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• The usual starting dose is one tablet 2 or 3

RX times daily given during or after meals. After 10
to 15 days the dose should be adjusted on the
METFORMIN basis of blood glucose measurements. A slow
increase of dose may improve gastrointestinal
TABLETS tolerability.

500MG The maximum recommended dose of metformin

is 3g daily, taken as 3 divided doses.
1.NAME OF THE MEDICINAL PRODUCT • If transfer from another oral anti-diabetic is
Metformin 500mg Tablets intended, discontinue the other agent and initiate
metformin at the dose indicated above.
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION Combination with insulin:
Each film-coated tablet contains metformin Metformin and insulin may be used in
hydrochloride 500mg. combination therapy to achieve better blood
glucose control. Metformin is given at the usual
For a full list of excipients, see section 6.1. starting dose of one tablet 2-3 times daily, while
3. PHARMACEUTICAL FORM insulin dosage is adjusted on the basis of blood
glucose measurements.
White coloured, film-coated, round biconvex
tablets Renal impairment

4. CLINICAL PARTICULARS A GFR should be assessed before initiation of

treatment with metformin containing products
4.1 Therapeutic indications and at least annually thereafter. In patients at an
Treatment of type 2 diabetes mellitus increased risk of further progression of renal
,particularly in overweight patients, when impairment and in the elderly, renal function
dietary management and exercise alone does not should be assessed more frequently, e.g. every
result in adequate glycaemic control. 3-6 months.
• In adults,metformin 850mg tablets may be
GFR Total maximum Additional
used as monotherapy or in combination with mL/min daily dose considerations
other oral anti-diabetic agents, or with insulin.
60-89 3000 mg Dose reduction may be
• In children from 10 years of age and considered in relation to
adolescents, Metformin tablets may be used as declining renal function
monotherapy or in combination with insulin. 45-59 2000 mg Factors that may
30-44 1000 mg increase the risk of lactic
A reduction of diabetic complications has been acidosis (see section 4.4)
shown in overweight type 2 diabetic patients should be reviewed
treated with metformin as first-line therapy after before considering
diet failure (see 5.1 pharmacodynamic initiation of metformin.
properties). The starting dose is at
most half of the
4.2 Posology and method of administration maximum dose.
Adults: <30 - Metformin is
contraindicated
Adults with normal renal function (GFR≥ 90 Elderly: Due to potential for decreased renal
mL/min) function in elderly subjects, the metformin
Monotherapy and combination with other oral dosage should be adjusted based on renal
antidiabetic agents: function. Regular assessment of renal function is
necessary (see section 4.4)
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Children and adolescents: Lactic acidosis, a very rare but serious metabolic
complication, most often occurs at acute
Monotherapy and combination with insulin
worsening of renal function or cardiorespiratory
• Metformin tablets can be used in children from illness or sepsis. Metformin accumulation occurs
10 years of age and adolescents. at acute worsening of renal function and
increases the risk of lactic acidosis.
• The usual starting dose is one tablet of 500 mg
or 850 mg once daily, given during meals or In case of dehydration (severe diarrhoea or
after meals. vomiting, fever or reduced fluid intake),
metformin should be temporarily discontinued
After 10 to 15 days the dose should be adjusted and contact with a health care professional is
on the basis of blood glucose measurements. A recommended.
slow increase of dose may improve
gastrointestinal tolerability. The maximum Medicinal products that can acutely impair renal
recommended dose of metformin is 2 g daily, function (such as antihypertensives, diuretics
taken as 2 or 3 divided doses. and NSAIDs) should be initiated with caution in
metformin-treated patients. Other risk factors for
4.3 Contraindications lactic acidosis are inadequately controlled
• Hypersensitivity to metformin hydrochloride diabetes, ketosis, prolonged fasting, excessive
or to any of the Excipients listed in section 6.1. alcohol intake, hepatic insufficiency and any
• diabetic pre-coma condition associated with hypoxia, as well as
concomitant use of medicinal products that may
• Acute conditions with the potential to alter cause lactic acidosis (see section 4.3 and 4.5)
renal function such as:
