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GLEPARK 0.18MG TABLETS

Active substance(s): PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLEPARK 0.088mg tablets
GLEPARK 0.18mg tablets
GLEPARK 0.35mg tablets
GLEPARK 0.7mg 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. Do not pass it on
to others. It may harm them, even if their sings of ilness are the
same as yours.
If you get any of the 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 GLEPARK is and what it is used for
2. Before you take GLEPARK
3. How to take GLEPARK
4. Possible side effects
5. How to store GLEPARK
Contents of the pack and other information
1. WHAT GLEPARK IS AND WHAT IT IS USED FOR
GLEPARK 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.
GLEPARK 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLEPARK
DO NOT take GLEPARK
- if you are allergic (hypersensitive) to pramipexole or to any of the
other ingredients of the tablets (listed insection 6).
Warnings and precautions
Talk to your doctor before taking GLEPARK.
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 dyskinesias during the uptitration of
GLEPARK.
- 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
GLEPARK
- 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 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
GLEPARK is not recommended for use in children or adolescents
under 18 years.
Other medicines and Glepark
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 GLEPARK 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 nighttime 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 GLEPARK.
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
GLEPARK may affect your ability to drive and operate machinery.
GLEPARK with food and drink and alcohol
You should be cautious while drinking alcohol during treatment with
GLEPARK.
GLEPARK can be taken with or without food. Swallow the tablets
with water.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might 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 GLEPARK .
The effect of GLEPARK on the unborn child is not known. Therefore,
do not take GLEPARK if you are pregnant unless your doctor tells
you to do so.
GLEPARK should not be used during breast-feeding. GLEPARK can
reduce the production of breast milk. Also, it can pass into the breast
milk and can reach your baby. If use of GLEPARK is unavoidable,
breast-feeding should be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
GLEPARK can cause hallucinations (seeing, hearing or feeling
things that are not there). If affected, do not drive or use machines.
GLEPARK 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 GLEPARK
Always take GLEPARK 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 GLEPARK 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 GLEPARK 0.088 mg
tablet three times a day (equivalent to 0.264 mg daily):
1st week
Number of tablets

1 tablet GLEPARK 0.088 mg tablet
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
Number of
tablets

3rd week

1 tablet GLEPARK 0.18 1 tablet GLEPARK 0.35
mg tablet
mg tablet

Total daily dose
(mg)

three times a day

three times a day

OR

OR

2 tablets GLEPARK
0.088 mg

2 tablets GLEPARK
0.18 mg

three times a day

three times a day

0.54

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 GLEPARK
0.088 mg tablets a day is also possible.
Lowest
maintenance dose

Highest
maintenance dose

Number of tablets

1 tablet GLEPARK
0.088 mg three
times a day

1 tablet Pramipexole
1.1 mg three
times a day

Total daily dose
(mg)

0.264

3.3

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

GLEPARK 0.088 mg a day.
If you take more GLEPARK 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 GLEPARK
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 GLEPARK
Do not stop taking GLEPARK 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 GLEPARK 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, GLEPARK 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

Common:

may affect up to 1 in 10 people

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

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)
Common:
- Hallucinations (seeing, hearing or feeling things that are not
there)
- Confusion
- Tiredness (fatigue)
- Excess of fluid, usually in the legs (peripheral oedema)
- Headache
- Abnormal dreams
- Constipation
- Sleeplessness (insomnia)
- Urge to behave in an unusual way
- Visual impairment
- Vomiting (being sick)
- Weight loss including decreased appetite
- Hypotension (low blood pressure)
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
- Dyspnoea (difficulties to breathe)
- Pneumonia (infection of lungs)
- Cardiac failure (heart problems which can cause shortness of
breath or ankle swelling)*
- Inappropriate antidiuretic hormone secretion*
- Restlessness
- Hiccups
- 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)
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 the leaflet. You can
also report side effects directly via the Yellow Card Scheme website
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 GLEPARK
Keep this medicine out of the sight and reach of children.
Do not use GLEPARK after the expiry date which is stated on the
carton and blister after .
The expiry date refers to the last day of that month.
Store in the original package to protect the tablets from light. This
medicinal product does not require any special temperature 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 GLEPARK contains
The active substance is pramipexole.
Each 0.088mg tablet contains 0.088mg of pramipexole base (as
0.125mg of pramipexole dihydrochloride monohydrate)
Each 0.18mg tablet contains 0.18mg of pramipexole base (as
0.25mg of pramipexole dihydrochloride monohydrate
Each 0.35 mg tablet contains 0.35mg of pramipexole base (as
0.5mg of pramipexole dihydrochloride monohydrate)
Each 0.7mg tablet contains 0.7mg of pramipexole base (as 1.0mg of
pramipexole dihydrochloride monohydrate)
The other ingredients are:
mannitol (E 421); maize starch; povidone K 30 (E 1201); silica,
colloidal anhydrous; magnesium stearate (E470b)
What GLEPARK looks like and contents of the pack
0.088mg tablets: circular, white, flat bevelled tablets engraved with
‘PX” on one side and plain on the other side
0.18mg tablets: oval, white, flat bevelled uncoated tablets engraved
with ‘PX’ and ‘1’ on either side of score line on one side and score
line on the other side. The tablet can be divided into equal halves.
0.35mg tablets: oval white, flat bevelled uncoated tablets engraved
with ‘PX’ and ‘2’ on either side of score line on one side and score
line on other side. The tablet can be divided into equal halves.
0.7mg tablets: oval, white, flat bevelled uncoated tablets engraved
with ‘PX’ and ‘3’ on either side of score line on one side and score
line on other side. The tablet can be divided into equal halves.
GLEPARK 0.088mg, 0.18mg, 0.35mg, 0.7mg tablets are available in
aluminium/aluminium blisters of 30,100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Ltd, Laxmi House, 2-B Draycott
Avenue, Kenton, Harrow,
Middx, HA3 0BU. United Kingdom
Manufacturer
Glenmark Pharmaceuticals Europe Limited, Building 2, Croxley
Green Business Park, Croxley Green, Hertfordshire, WD18 8YA,
United Kingdom
Glenmark Pharmaceuticals s.r.o., Hvězdova 1716/2b, 140 78 Praha
4, Czech Republic
PL 25258/0004-7
This medicinal product is authorised in the Member States of
the EEA under the following names:
Czech Republic, Denmark, Finland, Germany, Greece, Romania,
Slovak Republic, The Netherlands, UK
Glepark
This leaflet was last revised in June 2014

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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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