The safety and efficacy of cabergoline has not been investigated in children as Parkinson's disease does not affect this population. 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:

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. Valvulopathy has been associated with cumulative doses, therefore, patients should be treated with the lowest effective dose. At each visit, the risk benefit profile of cabergoline treatment for the patient should be reassessed to determine the suitability of continued treatment with cabergoline. Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Dostinex (see section 4.4). Cabergoline is a tablet treatment used to reduce the production of a hormone called prolactin by the pituitary gland (a gland at the base of the brain). If you have a prolactinoma (overproduction of prolactin by a cluster of cells in the pituitary), cabergoline treatment is also used to shrink the size of the swelling on the pituitary gland. How should I take cabergoline?The concomitant use of antiparkinson non-dopamine agonists (e.g. selegiline, amantadine, biperiden, trihexyphenidyl) was allowed in clinical studies for patients receiving cabergoline. In studies where the pharmacokinetic interactions of cabergoline with L-dopa or selegiline were evaluated, no interactions were observed. There are other medicines such as other ergot alkaloids, medicines to prevent vomiting (metoclopramide), and macrolide antibiotics (such as erythromycin) that may affect the activity and tolerability of Cabergoline. 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) Lower doses of cabergoline should be considered in patients with severe hepatic insufficiency. Compared to normal volunteers and those with lesser degrees of hepatic insufficiency, an increase in AUC has been seen in patients with severe hepatic insufficiency (Child-Pugh Class C) who received a single 1 mg dose. Cabergoline is prescribed for a number of different medical conditions. Your doctor will tell you why it has been prescribed for you.

In post-partum studies with cabergoline, blood pressure decreases were mostly asymptomatic and were frequently observed on a single occasion 2 to 4 days after treatment. Since decreases in blood pressure are frequently noted during the puerperium, independently of drug therapy, it is likely that many of the observed decreases in blood pressure after cabergoline administration were not drug-induced. However, periodic monitoring of blood pressure, particularly during the first few days after cabergoline administration, is advised. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The tablets should be taken with meals to reduce certain side effects such as nausea, vomiting and stomach pains. Lower doses should be considered in patients with severe hepatic insufficiency (Child-Pugh Class C). Contraindications The weekly dose may be given as a single administration or divided into two or more doses per week according to patient tolerability. Division of the weekly dose into multiple administrations is advised when doses higher than 1 mg per week are to be given since the tolerability of doses greater than 1 mg taken as a single weekly dose has been evaluated only in a few patients.Cabergoline is a long-acting medicine, which only needs to be taken once or twice a week. Your specialist will recommend the appropriate dose for you. Common side-effects of cabergoline Your endocrinologist will measure the levels of prolactin in blood tests. They may also repeat your pituitary MRI scan once you have been treated for a while. To reduce the risk of developing the rare side-effects of cabergoline treatment, your endocrinologist will usually recommend the lowest effective dose. Some patients go into remission after a couple of years of treatment and the cabergoline can be stopped: blood tests and scans will enable your specialist to monitor for any recurrence. What about pregnancy? After cabergoline withdrawal, recurrence of hyperprolactinaemia is usually observed. However, persistent suppression of prolactin levels has been observed for several months in some patients. Of the group of women followed up, 23/29 had ovulatory cycles which continued for greater than 6 months after cabergoline discontinuation. Due to the long half-life of the drug and limited data on in utero exposure, women planning to become pregnant should discontinue cabergoline one month before intended conception. If conception occurs during therapy, treatment should be discontinued as soon as pregnancy is confirmed to limit foetal exposure to the drug.

On the basis of the elimination half-life, steady state conditions should be achieved after 4 weeks, as confirmed by the mean peak plasma levels of cabergoline obtained after a single dose (37 ± 8 pg/ml) and after a 4 week multiple regimen (101 ± 43 pg/ml). The safety and efficacy of cabergoline has not been established in subjects less than 16 years of age. As with other ergot derivatives, cabergoline should not be used in women with pregnancy-induced hypertension, for example, preeclampsia or post-partum hypertension, unless the potential benefit is judged to outweigh the possible risk. Treatment with medicines like cabergoline can sometimes cause problems with impulsive types of behaviour. If you notice any changes in your behaviour, such as an increased desire to gamble, binge eat, or spend excessively, or an increased sex drive, you must let your doctor know as soon as possible. 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 up to 1 in 100 people).Cabergoline is indicated for the treatment of dysfunctions associated with hyperprolactinaemia, including amenorrhoea, oligomenorrhoea, anovulation and galactorrhoea. Cabergoline is indicated in patients with prolactin-secreting pituitary adenomas (micro- and macroprolactinomas), idiopathic hyperprolactinaemia, or empty sella syndrome with associated hyperprolactinaemia, which represent the basic underlying pathologies contributing to the above clinical manifestations. Cabergoline is a dopaminergic ergoline derivative endowed with a potent and long-lasting PRL-lowering activity. It acts by direct stimulation of the D 2-dopamine receptors on pituitary lactotrophs, thus inhibiting PRL secretion. In rats the compound decreases PRL secretion at oral doses of 3-25 mcg/kg, and in-vitro at a concentration of 45 pg/ml. In addition, cabergoline exerts a central dopaminergic effect via D 2 receptor stimulation at oral doses higher than those effective in lowering serum PRL levels. The long lasting PRL-lowering effect of cabergoline is probably due to its long persistence in the target organ as suggested by the slow elimination of total radioactivity from the pituitary after single oral dose in rats (t ½of approximately 60 hours). As expected for dopamine agonists, dose response for both efficacy and side effects appears to be linked to individual sensitivity. Optimization of dose should be obtained through slow initial dose titration, from starting doses of 1 mg daily. The dosage of concurrent levodopa may be gradually decreased, while the dosage of cabergoline is increased, until the optimum balance is determined. In view of the long half-life of the compound, increments of the daily dose of 0.5-1 mg should be done at weekly (initial weeks) or bi-weekly intervals, up to optimal doses. Suppression of milk secretion and relief of breast engorgement and pain are obtained in approximately 85% of nursing women treated with a total dose of 1 mg cabergoline given in four divided doses over two days. Rebound breast symptomatology after day 10 is uncommon (approximately 2% of cases). Postural hypotension can occur following administration of cabergoline, particularly during the first days of administration of cabergoline. Care should be exercised when administering cabergoline concomitantly with other drugs known to lower blood pressure.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If it is almost time to take the next dose, skip the forgotten dose and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

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The pharmacodynamic effects of cabergoline have been studied in healthy volunteers, puerperal women and hyperprolactinaemic patients. After a single oral administration of cabergoline (0.3 - 1.5 mg), a significant decrease in serum PRL levels was observed in each of the populations studied. The effect is prompt (within 3 hours from administration) and persistent (up to 7 - 28 days in healthy volunteers and hyperprolactinaemic patients, and up to 14 - 21 days in puerperal women). The PRL-lowering effect is dose-related both in terms of degree of effect and duration of action. 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. Cabergoline generally exerts a hypotensive effect in patients on long-term treatment; Postural hypotension, hot flushes** blood problems including low blood count (symptoms may include tiredness), abnormal liver function tests Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.