PRAMIPEXOLE 0.088 MG TABLETS

Active substance: 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 because it contains important
information for you.

Keep this leaflet. You may need to read it again.

I
 f you have any further questions, ask your doctor
or pharmacist.
•   his medicine has been prescribed for you only.
T
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.

I
 f you get any of the side effects, talk to your
doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.

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 contains the active substance pramipexole
and belongs to a group of medicines called 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).
• treat the symptoms of moderate to severe primary

Restless Legs Syndrome (RLS).

2 WHAT YOU NEED TO KNOW BEFORE YOU

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.

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 this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.
The doctor will advise you on the right dosing.
You can take Pramipexole 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
Total daily dose (mg)

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
OR
2 tablets
Pramipexole
0.088 mg three
times a day

DO NOT take Pramipexole

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
•  allucinations (seeing, hearing or feeling things that are
H
not there). Most hallucinations are visual.
•  yskinesia (e.g. abnormal, uncontrolled movements of
D
the limbs). If you have advanced Parkinson’s disease and
are also taking levodopa, you might develop dyskinesia
during the up-titration of Pramipexole.
• Sleepiness and episodes of suddenly falling asleep
•  sychosis, (e.g. comparable with symptoms of
P
schizophrenia)
•  ision impairment. You should have regular eye
V
examinations during treatment with Pramipexole.
•  evere heart or blood vessels disease. You will need to
S
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).
•  ugmentation. You may experience that symptoms start
A
earlier than usual, be more intense and involve other
limbs.
Tell your doctor if you or your family/carer notices you are
developing urges or cravings to behave in ways that are
unusual for you or you cannot resist the impulse, drive or
temptation to carry out certain activities that could harm
yourself or others. These behaviours are called impulse
control disorders and can include addictive gambling,
excessive eating or spending, an abnormally high sex
drive or a an increase in sexual thoughts or feelings.
Your doctor may need to adjust or stop your dose.

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 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 stomach
c
ulcers)
•  mantadine (which can be used to treat Parkinson’s
a
disease)
•  exiletine (to treat irregular heartbeats, a condition
m
known as ventricular arrhythmia);
•  idovudine (which can be used to treat the acquired
z
immune deficiency syndrome (AIDS), a disease of the
human immune system);
• cisplatin (to treat various types of cancers);
•  uinine (which can be used for the prevention of painful
q
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.

Number of
tablets

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine. Your doctor will
then discuss with you if you should continue to take
Pramipexole.

1.1

Total
daily
dose
(mg)

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
maintenance
dose
1 tablet
Pramipexole
0.088 mg
three times a
day

Highest
maintenance
dose
1 tablet
Pramipexole
1.1 mg three
times a
day

0.264

Number of
tablets

3.3

Total daily
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 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.

Restless Legs Syndrome

The dose is usually taken once a day, in the evening, 2-3
hours before bedtime.
During the first week, the usual dose is 1 tablet
Pramipexole 0.088 mg once a day (equivalent to
0.088 mg daily):
1st week
1 tablet
Pramipexole
0.088 mg
0.088

Number of tablets
Total daily dose (mg)

This will be increased every 4 - 7 days as directed by your
doctor until your symptoms are controlled (maintenance
dose).
2nd week

3rd week

Number
of tablets

1 tablet
Pramipexole
0.18 mg
OR
2 tablets
Pramipexole
0.088 mg

1 tablet
Pramipexole
0.35 mg
OR
2 tablets
Pramipexole
0.18 mg
OR
4 tablets
Pramipexole
0.088 mg

Total daily
dose (mg)

0.18

0.35

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

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

0.54

TAKE PRAMIPEXOLE

if you are allergic to pramipexole or any of the other
ingredients of this medicine (listed in section 6).

1st week
1 tablet Pramipexole
0.088 mg three times
a day
0.264

4rd week
1 tablet
Pramipexole
0.35 mg
and 1 tablet
Pramipexole
0.18 mg
OR
3 tablets
Pramipexole
0.18 mg
OR
6 tablets
Pramipexole
0.088 mg
0.54

The daily dose should not exceed 6 tablets Pramipexole
0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
If you stop taking your tablets for more than a few days
and want to restart the treatment, you must start again at
the lowest dose. You can then build up the dose again, as
you did the first time. Ask your doctor for advice.

Continued top of next column
AAAF3849

Continued over page

Pramipexole 0.088mg, 0.18mg, 0.35mg, 0.7mg & 1.1mg PIL - UK

colours/plates:
1. Black

item no: AAAF3849

dimensions: 170 x 500

print proof no: 4

pharmacode:

origination date: 17.05.13

min pt size: 8pts

3.
4.
5.
6.

originated by: SA
approved for print/date

2.

revision date: 05.06.13

Technical Approval

revised by: SA

date sent: 17.05.13

supplier: Pharmathen

technically app. date: 20.05.13

Non Printing Colours
1.
2.
3.

Your doctor will review your treatment after 3 months to
decide whether or not to continue the treatment.
Patients with kidney disease:
If you have severe kidney disease, Pramipexole may not
be a suitable treatment for you.

