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PERGOLIDE 1000 MICROGRAM TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PERGOLIDE 50 microgram, 250 microgram or 1 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.
What is in this leaflet:
1. What Pergolide is and what it is used for
2. What you need to know before you take Pergolide
3. How to take Pergolide
4. Possible side effects
5. How to store Pergolide
6. Contents of the pack and other information

1.

WHAT PERGOLIDE IS AND WHAT IT IS USED FOR

Pergolide belongs to a group of medicines known as dopamine receptor agonists.
Pergolide is used to reduce the symptoms and problems associated with Parkinson’s disease when
patients are intolerant to or have failed alternate treatments with other medicines.
Pergolide is sometimes used with other medicines that contain levodopa, e.g. Madopar and
Sinemet.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERGOLIDE
Do not take Pergolide if you:
 are allergic (hypersensitive) to pergolide mesilate or any of the other ingredients of this
medicine listed in section 6
 have a known sensitivity to ‘ergot’ medicines, e.g. bromocriptine or lisuride, or ‘ergot’
medicines used to treat or prevent migraine, e.g. ergotamine or methysergide
 have or had fibrotic reactions (scar tissue) affecting your heart
 have heart valve problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pergolide if you:
 have or had fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen. Before
treatment your doctor will check whether your heart, lungs and kidneys are in good condition.
You will also have an echocardiogram (an ultrasound test of the heart) taken before treatment is
started and at regular intervals during treatment. If fibrotic reactions occur treatment will have to
be discontinued.
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 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.
While taking Pergolide you may need to have blood tests, a chest x-ray, and checks that your lungs,
heart, and kidneys are working satisfactorily.
Children and adolescents
Pergolide is not recommended for use in children and adolescents.

Other medicines and Pergolide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Especially talk to your doctor if you are taking any of the following:
 L-dopa (levodopa), also used in the treatment of Parkinson’s disease. Occasionally, movement
disorder, confusion and hallucinations have been caused, or made worse, by Pergolide and
levodopa being taken together
 warfarin (a medicine which stops your blood clotting), as the dosage of either medicine may
need to be reduced
 medicines for high blood pressure, as Pergolide may also cause a lowering of blood pressure
 medicines for treatment of a psychotic condition (e.g. haloperidol or flupentixol). These
medicines may reduce the effect of Pergolide
 metoclopramide or prochlorperazine (to stop you feeling sick). These medicines may reduce the
effect of Pergolide. If you feel sick at the start of treatment, talk to your doctor or pharmacist
before taking any anti-sickness medication.
Pregnancy and breast-feeding
 If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for
advice before taking this medicine.
Driving and using machines
 Pergolide may make you feel drowsy, or cause you to fall asleep suddenly, sometimes without
warning. If you are affected, DO NOT drive or operate machinery.
Important information about some of the ingredients of Pergolide
 Patients who are intolerant to lactose should note that Pergolide Tablets contain a small amount
of lactose which is a sugar. If your doctor has told you that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

