Pergolide 250 Microgram Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
♦ Keep this leaflet.You mayneedto read It again.
♦ Ifyou have anyfurtherquestions, askyourdoctor or pharmacist.
♦ This medicine has been prescribed foryou only. Do not pass itonto others. It may harm them, even if their signs of illness are the same as yours.
♦ If you get any side effects, talk to yourdocfor or pharmacist. This includes any possible side effects not listed infhis 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
OWHAT PERGOLIDE IS AND WHAT IT IS USED FOR
Pergolide belongs to a group ofdrugs known as dopamine receptor agonists.
Pergolide is usedfo help control and reducefhe effects or symptoms of Parkinson's disease when patients are intolerant to orhave failed alternate freatmentswith other medicines.
Pergolide is sometimes used with other medicines that contain levodopa, e.g. Madopar® and Sinemet®.
OWHAT YOU NEED TO KNOW BEFORE YOU TAKE PERGOLIDE DO NOT take Pergolide if you:
♦ are allergic (hypersensitive) to pergolide orany 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 'ergot1 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 orhad fibrotic reactions (scartissue) affecting your heart
♦ haveheartvalveproblems ♦ arepregnantorbreast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Pergolide if you:
♦ have orhad fibrotic reactions (scartissue) affecting your heart, lungsor abdomen. Before treatment your doctor will checkwhetheryour heart, lungs and kidneys are in good condition. You will also haveanechocardiogram (an ultrasound test ofthe heart) taken before treatments started and at regular intervals during treatment. If fibrotic reactions occurtreatmentwill have to be discontinued.
♦ oryourfamily/carer noticesthatyou are developing urges or cravings to behave in ways thatare unusual foryou and you cannot resist the impulse, drive ortemptationto carry out certain activities that could harm yourselforothers. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sexdrive 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 thatare not really there)
♦ have oreverhad arrhythmia (irregular heart beat) or heart disease
♦ have orever had psychiatric disorders.
During the treatment with pergolide you may feel
♦ Low blood pressurewhich can makeyou feel dizzy orfaint, especially after standing upfrom a sitting or lying position. It is importantto start taking your medicine at a low dose and then increase it gradually. This will make iteasierforyou to endure the low blood pressure.
♦ 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, confusionand hallucinations have been caused or made worse, by Pergolide and levodopa being takentogether.
♦ warfarin (a medicinewhich stopsyour blood clotting), asthe dosage of either medicine may need to be reduced
♦ medicines for high blood pressure,as Pergolide may also cause a lowering of blood pressure
♦ medicinesto stopyou feeling sick e.g. metoclopramide or prochlorperazine. These medicines may reducethe effect of pergolide. If you feel sickatthe start oftherapy, you must consultyourdoctoror 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)
♦ drugsthatmimicthesympathetic nervoussystem and stimulate alpha subtype of receptors (e.g. ephedrine, methyldopa)
♦ any medicine for treating plasma proteins inyour body.
Do not stop taking othermedicines you have already been prescribed byyour doctorwithouttalking toyour doctor first.
Pregnancy and breast-feeding
♦ You mustnottake pergolide ifyou are pregnant or breast-feeding
♦ Ifyou are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking anymedicine.
Driving and using machines
♦ Pergolide maymake you feel drowsy, or cause you to fall asleep suddenly, sometimes withoutwarning. If you are affected, DO NOT drive or operate machinery.
HOW TO TAKE PERGOLIDE
Always take Pergolide exactly asyour doctor has told you. Checkwithyourdoctoror pharmacist if you are not sure.
Eventhoughyou aretaking Pergolide, you should continueto takeany othermedicines yourdoctorhas prescribed for Parkinson1 disease. Make sureyou followanyadviceyour doctor has givenyou about reducing the dose of these medicines.
