Active Ingredient : Cabergoline 0.5 mg

Inhibition/suppression of physiological lactation: Cabergamoun is indicated for the inhibition of physiological lactation soon after delivery and for suppression of already established lactation: 1. After parturition, when the mother elects not to breast feed the infant or when breast feeding is contraindicated due to medical reasons related to the mother or the new-born. 2. After stillbirth or abortion. Cabergamoun prevents/suppresses physiological lactation by inhibiting prolactin secretion. • In controlled clinical trials, Cabergoline given as a single 1 mg administration during the first day post-partum, was effective in inhibiting milk secretion, as well as breast engorgement and pain in 70 - 90% of the women. Less than 5% of women experienced rebound breast symptomatology during the third post-partum week (which was usually mild in severity). 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 Cabergamoun given in four divided doses over two days. Rebound breast symptomatology after day 10 is uncommon (approximately 2% of cases). Treatment of hyperprolactinaemic disorders: Cabergamoun is indicated for the treatment of dysfunctions associated with hyperprolactinaemia, including amenorrhoea, oligomenorrhoea, anovulation and galactorrhoea. Cabergamoun 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. On chronic therapy, Cabergamoun at doses ranging between 1 and 2 mg per week, was effective in normalising serum prolactin levels in approximately 84% of hyperprolactinaemic patients. Regular cycles were resumed in 83% of previously amennorhoeic women. Restoration of ovulation was documented in 89% of women with progesterone levels monitored during the luteal phase. Galactorrhoea disappeared in 90% of cases showing this symptom before therapy. Reduction in tumour size was obtained in 50 - 90% of female and male patients with micro- or macroprolactinoma. Posology and method of administration: Cabergamoun is to be administered by the oral route. Inhibition/suppression of physiological lactation: For inhibition of lactation Cabergamoun should be administered during the first day post-partum. The recommended therapeutic dose is 1 mg (two 0.5 mg tablets) given as a single dose. For suppression of established lactation the recommended therapeutic dosage regimen is 0.25 mg (one-half 0.5 mg tablet) every 12 hours for two days (1 mg total dose). This dosage regimen has been demonstrated to be better tolerated than the single dose regimen in women electing to suppress lactation having a lower incidence of adverse events, in particular of hypotensive symptoms. Treatment of hyperprolactinaemic disorders: The recommended initial dosage of Cabergamoun is 0.5 mg per week given in one or two (one-half of one 0.5 mg tablet) doses (e.g. on Monday and Thursday) per week. The weekly dose should be increased gradually, preferably by adding 0.5 mg per week at monthly intervals until an optimal therapeutic response is achieved. The therapeutic dosage is usually 1 mg per week and ranges from 0.25 mg to 2 mg per week. The maximum dose should not exceed 3mg per day. 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. Patients should be evaluated during dose escalation to determine the lowest dosage that produces the therapeutic response. Monitoring of serum prolactin levels at monthly intervals is advised since, once the effective therapeutic dosage regimen has been reached, serum prolactin normalisation is usually observed within two to four weeks. After Cabergamoun 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 Cabergamoun discontinuation. Use in children: The safety and efficacy of Cabergamoun has not been established in subjects less than 16 years of age. Use in the elderly: As a consequence of the indications for which Cabergamoun is presently proposed, the experience in elderly is very limited. Available data do not indicate a special risk.

Hypersensitivity to Cabergamoun, any excipient of the product or any ergot alkaloid. History of pulmonary, pericardial and retroperitoneal fibrotic disorders. Cabergamoun is contraindicated in patients with hepatic insufficiency and with toxaemia of pregnancy. Cabergamoun should not be co-administered with anti-psychotic medications or administered to women with a history of puerperal psychosis. For long-term treatment: Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.

Carton box contains AL/PVC strip of 2 tablets in packing 1, 2, 3 strips with enclosed leaflet .

