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PRAMIPEXOLE 0.18 MG TABLETS

Active substance(s): PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

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Package leaflet: Information for the user

Pramipexole 0.088 mg tablets
Pramipexole 0.18 mg tablets
Pramipexole 0.35 mg tablets
Pramipexole 0.7 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.
•  If you have any further questions, ask your doctor
or pharmacist.
•  This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

What is in this leaflet:
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 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.
• Abnormal, uncontrolled movements of the limbs
(dyskinesia).
If you have advanced Parkinson’s disease and are also taking
levodopa, you might develop dyskinesia during the uptitration 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.
• 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 overexcited) 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 Pramipexole treatment.
If the problems persist more than a few weeks, your doctor
may need to adjust your treatment.

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.
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.

Parkinson’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)

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

This will be increased every 5 - 7 days as directed by your
doctor until your symptoms are controlled (maintenance
dose).
Number of
tablets

Total daily dose
(mg)

2nd week
1 tablet
Pramipexole
0.18 mg
three times a day
OR
2 tablets
Pramipexole
0.088 mg
three times a day
0.54

3rd week
1 tablet
Pramipexole
0.35 mg
three times a day
OR
2 tablets
Pramipexole
0.18 mg
three times a day
1.1

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
Number of
1 tablet
1 tablet
tablets
Pramipexole 0.088 Pramipexole 1.1
mg three times
mg three times
a day
a day
Total daily dose
0.264
3.3
(mg)
Patients with kidney disease:
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.

If you take more Pramipexole than you should

Children and adolescents

Pramipexole is not recommended for use in children or
adolescents under 18 years.

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”.

Other medicines and Pramipexole

If you forget to take 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:
• c imetidine (to treat excess stomach acid and stomach
ulcers)
• a mantadine (which can be used to treat Parkinson’s
disease)
•m
 exiletine (to treat irregular heartbeats, a condition known
as ventricular arrhythmia);
• z idovudine (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);
•q
 uinine (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.

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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:
• loss of muscle movement (akinesia)
• rigid muscles
• fever
• unstable blood pressure
• increased heart rate (tachycardia)
• confusion
• depressed level of consciousness (e.g. coma)
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor immediately and stop taking Pramipexole
if you experience swelling of the face, lips, tongue or throat
and difficulty breathing, as these may be sings of a serious
allergic reaction.

Continued over page

If you suffer from Parkinson’s disease, you may experience the
following side effects:
Very common (may affect more than 1 in 10 people):
• Abnormal, uncontrolled movements of the limbs
(dyskinesia)
• Sleepiness
• Dizziness
• Sickness (nausea)
Common (may affect up to 1 in 10 people):
• 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
• Low blood pressure (hypotension)
• Abnormal dreams
• Constipation
• Visual impairment
• Vomiting (being sick)
• Weight loss including decreased appetite
Uncommon (may affect up to 1 in 100 people):
• Excessive fear for one’s own well-being (paranoia)
• Delusion
• Excessive daytime sleepiness and suddenly falling asleep
• Memory disturbance (amnesia)
• Increased movements and inability to keep still
(hyperkinesia)
• 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
• Difficulties to breathe (dyspnoea)
• Hiccups
• Infections of the lungs (pneumonia)
• 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 (may affect up to 1 in 1,000 people):
• Mania (agitation, feeling elated or over-excited)
Not known (frequency cannot be estimated from the
available data):
• After stopping or reducing your Pramipexole 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.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme (Website: 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 and the blister 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 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 0.7 mg:
Each Pramipexole 0.7 mg tablet contains 0.7 mg
of pramipexole base (as 1.0 mg of pramipexole
dihydrochloride monohydrate).
• The other ingredients are Starch, pregelatinized (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)
0.18 mg White, round tablets, marked on one side
with a “1” (one), scored on the other side
0.35 mg White, round tablets, marked on one side
with a “2” (two), scored on the other side
0.70 mg White, round tablets, marked on one side
with a “3” (three), scored on the other side
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 and Manufacturer
Pharmathen S.A.
6 Dervenakion str.
15351 Pallini Attiki
Greece
This leaflet was last revised in 07/2017.
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Actavis, Barnstaple, EX32 8NS, UK

+ Expand Transcript

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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