Fortesia Special Precautions

General: Fortesia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Pancreatitis: There have been reports of acute pancreatitis, including fatal and non-fatal haemorrhagic or necrotizing pancreatitis (see Side Effects) in patients taking sitagliptin. Patients should be informed of the characteristic symptom of acute pancreatitis; persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of sitagliptin. If pancreatitis is suspected Fortesia and other potentially suspect medicinal products should be discontinued.
Hypoglycaemia in Combination with Sulfonylurea or with Insulin: As is typical with other antihyperglycaemic agents, hypoglycaemia is expected to be observed when Fortesia was used in combination with insulin or a sulfonylurea (see Side Effects). Therefore, to reduce the risk of sulfonylurea- or insulin-induced hypoglycaemia, a lower dose of sulfonylurea or insulin may be considered (see Dosage & Administration).
Hypersensitivity Reactions: The reactions include anaphylaxis, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, discontinue Fortesia, assess for other potential causes for the event, and institute alternative treatment for diabetes (see Contraindications and Side Effects).
Severe and disabling arthralgia: Consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue drug if appropriate.
Bullous Pemphigoid: Tell patients to report development of blisters or erosions while receiving Fortesia. If bullous pemphigoid is suspected, Fortesia should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.
Effects on Ability to Drive and Use Machines: Fortesia has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, it should be taken into account that dizziness and somnolence have been reported.
In addition, patients should be alerted to the risk of hypoglycaemia when Fortesia is used in combination with a sulphonylurea or with insulin.
Use in Patients with Renal Insufficiency: Fortesia is renally excreted. To achieve plasma concentrations of Fortesia Tablet similar to those in patients with normal renal function; lower dosages are recommended in patients with moderate and severe renal insufficiency, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis. (See Patients with renal impairment under Dosage & Administration.)
Use in Children: Fortesia has not been studied in paediatric patients under 10 years of age.
Use in the Elderly: No dosage adjustment is required based on age. Elderly patients are more likely to have renal impairment; as with other patients, dosage adjustment may be required in the presence of significant renal impairment (see Patients with renal impairment under Dosage & Administration).