General: The safety and efficacy of Cabergamoun have not yet been established in patients with renal and hepatic disease. As with other ergot derivatives, Cabergamoun should be given with caution to patients with severe cardiovascular disease, Raynaud's syndrome, renal insufficiency, peptic ulcer or gastrointestinal bleeding, or with a history of serious, particularly psychotic, mental disorders. Particular care should be taken when patients are taking concomitant psychoactive medication. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Symptomatic hypotension can occur with Cabergamoun administration for any indication. Care should be exercised when administering Cabergamoun concomitantly with other drugs known to lower blood pressure. Before Cabergamoun administration, pregnancy should be excluded and after treatment pregnancy should be prevented for at least one month. Hepatic Insufficiency: Lower doses should be considered in patients with severe hepatic insufficiency who receive prolonged treatment with Cabergamoun. 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. Postural Hypotension: Postural hypotension can occur following administration of Cabergamoun Somnolence/Sudden Sleep Onset: Cabergamoun has been associated with somnolence. Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders. Inhibition/suppression of physiological lactation: As with other ergot derivatives, Cabergamoun 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. periodic monitoring of blood pressure, particularly during the first few days after Cabergamoun administration, is advised. A single dose of 0.25 mg of Cabergamoun should not be exceeded in nursing women treated for suppression of established lactation to avoid potential postural hypotension. Treatment of hyperprolactinaemic disorders: Because hyperprolactinaemia accompanied with amenorrhoea /galactorrhoea and infertility may be associated with pituitary tumour, a complete evaluation of the pituitary is indicated before treatment with Cabergamoun is initiated. Cabergamoun restores ovulation and fertility in women with hyperprolactinaemic hypogonadism. 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 Cabergamoun and after discontinuation of Cabergamoun 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. Before administration of Cabergamoun, pregnancy should be excluded. Because clinical experience is still limited and the product has a long half-life, as a precautionary measure it is recommended that once regular ovulatory cycles have been achieved women seeking pregnancy discontinue Cabergamoun one month before intended conception. Should pregnancy occur during treatment, Cabergamoun is to be discontinued. 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. Regular gynaecological assessment, including cervical and endometrial cytology, is recommended for patients taking Cabergamoun for extensive periods. Fibrosis and cardiac valvulopathy and possibly related clinical phenomena: Fibrotic and serosal inflammatory disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral and tricuspid) or retroperitoneal fibrosis have occurred after prolonged usage of ergot derivatives with agonist activity at the serotonin 5HT2B receptor, such as Cabergamoun. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of Cabergamoun. Erythrocyte sedimentation rate (ESR) has been found to be abnormally increased in association with pleural effusion/fibrosis. Chest x-ray examination is recommended in cases of unexplained ESR increases to abnormal values. 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 Cabergamoun treatment for the patient should be reassessed to determine the suitability of continued treatment with Cabergamoun. For Cabergoline the risk of fibrosis of the heart valves is well established , so patient with evidence of heart valve problems should not take them , and the medicine should only be used for parkinson’s disease in patients who have already taken or cannot take other treatment . Patient must be monitored for signs of fibrosis with echocardiography before treatment is started and regularly during treatment ; a reduction of the maximum recommended dose to 3 mg per day . Cardiac fibrosis is a very common side effect ( seen in more than 1 patient in 10 taking this medicine ) Before initiating long-term treatment: All patients must undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of asymptomatic valvular disease. It is also appropriate to perform baseline investigations of erythrocyte sedimentation rate or other inflammatory markers, lung function/chest X-ray and renal function prior to initiation of therapy. In patients with valvular regurgitation, it is not known whether cabergoline treatment might worsen the underlying disease. If fibrotic valvular disease is detected, the patient should not be treated with Cabergamoun . During long-term treatment: Fibrotic disorders can have an insidious onset and patients should be regularly monitored for possible manifestations of progressive fibrosis. Therefore, during treatment, attention should be paid to the signs and symptoms of: Pleuro-pulmonary disease such as dyspnoea, shortness of breath, persistent cough or chest pain. 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. Cardiac failure: cases of valvular and pericardial fibrosis have often manifested as cardiac failure. Therefore, valvular fibrosis (and constrictive pericarditis) should be excluded if such symptoms occur. Clinical diagnostic monitoring for development of fibrotic disorders, as appropriate, is essential. Following treatment initiation, the first echocardiogram must occur within 3-6 months, thereafter, the frequency of echocardiographic monitoring should be determined by appropriate individual clinical assessment with particular emphasis on the above-mentioned signs and symptoms, but must occur at least every 6 to 12 months. Cabergamoun should be discontinued if an echocardiogram reveals new or worsened valvular regurgitation, valvular restriction or valve leaflet thickening . The need for other clinical monitoring (e.g. physical examination including, cardiac auscultation, X-ray, CT scan) should be determined on an individual basis. Additional appropriate investigations such as erythrocyte sedimentation rate, and serum creatinine measurements should be performed if necessary to support a diagnosis of a fibrotic disorder. Interaction with other medicinal products and other forms of interaction. The concomitant use of other drugs during early puerperium, particularly of ergot alkaloids, was not associated with detectable interactions modifying the efficacy and safety of Cabergamoun. No information is available about the interaction between Cabergamoun and other ergot alkaloids; therefore, the concomitant use of these medications during long-term treatment with Cabergamoun is not recommended. Since Cabergamoun 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 prolactin-lowering effect of Cabergamoun. As with other ergot derivatives, Cabergamoun should not be used with macrolide antibiotics (e.g. erythromycin) due to increased systemic bioavailability of Cabergamoun.

Store at temperature not exceeding 30° C. Cabergamoun tablets absorb moisture , so you should always keep it in dry place.

: Before Cabergamoun administration, pregnancy should be excluded and after treatment pregnancy should be prevented for at least one month. As cabergoline has an elimination half-life of 79-115 hours in hyperprolactinaemic patients, once regular ovulatory cycles have been achieved women seeking pregnancy should discontinue Cabergamoun one month before intended conception. This will prevent possible foetal exposure to the drug and will not interfere with the possibility of conception since ovulatory cycles persist in some cases for six months after drug withdrawal. If conception occurs during therapy, treatment should be discontinued as soon as pregnancy is confirmed to limit foetal exposure to the drug. Mothers should be advised not to breast-feed in case of failed lactation inhibition/suppression by Cabergamoun. Since it prevents lactation, Cabergamoun should not be administered to mothers with hyperprolactinemic disorders who wish to breast-feed their infants. Effects on ability to drive and use machines: During the first days of Cabergamoun administration, patients should be cautioned about re-engaging in activities requiring rapid and precise responses such as driving an automobile or operating machinery. Patients being treated with Cabergamoun and presenting with somnolence must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves and others at risk of serious injury or death (e.g. operating machines) unless patients have overcome such experiences of somnolence.

Adverse events are generally dose-related. In patients known to be intolerant to dopaminergic drugs, the likelihood of adverse events may be lessened by starting therapy with Cabergamoun at reduced doses, e.g. 0.25mg once a week, with subsequent gradual increase until the therapeutic dosage is reached. If persistent or severe adverse events occur, temporary reduction of dosage followed by a more gradual increase, e.g. increments of 0.25mg/week every two weeks, may increase tolerability.