Cabergoline 2mg Tablets
PACKAGE LEAFLET: INFORMATION FORTHE USER
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.
♦ Ifyou have anyfurther questions askyourdoctor or pharmacist.
♦ This medicine has been prescribed foryou only. Do not pass it on to others. It may harmthem, even iftheirsignsof illness arethe same as yours.
♦ Ifyou getanyside effects talkto yourdoctoror pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Cabergoline is and what it is used for
2. What you need to know before you take Cabergoline
3. How to take Cabergoline
4. Possible side effects
5. How to store Cabergoline
6. Contents of the pack and other information
WHAT CABERGOLINE IS AND WHAT IT IS USED FOR
Cabergoline belongs to a group of medicines known as dopamine agonists. Cabergoline acts in a similar way to a chemical present inthe nervous system called dopamine. Patients with Parkinson's disease do not have enough ofthis important chemical.
Cabergoline 1 mg and 2 mg is used to treat Parkinson's disease. It can be used either taken alone or in combination with levodopa, as second choice following non-ergot derived therapies.
Treatmentundera specialist is required.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABERGOLINE
Do not take Cabergoline if you:
♦ areallergic to cabergoline or other ergot alkaloids (e.g. bromocriptine), orto anyof the other ingredients ofthis medicine (listed in section 6)
♦ have swelling ofthe hands, feet and a high blood pressure during pregnancy (pre-eclampsia, eclampsia)
♦ have uncontrolled high blood pressure
♦ will be treated with Cabergoline for a long period and have or had fibrotic reactions (scartissue) affecting the lungs, back ofthe abdomen and kidneys orheart.
Before you are given Cabergoline your doctor will arrangeforyou to have tests to assess thecondition ofyour heart.Yourdoctorwill continue to monitor your medical condition while taking Cabergoline.
Warnings and precautions
Ifyou have any of the following health problems you must inform yourdoctor before taking Cabergoline as the medicinal product may be unsuitable for you:
♦ cardiovascular disease
♦ stomach ulcer or bleeding in the gastrointestinal tract, (this condition can cause blackfaecesorvomiting with blood)
♦ impaired kidney function
♦ have or had fibrotic reactions (scartissue) affecting your heart, lungs, kidneys or abdomen
♦ have impaired liverfunction
♦ have (or have had inthe past) psychosis oryou areat risk of psychosis after childbirth
♦ Raynaud's disease (when it is cold the fingers and toes become bluish white, with no pulse, cold, insensitive and numb)
♦ low blood pressure
♦ serious chest complaint(e.g. pain inthechest when breathing, fluidinthelungs, inflammation or infection ofthe lungs).
In case you are treated with Cabergoline fora long period, yourdoctorwill check before starting treatment whetheryour heart, lungs and kidneys areinagood condition. He/she 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.
Tell your doctor if you or yourfamily/carer notices that you are developing urges or cravings to behave in ways that are unusual foryou and you cannot resist the impulse, drive ortemptation 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 oran increase in sexual thoughts orfeelings. Your doctor may need to adjust or stop your dose.
Infertility can be reversed in women taking Cabergoline, and pregnancy can occur before the menstrual cycle has normalised. Suitable means of contraception should therefore be used during treatment if necessary.
Children and adolescents
The safety and efficacy of Cabergoline has not been established in children and adolescents less than 16 years of age.
Other medicines and Cabergoline
♦ Certain medicines used for reducing blood pressure and certain medicinal products (e.g. phenothiazines, butyrophenones, thioxanthene) used forthe treatment of psychological illnesses (schizophrenia or psychoses), iftakenatthe same time as Cabergoline, can interfere with the effects of cabergoline.The treating doctor should therefore be aware of such concomitant medication.
♦ There are other medicines such as other ergot alkaloids, medicines to prevent vomiting (metoclopramide), medicines for reducing high blood pressure, and macrolide antibiotics (such as erythromycin) that may affect the activity and tolerability of Cabergoline.
