Possible side effects
2.25 mg, 3 mg, 3.75 mg and 4.5 mg pramipexole
Like all medicines, this medicine can cause side dihydrochloride monohydrate, respectively.
effects, although not everybody gets them. - The other excipient(s) are hypromellose,
calcium hydrogen phosphate, anhydrous,
Evaluation of these side effects is based on the
magnesium stearate, silica, colloidal
following frequencies:
anhydrous.
Very common may affect more than 1 in 10 people
What Pramipexole 0.26mg, 0.52mg,
Common
may affect up to 1 in 10 people
1.05mg, 1.57mg, 2.10mg, 2.62mg and
Uncommon may affect up to 1 in 100 people
Rare
may affect up to 1 in 1,000 people 3.15mg prolonged-release tablets looks
Very rare
may affect up to 1 in 10,000 people like and contents of the pack
Not known frequency cannot be estimated Pramipexole 0.26 mg prolonged-release tablets:
The tablets of 9 mm are white or nearly white,
from the available data
cylindrical, plans, with beveled edges and marked
You may experience the following side effects:
with 026 on one side
Very common:
Pramipexole 0.52 mg prolonged-release tablets: The
- Dyskinesia (e.g. abnormal, uncontrolled movements tablets of 10 mm are white or nearly white, cylindrical,
of the limbs)
biconvex and marked with 052 on one side
- Sleepiness
Pramipexole 1.05 mg prolonged-release tablets: The
- Dizziness
tablets of 10 mm are white or nearly white, cylindrical,
- Nausea (sickness)
biconvex, and marked with 105 on one side
Pramipexole 1.57 mg prolonged-release tablets: The
Common:
- Urge to behave in an unusual way
tablets of 10 mm are white or nearly white, cylindrical,
- Hallucinations (seeing, hearing or feeling things biconvex and marked with 157 on one side
that are not there)
Pramipexole 2.10 mg prolonged-release tablets: The
- Confusion
tablets of 10 mm are white or nearly white, cylindrical,
- Tiredness (fatigue)
biconvex and marked with 210 on one side
- Sleeplessness (insomnia)
Pramipexole 2.62 mg prolonged-release tablets: The
- Excess of fluid, usually in the legs (peripheral tablets of 10 mm are white or nearly white, cylindrical,
oedema)
biconvex and marked with 262 on one side
- Headache
Pramipexole 3.15 mg prolonged-release tablets:
- Hypotension (low blood pressure)
The tablets of 11 mm are white or nearly white,
- Abnormal dreams
cylindrical, plans, with beveled edges and marked
- Constipation
with 315 on one side
- Visual impairment
- Vomiting (being sick)
Pramipexole is available in blister Al/OPA-Al-PVC:
- Weight loss including decreased appetite
10, 30 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Uncommon:
- Paranoia (e.g. excessive fear for one’s own Marketing Authorisation Holder and
well-being)
Manufacturer
- Delusion
Marketing Authorisation Holder
- Excessive daytime sleepiness and suddenly
Zentiva, One Onslow Street, Guildford, Surrey,
falling asleep
GU1 4YS, UK
- Amnesia (memory disturbance)
- Hyperkinesia (increased movements and inability Manufacturer
Laboratorios Normon, S.A
to keep still)
Ronda de Valdecarrizo, 6,
- Weight increase
- Allergic reactions (e.g. rash, itching, hypersensitivity) Tres Cantos, 28760, Madrid.
- Fainting
This leaflet was last revised in November 2017.
- Cardiac failure (heart problems which can
cause shortness of breath or ankle swelling)*
- Inappropriate antidiuretic hormone secretion*
- Restlessness
- Dyspnoea (difficulties to breathe)

000000

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Pramipexole All Strengths m1-3-2-leaflet-mock-up UK
Leaflet
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567710 iss3
598139
25-Oct-17
1
2 of 2
170 x 660mm
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1
Black

Cutter

FOR
SANOFI ONLY
Regulatory
Approved: Yes
Date:
Signature:

No

N/A

THESE
SIGNATURES
ARE
Head
of Regulatory
Approved: Yes
No
N/A
Date:
FOR
Signature:
HEAD
OFFICE USE
Other
- as required
Approved: Yes
No
ONLY
Date:
Signature:

000000
Fonts used:
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HelveticaLTStd-BoldCond
HelveticaLTStd-LightCond
HelveticaNeueLTStd-Cn
Smallest point sized used:
8.0 pt
Average Text Size (Body Text):
12.0 pt

Package leaflet: Information for the user

CODE

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 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, or pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Pramipexole is and what it is used for
2. What you need to know before you take
Pramipexole
3. How to take Pramipexole
4. Possible side effects
5. How to store Pramipexole
6. Contents of the pack and other information
1. What Pramipexole is and what it is used for
Pramipexole 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 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
Do not take Pramipexole
- 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 Pramipexole. 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.
- 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.
- Excessive use and craving for the product.
- Psychosis (e.g. comparable with symptoms of
schizophrenia).
- Vision impairment. You should have regular eye
examinations during treatment with Pramipexole.
- 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.
Tell your doctor if you experience symptoms such
as depression, apathy, anxiety, fatigue, sweating or
pain after stopping or reducing your Pramipexol
treatment. If the problems persist more than a few
weeks, your doctor may need to adjust your
treatment.
Pramipexol prolonged-release tablets is a specially
designed tablet from which the active ingredient is
gradually released, once the tablet has been
ingested. Parts of tablets may occasionally be
passed and seen in the stool (faeces) and may look
like whole tablets. Inform your doctor if you find
tablet pieces in your faeces.
Children and adolescents
Pramipexole is not recommended for use in children
or adolescents under 18 years.
Other medicines and Pramipexole
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 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.
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 may
affect your ability to drive and operate machinery.
Pramipexole with food, drink and alcohol
You should be cautious while drinking alcohol
during treatment with Pramipexole.
Pramipexole can be taken with or without food.

