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. 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. The tablets should be taken with meals to reduce certain side effects such as nausea, vomiting and stomach pains. Because pregnancy might occur prior to reinitiation of menses, a pregnancy test is recommended at least every four weeks during the amenorrhoeic period and, once menses are reinitiated, every time a menstrual period is delayed by more than three days. Women who wish to avoid pregnancy should be advised to use mechanical contraception during treatment with cabergoline and after discontinuation of cabergoline until recurrence of anovulation. As a precautionary measure, women who become pregnant should be monitored to detect signs of pituitary enlargement since expansion of pre-existing pituitary tumours may occur during gestation.

The pharmacokinetic and metabolic profiles of cabergoline have been studied in healthy volunteers of both sexes and in female hyperprolactinaemic patients.Ten days after administration about 18% and 72% of the radioactive dose was recovered in urine and faeces, respectively. Unchanged drug in urine accounted for 2-3% of the dose. 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. Sometimes people taking cabergoline can fall asleep suddenly with little or no warning of being tired beforehand. Until you know how you react, take extra care if you drive and if you operate machinery. If you do find yourself falling asleep suddenly, you should see your doctor as soon as possible for advice. Avoid driving and avoid use of tools and machines in the meantime. will be treated with Cabergoline for a long period and have or had fibrotic reactions (scar tissue) affecting your heart.

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. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 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? Since cabergoline exerts its therapeutic effect by direct stimulation of dopamine receptors, it should not be concurrently administered with drugs which have dopamine antagonist activity (such as phenothiazines, butyrophenones, thioxanthenes, metoclopramide) since these might reduce the therapeutic effect of cabergoline. Cabergoline should only be used during pregnancy if clearly indicated and after an accurate benefit/risk evaluation. (See section 4.4).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. serious chest complaint (e.g. pain in the chest when breathing, fluid in the lungs, inflammation or infection of the lungs). If you stop using Cabergoline the symptoms of your illness may become more severe and you should consult your doctor before you discontinue therapy.

Cabergoline generally exerts a hypotensive effect in patients on long-term treatment; Postural hypotension All patients must undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of asymptomatic valvular disease. Also perform baseline investigations of erythrocyte sedimentation rate or other inflammatory markers, lung function/chest X-ray, serum creatinine and renal function prior to initiation of therapy. If fibrotic valvular disease is detected, the patient should not be treated with cabergoline. There were maternotoxic effects but no teratogenic effects in mice given cabergoline at doses up to 8 mg/kg/day (approximately 55 times the maximum recommended human dose) during the period of organogenesis. Renal insufficiency or ureteral/abdominal vascular obstruction that may occur with pain in the loin/flank, and lower limb oedema, as well as any possible abdominal masses or tenderness that may indicate retroperitoneal fibrosis. The safety and efficacy of cabergoline has not been investigated in children as Parkinson's disease does not affect this population.

Patient leaflet - CABERGOLINE 2 MG TABLETS

If you are a woman, you may want to discuss what forms of contraception are suitable for you. Hormonal forms of contraception (such as 'the pill') may not be suitable while you are taking cabergoline. You should avoid becoming pregnant during treatment with cabergoline and for one month after stopping. 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. Symptomatic hypotension can occur with cabergoline administration for any indication. Care should be exercised when administering cabergoline concomitantly with other drugs known to lower blood pressure. have swelling of the hands and feet and a high blood pressure during pregnancy (preeclampsia, eclampsia) 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?

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)

Uses

Changes in the way you feel (such as being depressed or confused), thinking things that are not true (hallucinations), uncontrollable muscle movements Lower doses should be considered in patients with severe hepatic insufficiency who receive prolonged treatment with cabergoline. 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 suppresses lactation through its inhibition of prolactin release from the anterior pituitary gland. Therefore, it is not recommended for any woman wishing to breastfeed. 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.