Patients and/or care-givers should be informed
- dehydration of the risk of lactic acidosis.
- severe infection Diagnosis:
- shock Lactic acidosis is characterised by acidotic
- intravascular administration of iodinated dysponea, abdominal pain, muscle cramps,
contrast agents (see section 4.4) asthenia and hypothermia followed by coma. In
case of suspected symptoms, the patients should
• Acute or chronic disease which may cause stop taking metformin and seek immediate
tissue hypoxia such as: medical attention. Diagnostic laboratory findings
are decreased blood pH (<7.35), increased
- respiratory failure
plasma lactate levels (>5 mmol/L) and an
- decompensated heart failure increased anion gap and lactate/pyruvate ratio
(see section 4.9).
- recent myocardial infarction
Renal Function:
- shock
GFR should be assessed before treatment
• Hepatic insufficiency, acute alcohol initiation and regularly thereafter, see section
intoxication, alcoholism 4.2. Metformin is contraindicated in patients
• Any type of acute metabolic acidosis (such as with GFR <30 mL/min and should be
lactic acidosis, diabetic ketoacidosis) temporarily discontinued in the presence of
conditions that alter renal function, see section
• Severe renal failure (GFR <30 mL/min) 4.3.
4.4 Special Warnings and precautions for use As metformin is excreted by the kidneys, serum
Lactic acidosis: creatinine levels should be determined before
initiating treatment and regularly thereafter:
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• at least annually in patients with normal renal No effect of metformin on growth and puberty
function. has been detected during controlled clinical
studies of one-year duration but no long-term on
• at least two to four times a year in patients with these specific points are available.
serum creatinine levels at the upper limit of
normal and in elderly subjects. Therefore, a careful follow-up of the effect of
metformin on these parameters in metformin-
Decreased renal function in elderly subjects is treated children, especially pre-pubescent
frequent and asymptomatic. Special caution children, is recommended
should be exercised in situations where renal
function may become impaired, for example Children aged between 10 to 12 years:
when initiating antihypertensive therapy or
Only 15 subjects aged between 10 and 12 years
diuretic therapy and when starting therapy with
an NSAID were included in the controlled clinical studies
conducted in children and adolescents. Although
Cardiac function metformin efficacy and safety in this group of
children did not differ from efficacy and safety
Patients with heart failure are more at risk of in older children, particular caution is
hypoxia and renal insufficiency. In patients with
recommended when prescribing to children aged
stable chronic heart failure, metformin may be between 10 and 12 years.
used with a regular monitoring of cardiac and
renal function. Other precautions:
For patients with acute and unstable heart • All patients should continue their diet with a
failure, metformin is contraindicated (see section regular distribution of carbohydrate intake
4.3). during the day. Overweight patients should
continue their energy-restricted diet.
Administration of iodinated contrast agent:
• The usual laboratory tests for diabetes
As the intravenous administration of iodinated monitoring should be performed regularly.
contrast material in radiologic studies can lead to
contrast induced nephropathy resulting in • Metformin alone never causes hypoglycaemia,
metformin accumulation and an increased risk of although caution is advised when it is used in
lactic acidosis. Metformin should be combination with insulin or other oral
discontinued prior to, or at the time of the antidiabetics (e.g. sulfonylureas or meglitinides).
imaging procedure and not restarted until at least
48 hours after, provided that renal function has 4.5 Interaction with other medicinal products
been re-evaluated and found to be stable (see and other forms of interaction
sections 4.2 and 4.5) Concomitant use not recommended:
Surgery: Alcohol
Metformin Hydrochloride must be discontinued Alcohol intoxication is associated with an
48 hours before elective surgery under general, increased risk of lactic acidosis, particularly in
spinal or peridural anaesthesia. Therapy may be cases of fasting, malnutrition or hepatic
restarted no earlier than 48 hours following impairment.
surgery or resumption of oral nutrition and renal
function has been re-evaluated and found to be Avoid consumption of alcohol and alcohol-
stable. containing medications.

