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PRAMIPEXOLE 0.088 MG TABLETS

Active substance(s): PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

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Pramipexole 0.088 mg tablets
Pramipexole 0.18 mg tablets
Pramipexole 0.35 mg tablets
Pramipexole 0.7 mg tablets
Pramipexole 1.1 mg tablets
Pramipexole
Read all of this leaflet carefully before you
start taking this medicine.
•  eep this leaflet. You may need to read it
K
again.
•   f you have any further questions, ask
I
your doctor or pharmacist.
•   his medicine has been prescribed for
T
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
•   f any of the side effects gets serious, or
I
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist. See section 4.

In this leaflet:
1 What Pramipexole is and what it is
used for
2 Before you take Pramipexole
3 How to take Pramipexole
4 Possible side effects
5 How to store Pramipexole
6 Further information
1 WHAT PRAMIPEXOLE IS AND WHAT
IT IS USED FOR
Pramipexole tablets belong 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. It can be used alone or in
combination with levodopa (another
medicine for Parkinson´s disease).

2 BEFORE YOU TAKE PRAMIPEXOLE
DO NOT take Pramipexole

• f you are allergic (hypersensitive) to
i
pramipexole or any of the other ingredients
of the tablets (See Section 6, “Further
information”).

Take special care with Pramipexole

Tell your doctor if you have (had) or develop
any medical conditions or symptoms,
especially any of the following:
• Kidney disease
•  allucinations (seeing, hearing or
H
feeling things that are not there). Most
hallucinations are visual.
•  yskinesia (e.g. abnormal, uncontrolled
D
movements of the limbs).
If you have advanced Parkinson’s disease
and are also taking levodopa, you might
develop dyskinesia during the uptitration of
Pramipexole.
•  leepiness and episodes of suddenly falling
S
asleep
• 
Behavioural changes (e. g. pathological
gambling, compulsive shopping), increased
libido (e.g. increased sexual desire), binge
eating.
•  sychosis, (e.g. comparable with symptoms
P
of schizophrenia)
•  ision impairment
V
You should have regular eye examinations
during treatment with Pramipexole.
•  evere heart or blood vessels disease.
S
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)
Children and adolescents
Pramipexole is not recommended for use in
children or adolescents under 18 years.

Taking other medicines

Please tell your doctor or pharmacist if you
are taking or have recently taken 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:
•  imetidine (to treat excess stomach acid and
c
stomach ulcers)
•  mantadine (which can be used to treat
a
Parkinson’s disease)
•  exiletine (to treat irregular heartbeats, a
m
condition known as ventricular arrhythmia).
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.

Taking Pramipexole with food and
drink

You should be cautious while drinking
alcohol during treatment with Pramipexole.
Pramipexole can be taken with or without
food. Swallow the tablets with water.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think
you might be pregnant or if you intend to
become pregnant. 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, breastfeeding should be stopped.
Ask your doctor or pharmacist for advice
before taking any medicine.

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.

3 HOW TO TAKE PRAMIPEXOLE
Always take Pramipexole exactly as your
doctor has told you. The doctor will advise
you on the right dosing.
You can take Pramipexole with or without
food. Swallow the tablets with water.

Parkison’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 0.088 mg three times a
day (equivalent to 0.264 mg daily):

Number of tablets

1st week
1 tablet Pramipexole
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).
2nd week
1 tablet
Pramipexole
0.18 mg three
times a day
Number
OR
of tablets
2 tablets
Pramipexole
0.088 mg three
times a day
Total
daily
0.54
dose
(mg)

3rd week
1 tablet
Pramipexole
0.35 mg three
times a day
OR
2 tablets
Pramipexole
0.18 mg three
times a day

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 0.088 mg tablets a day is also
possible.
Lowest
Highest
maintenance maintenance
dose
dose
1 tablet
1 tablet
Pramipexole
Number of
Pramipexole
0.088 mg
tablets
1.1 mg three
three times a
times a day
day
Total daily
0.264
3.3
dose (mg)
Patients with kidney diseases:
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

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AAAG4992

Continued over page

Pramipexole 0.088mg, 0.18mg, 0.35mg, 0.7mg & 1.1mg Tablets PIL - UK
item no: AAAG4992

dimensions: 170 x 500

print proof no: 1

pharmacode:

origination date: 27.01.14

min pt size:

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

1.1

revision date:

Technical Approval

revised by:

date sent: 27.01.14

supplier: Pharmathen

technically app. date: 27.01.14

Non Printing Colours
1.
2.
3.

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

If you take more Pramipexole than
you should

If you accidentally took too many tablets,
• Contact your doctor or nearest hospital

casualty department immediately for
advice.
•  ou may experience vomiting, restlessness,
Y
or any of the side effects as described in
chapter 4, “Possible side effect”.

