Cabergoline 0.5mg tablets

• 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.

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

• 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 childbirth (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.

Talk to your doctor or pharmacist before taking this medicine 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 this medicine.

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).

See section 3 ‘How to take Cabergoline’.

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 this medicine, you should use another method of feeding your baby.

This medicine 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.

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 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.

Your doctor will advise you how long to take this medicine. You should not stop until your doctor tells you.

• 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.

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 hunger).

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.

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 (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.

The active substance is cabergoline. Each tablet contains 0.5mg of cabergoline. The other ingredients are microcrystalline cellulose, citric acid anhydrous, croscarmellose sodium and magnesium stearate.

Cabergoline tablets are flat oval-shaped, scored, white to off-white tablets. The tablets are contained in high-density polyethylene bottles with a child-resistant polypropylene cap which contains 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.