Paediatric population: Iodinated contrast agents (see section 4.4)

The diagnosis of type 2 diabetes mellitus should Metformin should be discontinued prior to or at
be confirmed before treatment with metformin is the time of the imaging procedure and not
initiated. restarted until at least 48 hours, provided that
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renal function has been re-evaluated and found metformin plasma concentration may increase.
to be stable, see sections 4.2 and 4.4. If needed, dose adjustment of metformin may be
considered as OCT inhibitors/inducers may alter
Combinations requiring precautions for use the efficacy of metformin.
Some medicinal products can adversely affect
4.6 Fertility, Pregnancy and lactation
renal function which may increase the risk of
lactic acidosis, e.g. NSAIDs, including selective Pregnancy
cyclooxygenase (COX) II inhibitors, ACE
inhibitors, angiotension II receptor antagonists Uncontrolled diabetes during pregnancy
and diuretics, especially loop diuretics. When (gestational or permanent) is associated with
increased risk of congenital abnormalities and
starting or using such products in combinations
perinatal mortality.
with metformin, close monitoring of renal
function is necessary. A limited amount of data from the use of
metformin in pregnant women does not indicate
Glucocorticoids (systemic and local routes),
beta-2-agonists and diuretics have intrinsic an increased risk of congenital abnormalities.
hyperglycaemic activity. Inform the patient and Animal studies do not indicate harmful effects
with respect to pregnancy, embryonic or foetal
perform more frequent blood glucose
monitoring, especially at the beginning of the development, parturition or postnatal
development (see section 5.3).
treatment. If necessary, adjust the dosage of the
antidiabetic drug during therapy with the other When the patient plans to become pregnant and
drug and upon its discontinuation. during pregnancy, diabetes should not be treated
ACE-inhibitors may decrease the blood glucose with metformin but insulin should be used to
levels. If necessary, adjust the dosage of the maintain blood glucose levels as close to normal
antidiabetic drug during therapy with the other as possible in order to lower the risk of foetal
drug and upon its discontinuation. malformations associated with abnormal blood
glucose levels.
Organic cation transporters (OCT)
Breast-feeding
Metformin is a substrate of both transporters
OCT1 and OCT2. Metformin is excreted into human breast milk.
No adverse effects were observed in breastfed
Co-administration of metformin with newborns/infants. However, as only limited data
are available, breast-feeding is not
• Inhibitors of OCT1 (such as verapamil) may
recommended during metformin treatment. A
reduce efficacy of metformin.
decision on whether to discontinue breast-
• Inducers of OCT1 (such as rifampicin) may feeding should be made, taking into account the
increase gastrointestinal absorption and efficacy benefit of breast-feeding and the potential risk to
of metformin. adverse effects on the child.
• Inhibitors of OCT2 (such as cimetidine, Fertility
dolutegravir, ranolazine, trimethoprime,
Fertility of male or female rats was unaffected
vandetanib, isavuconazole) may decrease the by metformin when administered at doses as
renal elimination of metformin and thus lead to high as 600 mg/kg/day, which is approximately
an increase in metformin plasma concentration.
three times the maximum recommended human
• Inhibitors of both OCT1 and OCT2 (such as daily dose based on body surface area
crizotinib, olaparib) may alter efficacy and renal comparisons.
elimination of metformin.
4.7 Effects on ability to drive and use