The tablets should be swallowed preferably with a drinkofwater. The tablets can betaken either with or withoutfood. The usual dose is:
Adults
♦ The usual dose starts with one 50microgram tablet for the first one or two days
♦ Yourdoctor will gradually increase the dose every third orfourth day overa period ofseveral weeks, until the optimal dose is reached
♦ You will usuallytakethetablets3timesa day,at regular intervals
♦ Do nottake more than3light pinktablets
(3 x 1000 microgram) or 12 light green tablets (12x 250 microgram),or60 light yellow tablets (60x50 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 (orsomeone elseltaketoo many tablets, or if you thinka child hasswallowed any of the tablets, contactyour nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause palpitations (awareness ofyour heartbeat), being sick, low blood pressure, agitation, hallucinations, involuntary movements,and tingling sensations.
Please take this leaflet, any remaining tablets, and the containerwith you to the hospital ordoctorso that they knowwhichtablets 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 nearlytimeto take the nextone. DO NOT take a double dose to make upfor a forgotten dose. Take the remaining doses atthe correct time.
If you stop taking Pergolide
You should continuetotakethesetabletsfor as long
as yourdoctor tells you to.
♦ DONOT stoptaking yourmedicinewithouttalkingto yourdoctorfirsteven if you feel better
♦ DONOT stoptaking yourfablefs suddenly
♦ The doctor will gradually reduceyourdailydose if the side effects are causing you difficulties.
♦ DONOT reduceyourdosewithoutasking your doctor first
♦ Stopping or reducing yourdose 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 ofyour blood pressure ect.
If you haveany further questions on the use offhis medicine, askyourdoctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Pergolide can cause side effects, although not everybody getsthem.
Some ofthe symptoms may be caused by Parkinson's disease, other conditions, or by medicines you are already taking.
You may feel sickwhenyou first startyourmedicine. This usually wears off, butyourdoctor may decidefo give you anothermedicine to reduce this feeling.
You may also feel faint, be dizzy or light headed when you get up orstand up.
If you experiencethese 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 iffhe following happens:
♦ an allergic reaction causing swelling ofthe 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 urgentmedical attention or hospitalisation.
Tell your doctor immediately if you experience any of the following serious effects:
♦ heartvalve and related disorders e.g. inflammation (pericarditis) or leaking offluid in the pericardium (pericardial effusion). The early symptoms may be one ormore ofthe following: difficulty breathing, shortness of breath, chest or back pain and swollen legs. This is a very common side effect (affecting more thanone person inten); 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 yourdoctor may stopyour treatment
♦ elevated body temperature, rigid muscles, changes in consciousness and changes in stability ofyour blood pressure ect, as these could be the signs of Neuroleptic MalignantSyndrome.
You may experience the following side effects:
♦ inability to resist the impulse, drive ortemptationto perform enaction that could be harmful to you or others, which may include:
♦ Strong impulse to gamble excessively despite serious personal or family consequences
♦ Altered orincreased sexual interest and behaviourof significant concern to you orto others, forexample, an increased sexual drive
♦ Uncontrollable excessive shopping or spending
♦ binge eating (eating large amounts offood 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 effectsalso have been reported:
♦ painsand stomach aches
♦ feeling or being sick, indigestion/heartburn
♦ involuntary movements (shaking and twitching)
♦ hallucinations, double vision
♦ confusion
♦ excessive drowsiness (somnolence)
♦ falling asleepwithoutwarning (sudden sleep onset episodes)
♦ difficulty sleeping
♦ difficultyinbreathing
♦ runny and itchynose
♦ constipation, diarrhoea
♦ dizziness,fainting (which may ormay not occuras a result of standing up)
♦ abnormal liver function test results
♦ rash
♦ fever
♦ being aware ofyourheart beat (palpitations), or changes to yourheartbeate.g. a racing heart
♦ coldfingersortoes
♦ increased blood creatinine phosphokinasefcan be seen in blood tests only)
♦ hiccups
♦ warm, red, painful swelling oftheextremities (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.
HOW TO STORE PERGOLIDE
Keep out of the reach and sight of children.
Do not use Pergolide after the expiry date that is stated onthe outer packaging. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater orhousehold waste.Askyourpharmacist how to dispose of medicines no longer required. These measures will help to protectthe environment.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Pergolide Tablets contain:
♦ The active ingredient is pergolide mesilate, 50 micrograms, 250micrograms 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 250microgram 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,WestYorkshire,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