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Active substance(s): CABERGOLINE

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What is in this leaflet
1. What Dostinex is and what it is used for
2. What you need to know before you take Dostinex
3. How to take Dostinex
4. Possible side effects
5 How to store Dostinex
6. Contents of the pack and other information

Package leaflet: Information for the patient

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
- 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.

1. What Dostinex is and what it is used for
- Dostinex contains the active ingredient cabergoline.
This medicine belongs to a class of medicines called
‘dopamine agonists’. Dopamine is produced naturally in
the body and helps to transmit messages to the brain.
- Dostinex is used to stop breast milk production
(lactation) soon after childbirth, stillbirth, abortion or
miscarriage. It can also be used if you do not want
to continue to breast-feed your baby once you have
- Dostinex can also be used to treat other conditions
caused by hormonal disturbance which can result in
high levels of prolactin being produced. This includes
lack of periods, infrequent and very light menstruation,
periods in which ovulation does not occur and secretion
of milk from your breast without breast-feeding. Also
in conditions in which high levels of prolactin are due
to unknown causes (idiopathic hyperprolactinaemia)
or are caused by tumours of the pituitary gland in both
men and women.
- Cabergoline mimics the action of dopamine to reduce
the production of prolactin in the blood. Prolactin is the
hormone which stimulates the breast to produce milk.
- Dostinex should only be used in adults. It is not suitable

for children under the age of 16 years.
- You must talk to a doctor or pharmacist if you do not
feel better or if you feel worse.
2. What you need to know before you take Dostinex
Do not take Dostinex:
- If you are allergic to cabergoline, to other medicines
called ergot alkaloids, (e.g. pergolide, bromocriptine,
lisuride, ergotamine or ergometrine) or to any of the
other ingredients of this medicine (listed in section 6)
- If you have severe liver disease
- If you have high blood pressure in pregnancy associated
with swelling and protein in the urine (toxaemia of
- If you are being treated with anti-psychotics or have
a history of mental illness associated with child-birth
(puerperal psychosis)
- If you are pregnant or breast-feeding
- If you will be treated with Dostinex for a long period
and have stiff and inflamed heart valves (cardiac
- If you have had fibrotic reactions (scar tissue) affecting
your abdomen, heart or lungs.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dostinex
if you have or had any of the following conditions:
- Disease that involves the heart and blood vessels
(cardiovascular disease)
- Cold hands and feet (Raynaud’s syndrome)
- Gnawing pain in the abdomen when hungry (peptic
ulcer) or bleeding from the stomach and intestines

(gastrointestinal bleeding)
- History of serious mental disease, particularly psychotic
- Reduced liver function
- Kidney function abnormality or kidney disease
- Increased blood pressure after giving birth
- Fibrotic reactions (scar tissue) affecting your heart, lungs
or abdomen. In case you are treated with Dostinex for
a long period, your physician will check before starting
treatment whether your heart, lungs and kidneys are in
good condition. They 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
- Low blood pressure (postural hypotension) or you are
taking any medicines to lower your blood pressure.
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.
It is recommended that women on long term treatment
with Dostinex for hormonal disorders should have regular
gynaecological exams including smear tests. Your doctor
will continue to monitor your medical condition while you
are taking Dostinex tablets.

Other medicines and Dostinex
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription.
Some medicines can reduce the effectiveness of Dostinex,
these include:
- Medicines used to treat mental illness (e.g. antipsychotic
medicines like chlorpromazine, haloperidol)
- Medicines for nausea and vomiting (e.g. domperidone,
Some medicines can increase the amount of Dostinex
in your blood and so could increase the side effects,
these include:
- Medicines for Parkinson’s disease
- Medicines for severe migraine headaches (e.g. pergolide,
bromocriptine, lisuride, ergotamine, dihydroergotamine,
ergometrine or methysergide)
- Antibiotics (e.g. erythromycin).
Dostinex with food and drink
See section 3 ‘How to take Dostinex’.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine. You should also take
care not to become pregnant for at least one month once
you have stopped taking this medicine. If you become
pregnant during treatment with Dostinex, stop taking

Dostinex and inform your doctor who will then monitor
your pregnancy as Dostinex can result in congenital
abnormalities if you use it during pregnancy.
As Dostinex will stop you producing milk for your baby,
you should not take this medicine if you plan to breastfeed. If you need to take Dostinex you should use another
method of feeding your baby.
Driving and using machines
Dostinex can cause drowsiness (somnolence) and sudden
sleepy episodes, in some cases without any warning signs
or awareness. You are advised not to drive or operate
machines or engage in activities requiring mental alertness
or coordination during treatment with this medicine.
Your doctor will decide if you can continue treatment on
Dostinex if this occurs.
Dostinex contains lactose
Lactose is a type of sugar, if you have been told you have
an intolerance to sugars, consult your doctor before you
take this medicine.
3. How to take Dostinex
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
It is recommended you take Dostinex with or after food
to help reduce feelings of nausea or vomiting.

