Metformin 500mg tablets (PL 16363/0111) - Summary of Product Characteristics (SmPC) (2023)

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Metformin 500mg tablets (PL 16363/0111)

Active Ingredient:

metformin hydrochloride

Company:

Aurobindo Pharma - Milpharm Ltd.See contact details

ATC code:

A10BA02

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Last updated on emc:24 Feb 2023

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Undesirable EffectsPharmacological PropertiesInteractionsPosologyContraindicationsExcipients

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1. Name of the medicinal product

Metformin 500mg Tablets

2. Qualitative and quantitative composition

Each film-coated tablet contains metformin hydrochloride 500mg.

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet

White coloured, film-coated, round, biconvex tablets embossed with 'M 500' on one side.

4. Clinical particulars
4.1 Therapeutic indications

Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.

• In adults, Metformin tablets may be used as monotherapy or in combination with other oral anti-diabetic agents, or with insulin.

• In children from 10 years of age and adolescents, Metformin tablets may be used as monotherapy or in combination with insulin.

A reduction of diabetic complications has been shown in overweight type 2 diabetic patients treated with metformin as first-line therapy after diet failure (see section 5.1).

4.2 Posology and method of administration

Posology

Adults with normal renal function (GFR≥ 90 mL/min)

Monotherapy and combination with other oral antidiabetic agents

The usual starting dose is 500 mg or 850 mg 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 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 and insulin may be used in combination therapy to achieve better blood glucose control. Metformin hydrochloride is given at the usual starting dose of 500 mg or 850 mg 2 or 3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.

Elderly

Due to potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see section 4.4)

Renal impairment

A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at an 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.

GFR (mL/min)

Total maximum daily dose

(to be divided into 2-3 daily doses)

Additional considerations

60-89

3000 mg

Dose reduction may be considered in relation to declining renal function

45-59

2000 mg

Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin. The starting dose is at most half of the maximum dose.

30-44

1000 mg

<30

-

Metformin is contraindicated

Paediatric population

Monotherapy and combination with insulin

• Metformin tablets can be used in children from 10 years of age and adolescents.

• The usual starting dose is one tablet of 500 mg or 850 mg 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 daily, taken as 2 or 3 divided doses.

4.3 Contraindications

• Hypersensitivity to metformin or to any of the Excipients listed in section 6.1.

• Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)

• Diabetic pre-coma

• Severe renal failure (GFR <30 mL/min)

• 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

4.4 Special warnings and precautions for use

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. Other risk factors for lactic acidosis are inadequately controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any condition associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see section 4.3 and 4.5).

Patients and/or care-givers should be informed of 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 metformin and seek immediate medical attention. Diagnostic laboratory findings are decreased blood pH (<7.35), increased plasma lactate levels (>5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.

Renal function

GFR should be assessed before treatment initiation and regularly thereafter, see section 4.2. Metformin is contraindicated in patients with GFR <30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.

Cardiac function

Patients with heart failure are more at risk of hypoxia and renal insufficiency. In patients with stable chronic heart failure, metformin may be used with a regular monitoring of cardiac and renal function.

For patients with acute and unstable heart failure, metformin is contraindicated (see section 4.3).

Administration of iodinated contrast agents

Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy resulting in metformin accumulation and an increased risk of lactic acidosis. Metformin should be discontinued prior to, or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 4.5)

Surgery

Metformin Hydrochloride must be discontinued at the time of surgery under general, spinal or epidural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.

Paediatric population

The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin 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 on these specific points are available.

Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially pre-pubescent 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 in these children did not differ from efficacy and safety in older children and adolescents, particular caution is recommended when prescribing to children aged between 10 and 12 years.

Other precautions

All patients should continue their diet with a regular distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet.

The usual laboratory tests for diabetes monitoring should be performed regularly.

