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CABERGOLINE 0.5MG TABLETS

Active substance(s): CABERGOLINE / CABERGOLINE / CABERGOLINE

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Cabergoline 0.5mg Tablets
Your medicine is known by the above name, but will be referred to as
Cabergoline throughout the following:
Patient Information Leaflet
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. 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

1) What Cabergoline is and what it is used for
Cabergoline belongs to 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 of the
hormone prolactin in the blood.

2) What you need to know before you take Cabergoline
DO not take Cabergoline if you:
 are allergic to cabergoline or other ergot alkaloids (e.g. bromocriptine), or
to any of the other ingredients of this medicine (listed in section 6)
 have (or have had in the past) psychosis or you are at risk of psychosis
after childbirth
 have severely impaired liver function
 have swelling of the hands, feet and a high blood pressure during
pregnancy (pre-eclampsia, eclampsia)
 have uncontrolled high blood pressure or high 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 (scar tissue) affecting your heart
Warnings and precautions
If you have any of the following health problems you must inform your
doctor 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 black faeces or vomiting with blood)
 impaired kidney function
 liver or kidney disease
 history of serious mental disease, particularly psychotic disorders.
 Raynaud’s disease (when it is cold the fingers and 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 in the chest when breathing, fluid in the
lungs, inflammation or infection of the lungs)
 if you have ever been diagnosed in the past with a problem known as
fibrotic disease (scar tissue) affecting the lungs, lower back and kidneys
or heart.
In case you are treated with Cabergoline for a long period, your doctor will
check before starting treatment whether your heart, lungs and kidneys are
in a good 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.

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 with on long term treatment with
Cabergoline for hormonal disorders should have regular gynaecological
exams including smear tests. Your doctor will continue to monitor your
medical condition while you 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), if taken at the 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 your doctor or pharmacist if you are taking, 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
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
 There is only limited experience of the use of Cabergoline during
pregnancy. You should therefore consult your doctor if you are pregnant
or plan to 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 your doctor as
soon as possible.
 Contraception should be continued for at least 4 weeks 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 milk
can diminish.
Fertility
 If you are planning to become pregnant the Cabergoline should 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 a high 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 in which reduced alertness could incur a risk of serious
harm (e.g. using machines), until such recurrent episodes and
somnolence have resolved.
Cabergoline contains lactose
 Cabergoline 0.5mg tablets contain lactose. If you have been told by your
doctor that you have an intolerance to some sugars you should contact
your doctor before taking this medicine.

3) How to take Cabergoline
Tell your doctor if you 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.

Always take Cabergoline exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
The dose is determined by your doctor who adjusts it individually for 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:
The usual dose is 1 mg (as a single dose) within 24 hours after giving
birth.
 To reduce the concentration of prolactin in the body:
Usually the treatment is started with 0.5 mg per week, but higher doses
may then be necessary. Your doctor will tell you for how long you must
take your tablets.
Cabergoline 0.5mg Tablets 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 when trying to sit, stand or lie down, this is because
Cabergoline may cause a drop in blood pressure that could 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
of dizziness.
During treatment your doctor may need to check your blood pressure,
particularly in the first few days of treatment. A gynaecological assessment
may also be carried out on the cells of your cervix or womb 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 or a doctor for advice, if you have
taken too many tablets or if you think a 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
If you 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, skip the forgotten dose and take
the next dose as usual.
If you stop using Cabergoline
If you stop using cabergoline the symptoms of your illness may become
more severe and you should discuss with your doctor 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.
If you have any other questions on the use of this medicine, ask your doctor
or 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 of time. 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) or
leaking 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 of the 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 affect the lungs, heart/heart valves or
lower back.
 development of a widespread itchy rash, difficulty breathing with or
without wheezing, feeling faint, unexplained swelling of the body or
tongue or any other symptoms which appear to 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 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.

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 of the 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 of the 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, your fingers or toes turn white or blue
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 scar tissue, fluid in the
space 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 of the lung (pleuritis), an
increase in the level of some enzymes in the blood, loss of vision and
aggression.
Development of excess fibrous connective tissue (fibrosis) e.g. in the heart,
lungs, kidneys has been reported. You should become aware of this as
difficulty breathing, chest pain, back pain and swelling of the legs.
Cabergoline has been linked with somnolence and sudden sleep attacks.
Reporting of side effects:
If you get any side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via: Yellow Card Scheme 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 Cabergoline
 Keep all medicines out of the sight and reach of children.
 Do not use cabergoline after the expiry date which is printed on the carton
or the bottle label after EXP: The expiry date refers to the last day of that
month.
 Do not store above 25°C. Store in the original package in order to protect
from moisture. The drying bag with silica gel must not be removed from
the bottle.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.
 Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6) Contents of the pack and other information
What Cabergoline contains
 The active substance is Cabergoline.
Each tablet contains 0.5mg cabergoline.
 The other ingredients are anhydrous lactose, L-leucine and magnesium
stearate.
What Cabergoline looks like and the contents of the pack
White, oval, flat tablets with bevelled edges. One side is smooth and the
other side has a dividing score line and is debossed with ‘CBG’ and ‘0.5’ on
either side of the score.
Each amber glass bottle contains 8 tablets with a tamper evident,
child-resistant screw cap which contain silica gel desiccant.
PL 10383/2123

Cabergoline 0.5mg Tablets

POM

Who makes and repackages your medicine:
Your medicine is manufactured by Ratiopharm GmbH, Graf-Arco Strasse
3 – 89079 Ulm, Germany. Procured from within the EU and repackaged by
the Product Licence holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 10.10.2014

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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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