The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Budesonide gastro-resistant capsule (Budenofalk®) has been accepted for symptomatic relief of chronic diarrhoea due to collagenous colitis.
Budesonide 9mg gastro-resistant granules (Budenofalk®) have been accepted for the induction of remission in patients with active collagenous colitis.
Dapagliflozin (Forxiga®) has been accepted for restricted use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control. Recommended use is restricted to use as dual therapy in combination with metformin, when metformin alone with diet and exercise does not provide adequate glycaemic control and a sulphonylurea is inappropriate.
Etoricoxib (Arcoxia®) has been rejected for use in the short-term treatment of moderate pain associated with dental surgery.
Glycopyrronium (Seebri Breezhaler®) has been accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Hydrocortisone (Plenadren®) has been rejected for the treatment of adrenal insufficiency in adults. The manufacturer failed to make a submission.
Tadalafil (Cialis®) has been rejected for the treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. The manufacturer failed to make a submission.
Vildagliptin (Galvus®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus in adults as monotherapy in patients inadequately controlled by diet and exercise alone. Recommended use is restricted to patients for whom both metformin and sulphonylureas are inappropriate due to contraindications or intolerance.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
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