METFORMIN COLONIS

25 ml) metformin hydrochloride 2 or 3 times daily given during or after meals. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability.

The maximum recommended dose of metformin hydrochloride is 3 g (15 ml) daily, taken as 3 divided doses. If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin at the dose indicated above.

Combination with insulin Metformin hydrochloride and insulin may be used in combination therapy to achieve better blood glucose control. 25 ml) 2 or 3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.

Elderly Due to the potential for decreased renal function in elderly subjects, the metformin hydrochloride dosage should be adjusted based on renal function. 4). 25 ml) metformin hydrochloride, once daily. The maximum dose is 1000 mg (5 ml) daily, given as 2 divided doses.

The renal function should be closely monitored (every 3-6 months). 73 m2 respectively, metformin hydrochloride must be discontinued immediately. Paediatric population Monotherapy and combination with insulin • Metformin Colonis Oral Solution can be used in children from 10 years of age and adolescents.

25 ml) metformin hydrochloride once daily, given during or after meals. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 2 g (10 ml) daily, taken as 2 or 3 divided doses.

Method of administration Metformin Colonis oral solution is for oral use only. A graduated oral syringe and a Press-In Bottle Adapter (PIBA) are provided with the product. Open the bottle and at first use insert the Press-In Bottle Adapter (PIBA).

Insert the syringe into the PIBA and draw out the required volume from the inverted bottle. Discharge the syringe contents into the mouth. Repeat steps 2 to 4 as needed to achieve the required dose. 5. Rinse the syringe and replace the cap on the bottle (PIBA remains in place).

A graduated dosing spoon of 10 ml is also included in the pack. Note If necessary, Metformin Colonis oral solution can be administered via a gastric, duodenal, and nasal feeding tube, that should be rinsed twice with 10 ml of water immediately after administration.

During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite which resolve spontaneously in most cases. To prevent them, it is recommended to take metformin hydrochloride in 2 or 3 daily doses and to increase the doses slowly.

The following adverse reactions may occur under treatment with metformin. Frequencies are defined as follows: very common: ≥1/10; common ≥1/100, <1/10; uncommon ≥1/1,000, <1/100; rare ≥1/10,000, <1/1,000; very rare <1/10,000. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

4). 4). Nervous system disorders Common • Taste disturbance. Gastrointestinal disorders Very common • Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases.

To prevent them, it is recommended that metformin hydrochloride be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability. Hepatobiliary disorders Very rare • Isolated reports of liver function tests abnormalities or hepatitis resolving upon metformin hydrochloride discontinuation.

Skin and subcutaneous tissue disorders Very rare • Skin reactions such as erythema, pruritus, and urticaria. Paediatric population In published and post marketing data and in controlled clinical studies in a limited paediatric population aged 10-16 years treated during 1 year, adverse event reporting was similar in nature and severity to that reported in adults.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Lactic acidosis Lactic acidosis is a very rare, but serious (high mortality rate in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation. Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with impaired renal failure or acute worsening of renal function.

Special caution should be paid to situations where renal function may become impaired, for example in case of dehydration (severe diarrhoea or vomiting), or when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID).

In the acute conditions listed, metformin hydrochloride should be temporarily discontinued. 3). The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps, digestive disorders as abdominal pain and severe asthenia.

Patients should be instructed to notify these signs immediately to their physicians if they occur, notably if patients had a good tolerance to metformin before. Metformin hydrochloride should be discontinued, at least temporarily, until the situation is clarified.

Reintroduction of metformin should then be discussed taking into account the benefit/risk ratio on an individual basis as well as renal function.

Diagnosis:

Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma. Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/L, and an increased anion gap and lactate/pyruvate ratio.

9). Physicians should alert patients to the risk and the symptoms of lactic acidosis. 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. Renal function As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) or eGFR should be determined before initiating treatment and regularly thereafter: • at least annually in patients with normal renal function, • at least two to four times a year in patients with creatinine clearance at the lower limit of normal, and in elderly subjects.

3). Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example in case of dehydration, or when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID).

In these cases, it is also recommended to check renal function before initiating treatment with metformin hydrochloride. Cardiac function Patients with heart failure are more at risk of hypoxia and renal insufficiency. In patients with stable chronic heart failure, metformin hydrochloride may be used with regular monitoring of cardiac and renal function.

3). Administration of iodinated contrast media The intravascular administration of iodinated contrast media in radiologic studies can lead to renal failure. This may induce metformin accumulation and may increase the risk for lactic acidosis.

5). 5). Surgery Metformin hydrochloride must be discontinued 48 hours before elective surgery under general, spinal or peridural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established.

Paediatric population The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin hydrochloride is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available.

Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended. Children aged between 10 and 12 years Only 15 subjects aged between 10 and 12 years were included in the controlled clinical studies conducted in children and adolescents.

Although efficacy and safety of metformin hydrochloride in these children did not differ from efficacy and […]

1. • Diabetic ketoacidosis, diabetic pre-coma. 73 m2). • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock. • Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.

• Hepatic insufficiency, acute alcohol intoxication, alcoholism.