Tell your doctor or pharmacist ifyou are taking or have recently taken any other medicinal products, including those obtained without a prescription and natural medical products/natural products.
Cabergoline with food and drink
♦ Cabergolineshouldbetakenby mouth, preferably with meals.
Pregnancy, breast-feeding and fertility
Ifyou are pregnant or breast-feeding, think you may be pregnant orare planning to have a baby, ask yourdoctoror pharmacist for advice before taking this medicine. Pregnancy
♦ Thereisonly limited experience oftheuse ofCabergolineduring pregnancy.You should therefore consult your doctor ifyou are pregnant orplanto become pregnant before thetreatment is started.
♦ Ifyou are being treated with Cabergolineand become pregnant duringthis time you should discontinuethe treatment and contact your doctoras soon as possible
♦ Contraception should be continued for at least 4weeks after stopping cabergoline. Breast-feeding
♦ It is not known whether cabergoline passes into breast milk
♦ Cabergoline should not be taken by mothers who intend to breast-feed as it prevents lactation. Nursing mothers should note that the quantity of milkcan diminish.
Fertility
♦ Ifyou are planning to become pregnanttheCabergoline should be discontinued one month before intended pregnancy.You should therefore consult your doctor ifyou are pregnant or planto become pregnant before the treatment is started.
Driving and using machines
♦ Cabergoline can negatively affect the ability to react in some people and this should be considered in cases where ahigh level of alertness is required, e.g. driving a car and in precision work
♦ Cabergoline can cause somnolence (extreme drowsiness) and sudden sleep onset. Persons affected by this should therefore not drive or take part in activities inwhich reduced alertness could incura riskofserious harm(e.g. using machines), until such recurrent episodes and somnolence have resolved. If affected, consult yourdoctor.
Cabergoline contains lactose
♦ Cabergoline 1 mg and 2 mg tablets contain lactose. Ifyou have been told by your doctorthat you have an intolerance to some sugars you should contact your doctor before taking this medicine.
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Always take Cabergoline exactly as yourdoctor has told you. You should check with yourdoctor or pharmacist ifyou are not sure.
The tablets should be taken with meals to reduce certain side effects such as nausea, vomiting and stomach pains.
* Adults and elderly patients
The dose is determined by your doctor who adjusts it individuallyforyou.The usual dose at the start oftreatment is 0.5 -1 mg cabergoline daily.The dose is then increased gradually as directed by the doctorup to a suitable maintenance dose.
Theusual maintenance dose is from 2 mg upto3 mg cabergoline daily. Cabergoline 1 mg and 2 mg Tablets have a score and can be divided into two equal halves.
If you take more Cabergoline than you should
It is important not to take too many tablets. Contact your nearest hospital Accident and Emergency department ora doctorfor advice ifyou have taken too many tablets or ifyouthinka child has swallowed any.
Symptoms ofoverdose may include nausea,vomiting, reduced blood pressure, stomach pain, changes in behaviour, confusion or hallucinations (seeing things).
Take this leaflet and any tablets that you still have to show the doctor.
If you forget to take Cabergoline
Ifyou forget to take a dose atthe right time, you can take it as soon as you remember it.
If it is almost time to take the next dose, skip the forgotten dose and take the next dose as usual.
If you stop using Cabergoline
Ifyou stop using cabergoline the symptoms ofyour illness may become more severe and you should discuss with yourdoctor before you discontinue therapy. Cabergoline takes many days to be cleared from the bloodstream and effects may worsen over a 2 week period resulting inworsening of symptoms of Parkinson's disease.
Ifyou have anyfurther questions onthe useofthis medicine, askyourdoctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
You may experience the following side effects:
Inability to resistthe impulse, drive ortemptation 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 behaviourof significant concern to you or to others, for example, an increased sexual drive
♦ Uncontrollable excessive shopping or spending
♦ Binge eating (eating large amounts offood ina 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.
