Quest for the right Drug
דוסטינקס DOSTINEX (CABERGOLINE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליה : TABLETS
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Adverse reactions : תופעות לוואי
4.8. 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, e.g. 0.25 mg 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 0.25 mg/week every two weeks, may increase tolerability. The following undesirable effects have been observed and reported during treatment with cabergoline with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data). MedDRA Frequency Undesirable Effects System Organ Class Valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial Very Common effusion) Cardiac disorders Uncommon Palpitations Not Known Angina pectoris Dyspnea, pleural effusion, fibrosis, (including Uncommon pulmonary fibrosis), epistaxis Respiratory, thoracic and Very rare Pleural fibrosis mediastinal disorders Respiratory disorder, respiratory failure, Not Known pleuritis, chest pain Uncommon Hypersensitivity reaction Immune system disorders Nervous system disorders Very common Headache*, dizziness/vertigo* Common somnolence Uncommon Transient hemianopsia, syncope, paresthesia Not Known Sudden sleep onset, tremor Eye disorders Not Known Visual impairment Common Depression Uncommon Increased libido Psychiatric disorders Aggression, delusions, hypersexuality, Not Known pathological gambling, psychotic disorder, hallucinations Vascular disorders Common Cabergoline generally exerts a hypotensive effect in patients on long-term treatment; Postural hypotension, hot flushes** Uncommon Digital vasospasm, fainting Nausea*, dyspepsia, gastritis, abdominal pain* Gastrointestinal disorders Very common Common Constipation, vomiting** Rare Epigastric pain General disorders and Very Common Asthenia***, fatigue administration site conditions Oedema, peripheral oedema Uncommon Hepato-biliary disorders Not Known Hepatic function abnormal Skin and subcutaneous tissue Uncommon Rash, alopecia disorders Musculoskeletal and connective Uncommon Leg cramps tissue disorders Reproductive system and Common Breast pain breast disorders Investigations Common Asymptomatic decreases in blood pressure ( 20 mmHg systolic and 10 mmHg diastolic) Uncommon A decrease in haemoglobin values have been observed in amenhorrheic women during the first few months after menses. Not Known Blood creatinine phosphokinase increased, liver function tests abnormal *Very common in patients treated for hyperprolactinaemin disorders; Common in patients treated for inhibition/supression of lactation ** Common in patients treated for hyperprolactinaemin disorders; Uncommon in patients treated for inhibition/supression of lactation *** Very common in patients treated for hyperprolactinaemin disorders; Uncommon in patients treated for inhibition/supression of lactation Impulse control disorders 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). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il.
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
01/01/2000
הגבלות
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