Metformin may reduce vitamin B12 serum levels. The risk of low vitamin B12 levels increases with increasing metformin dose, treatment duration, and/or in patients with risk factors known to cause vitamin B12 deficiency. In case of suspicion of vitamin B12 deficiency (such as anaemia or neuropathy), vitamin B12 serum levels should be monitored. Periodic vitamin B12 monitoring could be necessary in patients with risk factors for vitamin B12 deficiency. Metformin therapy should be continued for as long as it is tolerated and not contra-indicated and appropriate corrective treatment for vitamin B12 deficiency provided in line with current clinical guidelines.

Metformin alone does not cause hypoglycaemia, but caution is advised when it is used in combination with insulin or other oral antidiabetics (e.g. sulfonylureas or meglitinides).

Metformin tablets contains Sodium:

Metformin tablets contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially 'sodium-free.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use not recommended

Alcohol:

Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic impairment.

Iodinated contrast agents:

Metformin must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4.

Combinations requiring precautions for use:

Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclooxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics. When starting or using such products in combination with metformin, close monitoring of renal function is necessary.

Medicinal products with intrinsic hyperglycaemic activity (e.g. glucocorticoids (systemic and local routes) and sympathomimetics)

More frequent blood glucose monitoring may be required, especially at the beginning of the treatment. If necessary, adjust the metformin dosage of the antidiabetic drug during therapy with the respective medicinal product and upon its discontinuation.

Organic cation transporters (OCT)

Metformin is a substrate of both transporters OCT1 and OCT2.

Co-administration of metformin with

• Inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin.

• Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin.

• Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.

• Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin.

Caution is therefore advised, especially in patients with renal impairment, when these drugs are co-administered with metformin, as metformin plasma concentration may increase. If needed, dose adjustment of metformin may be considered as OCT inhibitors/inducers may alter the efficacy of metformin.

4.6 Fertility, pregnancy and lactation

Pregnancy

Uncontrolled hyperglycaemia in the periconceptional phase and during pregnancy is associated with increased risk of congenital abnormalities, pregnancy loss, pregnancy-induced hypertension, preeclampsia, and perinatal mortality. It is important to maintain blood glucose levels as close to normal as possible throughout pregnancy, to reduce the risk of adverse hyperglycaemia-related outcomes to the mother and her child.

Metformin crosses the placenta with levels that can be as high as maternal concentrations

A large amount of data on pregnant women (more than 1000 exposed outcomes) from a register-based cohort study and published data (meta-analyses, clinical studies, and registries) indicates no increased risk of congenital abnormalities nor feto/neonatal toxicity after exposure to metformin in the periconceptional phase and/or during pregnancy.

There is limited and inconclusive evidence on the metformin effect on the long-term weight outcome of children exposed in utero. Metformin does not appear to affect motor and social development up to 4 years of age in children exposed during pregnancy although data on long term outcomes are limited.

If clinically needed, the use of metformin can be considered during pregnancy and in the periconceptional phase as an addition or an alternative to insulin.

Breast-feeding

Metformin is excreted into human breast milk. No adverse effects were observed in breastfed newborns/infants. However, as only limited data are available, breast-feeding is not recommended during metformin treatment. A decision on whether to discontinue breast-feeding should be made, taking into account the benefit of breast-feeding and the potential risk to adverse effects on the child.

Fertility

Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.

4.7 Effects on ability to drive and use machines

Metformin monotherapy does not cause hypoglycaemia and therefore has no effect on the ability to drive or to use machines.

However, patients should be alerted to the risk of hypoglycaemia when metformin is used in combination with other antidiabetic agents (e.g. sulfonylureas, insulin, or meglitinides).

4.8 Undesirable effects

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 in 2 or 3 daily doses and to increase slowly the doses.

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, not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Metabolism and nutrition disorders

Common

• Vitamin B12 decrease/deficiency (see section 4.4).

Very rare

• Lactic acidosis (see section 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, 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 products 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g, although lactic acidosis has occurred in such circumstances. High overdose of metformin or concomitant risks may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Blood glucose lowering drugs. Biguanide oral hypoglycaemic agents-ATC code: A10BA02

Mechanism of action

Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and post-prandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.

