Pergolide 250 Microgram Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pergolide 50 micrograms, 250 micrograms and 1 mg Tablets (pergolide mesilate)
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 drugs known as dopamine receptor agonists.
Pergolide is used to help control and reduce the effects or symptoms of 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 or any of the other ingredients of this medicine listed in section 6
• have a known sensitivity to any other ‘ergot’ medicines e.g. bromocriptine or lisuride, or 'ergot' medicines used to treat or prevent migraine e.g. ergotamine or methysergide
• have ever experienced shortness of breath, chest or back pain, swollen legs or heart trouble after previously taking ergot medicines
• have or had fibrotic reactions (scar tissue) affecting your heart
• have heart valve problems.
• are pregnant or breast-feeding.
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.
• 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.
• have ever had hallucinations (seeing or hearing things that are not really there)
• have or ever had arrhythmia (irregular heart beat) or heart disease
• have or ever had psychiatric disorders
During the treatment with pergolide, you may feel
o Low blood pressure which can make you feel dizzy or fainting, especially after standing up from sitting or lying position. It is important to start taking your medicine at low dose and than increase it gradually. This will make you easier to endure the low blood pressure. o Drowsiness, falling asleep suddenly.
• DO NOT crush pergolide tablets because they can cause eye irritation, irritating smell, or headache. 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 to stop you feeling sick e.g. metoclopramide or prochlorperazine. These medicines may reduce the effect of pergolide. If you feel sick at the start of therapy, you must consult your doctor or pharmacist before taking anti-sickness medication with Pergolide Tablets
• any medicines used to treat mental health conditions, particularly neuroleptic medicines (phenothiazines such as chlorpromazine, prochlorperazine; butyrophenones such as haloperidol, benperidol; thioxanthenes such as flupentixol, zuclopenthixol)
• rye ergot alkaloids (e.g. ergotamine, dihydroergotamine, methylergotamine)
• macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin)
• drugs that mimic the sympathetic nervous system and stimulate alpha subtype of receptors (e.g ephedrine, methyldopa)
• any medicine for treating plasma proteins in your body.
Do not stop taking other medicines you have already been prescribed by your doctor without talking to your
doctor first.
Pregnancy and breast-feeding
■ You must not take pergolide if you are pregnant or breast-feeding.
■ If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking any 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.
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 to take any other medicines your doctor has prescribed for Parkinson' 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 either 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 light pink tablets (3 x 1000 microgram) or 12 light green tablets (12 x 250 microgram), or 60 light yellow tablets (60 x 50 microgram) per day
Using in children and adolescents
Pergolide is not recommended for use in children and adolescents.
If you take more Pergolide than you should
If you (or someone else) take too many tablets, 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 (awareness of your heartbeat), 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.
• The doctor will gradually reduce your daily dose if the side effects are causing you difficulties.
• DO NOT reduce your dose without asking your doctor first.
• 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 , changes in heart-rate, changes in consciousness and changes in stability of your blood pressure ect.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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, but your doctor may decide to give you another medicine to reduce this feeling.
You may also feel faint, be dizzy or light headed when you get up or stand up.
If you experience these problems and they persist or worry you, talk to your doctor.
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, 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
• elevated body temperature, rigid muscles ,changes in consciousness and changes in stability of your blood pressure ect. as these could be the signs of Neuroleptic Malignant Syndrome
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:
> 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)
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
The following side effects also have been reported:
• pains and stomach aches
• feeling or being sick, indigestion/heartburn
• involuntary movements (shaking and twitching)
• hallucinations, double vision
• confusion
• excessive drowsiness (somnolence)
• falling asleep without warning (sudden sleep onset episodes)
• difficulty sleeping
• difficulty in breathing
• runny and itchy nose
• constipation, diarrhoea
• dizziness, fainting (which may or may not occur as a result of standing up)
• abnormal liver function test results
• rash
• fever
• being aware of your heart beat (palpitations), or changes to your heartbeat e.g. a racing heart
• cold fingers or toes.
• increased blood creatinine phosphokinase (can be seen in blood tests only)
• hiccups
• warm, red, painful swelling of the extremities (erythromelalgia)
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme, on Freephone 0808 100 3352 or via the 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 PERGOLIDE Keep out of the reach and sight of children.
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, 50 micrograms, 250 micrograms or 1 mg.
• The other ingredient(s) are microcrystalline cellulose, glyceryl dibehenate, magnesium stearate, mannitol, iron oxide (E172) and indigo carmine (E132).
What Pergolide Tablets look like and contents of the pack:
• Pergolide 50 microgram Tablets are light yellow, rectangular shaped tablets with a score line on one side and the letter ‘G’ on the other side.
• Pergolide 250 microgram Tablets are light green, rectangular shaped tablets with a score line on one side and the letter ‘G’ on the other side.
• Pergolide 1 mg Tablets are light pink, rectangular shaped tablets with a score line on one side and the letter ‘G’ on the other side.
• Pergolide tablets are available in packs of 10, 20, 30, 50 and 100 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX
The company responsible for manufacture is: Teva Czech Industries s.r.o., Ostravska 29, C.P. 305,
Opava,Komarov, CZ-747 70, Czech Republic.
This leaflet was last revised: March 2013
PL 00530/0651-0653