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3. HOW TO TAKE PERGOLIDE
Always take Pergolide exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
Even though you are taking Pergolide, you should continue taking any other medicines you have
been prescribed for Parkinson’s disease. Make sure you follow any advice your doctor has given
you about reducing the dose of these medicines.
The tablets should be swallowed preferably with a drink of water. The tablets can be taken with or
without food. The usual dose is:
Adults:
 The usual dose starts with one 50 microgram tablet for the first one or two days.
 Your doctor will gradually increase the dose every third or fourth day over a period of several
weeks, until the optimal dose is reached.
 You will usually take the tablets 3 times a day, at regular intervals.
 Do not take more than 3 mottled pink tablets (3 x 1000 microgram) or 12 mottled green tablets
(12 x 250 microgram), or 60 ivory coloured tablets (60 x 50 microgram) per day
Use in children and adolescents:
 Pergolide is not recommended for use in children and adolescents.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
If you take more Pergolide than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has
swallowed any of the tablets, contact your nearest hospital casualty department or your doctor
immediately.
An overdose is likely to cause palpitations, being sick, low blood pressure, agitation, hallucinations,
involuntary movements, and tingling sensations.
Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor
so that they know which tablets were consumed.
If you forget to take Pergolide
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the
next one. DO NOT take a double dose to make up for a forgotten dose. Take the remaining doses at
the correct time.
If you stop taking Pergolide
You should continue to take these tablets for as long as your doctor tells you to.
DO NOT stop taking your medicine without talking to your doctor first even if you feel better.
DO NOT stop taking your tablets suddenly. When your doctor decides to stop your tablets, the dose
will be reduced gradually over a period of time. Stopping or reducing your dose of Pergolide too
quickly may lead to hallucinations, confusion, high body temperature, muscle rigidity, coma, and
cause other changes such as sweating, digestive problems and changes in heart-rate.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Pergolide can cause side effects, although not everybody gets them.
Some of the symptoms may be caused by Parkinson’s disease, other conditions, or by medicines
you are already taking.
You may feel sick when you first start your medicine. This usually wears off; however, your doctor
may decide to give you something to help this.
Stop taking the tablets and tell your doctor immediately or go to the casualty department at your
nearest hospital if the following happens:
 an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in
breathing, or severe skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or
hospitalisation.
Tell your doctor immediately if you experience any of the following serious effects:
 heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the
pericardium (pericardial effusion). The early symptoms may be one or more of the following:
difficulty breathing, shortness of breath, chest or back pain and swollen legs. This is a very
common side effect (affecting more than one person in ten); if you experience any one of these
symptoms you must tell your doctor immediately.
 severe hallucinations, as this medicine may not be suitable for you and your doctor may stop
your treatment
You may 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:
o Strong impulse to gamble excessively despite serious personal or family
consequences.
o Altered or increased sexual interest and behaviour of significant concern to you or to
others, for example, an increased sexual drive.
o Uncontrollable excessive shopping or spending
o 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)

Tell your doctor if you experience any of these behaviors; they will discuss ways of managing
or reducing the symptoms.
The following side effects have also been reported:
 pains, stomach ache
 feeling sick, being sick, indigestion/heartburn
 abnormal movements, double vision, hallucinations
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somnolence (excessive drowsiness)














sudden sleep onset episodes
difficulty in breathing
runny and itchy nose
difficulty sleeping
confusion
constipation, diarrhoea
dizziness, fainting (which may or may not occur as a result of standing up)
abnormal liver function test results
rash
fever
palpitations and changes in heart beat
cold fingers or toes

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet.

5. HOW TO STORE PERGOLIDE
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the package supplied. Keep container in the outer carton. Do not
transfer the tablets to another container.
Do not use Pergolide after the expiry date that is stated on the outer packaging. 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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pergolide Tablets contain:
 The active ingredient is pergolide mesilate.
 The other ingredients are lactose monohydrate, pregelatinised starch, sodium starch glycolate
(Type A), microcrystalline cellulose and magnesium stearate. The tablets contain the following
colours:
 50 microgram tablets: yellow iron oxide (E172)
 250 microgram tablets: indigo carmine (E132) and yellow iron oxide (E172)
 1 mg tablets: red iron oxide (E172)
What Pergolide Tablets look like and contents of the pack:
 The 50 microgram tablets are ivory, capsule-shaped tablets, scored on one side and marked ‘9’
and ‘3’ on either side of the score. The other side is marked ‘7160’.
 The 250 microgram tablets are mottled green, capsule-shaped tablets, scored on one side and
marked ‘9’ and ‘3’ on either side of the score. The other side is marked ‘7159’.
 The 1 mg tablets are mottled pink, capsule-shaped tablets, scored on one side and marked ‘9’
and ‘3’ on either side of the score. The other side is marked ‘7161’
 The 50 microgram tablets are available in pack sizes of 30, 50, 100, or 300 tablets.
 The 250 microgram tablets are available in pack sizes of 20, 30, 40, 50, 100, or 200 tablets.
 The 1 mg tablets are available in pack sizes of 20, 30, 100, or 200 tablets.
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Starter packs are available in pack sizes of 75 x 50 microgram & 6 x 250 microgram or 109 x 50
microgram & 57 x 250 microgram tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG, England.
Distributed by TEVA UK Ltd, Leeds, LS27 0JG, England.
This leaflet was last revised:
December 2012

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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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