Very common side effects (may affect more than 1 user in 10):
♦ swelling ofyourfeet and ankles, feeling sick (nausea)
♦ 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 ofthefollowing: difficulty breathing, shortness of breath, chest or back pain and swollen legs. If you experience any one of these symptoms you must tell your doctor immediately.
Common side effects (may affect 1 to 10 users in 100):
♦ being sick (vomiting), indigestion, stomach pain, inflammation ofthe stomach lining (gastritis), constipation, dizziness, low blood pressure (which can result in dizziness), spinning feeling (vertigo), chest pain (angina), shortness of breath, seeing or hearing things that are not real (hallucinations), confusion, sleep disorders, headache, excessive sleepiness (somnolence), increased sex drive, involuntary movements, lowering of red blood count inthe blood, low protein in your red blood cells, muscle weakness and fatigue, abnormal liverfunction tests.
Uncommon side effects (may affect 1 to 10 users in 1000):
♦ redness, swelling and pain in the extremities of the arms and legs (erythromelalgia), somnolence (extreme drowsiness), episodes of sudden sleepiness, skin rash, allergic reaction, fluid in the layers of the membrane lining the lungs and chest cavity, swelling due to accumulation of fluid in the tissues, abnormal liver function, excessive abnormal movements, delusions or psychotic disorder.
Ergot related fibrosis has been reported. Ergot related fibrosis is an inflammatory condition ofthe inner lining ofthe body cavities possibly affecting the heart, lungs and kidneys. You should become aware of this as difficulty breathing, chest pain, back pain, pelvic painand swelling ofthe legs. Tell your doctor immediately if you experience such symptoms.
Very rare side effects (may affect less than 1 in 10,000 users):
♦ formation offibrous tissues
Not known (cannot be estimated from the available data):
♦ sudden sleep attacks, leg cramps, unintentional trembling or shaking movements (tremor), loss ofvision,fainting, respiratory disorders and failure, breathing problems with inadequate intake of oxygen, inflammation ofthe lining ofthe lung (pleuritis), chest pain, yourfingers or toes turn white orblue with a feeling of numbness after exposure to cold (digital vasospasm), hair loss (alopecia), increases in blood creatinine phosphokinase test results.
The following side effects have been reported with lower doses of cabergoline (0.25 - 2 mg per week):
♦ depression, headache, fatigue, pins and needles, heart pounding, constipation, reduction in vision, nose bleeds, extreme drowsiness (somnolence), fainting and cramp in fingers and calves.
Reporting of side effects
If you getanyside effects, talkto your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.You can also report side effectsdirectly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the package.
Do not store above 30®C. Store inthe original package in orderto protect from moisture.
The drying capsule or bag with silica gel must not be removed from the bottle.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will helpto protect the environment.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Cabergoline contains
The active substance is cabergoline.
Each tablet contains 1 mg or 2 mg cabergoline
The other ingredients are: anhydrous lactose, L-leucine and magnesium stearate.
What Cabergoline looks like and contents of the pack
Cabergoline 1 mg tablets are white, oval-shaped biconvex tablets with a dividing score line on both sidesofthetablet. One side ofthetablet is marked 'CBG'and'1' on eithersideofthe dividing score line.
Cabergoline 2 mg tablets are white, capsule-shaped, biconvex tablets with a dividing score line on both sidesofthe tablet. One side ofthetablet is marked 'CBG' and '2' on either side ofthe dividing score line.
Cabergoline 1 mg are available in packs of 2, 8,14,15,16,20, 28, 30, 32,40,48, 50, 60, 90, 98 and 100 tablets.
Cabergoline 2 mg are available in packs of 2, 8,14,15,16,20, 28, 30, 32,40,48, 50, 60, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:Teva UK, Eastbourne, BN22 9AG.
Company responsiblefor manufacture:Teva Czech Industries s.r.o., Ostravska 29, indication number 305, Opava, Komarov, postal code 747 70, Czech Republic. This leaflet was last revised: December 2013
PL 00289/0989-90