Patient leaflet - Cabergoline 0.5 mg tablets

1. What Cabergoline is and what it is used for

Cabergoline 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.
Cabergoline 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 started.
Cabergoline 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.
Cabergoline 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 Cabergoline

Do not take Cabergoline:

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 pregnancy)
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 Cabergoline for a long period and
have stiff and inflamed heart valves (cardiac valvulopathy)
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 Cabergoline 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
disorders
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 Cabergoline 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 discontinued
Low blood pressure (postural hypotension) or you are taking
any medicines to lower your blood pressure.
If you have just given birth you may be more at risk of certain conditions. These may include high blood pressure, heart attack, convulsion, stroke or mental health problems. Therefore, your doctor will need to check your blood pressure regularly during the treatment. Speak immediately to your doctor if you experience high blood pressure, chest pain or unusually severe or persistent headache (with or without vision problems).
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 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.
Other medicines and Cabergoline
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 Cabergoline, these include:
- Medicines used to treat mental illness (e.g. antipsychotic medicines like chlorpromazine,
- haloperidol)
- Medicines for nausea and vomiting (e.g. domperidone, metoclopramide)

Some medicines can increase the amount of Cabergoline 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).

Cabergoline with food and drink

See section 3 ‘How to take Cabergoline’

Pregnancy, breast-feeding and fertility

Pregnancy

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 Cabergoline, stop taking Cabergoline and inform your doctor who will then monitor your pregnancy as Cabergoline can result in congenital abnormalities if you use it during pregnancy.

Breast-feeding

As Cabergoline will stop you producing milk for your baby, you should not take this medicine if you plan to breast-feed. If you need to take Cabergoline you should use another method of feeding your baby.

Driving and using machines

Cabergoline 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 Cabergoline if this occurs.

Cabergoline contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Cabergoline

Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure.

It is recommended you take Cabergoline 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 delivery.
To stop lactation once you have started to breast-feed: You should take 0.25 mg (one half of Cabergoline 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.

Package leaflet: Information for the user

Cabergoline 0.5mg Tablets

Version: 02

Date & Time: 13.08.2025 & 5.30 pm

Submission Code: N15535_u15f

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 Cabergoline than you should

If you take too many Cabergoline 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 Cabergoline

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.

If you stop taking Cabergoline

Your doctor will advise you how long to take Cabergoline. 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 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.

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:
o Strong impulse to gamble excessively despite serious
personal or family consequences.
o Aggression and altered or increased sexual interest and
behaviour of significant concern to you or to others, for example, an increased sexual drive.
o Uncontrollable excessive shopping or spending.
o 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 effects:

Very common: may affect more than 1 in 10 people:
drowsiness, nausea, headache, dizziness, vertigo, 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 re-started, temporary partial vision loss, cold hands and feet.
Rare: may affect up to 1 in 1000 people: pain in the stomach.
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
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cabergoline

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light. Silica gel desiccant should not be removed from the 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 to protect the environment.

6. Contents of the pack and other information

What Cabergoline contains

The active substance is Cabergoline. Each tablet contains
0.5 mg of Cabergoline.
The other ingredients are leucine, lactose monohydrate and magnesium stearate

What Cabergoline looks like and contents of the pack

White to off-white, capsule shaped, approximately 8 x 4mm, flat faced, bevel edged, uncoated tablets debossed with ‘C 0.5’ on one side and break line on other side.

Cabergoline 0.5mg Tablets are marketed in container pack with white opaque round HDPE container closed with white opaque polypropylene child resistant closure with wad having induction sealing liner. Each HDPE container shall contain silica gel as desiccant.

Pack size: 8 tablets.

Marketing Authorisation Holder

Milpharm Limited

Ares Block

Odyssey Business Park

West End Road

Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000, Malta