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Orphacol
Eintrag öffnenOrphacol · 4.1 Therapeutic indications · 1
Eintrag öffnenOrphacol · 4.3 Contraindications · 1
Eintrag öffnenOrphacol · 4.3 · Concomitant use of phenobarbital and primidone with cholic acid (see section 4.5).
Eintrag öffnenOrphacol · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenOrphacol · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenOrphacol · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenOrphacol · 4.5 · Bile acid sequestrants (cholestyramine, colestipol, colesevelam) and certain antacids (e.g. aluminium hydroxid
Eintrag öffnenOrphacol · 4.5 · Ciclosporin alters the pharmacokinetics of cholic acid by inhibition of the hepatic uptake and hepatobiliary s
Eintrag öffnenOrphacol · 4.5 · Phenobarbital and primidone, which is partially metabolized in phenobarbital, antagonise the effect of cholic
Eintrag öffnenOrphacol · 4.5 · The effect of food on the bioavailability of cholic acid has not been studied. There is a theoretical possibil
Eintrag öffnenOrphacol · 4.5 · Ursodeoxycholic acid competitively inhibits absorption of other bile acids, including cholic acid, and replace
Eintrag öffnenOrphacol · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenOrphacol · 4.8 Undesirable effects · 1
Eintrag öffnenOrphacol · 4.8 · Description of selected adverse reactions The development of pruritus and/or diarrhoea has been observed durin
Eintrag öffnenOrphacol · 4.8 · Gallstones have been reported after long-term therapy.
Eintrag öffnenOrphacol · 4.8 · MedDRA System Organ Class Adverse reaction Gastrointestinal disorders Diarrhoea Hepatobiliary disorders Transa
Eintrag öffnenOrphacol · 4.8 · Other special populations Please refer to section 4.2 for use of Orphacol in special populations.
Eintrag öffnenOrphacol · 4.8 · Paediatric population The presented safety information is derived principally from paediatric patients. The av
Eintrag öffnenOrphacol · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
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