• To prevent milk production (lactation): You should
take 1 mg (two 0.5 mg tablets) on the first day after
• To stop lactation once you have started to breastfeed: You should take 0.25 mg (one half of Dostinex
0.5 mg tablet) every 12 hours for two days.
• To reduce prolactin levels in other conditions: You
should initially take one 0.5 mg tablet (to be taken in
two doses) spread out over a week (e.g. half a tablet on
Monday and the other half of the tablet on Thursday).
Your dose will be increased up to a maximum dose of
4.5 mg per week or until you have responded fully to
treatment. The maximum dose should not exceed 3
mg per day.
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 this medicine may cause a drop
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 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 Dostinex than you should
If you take too many Dostinex tablets, contact your
doctor immediately or go to the nearest hospital casualty
department. Symptoms of overdose may include nausea,

vomiting, gastric complaints, low blood pressure when
standing, confusion/psychosis or hallucinations.
If you forget to take Dostinex
If you forget to take a dose take the next one as normal
and tell your doctor if you have trouble remembering to
take your tablets. Do not take a double dose to make up
for a forgotten dose.

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.

Tell your doctor if you experience any of these
behaviours; they will discuss ways of managing or
reducing the symptoms.

stomach pain, indigestion, inflamed stomach lining,
fatigue, lack of bodily strength, weakness.
Common: may affect up to 1 in 10 people:
constipation, blurred vision, low blood pressure after
childbirth which may not have any symptoms, breast
pain, depression, sleep disturbances, excessive
daytime drowsiness/sleepiness, vomiting, low blood
pressure, hot flushes.
Uncommon: may affect up to 1 in 100 people: loss of
hair, severe itching, hypersensitivity reaction, shortness
of breath, fainting, nosebleed, leg cramps, swelling
due to accumulation of fluid in the tissues (oedema),
rash, irregular or strong heartbeat (palpitations), pins
and needles sensation, decrease in haemoglobin in
women whose periods had stopped and then restarted, temporary partial vision loss, cold hands and
Rare: may affect up to 1 in 1000 people: pain in the
Not known: frequency cannot be estimated from the
available data: abnormal liver and abnormal blood tests
of liver function, breathing problems with inadequate
intake of oxygen, chest pain, tremor, an increase in the
level of some enzymes in the blood, abnormal vision,
episodes of sudden sleep onset, seeing or hearing
things that are not really there (hallucinations), delusions,
psychotic disorder.

During treatment you may also notice the following
• Very common: may affect more than 1 in 10 people:
drowsiness, nausea, headache, dizziness, vertigo,

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

If you stop taking Dostinex
Your doctor will advise you how long to take Dostinex.
You should not stop until your doctor tells you.
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 everybody gets them.
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 people). 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

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.
• Aggression and 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

(see details below). By reporting side effects you can help
provide more information on the safety of this medicine.

The other ingredients are lactose and leucine (see section
2 Dostinex contains lactose).

United Kingdom
Yellow Card Scheme website:

What Dostinex looks like and contents of the pack
Dostinex tablets are flat capsule-shaped, scored,
white tablets. The tablets are contained in either amber
glass bottles, stoppered with an aluminium tamperevident screw cap with silica gel insert, or high-density
polyethylene bottles with a child-resistant polypropylene
cap which has a desiccant canister containing silica gel.
Each bottle contains 2, 4 or 8 tablets and is enclosed in
an outer cardboard carton.
Not all pack sizes may be marketed.

ADR Reporting
5. How to store Dostinex
• Keep this medicine out of the sight and reach of
• Do not use this medicine after the expiry date which is
stated on the carton and on the bottle label after EXP.
The expiry date refers to the last day of that month.
• Do not store above 25°C. Keep the bottle tightly closed
in order to protect from moisture.
• The bottle caps contain desiccant granules. Do not
remove desiccant granules from cap or transfer tablets
to another container.
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 Dostinex contains
The active substance is cabergoline. Each tablet contains
0.5 mg of cabergoline.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ


Pharmacia Italia
Marino Del Tronto
Ascoli, Piceno

Company Contact Address
For any further information about this medicine, please
contact Medical Information at: Pfizer Limited, Walton
Oaks, Tadworth, Surrey, KT20 7NS. Tel: 01304 616161
This leaflet was last revised in 03/2016
Ref: DX 14_1

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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.