Metformin may act via 3 mechanisms:

• reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis.

• in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilisation.

• and delay of intestinal glucose absorption.

Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.

Metformin increases the transport capacity of all types of membrane glucose transporters (GLUTs) known to date.

Pharmacodynamic effects

In clinical studies, use of metformin was associated with either a stable body weight or modest weight loss.

In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism. This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: Metformin reduces total cholesterol, LDL, cholesterol and triglyceride levels.

Clinical efficacy

The prospective randomised study (UKPDS) has established the long-term benefit of intensive blood glucose control in adult patients with type 2 diabetes.

Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:

• a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1000 patients-years) versus diet alone (43.3 events/1000 patient-years), p= 0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1000 patients-years), p=0.0034.

• a significant reduction of the absolute risk of the diabetes-related mortality: Metformin 7.5 events/1000 patient-years, diet alone 12.7 events/1000 patient-year, p=0.017

• a significant reduction of the absolute risk of overall mortality: metformin hydrochloride 13.5 events/1000 patient-years versus diet alone 20.6 events/1000 patient-years (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1000 patient-years (p = 0.021)

• a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1000 patients-years, diet alone 18 events/1000 patient-years (p=0.01)

Benefit regarding clinical outcome has not been shown for metformin used as second-line therapy, in combination with a sulfonylurea.

In type I diabetes, the combination of metformin and insulin has been used in selected patients, but the clinical benefit of this combination has not been formally established.

Paediatric population

Controlled clinical studies in a limited paediatric population aged 10-16 years treated during 1 year demonstrated a similar response in glycaemic control to that seen in adults.

5.2 Pharmacokinetic properties

Absorption

After an oral dose of metformin hydrochloride tablet, maximum plasma concentration (Cmax) is reached in 2.5 hours (tmax). Absolute bioavailability of a 500mg or 850mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects. After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.

After oral administration, metformin absorption is saturable and incomplete. It is assumed that the pharmacokinetics of metformin absorption is non-linear.

At the recommended metformin doses and the dosing schedules, steady state plasma concentrations are reached within 24 to 48 hours and are generally less than 1μg/ml. In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 microgram/ml, even at maximum doses.

Food decreases the extent and slightly delays the absorption of metformin.

Following oral administration of a dose of 850 mg tablet, a 40% lower plasma peak concentration a 25% decrease in AUC (area under the curve) and a 35 minute prolongation of the time to peak plasma concentration were observed. The clinical relevance of these findings is unknown.

Distribution

Plasma protein binding is negligible. Metformin partitions into erythrocytes. The blood peak is lower than the plasma peak and appears approximately the same time. The red blood cells most likely represent a secondary compartment of distribution. The mean volume of distribution (Vd) ranged between 63-276 L.

Metabolism

Metformin is excreted unchanged in the urine. No metabolites have been identified in humans.

Elimination

Renal clearance of metformin is >400ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion. Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.

When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.

Characteristics in specific groups of patients

Renal impairment

The available data in subjects with moderate renal insufficiency are scarce and no reliable estimation of the systemic exposure to metformin in this subgroup as compared to subjects with normal renal function could be made. Therefore, the dose adaptation should be made upon clinical efficacy/tolerability considerations (see section 4.2).

Paediatric population

Single dose study: After single doses of metformin hydrochloride 500 mg, paediatric patients have shown similar pharmacokinetic profile to that observed in healthy adults.

Multiple dose study: Data are restricted to one study. After repeated doses of 500 mg twice daily for 7 days in paediatric patients the peak plasma concentration (Cmax) and systemic exposure (AUC0-t) were reduced by approximately 33% and 40%, respectively compared to diabetic adults who received repeated doses of 500 mg twice daily for 14 days. As the dose is individually titrated based on glycaemic control, this is of limited clinical relevance.

5.3 Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies on safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and reproductive toxicity.

