- Sitament® should not be used in patients with type1diabetes or for the treatment
of diabetic ketoacidosis.
- Acute pancreatitis: use of DPP-4 inhibitors has been associated with a risk of
developing acute pancreatitis. Patients should be informed of the characteristic
symptom of acute pancreatitis: persistent, severe abdominal pain which may or may
not be accompanied with vomiting.. If pancreatitis is suspected, Sitament® should
be discontinued; caution should be exercised in patients with a history of
pancreatitis. Gallstones, alcohol dependence or very high levels of triglycerides (a
form of fat) in the blood can increase the chance of getting pancreatitis
-Lactic acidosis: There have been postmarketing cases of metformin-associated
lactic acidosis, including fatal cases. If metformin-associated lactic acidosis is
suspected, general supportive measures should be instituted promptly in a hospital
setting, along with immediate discontinuation of Sitament® . Symptoms of lactic
acidosis include: vomiting, stomach ache (abdominal pain), muscle cramps, a
general feeling of not being well with severe tiredness, difficulty in breathing,
reduced body temperature and heartbeat.
-Heart Failure: An association between dipeptidyl peptidase-4 (DPP-4) inhibitor
treatment and heart failure has been observed in cardiovascular outcomes trials for
two other members of the DPP-4 inhibitor class. Consider the risks and benefits of
Sitament® prior to initiating treatment in patients at risk for heart failure
-Renal function: GFR should be assessed before treatment initiation and regularly
thereafter. Sitament® is contraindicated in patients with GFR < 30 mL/min and
should be temporarily discontinued during conditions with the potential to alter renal
-Hypoglycaemia: if sulphonylurea, insulin or diabetes medicines are taken together
with Sitament® , the dose of sulphonylurea or insulin may be reduced.
-Hypersensitivity reactions: include anaphylaxis, angioedema, and exfoliative skin
conditions including Stevens-Johnson syndrome. If a hypersensitivity reaction is
suspected, Sitament® should be discontinued.
-Surgery: as Sitament® contains the metform in hydrochloride , the treatment
should be discontinued 48 hours before elective of surgery with general, spinal or
-Vitamin B12 deficiency: Metformin may lower vitamin B12 levels. Measurement
of hematologic parameter on annual basis is advised in patients on Sitament®.
-Severe and Disabling Arthralgia.
Effects on ability to drive and use machines
- Sitament® has no or negligible influence on the ability to drive and use machines.
However, dizziness and drowsiness have been reported with sitagliptin, which may
affect the ability to drive or use machines. In addition, patients should be alerted to
the risk of hypoglycaemia when Sitament® is used in combination with a
sulphonylurea or with insulin.