If you take more Pramipexole than you should

If you accidentally took too many tablets,
•  ontact your doctor or nearest hospital casualty
c
department immediately for advice.
•  ou may experience vomiting, restlessness, or any of
y
the side effects as described in chapter 4, (Possible side
effects).

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

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
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:
Common:
Uncommon:
Rare:
Very rare:

may affect more than 1 in 10 people
may affect up to1 in 10 people
may affect up to 1 in 100 people
may affect up to 1 in 1,000 people
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:
•  yskinesia (e.g. abnormal, uncontrolled movements of
D
the limbs)
• Sleepiness
• Dizziness
• Nausea (sickness)
Common:
• Urge to behave in an unusual way
•  allucinations (seeing, hearing or feeling things that are
H
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)
•  yperkinesia (increased movements and inability to
H
keep still)
• Weight increase
• Allergic reactions (e.g. rash, itching, hypersensitivity)
• Fainting
•  ardiac failure (heart problems which can cause
C
shortness of breath or ankle swelling)*
• Inappropriate antidiuretic hormone secretion*
• Restlessness
• Dyspnoea (difficulties to breathe)
• Hiccups
• Pneumonia (infection of the lungs)
•  nability to resist the impulse, drive or temptation to
I
perform an action that could be harmful to you or
others, which may include:
•  trong impulse to gamble excessively despite serious
S
personal or family consequences.
•  ltered or increased sexual interest and behaviour of
A
significant concern to you or to others, for example, an
increased sexual drive.
• Uncontrollable excessive shopping or spending
•  inge eating (eating large amounts of food in a short
B
time period) or compulsive eating (eating more food
than normal and more than is needed to satisfy your
hunger)*

• Excess of fluid, usually in the legs (peripheral oedema)
• Allergic reactions (e.g.rash, itching, hypersensitivity)
• Fainting
• Restlessness
• Visual impairment
• Weight loss including decreased appetite
• Dyspnoea (difficulties to breathe)
• Hiccups
• Pneumonia (infection of the lungs)*
• Inability to resist the impulse, drive or temptation to

perform an action that could be harmful to you or
others, which may include:
•  trong impulse to gamble excessively despite serious
S
personal or family consequences. *
•  ltered or increased sexual interest and behaviour of
A
significant concern to you or to others, for example, an
increased sexual drive. *
• Uncontrollable excessive shopping or spending *
•  inge eating (eating large amounts of food in a short
B
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
behaviors; they will discuss ways of managing or
reducing the symptoms
For the side effects marked with * a precise frequency
estimation is not possible, since these side effects were
not observed in clinical studies among 1,395 patients
treated with pramipexole. The frequency category is
probably not greater than “uncommon”.
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.

5 HOW TO STORE PRAMIPEXOLE
Keep this medicine out of the sight and reach of children.
Do not use Pramipexole after the expiry date, which is
stated on the pack. 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 to protect the environment.

6 CONTENTS OF THE PACK AND OTHER

INFORMATION

What Pramipexole contains
•  he active substance is pramipexole.
T
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).
•  he other ingredients are Starch, pregelatinized (Starch
T
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 ± 0.1 mm 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
± 0.1 mm in diameter and 3.0 mm ± 0.2
mm in thickness

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

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).

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”.

Not all pack sizes may be marketed.

If you suffer from Restless Legs Syndrome, you may
experience the following side effects:
Very common:
• Nausea (sickness)
Common:
•  hanges in sleep pattern, such as sleeplessness
C
(insomnia) and sleepiness
• Tiredness (fatigue)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (being sick)

Marketing Authorisation Holder
Pharmathen S.A.,
Dervenakion 6 str.,
15351, Pallini, Attiki , Greece
Manufacturer
Pharmathen S.A., Dervenakion 6, 15351,
Pallini, Attiki , Greece
This leaflet was last revised in June 2013.

Uncommon:
• Urge to behave in an unusual way*
•  ardiac failure (heart problems which can cause
C
shortness of breath or ankle swelling)*
• Inappropriate antidiuretic hormone secretion*
•  yskinesia (e.g. abnormal, uncontrolled movements of
D
the limbs)
•  yperkinesia (increased movements and inability to
H
keep still)*
• Paranoia (e.g. excessive fear for one’s own well-being)*
• Delusion*
• Amnesia (memory disturbance)*
•  allucinations (seeing, hearing or feeling things that are
H
not there)
• Confusion
• Excessive daytime sleepiness and suddenly falling asleep
• Weight increase
• Hypotension (low blood pressure)
Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAF3849

Pramipexole 0.088mg, 0.18mg, 0.35mg, 0.7mg & 1.1mg PIL - UK

colours/plates:
1. Black

item no: AAAF3849

dimensions: 170 x 500

print proof no: 4

pharmacode:

origination date: 17.05.13

min pt size: 8pts

3.
4.
5.
6.

originated by: SA
approved for print/date

2.

revision date: 05.06.13

Technical Approval

revised by: SA

date sent: 17.05.13

supplier: Pharmathen

technically app. date: 20.05.13

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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