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Dostinex Tablets Summary of Product Characteristics SmPC emc

Dostinex Tablets Summary of Product Characteristics SmPC emc

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. 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.

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. A single dose of 0.25 mg of cabergoline should not be exceeded in nursing women treated for suppression of established lactation to avoid potential postural hypotension (see section 4.2). 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.

Baby boy’s dark-brown eyes turn bright BLUE overnight after COVID treatment

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 (t½ of approximately 60 hours). 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). 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. 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.

Sufferers are known to have diminished supplies of dopamine because nerve cells that make it have died. It causes muscle stiffness, slowness of movement, tremors, sleep disturbance, chronic fatigue, an impaired quality of life and can lead to severe disability. ‘Pharmaceutical companies also have a responsibility to provide effective information, and work towards medication with less harmful side effects. They also consider young, male Parkinson’s patients with more than one psychiatric disorder to be most at risk of developing the side effect.

Product Details

The pharmacokinetic and metabolic profiles of cabergoline have been studied in healthy volunteers of both sexes and in female hyperprolactinaemic patients. 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. The safety and efficacy of cabergoline have not yet been established in patients with renal and hepatic disease. Particular care should be taken when patients are taking concomitant psychoactive medication.

  • The death rate due to TEN is estimated to be between 21 to 25 percent based on European cohorts from the 1990s and early 2000s.
  • Pfizer Australia, part of the global pharmaceutical company Pfizer, offered a settlement to patients who developed an addition to gambling and sex after taking medication to treat Parkinson’s disease.
  • These antipsychotic drugs are antagonists of alpha-1 noradrenergic receptors, which scientists believe is the underlying cause for cases of priapism.
  • Within just a week of taking the medication – far too soon for it to have noticeable effects on his mental health – his skin began changing to a grayish-blue color.
  • There are no adequate and well-controlled studies from the use of cabergoline in pregnant women.

Symptoms of overdose would likely be those of over-stimulation of dopamine receptors e.g. nausea, vomiting, gastric complaints, postural hypotension, confusion/psychosis or hallucinations. As with other ergot derivatives, cabergoline should not be used with macrolide antibiotics (e.g. erythromycin) due to increased systemic bioavailability of cabergoline. Some 170 patients claimed they were not warned of the side effects of thedrug Cabaser between 1996 and 2010. For a small number of people, other types of Parkinson’s medications, in particular levodopa, have also been shown to have similar side effects. It is believed to be caused by inadvertently blocking an enzyme called phosphodiesterase 6 which overly sensitizes rod cells in the retina, which are most effective at picking up blue.

Another woman in New Jersey frequently awakens to find a spoonful of peanut butter in the bed next to her, while yet another in Salinas, California would wake up to a mattress littered with candy wrappers. But anecdotal evidence of the drug’s impacts on nocturnal eating is becoming more and more widespread. It is estimated to affect between six and seventeen percent of people taking Ambien or its generic equivalent, zolpidem. The drug’s action on the CNS impacts thoughts and behaviors while blurring the line between sleep and wakefulness.

Pfizer Australia, part of the global pharmaceutical company Pfizer, offered a settlement to patients who developed an addition to gambling and sex after taking medication to treat Parkinson’s disease. Research has shown that around 17 per cent of people with Parkinson’s who take dopamine agonists experience impulsive and compulsive behaviour. A 74-year-old Parkinson’s patient became addicted to gambling in a bizarre side effect of his prescribed medication.


Dopamine agonist drugs have been shown to cause impulsive and compulsive behaviours in 17 per cent of those who use them. The Greek man’s desires to use slot machines started a month after his doctor prescribed pramipexole, a dopamine agonist. None of the men had prescriptions for the medication, suggesting they were not warned of the possible effect to their vision beforehand, and they started on the highest dose. The effect has been seen in men who take the highest recommended dose of the erection-causing medication whose main active ingredient is sildenafil.


While it’s not totally clear how many instances of priapism are linked to antipsychotics, some estimates say that the drugs are responsible for about 50 percent of drug-related priapism. The receptors are located on smooth muscles – the kinds that produce involuntary actions. Activating them is believed to relax those smooth muscles which leads to a widening of blood vessels, allowing for increased blood flow to the penis. Common antibiotic medications including sulfonamides, chloramphenicol, penicillins, and quinolones have been known to cause Toxic epidermal necrolysis (TEN) that causes damage to 30 percent of the skin. While his side effect was caused by medication that is not used in the US, millions of Americans take drugs that can cause similarly bizarre symptoms. Ten days after administration about 18% and 72% of the radioactive dose was recovered in urine and faeces, respectively.