Posology: Adults with normal renal function (GFR ≥90 ml/min): The recommended dose is one tablet twice daily. The dosage should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability using the recommended daily dose of 10 mg or 25 mg of empagliflozin, while not exceeding the maximum recommended daily dose of metformin.
For patients insufficiently controlled on metformin (either alone or in combination with other medicinal products for the treatment of diabetes): In patients insufficiently controlled on metformin alone or in combination with other medicinal products for the treatment of diabetes, the recommended starting dose of Jardiance Duo should provide empagliflozin 5 mg twice daily (10 mg daily dose) and the dose of metformin similar to the dose already being taken. In patients tolerating a total daily dose of empagliflozin 10 mg and who need tighter glycaemic control, the dose can be increased to a total daily dose of empagliflozin 25 mg. When Jardiance Duo is used in combination with a sulphonylurea and/or insulin, a lower dose of sulphonylurea and/or insulin may be required to reduce the risk of hypoglycemia (see Interactions and Adverse Reactions).
For patients switching from separate tablets of empagliflozin and metformin: Patients switching from separate tablets of empagliflozin (10 mg or 25 mg total daily dose) and metformin to Jardiance Duo should receive the same daily dose of empagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
For the different doses of metformin, Jardiance Duo is available in strengths of 5 mg empagliflozin plus 500 mg metformin hydrochloride, 5 mg empagliflozin plus 850 mg metformin hydrochloride, 5 mg empagliflozin plus 1,000 mg metformin hydrochloride, 12.5 mg empagliflozin plus 500 mg metformin hydrochloride, 12.5 mg empagliflozin plus 850 mg metformin hydrochloride, and 12.5 mg empagliflozin plus 1,000 mg metformin hydrochloride.
Missed dose: If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same time. In that case, the missed dose should be skipped.
Special populations: Renal impairment: No dose adjustment is recommended for patients with mild renal impairment. A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
If no adequate strength of Jardiance Duo is available, individual monocomponents should be used instead of the fixed dose combination. (See Table 9.)
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Hepatic impairment: This medicinal product must not be used in patients with hepatic impairment (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Elderly: Due to the mechanism of action, decreased renal function will result in reduced glycaemic efficacy of empagliflozin. Because metformin is excreted by the kidney and elderly patients are more likely to have decreased renal function, Jardiance Duo should be used with caution in these patients. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see Contraindications and Precautions). In patients 75 years and older, an increased risk for volume depletion should be taken into account (see Precautions and Adverse Reactions). Due to the limited therapeutic experience with empagliflozin in patients aged 85 years and older, initiation of therapy in this population is not recommended (see Precautions).
Paediatric population: The safety and efficacy of Jardiance Duo in children and adolescents aged 0 to 18 years has not been established. No data are available.
Method of administration: Jardiance Duo should be taken twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin. The tablets should be swallowed whole with water. All patients should continue their diet with an adequate distribution of carbohydrate intake during the day. Overweight patients should continue their energy restricted diet.