Vipdomet

5 mg/1 000 mg film-coated tablets. Adults (≥ 18 years old) with normal renal function (glomerular filtration rate (GFR) ≥ 90 mL/min) The dose should be individualised on the basis of the patient’s current treatment regimen. 5 mg/1 000 mg twice daily, corresponding to 25 mg alogliptin plus 1 700 mg or 2 000 mg metformin hydrochloride daily, depending on the dose of metformin hydrochloride already being taken.

5 mg twice daily (25 mg total daily dose) and metformin hydrochloride at a similar dose (either 850 mg or 1 000 mg twice daily) to that already being taken. 4). In case of hypoglycaemia, a lower dose of the thiazolidinedione or metformin may be considered.

For patients switching from separate tablets of alogliptin and metformin (as dual therapy or as part of triple therapy with insulin), both alogliptin and metformin should be dosed at the total daily dose already being taken; the individual dose of alogliptin should be halved as it will be taken twice daily whilst the dosing of metformin should remain unchanged.

5 mg twice daily (25 mg total daily dose) and a dose of metformin similar to the dose already being taken. A lower dose of insulin may be considered to reduce the risk of hypoglycaemia. Maximum daily dose The maximum recommended daily dose of 25 mg alogliptin should not be exceeded.

Special populations Elderly (≥ 65 years old) No dose adjustment is necessary based on age. However, dosing of alogliptin should be conservative in patients with advanced age due to the potential for decreased renal function in this population Renal impairment A GFR should be assessed before initiation of treatment with metformin containing medicinal products and at least annually thereafter.

g every 3-6 months. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. 4) should be reviewed before considering initiation of metformin in patients with GFR < 60 mL/min. If no adequate strength of Vipdomet is available, individual monocomponents should be used instead of the fixed dose combination.

4 GFR mL/min Metformin Alogliptin* 60-89 Maximum daily dose is 3 000 mg Dose reduction may be considered in relation to declining renal function. No dose adjustment Maximum daily dose is 25 mg 45-59 Maximum daily dose is 2 000 mg The starting dose is at most half of the maximum dose.

4). 4). 4). 4) which are attributed to Vipdomet. Clinical studies conducted to support the efficacy and safety of Vipdomet involved the co-administration of alogliptin and metformin as separate tablets. However, the results of bioequivalence studies have demonstrated that Vipdomet film-coated tablets are bioequivalent to the corresponding doses of alogliptin and metformin co-administered as separate tablets.

The information provided is based on a total of 7 150 patients with type 2 diabetes mellitus, including 4 201 patients treated with alogliptin and metformin, who participated in 7 phase 3 double-blind, placebo- or active-controlled clinical studies.

These studies evaluated the effects of co-administered alogliptin and metformin on glycaemic control and their safety as initial combination therapy, as dual therapy in patients initially treated with metformin alone, and as add-on therapy to a thiazolidinedione or insulin.

Tabulated list of adverse reactions The adverse reactions are listed by system organ class and frequency. Frequencies are defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000), not known (cannot be estimated from available data).

4). Gastrointestinal symptoms occur most frequently during initiation of therapy and resolve spontaneously in most cases. These may be prevented by taking metformin in 2 daily doses during or after meals. Isolated cases of hepatitis or liver function test abnormalities resolving on discontinuation of metformin have been reported.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

General Vipdomet should not be used in patients with type 1 diabetes mellitus. Vipdomet is not a substitute for insulin in insulin-requiring patients. Lactic acidosis Lactic acidosis, a very rare but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis.

Metformin accumulation occurs at acute worsening of renal function and increases the risk of lactic acidosis. In case of dehydration (severe diarrhoea or vomiting, fever, heat, reduced fluid intake) Vipdomet should be temporarily discontinued and contact with a health care professional is recommended.

Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs)) should be initiated with caution in metformin-treated patients. 5). Patients and/or care-givers should be informed on the risk of lactic acidosis.

Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma. In case of suspected symptoms, the patient should stop taking Vipdomet and seek immediate medical attention.

35), increased plasma lactate levels (> 5 mmol/L) and an increased anion gap and lactate/pyruvate ratio. Patients with known or suspected mitochondrial diseases In patients with known mitochondrial diseases such as Mitochondrial Encephalopathy with Lactic Acidosis, and Stroke-like episodes (MELAS) syndrome and Maternal inherited diabetes and deafness (MIDD), metformin is not recommended due to the risk of lactic acidosis exacerbation and neurologic complications which may lead to worsening of the disease.

In case of signs and symptoms suggestive of MELAS syndrome or MIDD after the intake of metformin, treatment with metformin should be withdrawn immediately and prompt diagnostic evaluation should be performed. Administration of iodinated contrast agents Intravascular administration of iodinated contrast media may lead to contrast induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.

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