6. Pharmaceutical particulars
6.1 List of excipients

Core

Sodium starch glycollate

Maize starch

Povidone

Colloidal anhydrous silica

Magnesium Stearate

Film-coating

Hypromellose

Titanium dioxide (E171)

Propylene Glycol

Macrogol 6000

Purified talc

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 Years

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package. Keep the containers tightly closed.

6.5 Nature and contents of container

Blister: Transparent PVC /PVdC/Aluminium foil. Packs of 28, 84 and 504's tablets in a carton

Opaque PVC /PVdC/Aluminium foil. Packs of 28, 84 and 504's tablets in a carton

Plastic securitainers with a tamper proof closures; 500 tablets

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Not applicable

7. Marketing authorisation holder

Milpharm Limited,

Ares,

Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

8. Marketing authorisation number(s)

PL 16363/0111

9. Date of first authorisation/renewal of the authorisation

19/02/2009

10. Date of revision of the text

21/02/2023

Aurobindo Pharma - Milpharm Ltd.

Metformin 500mg tablets (PL 16363/0111) - Summary of Product Characteristics (SmPC) (21)

Address

Odyssey Business Park, Ares Block, West End Road, South Ruislip, Middlesex, HA4 6QD

Telephone

+ 44 (0)208 845 8811

Medical Information e-mail

[emailprotected]

Customer Care direct line

+44 (0)208 845 8811

Medical Information Fax

+44 (0)208 845 8795

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FAQs

What are the characteristics of metformin? ›

Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and post-prandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.

What is metformin 500mg tablets used for? ›

Metformin is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly.

What is the best time to take metformin 500 mg? ›

It's best to take metformin tablets with, or just after, your evening meal to reduce the chance of getting side effects. Swallow your metformin tablets whole with a drink of water. Do not chew them.

How many 500mg metformin can you take a day? ›

Metformin alone (Glumetza®): At first, 500 mg once a day taken with the evening meal. Then, your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2000 mg per day. Metformin with a sulfonylurea: Your doctor will determine the dose of each medicine.

Which characteristic of metformin makes it a popular selection for diabetes care? ›

“Metformin is so popular because it is inexpensive and can reduce the glucose level and A1C [blood sugar average for three months] the most compared with other diabetes medications,” says Dr.

What characteristics of metformin make it the preferred choice as a first therapy? ›

Metformin is recommended as the first-line drug of choice for several reasons, including its efficacy, tolerability, safety and cost-effectiveness.

What diseases does metformin treat? ›

Metformin is used alone or with other medications, including insulin, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Metformin is in a class of drugs called biguanides.

What drugs should not be taken with metformin? ›

Carbonic anhydrase inhibitors

They include diuretics like acetazolamide and methazolamide. They also include seizure medications like topiramate (Topamax) and zonisamide (Zonegran). These medications can interact with metformin by raising the risk of a medical condition called lactic acidosis.

What happens to your body when you start taking metformin? ›

Nausea and diarrhea are common side effects of metformin, but they usually improve within a few weeks of starting the medication. You can limit these side effects by taking metformin with food. Metformin can cause more serious side effects like lactic acidosis, low vitamin B12 levels, and low blood sugar.

Is metformin hard on your kidneys? ›

Metformin doesn't cause kidney damage. The kidneys process and clear the medication out of your system through your urine. If your kidneys don't function properly, there's concern that metformin can build up in your system and cause a condition called lactic acidosis.

What fruits should diabetics avoid? ›

Diabetics should avoid fruits with a high GI or eat them in moderation so that their blood sugar levels do not spike abruptly. Pineapple, watermelon, mango, lychee, and banana have a high GI, so these are the worst fruits if you are diabetic.

Does metformin make you sleepy? ›

Anemia: Metformin can interfere with the body's ability to absorb vitamin B12, which plays an important role in healthy red blood cells. If this happens, it can lead to anemia, which may cause symptoms like extreme tiredness, feeling cold all the time, and dizziness.

