Cabergoline 0.5mg Tablets
PACKAGE LEAFLET: INFORMATION FORTHEUSER
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 ask yourdoctor or pharmacist.
♦ This medicine has been prescribed foryou only. Do not pass it on to others. It may harmthem, even if their signs of illness arethe same as yours.
♦ Ifyou getany side 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
Cabergoline belongsto a group of medicines known as prolactin inhibitors. Cabergoline prevents lactation (production of milk) by decreasing levels of a hormone known as prolactin.
Cabergoline can also be used to reduce abnormal quantities ofthe hormone prolactin in the blood.
[2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABERGOLINE
Do not take Cabergoline if you:
♦ areallergictocabergolineor otherergot alkaloids(e.g. bromocriptine), ortoany ofthe other ingredients in ofthis medicine (listed in section 6)
♦ have (or have had inthe past) psychosis oryou are at risk of psychosis after childbirth
♦ have severely impaired liver function
♦ have swelling ofthe hands, feet and a high blood pressure during pregnancy (pre-eclampsia, eclampsia)
♦ have uncontrolled high blood pressure orhigh blood pressure after childbirth
♦ are pregnant or breast-feeding
♦ have previously experienced side effects affecting lung, such as fibrosis, associated with the use of dopamine agonists (e.g. bromocriptine, pergolide)
♦ will be treated with Cabergoline for a long period and have or had fibrotic reactions (scartissue) affecting your heart.
Warnings and precautions
Ifyou have any ofthefollowing health problems you must inform yourdoctor
before taking Cabergolineasthe medicinal product may be unsuitable foryou:
♦ cardiovascular disease
♦ stomach ulcer or bleeding inthe gastrointestinal tract, (this condition can cause black faeces orvomiting with blood)
♦ impaired kidney function
♦ liver or kidney disease
♦ history ofserious mental disease, particularly psychotic disorders
♦ Raynaud's disease (when it is coldthefingersand toes become bluish white, with no pulse, cold, insensitive and numb)
♦ low blood pressure or you are taking medicines to lower blood pressure
♦ increased blood pressure after giving birth
♦ serious chest complaint(e.g. pain inthe chest when breathing, fluid inthe lungs, inflammation or infection ofthe lungs)
♦ ifyou have ever been diagnosed inthe past with a problem known as fibrotic disease (scartissue) affecting the lungs, lower back and kidneys orheart.
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 ifyou 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 andean include behaviours such as addictive gambling, excessive eating orspending,an abnormally high sex drive oran increase in sexual thoughts orfeelings. Your doctor may need to adjust or stop your dose.
The effect of alcohol on the tolerability of cabergoline is unknown.
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.
It is recommended that women on long term treatment with Cabergoline for hormonal disorders should have regular gynaecological exams including smear tests.Yourdoctorwill continue to monitoryour medical conditionwhileyou are taking Cabergoline tablets.
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 for the treatment of psychological illnesses (schizophrenia or psychoses), iftaken atthe same time as Cabergoline, can interfere with the effects of cabergoline.The treating doctor should therefore be aware of such simultaneous 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 yourdoctor 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
* Cabergoline should be taken by mouth, preferably with meals.
Pregnancy, breast-feeding and fertility
Ifyou are pregnant or breast-feeding, thinkyou may be pregnant orareplanningto
have a baby, askyourdoctor or pharmacist for advice before taking this medicine.
Pregnancy
♦ Thereisonly limited experience ofthe use of Cabergoline during pregnancy. You should therefore consult yourdoctor if you are pregnant orplanto become pregnant before the treatment is started.
♦ If you are being treated with Cabergoline and become pregnant during this time you should discontinue the treatment and contact yourdoctor as soon as possible
♦ Contraception should be continued for at Ieast4weeks 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 milkean diminish.
Fertility
♦ If you are planning to become pregnant theCabergolineshould be discontinued one month before intended pregnancy.You should therefore consult your doctor if you are pregnant or plan to 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 risk of serious harm(e.g. using machines), until such recurrent episodes and somnolence have resolved.
Cabergoline contains lactose
♦ Cabergoline0.5 mg tablets contain lactose. Ifyou have been told by yourdoctor that you have an intolerance to some sugars you should contact yourdoctor before taking this medicine.
^ HOW TO TAKE CABERGOLINE
Always take Cabergoline exactly as yourdoctor has told you. You should check with
yourdoctor or pharmacist ifyou are not sure.
Thedose is determined by your doctorwho adjusts it individuallyfor you.
The tablets should be taken with meals to reduce certain side effects such as nausea, vomiting and stomach pains.
♦ To stop the production of breast milk:
Theusual dose is 1 mg (asa singledose) within 24 hours after giving birth
♦ To reduce the concentration of prolactin in the body:
Usuallythe treatment is started with 0.5 mg perweek, but higher doses may then be necessary. Your doctor will tell you for how long you must take yourtablets. Cabergoline 0.5 mgTablets have a score and can be divided into two equal halves. When you first start taking the tablet, it is recommended you slowly change position whentryingto sit, stand or lie down,this is because Cabergoline may cause adrop in blood pressure that could make you dizzy when you move from a position. It is also recommended that you avoid alcohol and other medicines that cause drowsiness as this could increase the risk ofdizziness.
