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Synjardy is a brand name for Empagliflozin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Synjardy is indicated in adults and children aged 10 years and above for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: • in patients insufficiently controlled on their maximally tolerated dose of metformin alone • in combination with other medicinal products for the treatment of…
Verbatim from this product's EMA label. Tap a section to expand.
73 m2) 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 Synjardy 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. 8). 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 Synjardy should receive the same daily dose of empagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin (for available strengths see section 2).
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 The glycaemic efficacy of empagliflozin is dependent on renal function.
73 m2 (see Table 1). Because the glycaemic lowering efficacy of empagliflozin is reduced in patients with moderate renal impairment and likely absent in patients with 4 severe renal impairment, if further glycaemic control is needed, the addition of other anti- hyperglycaemic agents should be considered.
For dose adjustment recommendations according to eGFR or CrCL refer to Table 1. A eGFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. g. every 3-6 months. If no adequate strength of Synjardy is available, individual monocomponents should be used instead of the fixed dose combination.
For dosing recommendations in the paediatric population see subsection paediatric patients below. 73 m²] or CrCL [ml/min] Metformin Empagliflozin ≥60 Maximum daily dose is 3000 mg. Dose reduction may be considered in relation to declining renal function.
Summary of the safety profile The most commonly reported adverse reactions in clinical trials were hypoglycaemia in combination with insulin and/or sulphonylurea and gastrointestinal symptoms (nausea, vomiting, diarrhoea, abdominal pain and loss of appetite).
No additional adverse reactions were identified in clinical trials with empagliflozin as add-on to metformin compared to the side effects of the single components. Tabulated list of adverse reactions The adverse reactions are listed by absolute 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), or very rare (<1/10,000), and not known (cannot be estimated from the available data). 13 Table 2: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studies and from post-marketing experience System organ class Very common Common Uncommon Rare Very rare Infections and infestations Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection1, 2 Urinary tract infection (including pyelonephritis and urosepsis)1, 2 Necrotising fasciitis of the perineum (Fournier´s gangrene) a Metabolism and nutrition disorders Hypoglycaemia (when used with sulphonylurea or insulin)1 Thirst2 Vitamin B12 decrease/deficiency3,a Diabetic ketoacidosis a Lactic acidosis3 Nervous system disorders Taste disturbance3 Vascular disorders Volume depletion1, 2, d Gastrointestinal disorders Gastrointestinal symptoms3, 4 Constipation Hepatobiliary disorders Liver function tests abnormalities3 Hepatitis3 Skin and subcutaneous tissue disorders Pruritus (generalised)2, 3 Rash Urticaria Angioedema Erythema3 Renal and urinary disorders Increased urination1, 2 Dysuria2 Tubulointerstitial nephritis Investigations Serum lipids increased2, b Blood creatinine increased/ Glomerular filtration rate decreased1 Haematocrit increased2, c 1 See subsections below for additional information 2 Identified adverse reactions of empagliflozin monotherapy 3 Identified adverse reactions of metformin monotherapy 4 Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
4) 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 or reduced fluid intake), metformin 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 NSAIDs) should be initiated with caution in metformin-treated patients.
5). Patients and/or care-givers should be informed of the risk of lactic acidosis. Lactic acidosis is characterised by acidotic dyspnea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma. In case of suspected symptoms, the patient should stop taking metformin 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.
6 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. Diabetic ketoacidosis Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including empagliflozin.
In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl). It is not known if DKA is more likely to occur with higher doses of empagliflozin.
1. 4). • Diabetic pre-coma. 4). 8). 4). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Initiate with 10 mg. In patients tolerating 10 mg and requiring additional glycaemic control, the dose can be increased to 25 mg. 45 to <60 Maximum daily dose is 2000 mg. The starting dose is at most half of the maximum dose. b Continue with 10 mg in patients already taking empagliflozin.
30 to <45 Maximum daily dose is 1000 mg. The starting dose is at most half of the maximum dose. Initiate with 10 mg. b <30 Metformin is contraindicated. Empagliflozin is not recommended. 2). 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, Synjardy should be used with caution in these patients. 4). 8). Paediatric population The dosage should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability.
If empagliflozin is added in patients already receiving metformin, the metformin dose should remain the same as the patient is already taking. The recommended empagliflozin starting dose is 5 mg twice daily (10 mg total daily doses).
5 mg twice daily (25 mg total daily dose). If patients switching from separate tablets of empagliflozin and metformin to Synjardy the same daily dose of empagliflozin and metformin should remain as already being taken or the nearest therapeutically appropriate dose of metformin.
2). 73 m² and children below 10 years of age. Method of administration Synjardy 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.
1%. 0% for empagliflozin 10 mg and 25 mg, respectively, compared to 0% for placebo. In the EMPA-REG Outcome study, haematocrit values returned towards baseline values after a follow-up period of 30 days after treatment stop. 7% for placebo).
14 Description of selected adverse reactions Hypoglycaemia The frequency of hypoglycaemia depended on the background therapy in the respective studies and was similar for empagliflozin and placebo as add-on to metformin, as add-on to linagliptin and metformin, for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components, and as adjunct to standard care therapy.
7%). Major hypoglycaemia (events requiring assistance) The overall frequency of patients with major hypoglycaemic events was low (<1%) and similar for empagliflozin and placebo as add-on to metformin, and for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components, and as adjunct to standard care therapy.
5% of patients treated with empagliflozin 10 mg, empagliflozin 25 mg and placebo when added on to metformin and insulin, respectively. No patient had a major hypoglycaemic event in the combination with metformin and a sulphonylurea and as add-on to linagliptin and metformin.
8%). Similar to placebo, urinary tract infection was reported more frequently for empagliflozin in patients with a history of chronic or recurrent urinary tract infections. e. mild/moderate/severe) was similar to placebo. Urinary tract infection events were reported more frequently for empagliflozin 10 mg compared with placebo in female patients, but not for empagliflozin 25 mg.
The frequencies of urinary tract infections were low for male patients and were balanced across treatment groups. 3%), and were reported more frequently for empagliflozin compared to placebo in female patients. The difference in frequency was less pronounced in male patients.
Genital tract infections were mild and moderate in intensity, none was severe in intensity. Cases of phimosis/acquired phimosis have been reported concurrent with genital infections and in some cases, circumcision […]
The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
In patients where DKA is suspected or diagnosed, treatment with empagliflozin should be discontinued immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Monitoring of ketones is recommended in these patients. Measurement of blood ketone levels is preferred to urine. Treatment with empagliflozin may be restarted when the ketone values are normal and the patient’s condition has stabilised.
Before initiating empagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered. Prolonged diabetic ketoacidosis and prolonged glucosuria have been observed with empagliflozin. 2). Empagliflozin-independent factors, such as insulin deficiency, might be involved in prolonged periods of diabetic ketoacidosis.
g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
SGLT2 inhibitors should be used with caution in these patients. Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
Synjardy should not be used in patients with type 1 diabetes. Data from a clinical trial program in patients with type 1 diabetes showed increased DKA occurrence with common frequency in patients treated with empagliflozin 10 mg and 25 mg as an adjunct to insulin compared to placebo.
Administration of iodinated contrast agent Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis. 5). 7 Renal impairment Due to the mechanism of action, decreased renal function will result in reduced glycaemic efficacy of empagliflozin.
3). e. 2). - Prior to initiation of any concomitant medicinal product that may have a […]