If you forget to take Pramipexole

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

Unknown frequency:
•  ncreased eating (binge eating,
I
hyperphagia)
If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly
via the Yellow Card Scheme (Website:
HYPERLINK “http://www.mhra.gov.uk/
yellowcard” 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

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.

Keep out of the reach and sight of children.

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)

This medicinal product does not require any
special storage conditions.

If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Pramipexole can cause
side effects, although not everybody gets
them. Evaluation of these side effects is
based on the following frequencies:
Very common: affects more than 1 user
in 10
Common:
affects 1 to 10 users in
100
Uncommon:
affect 1 to 10 users in
1,000
Rare:
affects 1 to 10 users in
10,000
Very rare:
affects less than 1 user in
10,000
Not known
frequency cannot be
estimated from the
available data
Tell your doctor immediately and stop
taking Pramipexole if you experience
swelling of the face, lips, tongue or throat,
difficulty breathing or develop a rash or
itching, as these may be signs of a serious
allergic reaction.
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)
• Hypotension (low blood pressure)
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
• Abnormal dreams
• Constipation
• Restlessness
• Amnesia (memory disturbance)
• Visual disturbance
• Vomiting (being sick)
• Weight loss
Uncommon:
• Paranoia (e.g. excessive fear for one’s own

well-being)
• Delusion
• Excessive daytime sleepiness and suddenly

falling asleep
• Hyperkinesia (increased movements and

inability to keep still)
• Weight increase
• Increased sexual desire (e.g. increased

libido)
• Fainting
• Pathological gambling, especially when

taking high doses of Pramipexole
• Hypersexuality
• Compulsive shopping
• Dyspnoea (difficulties to breathe)
• Pneumonia (infections of the lungs)

Do not take Pramipexole after the expiry
date, which is stated on the pack. The expiry
date refers to the last day of that month.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6 FURTHER INFORMATION
What Pramipexole contains

• The active substance is pramipexole.
For 0.088 mg:
Each Pramipexole 0.088 mg tablet contains
0.088 mg of pramipexole base (as 0.125
mg of pramipexole dihydrochloride
monohydrate).
For 0.18 mg:
Each Pramipexole 0.18 mg tablet contains
0.18 mg of pramipexole base (as 0.25
mg of pramipexole dihydrochloride
monohydrate).
For 0.35 mg:
Each Pramipexole 0.35 mg tablet contains
0.35 mg of pramipexole base (as 0.5
mg of pramipexole dihydrochloride
monohydrate).
For 0.70 mg:
Each Pramipexole 0.7 mg tablet contains
0.7 mg of pramipexole base (as 1.0
mg of pramipexole dihydrochloride
monohydrate).
For 1.1 mg:
Each Pramipexole 1.1 mg tablet contains
1.1 mg of pramipexole base (as 1.5
mg of pramipexole dihydrochloride
monohydrate).
• The other ingredients are Starch,

pregelatinised (Starch maize 1500),
Mannitol, Cellulose, microcrystalline,
Povidone (27.0-32.4), Talc and Magnesium
stearate.
What Pramipexole looks like and
contents of the pack
0.088 mg White, round tablets, marked

on one side with a “0” (zero),

with no defects and

dimensions 6.0 ± 0.1mm in

diameter and 3.0 mm

± 0.2 mm in thickness
0.18 mg
White, round tablets, marked

on one side with a “1” (one),

scored on the other side with

no defects and dimensions

6.0 ± 0.1 mm in diameter and

3.0 mm ± 0.2 mm in thickness
0.35 mg
White, round tablets, marked

on one side with a “2” (two),

scored on the other side with

no defects and dimensions

6.0 ± 0.1 mm in diameter and

3.0 mm ± 0.2 mm in thickness
0.70 mg
White, round tablets, marked

on one side with a “3” (three),

scored on the other side

with no defects and

dimensions 6.0 ± 0.1 mm

in diameter and 3.0 mm

± 0.2 mm in thickness
1.1 mg
White, round tablets, marked

on one side with a “4” (four),

scored on the other side with

no defects and dimensions

6.0 ± 0.1mm in diameter and

3.0 mm ± 0.2 mm in

thickness
Pramipexole is available in aluminium/
aluminium blister strips 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
Pharmathen S.A.
6, Dervenakion str.,
15351 Pallini Attiki, Greece
Manufacturer
Pharmathen S.A., Dervenakion 6, 15351,
Pallini, Attiki , Greece
This leaflet was last approved in
06/08/2010

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAG4992

Pramipexole 0.088mg, 0.18mg, 0.35mg, 0.7mg & 1.1mg Tablets PIL - UK
item no: AAAG4992

dimensions: 170 x 500

print proof no: 1

pharmacode:

origination date: 27.01.14

min pt size:

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date:

Technical Approval

revised by:

date sent: 27.01.14

supplier: Pharmathen

technically app. date: 27.01.14

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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