Can I take metformin at night before bed? ›

The administration of metformin, as glucophage retard, at bedtime instead of supper time may improve diabetes control by reducing morning hyperglycemia.

What happens when you stop taking metformin? ›

Risks of stopping metformin

If left untreated, high blood glucose levels can lead to complications, such as: impaired vision, or diabetic retinopathy. kidney problems, or diabetic nephropathy. nerve damage, or diabetic neuropathy.

Can metformin cause weight loss? ›

Conclusion: Metformin is an effective drug to reduce weight in a naturalistic outpatient setting in insulin sensitive and insulin resistant overweight and obese patients.

Which metformin is best for diabetes? ›

Obimet. Obimet is often the first choice of metformin brands for people with diabetes and obesity. Obimet lowers hypoglycaemia risks and comes in blister packs of ten tablets, usually either 500mg or 1000mg. Obimet is sometimes prescribed as an initial therapy, or may be delivered alongside a sulphonylurea.

How successful is metformin for diabetes? ›

EVIDENCE METFORMIN IS EFFECTIVE

Any diabetes-related end point (hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.53–0.87) Myocardial infarction (HR 0.61, 95% CI 0.41–0.89) Diabetes-related death (HR 0.58, 95% CI 0.37–0.91) All-cause mortality (HR 0.64; 95% CI 0.45–0.91).

What type of diabetes requires metformin? ›

Metformin is a medication that helps the insulin you produce work better. You usually take it as a tablet. Metformin is the most common treatment for type 2 diabetes. You might also take it if you have gestational diabetes.

Why is metformin the best treatment for diabetes? ›

Metformin lowers, rather than increases, fasting plasma insulin concentrations and acts by enhancing insulin sensitivity, inducing greater peripheral uptake of glucose, and decreasing hepatic glucose output.

What is normal A1C for a 70 year old? ›

For functionally independent older adults, the IDF recommends an A1C goal of 7–7.5%, whereas for functionally dependent, frail patients or patients with dementia, an A1C goal of 7–8% is recommended.

What are the two most common side effects of metformin? ›

Common side effects
  • Feeling sick (nausea) Take metformin with food to reduce the chances of feeling sick. ...
  • Being sick (vomiting) Take small, frequent sips of water or squash to avoid dehydration. ...
  • Diarrhoea. ...
  • Stomach ache. ...
  • Loss of appetite. ...
  • A metallic taste in the mouth.

Does metformin cause joint and muscle pain? ›

Conclusions: People with diabetes taking metformin were less likely to report back, knee, neck/shoulder and multisite musculoskeletal pain than those not taking metformin. Therefore, when treating these patients, clinicians should be aware that metformin may contribute to fewer reports of musculoskeletal pain.

Does metformin lower blood pressure? ›

Abstract—Metformin, an antihyperglycemic agent used for treatment of type 2 diabetes mellitus, lowers blood pressure in humans and experimental animals. We recently demonstrated that short-term administration of metformin may lower blood pressure by reducing sympathetic neural outflow.

Is metformin a serious drug? ›

The safety profile for metformin is quite good. Side effects include nausea, stomach upset, or diarrhea; these tend to be mild. More serious side effects are rare. They include severe allergic reactions and a condition called lactic acidosis, a buildup of lactic acid in the bloodstream.

Is grapes good for diabetics? ›

Grapes are a beloved fruit that is healthy and safe for people with diabetes. They are safe to eat, and you can include them in a diabetic diet because they don't cause a rise in blood sugar. Consuming grapes can lower the risk of getting type 2 diabetes. Due to their fibre content, grapes keep one feeling full.

Can metformin cause heart attacks? ›

In conclusion, this meta-analysis shows that metformin can significantly reduce cardiovascular mortality and all-cause mortality as well as the incidence of cardiovascular events in diabetic and non-diabetic patients with coronary heart disease.

Are bananas good for diabetics? ›

A person with diabetes should include a variety of fresh, whole foods in their diet, such as nutrient-dense fruits and vegetables. Bananas are a safe and nutritious fruit for people with diabetes to eat in moderation as part of a balanced, individualized eating plan.

