Tenelia Adverse Reactions

In Japanese clinical studies, 232 adverse drug reactions (including abnormal laboratory values) were observed in 156 patients (9.5%) of total 1645 patients. Main adverse drug reactions were hypoglycaemia in 43 patients (2.6%) and constipation in 14 patients (0.9%).
Clinically significant adverse drug reactions: Hypoglycaemia (1.1-8.9%): Hypoglycaemia may occur with coadministration of this product with other drugs for diabetes mellitus. In particular, some cases of serious hypoglycemic symptoms that resulted in loss of consciousness have been reported in coadministration with insulin products or sulfonylurea. Dose reduction of insulin products or sulfonylurea should be considered when this product is coadministered with these drugs. Hypoglycaemia has also been reported with this product when not coadministered with other drugs for diabetes mellitus. If hypoglycemic symptoms are observed, appropriate therapeutic measures, such as intake of sugar-containing food, should be taken (see Precautions and Interactions).
Intestinal obstruction (0.1%): Intestinal obstruction may occur. The patient should be carefully monitored, and if any abnormalities, such as severe constipation, abdominal distension, persistent abdominal pain and vomiting, are observed, this product should be discontinued and appropriate therapeutic measures should be taken (see Precautions).
Hepatic impairment (incidence unknown): Hepatic impairment accompanied by increased AST (GOT) or ALT (GPT) may occur. The patients should be carefully monitored, and if any abnormalities are observed, appropriate therapeutic measures including discontinuation of administration should be taken.
Interstitial pneumonia (incidence unknown): Interstitial pneumonia may occur. If any abnormalities, such as cough, dyspnoea, pyrexia and lung crepitation, are observed, laboratory tests including chest X-ray, chest CT, serum marker, etc. should be promptly performed. If interstitial pneumonia is suspected, this product should be discontinued and appropriate therapeutic measures including administration of corticosteroids should be taken.
Pemphigoid (incidence unknown): Pemphigoid may occur. If blister, erosion, or other signs and symptoms are observed, patients should be referred to a dermatologist, and appropriate therapeutic measures such as discontinuation of administration should be taken.
Acute pancreatitis (incidence unknown): Acute pancreatitis may occur. Patients should be instructed to consult with a physician immediately if initial symptoms including persistent and intense abdominal pain and/or vomiting occur (see Precautions).
Other adverse drug reactions: If any adverse drug reactions are observed, appropriate therapeutic measures, such as discontinuation of this product, should be taken. (See Table 11.)

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