Caution is therefore advised, especially in machines
patients with renal impairment, when these Metformin monotherapy does not cause
drugs are co-administered with metformin, as
Metformin 500mg T ablets SMPC, Taj Phar mac euticals
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hypoglycaemia and therefore has no effect on Decrease of vitamin B12 absorption with
the ability to drive or to use machines. decrease of serum levels during long term use of
metformin hydrochloride. Consideration of such
However, patients should be alerted to the risk aetiology is recommended if a patient present
of hypoglycaemia when metformin is used in with megaloblastic anaemia.
combination with other antidiabetic agents
(sulfonylureas, insulin, repaglinide) Hepatobiliary disorders:
Very rare: Isolated reports of liver function tests
abnormalities or hepatitis resolving upon
4.8 Undesirable Effects metformin hydrochloride discontinuation.
During treatment initiation, the most common
adverse reactions are nausea, vomiting, Paediatric population
diarrhoea, abdominal pain and loss of appetite
In published and post marketing data and in
which resolve spontaneously in most cases. To
controlled clinical studies in a limited paediatric
prevent them, it is recommended to take
metformin in 2 or 3 daily doses and to increase population aged 10-16 years treated during 1
slowly the doses. year, adverse event reporting was similar in
nature and severity to that reported in adults.
The following undesirable effects may occur
under treatment with metformin hydrochloride. Reporting of suspected adverse reactions
Frequencies are defined as follows: very Reporting suspected adverse reactions after
common: 1/10; common>1/100, <1/10; authorisation of the medicinal products is
uncommon>1/1,000, <1/100; rare>1/10,000, important. It allows continued monitoring of the
<1/1,000; very rare<1/10,000, not known benefit/risk balance of the medicinal product.
(cannot be estimated from the available data).
4.9 Overdose
Within each frequency grouping, undesirable
effects are presented in order of decreasing Hypoglycaemia has not been seen with
seriousness. metformin doses up to 85g, although lactic
acidosis has occurred in such circumstances.
Nervous system disorders: High overdose or concomitant risks of
Common: taste disturbance metformin may lead to lactic acidosis. Lactic
acidosis is a medical emergency and must be
Gastrointestinal disorders: treated in hospital. The most effective method to
remove lactate and metformin is haemodialysis.
very common: Gastrointestinal disorders such as
nausea, vomiting, diarrhoea, abdominal pain and 5. PHARMACOLOGICAL PROPERTIES
loss of appetite. These undesirable effects occur
most frequently during initiation of therapy and 5.1 Pharmacodynamic properties
resolve spontaneously in most cases. To prevent
Pharmacotherapeutic Group: Blood glucose
them, it is recommended that Metformin
lowering drugs. Biguanide oral hypoglycaemic
Hydrochloride be taken in 2 or 3 daily doses
agents
during or after meals. A slow increase of the
dose may also improve gastrointestinal Mechanism of action
tolerability.
Metformin is a biguanide with
Skin and subcutaneous tissue disorders: antihyperglycaemic effects, lowering both basal
Very rare: Skin reactions such as erythema, and post-prandial plasma glucose. It does not
pruritus, urticaria stimulate insulin secretion and therefore does
not produce hypoglycaemia.
Metabolism and nutrition disorders:
Metformin may act via 3 mechanisms:
Very rare: Lactic acidosis (see section 4.4).
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1. Reduction of hepatic glucose production by events/1000 patient-years (p=0.011), and versus

