DOSTINEX Tablets (2016)
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Περιεχόμενα
Name of the medicinal product
Dostinex 0.5 mg Tablets.
Qualitative and quantitative composition
One Dostinex tablet contains 0.5 mg cabergoline. Excipients with known effect: Each tablet contains 75.90 mg of lactose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Flat, capsule-shaped, 4 8 mm, scored, white tablets.
Therapeutic indications
Inhibition/suppression of physiological lactation Cabergoline is indicated for the inhibition of physiological lactation soon after delivery and for suppression of already established lactation: After ...
Posology and method of administration
Cabergoline is to be administered by the oral route. Since in clinical studies cabergoline has been mainly administered with food and since the tolerability of this class of compounds is improved with ...
Contraindications
Hypersensitivity to cabergoline, any of the excipients listed in section 6.1 or any ergot alkaloid. History of pulmonary, pericardial and retroperitoneal fibrotic disorders. Cabergoline is contraindicated ...
Special warnings and precautions for use
General The safety and efficacy of cabergoline have not yet been established in patients with renal and hepatic disease. As with other ergot derivatives, cabergoline should be given with caution to patients ...
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 cabergoline. No information ...
Pregnancy and lactation
There are no adequate and well-controlled studies from the use of cabergoline in pregnant women. Animal studies have not demonstrated teratogenic effects, but reduced fertility and embryo-toxicity were ...
Effects on ability to drive and use machines
Patients should be careful when performing actions which require fast and accurate reaction during treatment initiation. During the first days of cabergoline administration, patients should be cautioned ...
Undesirable effects
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 cabergoline at reduced doses, ...
Overdose
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. Supportive measures ...
Pharmacodynamic properties
Pharmacotherapeutic group: Prolactine inhibitors ATC code: G02CB03 Cabergoline is a dopaminergic ergoline derivative endowed with a potent and long-lasting PRL-lowering activity. It acts by direct stimulation ...
Pharmacokinetic properties
The pharmacokinetic and metabolic profiles of cabergoline have been studied in healthy volunteers of both sexes and in female hyperprolactinaemic patients. After oral administration of the labelled compound, ...
Preclinical safety data
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. ...
List of excipients
Lactose Leucine
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Do not store above 25°C. Keep the bottle tightly closed in order to protect from moisture.
Nature and contents of container
Class I amber glass bottles, stoppered with an aluminum tamper-evident screw cap with silica gel insert or high-density polyethylene (HDPE) bottles with child-resistant polypropylene (PP) cap with inner ...
Special precautions for disposal and other handling
Bottles of Dostinex are supplied with desiccant in caps. This desiccant must not be removed.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9JN
Marketing authorization number(s)
PL 00057/0969
Date of first authorization / renewal of the authorization
24 June 2002
Date of revision of the text
04/2016
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