What organ is affected by metformin? ›

Metformin is a complex drug with multiple sites of action and multiple molecular mechanisms. Physiologically, metformin acts directly or indirectly on the liver to lower glucose production, and acts on the gut to increase glucose utilisation, increase GLP-1 and alter the microbiome.

At what A1C level should you start metformin? ›

Recent guidelines recommend considering use of metformin in patients with prediabetes (fasting plasma glucose 100-125 mg/dL, 2-hr post-load glucose 140-199 mg/dL, or A1C 5.7-6.4%), especially in those who are <60 years old, have a BMI >35 kg/m2, or have a history of gestational diabetes.

Can metformin damage the liver? ›

Conclusion: Metformin does not appear to cause or exacerbate liver injury and, indeed, is often beneficial in patients with nonalcoholic fatty liver disease. Nonalcoholic fatty liver frequently presents with transaminase elevations but should not be considered a contraindication to metformin use.

What pain reliever can I take with metformin? ›

Painkillers. It's fine to take over-the-counter painkillers such as paracetamol, ibuprofen or aspirin with metformin, assuming these are appropriate for you.

How can you tell metformin is working? ›

How to check if metformin is working. A medical provider can run a few tests to see how metformin is affecting your health: Blood work can check if your glucose, insulin, and HbA1C levels are in range. If they are, the medication is working.

Which fruit can heal diabetes? ›

In addition to raspberries, studies have shown that strawberries, blueberries, and blackberries may benefit blood sugar management by enhancing insulin sensitivity and improving glucose clearance from the blood ( 42 , 43 , 44 ).

What is the number one fruit for diabetics? ›

The Best Fruits for People With Diabetes

berries — Both citrus and berries are recommended as superfoods by the American Diabetes Association. cherries. plums. grapefruit.

Which color grapes are best for diabetics? ›

Also, grapes deliver a better insulin control as well as enhances insulin sensitivity. Grapes in all types i.e., green, red, or blue-purple are good for people with diabetes.

Does metformin cause urination? ›

Frequent urination and increased thirst

The body removes the excess glucose in the urine, taking water from the body with it. This can lead to excessive thirst and the need to drink and urinate more.

Does metformin cause leg cramps? ›

Researchers gauged a 23% reduced risk for muscle cramps and a 29% reduced risk for leg and calf pain during walking with the addition of metformin. “Metformin appears to reduce the risk of non-severe statin muscle pain,” they reported.

Can I stop taking metformin suddenly? ›

Risks of stopping metformin

If you stop taking metformin abruptly, your health may suffer. You may experience side effects such as higher blood sugars, an increased A1c, and even weight gain. Over time, higher blood sugar levels can lead to diabetes complications, including: Retinopathy and blindness.

Can you take metformin 30 minutes before meal? ›

Follow the directions on the prescription label. Take this medicine before meals. It should be taken no earlier than 30 minutes before meals. If a meal is skipped, skip the dose for that meal.

Why is my fasting blood sugar always high in the morning? ›

The dawn phenomenon

In the early hours of the morning, hormones, including cortisol and growth hormone, signal the liver to boost the production of glucose, which provides energy that helps you wake up. This triggers beta cells in the pancreas to release insulin in order to keep blood glucose levels in check.

Does metformin keep you awake? ›

Metformin-induced insomnia is also prevalent among obese and elderly patients recently diagnosed with diabetes mellitus. The adverse effect of insomnia is more prevalent in patients than nightmares [4].

Can metformin cause a stroke? ›

Acute administration of metformin immediately prior to focal ischemia may result in higher levels of lactate and paradoxically more severe stroke. This effect was dependent on the presence of AMPK and endothelial nitrous oxide (eNOS). The neuroprotective effects were not evident in AMPK and eNOS knockout mice (31).

