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CABERGOLINE 2MG TABLETS

Active substance(s): CABERGOLINE / CABERGOLINE

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Cabergoline 1mg Tablets/
Cabergoline 2mg Tablets
(cabergoline)
Your medicine is known by either of the above names, but will be referred to
as Cabergoline throughout the following:
Patient Information Leaflet

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.

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, please 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.

Children and adolescents
The safety and efficacy of Cabergoline has not been established in children
and adolescents less than 16 years of age.

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 dopamine agonists.
Cabergoline acts in a similar way to a chemical present in the nervous
system called dopamine. Patients with Parkinson’s disease do not have
enough of this important chemical.
Cabergoline 1mg and 2mg 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.
Treatment under a specialist is required.

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
any of the other ingredients of this medicine (listed in section 6)
 have swelling of the 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 (scar tissue) affecting the lungs, back of the abdomen and
kidneys or heart.
Before you are given Cabergoline your doctor will arrange for you to have
tests to assess the condition of your heart. Your doctor will continue to
monitor your medical condition while taking Cabergoline.
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
 have or had fibrotic reactions (scar tissue) affecting your heart, lungs,
kidneys or abdomen
 have impaired liver function
 have (or have had in the past) psychosis or you are at 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 in the chest when breathing, fluid in the
lungs, inflammation or infection of the lungs).
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 echodiagram (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 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.

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 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
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. If affected, consult your doctor.
Cabergoline contains lactose
 Cabergoline 1mg and 2mg 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
Always take Cabergoline exactly as your doctor has told you. You should
check with your doctor or pharmacist if you 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 individually for you.
The usual dose at the start of treatment is 0.5 -1 mg cabergoline daily. The
dose is then increased gradually as directed by the doctor up to a suitable
maintenance dose.
The usual maintenance dose is from 2 mg up to 3 mg cabergoline daily.

Cabergoline 1mg and 2mg Tablets have a score and 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 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 worsening of
symptoms of Parkinson's disease.
If you have any further 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.
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.
Very common side effects (may affect more than 1 user in 10):
 swelling of your feet 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 of the following: 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 of the
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 in the blood, low protein in your red blood
cells, muscle weakness and fatigue, abnormal liver function 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 of the inner lining of the body cavities possibly
affecting the heart, lungs and kidneys. You should become aware of this as
difficulty breathing, chest pain, back pain, pelvic pain and swelling of the
legs. Tell your doctor immediately if you experience such symptoms.
Very rare side effects (may affect less than 1 in 10 000 users):
 formation of fibrous tissues

Not known (cannot be estimated from the available data):
 sudden sleep attacks, leg cramps, unintentional trembling or shaking
movements (tremor), loss of vision, fainting, respiratory disorders and
failure, breathing problems with inadequate intake of oxygen,
inflammation of the lining of the lung (pleuritis), chest pain, your fingers or
toes turn white or blue 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 – 2mg 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 get any side effects, talk to your doctor or pharmacist.
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 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 capsule or 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 cabergoline 1mg OR 2mg
 The other ingredients are anhydrous lactose, L-leucin and magnesium
stearate.
What Cabergoline looks like and the contents of the pack
Cabergoline 1mg tablets are white, oval-shaped biconvex tablets with a
dividing score line on both sides of the tablet. One side of the tablet is
marked ‘CBG’ and ‘1’ on either side of the dividing score line.
Cabergoline 2mg tablets are white, capsule-shaped, biconvex tablets with a
dividing score line on both sides of the tablet. One side of the tablet is
marked ‘CBG’ and ‘2’ on either side of the dividing score line.
Each amber glass bottle contains 20 tablets and a silica gel desiccant
sealed with an aluminium membrane and a child-resistant screw cap.
PL 10383/2124
PL 10383/2125

Cabergoline 1mg Tablets
Cabergoline 2mg 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: 30.09.2014

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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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