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The concomitant intake of grapefruit and grapefruit juice has been reported to increase the bioavailability of ciclosporin.

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In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories. The two main types of capsules are: Except for the treatment of nephrotic syndrome, there is no adequate experience available with Neoral. Its use in children under 16 years of age for non-transplantation indications other than nephrotic syndrome cannot be recommended. Neoral should be prescribed only by physicians who are experienced in immunosuppressive therapy and can provide adequate follow-up, including regular full physical examination, measurement of blood pressure and control of laboratory safety parameters. Transplantation patients receiving this medicinal product should be managed in facilities with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should receive complete information for the follow-up of the patient. Neoral may also cause dose-dependent, reversible increases in serum bilirubin and in liver enzymes (see section 4.8). There have been solicited and spontaneous reports of hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis and liver failure in patients treated with ciclosporin. Most reports included patients with significant co-morbidities, underlying conditions and other confounding factors including infectious complications and co-medications with hepatotoxic potential. In some cases, mainly in transplant patients, fatal outcomes have been reported (see section 4.8). Close monitoring of parameters that assess hepatic function is required and abnormal values may necessitate dose reduction (see sections 4.2 and 5.2).It must be remembered that the ciclosporin concentration in blood, plasma, or serum is only one of many factors contributing to the clinical status of the patient. Results should therefore serve only as a guide to dosage in relationship to other clinical and laboratory parameters. Regular monitoring of blood pressure is required during Neoral therapy. If hypertension develops, appropriate antihypertensive treatment must be instituted. Preference should be given to an antihypertensive agent that does not interfere with the pharmacokinetics of ciclosporin, e.g., isradipine (see section 4.5).

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In recent years, consumers have become more aware of the origin, sustainability and health aspects of the products they buy. This is partly fueled by the tightening of labelling legislation and transparency on food products e.g. the EU law on food information to consumers. Skip ahead to find out which vitamin D supplements we recommend, or read on for more tips on choosing the right type and dosage for you and your family. In some patients, GVHD occurs after discontinuation of ciclosporin treatment, but usually responds favourably to re-introduction of therapy. In such cases an initial oral loading dose of 10 to 12.5 mg/kg should be given, followed by daily oral administration of the maintenance dose previously found to be satisfactory. Low doses of Neoral should be used to treat mild, chronic GVHD.With the exception of patients being treated for nephrotic syndrome, patients with impaired renal function should not receive ciclosporin (see subsection on additional precautions in non-transplantation indications in section 4.4). In nephrotic syndrome patients with impaired renal function, the initial dose should not exceed 2.5 mg/kg/day. The initial dose should be given on the day before transplantation. In most cases, Sandimmun concentrate for solution for infusion is preferred for this purpose. The recommended intravenous dose is 3 to 5 mg/kg/day. Infusion is continued at this dose level during the immediate post-transplant period of up to 2 weeks, before a change is made to oral maintenance therapy with Neoral at daily doses of about 12.5 mg/kg given in 2 divided doses. The primary gelatin types used in capsules are typically from bovine or porcine raw materials. Depending on the fill, formulation and on the target market group, manufacturers have flexibility in the raw material type, with some opting for a combination of porcine and bovine options. Bovine bone gelatin, for example, contributes to capsule firmness. Porcine options, on the other hand, offers plasticity and clarity characteristics. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or medication and increased susceptibility for infections. There is alimited amount of data from the use of alfacalcidol in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3).