Can metformin cause eye problems? ›

Blurry vision is a common side effect associated with a prolonged use of Metformin. This happens due to a deficiency of Vitamin B12 as Metformin is known to affect its absorption.

Should I take metformin for lifelong? ›

How long to take it for. Treatment for diabetes is usually for life. But if your kidneys are not working properly, your doctor will tell you to stop taking metformin and switch you to a different medicine.

Does metformin reduce belly fat? ›

Metformin treatment brought about a significant reduction of visceral fat mass compared to controls accompanied by an up-regulation of fat oxidation-related enzyme in the liver, UCP-1 in the brown adipose tissue and UCP-3 in the skeletal muscle.

Does metformin give you a belly? ›

Digestive Issues

Up to 25% of diabetes patients taking metformin find they have bloating, gas, diarrhea, belly pain, and constipation. Often these side effects disappear on their own. By starting with a low dose and taking metformin with food, you can ease the side effects.

How fast is weight loss on metformin? ›

How Fast Will You Lose Weight on Metformin? Based on the above studies, any weight loss with metformin appears to occur over the course of about 6 to 12 months. But people may see some results earlier.

What are 3 common indications for metformin? ›

Metformin also has several non-FDA-approved indications, including gestational diabetes, management of antipsychotic-induced weight gain, type 2 diabetes prevention, and the treatment and prevention of polycystic ovary syndrome (PCOS).

What are the pros and cons of metformin? ›

Table 10.
AdvantagesDisadvantages
InexpensiveGI side effects
No hypoglycemiaB12 deficiency
Once a day administration possibleLactic acidosis (very rare)
Long history of useNeed to monitor renal function
2 more rows

What is the main action of metformin? ›

Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

What foods should I avoid when taking metformin? ›

As much as possible, avoid white bread, white rice, white pasta, candy, soda, desserts, and snacks like chips or crackers. Eating foods that can spike your blood sugar will not necessarily make the metformin not work, however, it will increase the burden it has to work against.

Why would a doctor prescribe metformin if you don't have diabetes? ›

Metformin may also have health benefits for people who don't have diabetes. Doctors have long prescribed it off-label — that is, to treat conditions outside its approved use, including: Prediabetes. People with prediabetes have elevated blood sugar that isn't yet high enough to qualify as diabetes.

What A1c level requires metformin? ›

Recent guidelines recommend considering use of metformin in patients with prediabetes (fasting plasma glucose 100-125 mg/dL, 2-hr post-load glucose 140-199 mg/dL, or A1C 5.7-6.4%), especially in those who are <60 years old, have a BMI >35 kg/m2, or have a history of gestational diabetes.

Does metformin help with aging? ›

In addition to lowering blood glucose levels, metformin may slow down aging in the body. Metformin does this by lowering the risk of some diseases and bodily processes that speed up aging and damage the body. However, metformin is only approved for T2D. Studies on its other potential benefits are ongoing.

When should metformin not be used? ›

This medicine is not recommended in patients 80 years of age and older who have kidney problems.

Does metformin affect kidneys? ›

Metformin doesn't cause kidney damage. The kidneys process and clear the medication out of your system through your urine. If your kidneys don't function properly, there's concern that metformin can build up in your system and cause a condition called lactic acidosis.

What organs does metformin protect? ›

Metformin protects heart and pancreatic β cells in addition to its improved insulin sensitivity in the primary insulin-targeted organs, such as liver, fat and muscle. Metformin takes pleiotropic actions and exerts a protective effect from cardiovascular disease and heart failure.

Does metformin cause memory loss? ›

As detailed above, metformin has been reported to improve memory in some brain disorders. However, long-term metformin administration to healthy animals has been shown to impair memory function (Alhowail et al., 2019; Alharbi et al., 2020).

What is the number one side effect of metformin? ›

Metformin is an oral medication used to treat type 2 diabetes that is generally well tolerated. GI upset, especially diarrhea, is the most common side effect. This typically decreases over time. Although rare, lactic acidosis, hypoglycemia, and vitamin B12 deficiency can occur.

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