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PRAMIPEXOLE MYLAN 0.088MG 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
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, which
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

TBC

Do not take Pramipexole

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

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 as alcohol can increase the risk of
sleepiness and suddenly falling asleep.
Pramipexole can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning
to have a baby, ask your doctor of 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.

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 when taken with alcohol
or other medicines with a sedative effect. 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 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.
You can take Pramipexole with or without food. Swallow the
tablets with water.
The recommended daily dose is to be taken divided into
3 equal doses.
During the first week, the recommended dose is one tablet
Pramipexole 0.088 mg three times a day (equivalent
to 0.264 mg daily):

Warnings and precautions

Talk to your doctor or pharmacist before taking Pramipexole.

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 behaviors 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 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 (medicines used to treat certain
mental and emotional conditions. It helps to correct chemical
imbalances in the brain which cause mental illnesses).

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 HIV infection)
• 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.

Total daily dose (mg of base)

This will be increased every 5 - 7 days as directed by your doctor
until your symptoms are controlled (maintenance dose).
Second Week
Third Week
Number of One tablet Pramipexole
One tablet
tablets
0.18 mg three times
Pramipexole 0.35 mg
a day
three times a day
OR
OR
Two tablets Pramipexole
Two tablets
0.088 mg three times
Pramipexole 0.18 mg
a day
three times a day
Total daily
0.54
1.1
dose
(mg of base)
The recommended 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 Highest maintenance
dose
dose
Number of One tablet Pramipexole
One tablet
tablets
0.088 mg three times
Pramipexole 1.1 mg
a day
three times a day
Total daily
dose
0.264
3.3
(mg of base)

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 recommended starting dose is one tablet
Pramipexole 0.088 mg twice a day up to a maximum of
1.57 mg a day. In severe kidney disease, the recommended
starting dose is just one tablet Pramipexole 0.088 mg once a
day up to a maximum of 1.1 mg a day.

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 section 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 take a double dose to make up for a forgotten 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.

Date: 16 Mar 2015
Description Pramipexole Dihydrochloride 0.088/0.35/0.7/0.18 mg All
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 597774

SAP No. n/a

Superceded Affiliate Item Code n/a
TrackWise PR No. 597774

Vendor Job No. 249803
Proof No. 1

MA No. n/a

Client Market UK

Packing Site/Printer n/a

Keyline/Drawing No. n/a

Supplier Code n/a

Barcode Info n/a

Sign-offs

First Week
One tablet Pramipexole
0.088 mg three times a day
0.264

TBC

Tell your doctor if you have (or 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.
• Psychosis (e.g. comparable with symptoms of schizophrenia)
• Vision impairment. You should have regular eye examination
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, which can make you
dizzy or lose consciousness)

Number of tablets

No. of colours
Colours

1

Time: 17:05
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 195 x 410 mm

Body Text Size 9 pt

597774

Package leaflet: Information for the patient

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.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you notice any of the following side effects, seek urgent
medical advice immediately by contacting your doctor or going
to the nearest hospital casualty department straight away:
• Pneumonia (infection of the lungs that can cause fever,
shivering, sweating, difficulty breathing, chest pain and
feeling generally unwell)
• Heart failure (heart problems which can cause shortness
of breath or a persistent cough, extreme tiredness or
ankle swelling)*
• Signs of severe allergic reaction which can cause a rash or
skin reaction, swelling of the face, tongue, lips or throat
causing difficulty swallowing or breathing, sudden wheezing
• Inappropriate antidiuretic hormone secretion*, a hormone
that causes the body to retain water and dilute the blood,
reducing the amount of sodium. You may feel weak and
confused with aching of muscles.

You may also experience the following side effects:

• 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 gambling excessively despite serious
personal or family consequences.
• Altered or increased sexual interest 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)*
• Decreased awareness, confusion, loss of reality (delirium)
• Feeling agitated, elated or over-excited (mania)
Tell your doctor if you experience any of these behaviours;
they will discuss ways of managing or reducing the symptoms.

Other possible side effects

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
• Nausea (feeling sick)

Common: may affect up to 1 in 10 people

• Seeing, hearing or feeling things that are not there (hallucinations)
• Confusion
• Tiredness (fatigue)
• Sleeplessness (insomnia)
• Excess of fluid, usually in the legs (peripheral oedema)
• Headache
• Low blood pressure (hypotension)
• Abnormal dreams
• Constipation
• Problems with your vision such as blurred or double vision or
a reduced sharpness of vision
• Vomiting (being sick)
• Weight loss including decreased appetite

Do not store above 25ºC.

Blister: Store in the original package, in order to protect from light.
Bottle: Keep the bottle tightly closed in order to protect from light.
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.
Each Pramipexole 0.088 mg tablet contains 0.088 mg of
pramipexole base (as 0.125 mg of
pramipexole dihydrochloride monohydrate).
Each Pramipexole 0.18 mg tablet contains 0.18 mg of
pramipexole base (as 0.25 mg of
pramipexole dihydrochloride monohydrate).
Each Pramipexole 0.35 mg tablet contains 0.35 mg of
pramipexole base (as 0.5 mg of
pramipexole dihydrochloride monohydrate).
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: mannitol, maize starch pregelatinised,
sodium citrate anyhdrous, silica colloidal anhydrous, magnesium
stearate, hydroxypropylcellulose, crospovidone.

What Pramipexole looks like and contents of the pack

Pramipexole 0.088 mg tablets are white to off white round, flat
tablets marked with ‘PX1’ on one side of the tablet and ‘M’ on
the other side.
Pramipexole 0.18 mg tablets are white to off white oval tablets
marked with ‘PX2’ on one side of the tablet and ‘M’ on one side
of the breakline on the other side.
Pramipexole 0.35 mg tablets are white to off white oval tablets
marked with ‘PX3’ on one side of the tablet and ‘M’ on one side
of the breakline on the other side.
Pramipexole 0.7 mg tablets are white to off white round, flat
tablets marked with ‘M’ over ‘PX4’ on one side of the tablet and
a breakline on the other side.
Pramipexole is available in blisters of 10, 20, 30, 60, 80, 90,
100 or 200 tablets.
Pramipexole is available in polyethylene bottles of 30, 90, 100,
200 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan,
Potters Bar,
Hertfordshire EN6 1TL,
United Kingdom

Manufacturers

Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13,
Ireland
Generics [UK] Ltd.,
Potters Bar,
Hertfordshire EN6 1TL,
United Kingdom.

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
• Sexual desire problems (e.g. increased or decreased libido)
• Rash, itching
• Fainting
• Restlessness
• Shortness of breath (dyspnoea)
• Hiccups
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”.
In another indication, the same side effects as above
have been reported with pramipexole but with
different frequencies.

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 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
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, bottle or blister after EXP. The expiry date refers
to the last day of that month.

This leaflet was last revised in 03/2015.

Date: 16 Mar 2015
Description Pramipexole Dihydrochloride 0.088/0.35/0.7/0.18 mg All
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 597774

SAP No. n/a

Superceded Affiliate Item Code n/a
TrackWise PR No. 597774

Vendor Job No. 249803
Proof No. 1

MA No. n/a

Client Market UK

Packing Site/Printer n/a

Keyline/Drawing No. n/a

Supplier Code n/a

Barcode Info n/a

Sign-offs

No. of colours
Colours

1

Time: 17:05
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 195 x 410 mm

Body Text Size 9 pt

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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