Sanofi
Pramipexole All Strengths m1-3-2-leaflet-mock-up UK
Leaflet
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Pregnancy and 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 doctor will then discuss with you if you should
continue to take Pramipexole.
The effect of Pramipexole on the unborn child is not
known. Therefore, do not take Pramipexole if you
are pregnant unless your doctor tells you to do so.
Pramipexole should not be used during breast-feeding.
Pramipexole can reduce the production of breast milk.
Also, it can pass into the breast milk and can reach
your baby. If use of Pramipexole is unavoidable,
breast-feeding should be stopped.
Ask your doctor or pharmacist for advice before
taking any medicine.

598144
2-Nov-17
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1
Black

Cutter

FOR
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Driving and using machines
Pramipexole can cause hallucinations (seeing,
hearing or feeling things that are not there). If
affected, do not drive or use machines.
Pramipexole 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.

Regulatory
Approved: Yes
Date:
Signature:

No

N/A

THESE
SIGNATURES
ARE
Head
of Regulatory
Approved: Yes
No
N/A
Date:
FOR
Signature:
HEAD
OFFICE USE
Other
- as required
Approved: Yes
No
ONLY
Date:

3. How to take Pramipexole
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.

Signature:

000000

Take Pramipexole prolonged-release tablets only
once a day and each day at about the same time.
You can take Pramipexole with or without food.
Swallow the tablets whole with water.

Fonts used:
Helvetica-Bold
HelveticaLTStd-BoldCond
HelveticaLTStd-Condoblique
HelveticaLTStd-Cond

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.

Smallest point sized used:
10.0 pt
Average Text Size (Body Text):
12.0 pt

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
prolonged-release tablets
Week Daily dose (mg) Number of tablets
1

0.26

One Pramipexole 0.26 mg
prolonged-release tablet.

2

0.52

One Pramipexole 0.52 mg
prolonged-release tablet,
OR
two Pramipexole 0.26 mg
prolonged-release tablets.

3

1.05

One Pramipexole 1.05 mg
prolonged-release tablet,
OR
two Pramipexole 0.52 mg
prolonged-release tablets,
OR
four Pramipexole 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
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CODE

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Pramipexole 0.26 mg prolonged-release tablets
Pramipexole 0.52 mg prolonged-release tablets
Pramipexole 1.05 mg prolonged-release tablets
Pramipexole 1.57 mg prolonged-release tablets
Pramipexole 2.10 mg prolonged-release tablets
Pramipexole 2.62 mg prolonged-release tablets
Pramipexole 3.15 mg prolonged-release tablets

dose up to a maximum of 3.15 mg of pramipexole a
day. A lower maintenance dose of one Pramipexole
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 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
If you forget to take a dose of Pramipexole, 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
Do not stop taking Pramipexole 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 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 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
may affect up to 1 in 10 people
Common
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
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 Pramipexol 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 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 or,
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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Pramipexole
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
temperature storage conditions, but store in the
original package in order to protect from moisture.

Sanofi
Pramipexole All Strengths m1-3-2-leaflet-mock-up UK

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.

Leaflet
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567697 iss3
598144
2-Nov-17

6. Contents of the pack and other information
What Pramipexole 0.26mg, 0.52mg, 1.05mg, 1.57mg,
2.10mg, 2.62mg and 3.15mg prolonged-release
tablets contains
- The active substance(s) is pramipexole.
Each tablet contains 0.26 mg, 0.52 mg, 1.05 mg,
1.57 mg, 2.10 mg, 2.62 mg and 3.15 mg pramipexole
as 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg,
3.75 mg and 4.5 mg pramipexole dihydrochloride
monohydrate, respectively.
- The other excipient(s) are hypromellose, calcium
hydrogen phosphate, anhydrous, magnesium
stearate, silica, colloidal anhydrous.
What Pramipexole 0.26mg, 0.52mg, 1.05mg,
1.57mg, 2.10mg, 2.62mg and 3.15mg
prolonged-release tablets looks like and contents
of the pack
Pramipexole 0.26 mg prolonged-release tablets: The
tablets of 9 mm are white or nearly white,
cylindrical, plans, with beveled edges and marked
with 026 on one side
Pramipexole 0.52 mg prolonged-release tablets: The
tablets of 10 mm are white or nearly white,
cylindrical, biconvex and marked with 052 on
one side
Pramipexole 1.05 mg prolonged-release tablets: The
tablets of 10 mm are white or nearly white,
cylindrical, biconvex, and marked with 105 on
one side
Pramipexole 1.57 mg prolonged-release tablets: The
tablets of 10 mm are white or nearly white,
cylindrical, biconvex and marked with 157 on
one side
Pramipexole 2.10 mg prolonged-release tablets: The
tablets of 10 mm are white or nearly white,
cylindrical, biconvex and marked with 210 on
one side
Pramipexole 2.62 mg prolonged-release tablets: The
tablets of 10 mm are white or nearly white,
cylindrical, biconvex and marked with 262 on
one side
Pramipexole 3.15 mg prolonged-release tablets: The
tablets of 11 mm are white or nearly white,
cylindrical, plans, with beveled edges and marked
with 315 on one side
Pramipexole is available in blister Al/OPA-Al-PVC:
10, 30 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Manufacturer
Laboratorios Normon, S.A
Ronda de Valdecarrizo, 6,
Tres Cantos, 28760, Madrid.
This leaflet was last revised in November 2017.

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