inhibiting gluconeogenesis and glycogenolysis. the combined sulphonylurea and insulin
monotherapy groups 18.9 events/1000 patient-
2. In muscle, by increasing insulin sensitivity, years (p = 0.021)
improving peripheral glucose uptake and
utilisation. • A significant reduction in the absolute risk of
myocardial infarction: metformin hydrochloride
3. And delay of intestinal glucose absorption.
11 events/1000 patients-years, diet alone 18
Metformin stimulates intracellular glycogen events/1000 patients-years (p=0.01)
synthesis by acting on glycogen synthase. Benefit regarding clinical outcome has not been
Metformin increases the transport capacity of all shown for metformin hydrochloride used as
types of membrane glucose transporters second-line therapy, in combination with a
(GLUTs) known to date. sulfonylurea.
Pharmacodynamic effects In type I diabetes, the combination of metformin
and insulin has been used in selected patients,
In clinical studies, use of metformin was but the clinical benefit of this combination has
associated with either a stable body weight or not been formally established.
modest weight loss.
Paediatric population
In humans, independently of its action on
glycaemia, metformin has favourable effects on Controlled clinical studies in a limited paediatric
lipid metabolism. This has been shown at population aged 10-16 years treated during 1
therapeutic doses in controlled, medium-term or year demonstrated a similar response in
long-term clinical studies: Metformin reduces glycaemic control to that seen in adults.
total cholesterol, LDL, cholesterol and
5.2 Pharmacokinetic properties
triglycerides levels.
Absorption:
Clinical Efficacy:
After an oral dose of metformin, Tmax is
The prospective randomised (UKPDS) study has reached in 2.5 hours. Absolute bioavailability of
established long-term benefit of intensive blood
a 500mg or 850mg metformin tablet is
glucose control in type 2 diabetes.
approximately 50-60% in healthy subjects. After
Analysis of the results of the overweight patients an oral dose, the non-absorbed fraction
treated with metformin after failure of diet alone recovered in faeces was 20-30%.
showed:
After oral administration, metformin absorption
• A significant reduction of the absolute risk of is saturable and incomplete. It is assumed that
any diabetes-related complications in metformin the pharmacokinetics of metformin absorption is
group (29.8 events/1000 patients-years) versus non-linear. At the usual metformin doses and the
diet alone (43.3 events/1000 patient-years), p= dosing schedules, steady state plasma
0.0023, and versus the combined sulphonylurea concentrations are reached within 24 to 48 hours
and insulin monotherapy groups (40.1 and are generally less than 1μg/ml. In controlled
events/1000 patients-years), p=0.0034. clinical trials, maximum metformin plasma
levels (Cmax) did not exceed 4μg/ml, even at
• A significant reduction of the absolute risk of maximum doses.
the diabetes-related mortality: Metformin
hydrochloride 7.5 events/1000 patient-years, diet Food decreases the extent and slightly delays the
alone 12.7 events/1000 patient-year, p=0.017 absorption of metformin hydrochloride.
• A significant reduction of the absolute risk of Following administration of a dose of 850mg, a
overall mortality: metformin hydrochloride 13.5 40% lower plasma peak concentration a 25%
events/1000 patient-years versus diet alone 20.6 decrease in AUC (area under the curve) and a 35
minute prolongation of the time to peak plasma
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concentration were observed. The clinical (AUC0-t) were reduced by approximately 33%
relevance of these findings is unknown. and 40%, respectively compared to diabetic
adults who received repeated doses of 500 mg
Distribution:
twice for 14 days. As the dose is individually
Plasma protein binding is negligible. Metformin titrated based on glycaemic control, this is of
partitions into erythrocytes. The blood peak is limited clinical relevance.
lower than the plasma peak and appears
5.3 Preclinical safety data
approximately the same time. The red blood
cells most likely represent a secondary Preclinical data reveals no special hazard for
compartment of distribution. The mean volume humans based on conventional studies of safety
of distribution (Vd) ranged between 63-276 L. pharmacology, repeated dose toxicity,
genotoxicity, carcinogenic potential and
Metabolism
reproductive toxicity.
Metformin is excreted unchanged in urine. No
6. PHARMACEUTICAL PARTICULARS
metabolites have been identified in humans.
Elimination: 6.1 List of excipients
Core
Renal clearance of metformin is >400ml/min,
indicating that metformin is eliminated by Sodium starch glycollate
glomerular filtration and tubular secretion. Maize starch
Following an oral dose, the apparent terminal
elimination half-life is approximately 6.5 hours. Povidone
When renal function is impaired, renal clearance Colloidal anhydrous silica
is decreased in proportion to that of creatinine
Magnesium Stearate
and thus the elimination half-life is prolonged,
leading to increased levels of metformin in Film-coating
plasma.
Hypromellose
Characteristics in specific groups of patients
Titanium dioxide (E171)
Renal impairment
Propylene Glycol
The available data in subjects with moderate
renal insufficiency are scarce and no reliable Macrogol 6000
estimation of the systemic exposure to Purified talc
metformin in this subgroup as compared to
subjects with normal renal function could be 6.2 Incompatibilities
made. Therefore, the dose adaptation should be Not applicable.
made upon clinical efficacy/tolerability 6.3 Shelf life
considerations (see section 4.2). 3 years.
Paediatric population: 6.4 Special precautions for storage
Single dose study: After single doses of Do not store above 25°C. Store in the original
metformin 500 mg, paediatric patients have package. Keep the containers tightly closed.
shown similar pharmacokinetic profile to that 6.5 Nature and contents of container
observed in healthy adults.
Blister: Transparent PVC /PVdC/Aluminium
Multiple dose study: Data are restricted to one foil. Packs of 28, 84 and 504's tablets in a carton
study. After repeated doses of 500 mg twice for
7 days in paediatric patients the peak plasma Opaque PVC /PVdC/Aluminium foil. Packs of
concentration (Cmax) and systemic exposure 28, 84 and 504's tablets in a carton
Metformin 500mg T ablets SMPC, Taj Phar mac euticals
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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. MANUFACTURER:

Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad
438225, Gujarat, INDIA

This leaflet was last revised in October 2019