SEMACOM 14mg Semaglutide Tablets

INDICATIONS

SEMACOM is indicated for the treatment of adults with insuciently controlled type2diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise..as monotherapy when metformin is considered inappropriate due to intolerance orcontraindications.
.in combination with other medicinal products for the treatment of diabetes.

PRECAUTIONS
Iraceability

In order to improve the traceability of biological medicinal products, the name and thebatch number of the administered product should be clearly recorded.

General

Semaglutide should not be used in patients with type1diabetes mellitus or for thetreatment of diabetic ketoacidosis.
Diabetic ketoacidosis has been reported in insulin-dependent patients whom had rapiddiscontinuation or dose reduction of insulin when treatment with a GLP-1 receptoragonist is started.
There is no therapeutic experience with semaglutide in patients with bariatric surgery

Gastrointestinal effects
Use of GLP-1 receptor agonists may be associated with gastrointestinal adversereactions that can cause dehydration, which in rare cases can lead to a deterioration ofrenal function. Patients treated with semaglutide should be advised of the potential riskof dehydration in relation to gastrointestinal side eects and take precautions to avoiduid depletion.

Acute pancreatitis

Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patientsshould be informed of the characteristic symptoms of acute pancreatitis. If pancreatitisis suspected, semaglutide should be discontinued; if conrmed, semaglutide shouldnot be restarted. Caution should be exercised in patients with a history of pancreatitis.

Hypoglycaemia
Patients treated with semaglutide in combination with a sulfonylurea or insulin mayhave an increased risk of hypoglycaemia. The risk of hypoglycaemia can be lowered byreducing the dose of sulfonylurea or insulin when initiating treatment with semaglutide.

Diabetic retinopathy

In patients with diabetic retinopathy treated with insulin and s.c. semaglutide, anincreased risk of developing diabetic retinopathy complications has been observed, arisk that cannot be excluded for orally administered semaglutide. Caution should beexercised when using semaglutide in patients with diabeticretinopathy. These patientsshould be monitored closely and treated according to clinical guidelines. Rapidimprovement in glucose control has been associated with a temporary worsening ofdiabetic retinopathy,but other mechanisms cannot be excluded. Long- term glycaemiccontrol decreases the risk of diabetic retinopathy.

Treatment response
Compliance with the dosing reg imen is recommended for optimal eect of semaglutide.If the treatment response with semaglutide is lower than expected, the treatingphysician should be aware that the absorption of semaglutide is highly variable andmay be minimal (2- 4% of patients will not have any exposure), and that the absolutebioavailability of semaglutide is low.

DOSAGE AND ADMINISTRATION

SEMACOM is a tablet for once-daily oral use..This meticinal product should be taken on an emptastomacth at anytime of the dayequivalent to 120m). Tablets should not be split, crushed ochewed, as it is not knownwhether this impacts absorotion of semaalutide..Patients should wait at least 30 minutes before eating or drinking or taking otheroral medicinal products.Waiting less than 30 minutes decreases the absorption ofsemaglutide.
 

OVERDOSE
Effects of overdose with semaglutide in clinical studies may be associated withgastrointestinal disorders.In the event of overdose.appropriate supportive treatmentshould be initiated according to the patient's clinical signs and symptoms., A prolongedperiod of observation and treatment of the symptoms may be necessary, taking intoaccount the long half-life of semaglutide of approximately 1 week.There is no specicantidote for overdose with semaglutide.
 

PRESENTATION
1 blister strips of 10 tablets are packed in a printed carton along with a leaet.
 

STORAGE

Store in the original blister package in order to protect from light and moistureStore below 30'C
 

SHELF LIFE

Expiry date is stated on the carton.