During treatment yourdoctor may need to checkyour blood pressure, particularly in the first few days of treatment. A gynaecological assessment may also be carried outonthe cellsof yourcervix orwomb lining.
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 doctorforadvice if you have taken too many tablets or ifyou thinka child has swallowed any.
Symptoms of overdose 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 at the right time, you can take it as soon as you remember it.
If it is almost time to take the next dose, skipthe 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 in increased lactation.
Ifyou have any other questions ontheuse ofthis medicine, askyour doctoror pharmacist.
^4 POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them.
When used for stopping the production of breast milk approximately 14 in 100 patients have some form of side effects.The most common are low blood pressure, dizziness and headache. In treatment of increased prolactin levels side effects are more common as the tablets are taken for a longer period oftime. Approximately 70 in 100 patients then experience side effects, but the side effects mostly disappear or decrease after approx. 2 weeks.
Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. These symptoms can be severe:
♦ abnormal or unusual thoughts
♦ heart valve and related disorders e.g. inflammation (pericarditis) orleaking of fluid in the pericardium (pericardial effusion).This is a very common side effect (may affect more than 1 in 10 patients).The early symptoms may be one or more ofthe following: difficulty breathing, shortness of breath, pounding heart,feeling faint, chest pain, back pain, pelvic pain or swollen legs.These may be the first signs of a condition called pulmonary fibrosis, which can affectthe lungs, heart/heart valves or lower back.
♦ development of a widespread itchy rash, difficulty breathing with orwithout wheezing, feeling faint, unexplained swelling ofthe body ortongueorany other symptoms which appearto come on rapidly after taking this medication and make you feel unwell.These may be indicative of an allergic reaction.This is an uncommon side effect (may affect 1 to 10 users in 1000).
You may experience the following side effects:
Inability to resistthe impulse, drive ortemptation to perform an action that could be harmful to you orothers, which may include:
♦ Strong impulseto gamble excessively despite serious personal orfamily 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 in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfyyour hunger).
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
During treatment you may also notice the following side effects:
Very common side effects (may affect more than 1 user in 10):
♦ Dizziness or spinning feeling (vertigo), headache, feeling sick(nausea), stomach pain, upset stomach, inflammation ofthe stomach lining (gastritis), feeling weak, tired or fatigued.
Common side effects (may affect 1 to 10 users in 100):
♦ low blood pressure upon standing (which can result in dizziness), depression, excessive daytime sleepiness, blurred vision, being sick (vomiting), constipation, breast pain, hot flushes, redness ofthe face, low blood pressure after childbirth which may not have any symptoms, low blood pressure (long term-treatment).
Uncommon side effects (may affect 1 to 10 users in 1000):
♦ nosebleeds, leg cramps, fainting, yourfingers ortoes turnwhiteorblue with a feeling of numbness after exposure to cold (digital vasospasm), crawling/prickling sensations in the body, loss of half of the vision in one or both eyes, pounding of the heart (palpitations), rash, hair loss, increased sex drive, swelling due to accumulation of fluid in the tissue (oedema), low haemoglobin values in blood, lung scartissue, fluid inthespace around the lung (pleural effusion).
Rare side effects (may affect 1 to 10 users in 10,000):
♦ pain in the upper central abdomen
♦ cramps in fingers.
Not known (cannot be estimated from the available data):
♦ sudden sleep attacks, seeing and hearing things that are not real (hallucinations), delusions, psychotic disorder, unintentional trembling or shaking movements (tremor), chest pain (angina), abnormal liver and abnormal blood tests of liver function, breathing problems with inadequate intake of oxygen, inflammation of the lining ofthe lung (pleuritis), an increase inthe level of some enzymes inthe blood, loss ofvision and aggression.
Development of excess fibrous connective tissue (fibrosis) e.g. inthe heart, lungs, and kidneys has been reported.You should become aware ofthis as difficulty breathing, chest pain, back pain and swelling ofthe legs.
Cabergoline has been linked with somnolence and sudden sleep attacks.
Reporting of side effects
Ifyou getanyside effects, talkto yourdoctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety ofthis medicine.
HOW TO STORE CABERGOLINE
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 orhousehold waste. Askyour pharmacist how to dispose of medicines no longer required.These measures will helpto protect the environment.
What Cabergoline contains
The active substance is cabergoline.
Each tablet contains 0.5 mg cabergoline.
The other ingredients are anhydrous lactose, L-leucine and magnesium stearate. What Cabergoline looks like and contents of the pack
White, oval-shaped, flat bevelled tablets. One side is smooth and the other side has s dividing score line and is debossed with 'CBG' and '0.5' on either side of the score. Cabergoline 0.5 mg isavailable 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 Ltd., Eastbourne, BN22 9AG.
Company responsible for 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: May 2014
PL 00289/0988 85928-ZB