Glucophage 1000 mg
film-coated tablets metformin hydrochloride
Active ingredient: metformin hydrochloride
Each film-coated tablet of Glucophage 1000mg contains as active ingredient 1000mg metformin hydrochloride (equivalent to 780mg metformin base)
Excipients: Povidone K30, magnesium stearate and hypromellose
Glucophage is an antidiabetic medicine that belongs to the group of biguanides. Metformin, the active ingredient in Glucophage, reduces hepaticglucose production, increases insulin sensitivity in muscles and delays intestinal glucose absorption. A reduction of diabetic complications has been shown in overweight type2 diabetic adult patients treated with Glucophage as first-line therapy after diet therapy.
Glucophage is used for the treatment of type 2 diabetes as an adjunct to adequate diet and exercise. In adults, Glucophage may be given alone or with oral antidiabetic agents, or with insulin. In children from 10 years old and adolescents, Glucophage may be given alone or with insulin.t
Glucophage must not be used in the following cases:
– hypersensitivity to metformin hydrochloride or any of the ingredients
– severe destabilisation of diabetes with either pre-coma or ketoacidosis (a condition caused by substances called ‘ketone bodies’ accumulating in the blood; symptoms include stomach pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath),
– renal insufficiency, Moderate (stage 3b) and severe renal failure or renal dysfunction (CrCl< 45 ml/min or eGFR <45 ml/min/1.73m,)
– infectious diseases (for example respiratory tract infection, urinary tract i’nfection) – X-ray examination involving the use of iodinated contrast media (for example intravenous urography, angiography), see section ‘Special warnings andprecautions’,
– major surgery, see section ‘Special warnings and precautions – disease which may cause tissue hypoxia (heart failure, recent myocardial infarction, respiratory insufficiency, shock),
– hepatic insufficiency (impaired liver function],
– Acute conditions with the potential to alter renal function such as dehydration, severe infection 01 shock.
– excessive consumption of alcoholic beverages,
– during breast-feeding.
Pregnancy and lactation :
Glucophage is not the appropriate treatment of type 2 diabetes during pregnancy. Women Who are pregnant or plan to become pregnant have to consult their doctor for replacement of Glucophage by insulin.
Glucophage is contra-indicated during breast-feeding.
As a general rule, women who are pregnant or breast-feeding should always ask their doctor for advice before taking a medicine.
Special warnings and precautions :
Lactic acidosis is a rare, but serious (high mortality 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 significant renal failure .. ll is possible and recommended that the incidence of lactic acidosis be reduced by assessing other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any condition associated with hypoxia
Symptoms of lactic acidosis are vomiting, abdominal pain with muscle cramps, a general feeling of not being well with severe fatigue and difficulty in breathing. If these symptoms occur, STOP taking Glucophage immediately and consult your doctor promptly. Lactic acidosis is a medical emergency and must be treated in a hospital. The most effective way to remove lactate and metformin from the blood is haemodialysis.
Periodic laboratory tests have to be prescribed to assess blood glucose level and kidney function (creatinine levels or creatinine clearance) before treatment initiatipn and regularly thereafter
since metformin (active ingredient in Glucophage) is excreted main I y the kidneys. Special caution should be exercised in situations -wttere KIdney furtc iOn may become impaired, for example in the elderly or when initiating antihypertensive treatment or diuretic treatment and when starting treatment with a non-steroidal anti-inflammatory medicine.
Iodinated contrast media
If a patient is scheduled to undergo X-ray examinations involving the use of iodinated contrast media, such as intravenous urography or angiography, treatment with Glucophage must be discontinued prior to or at the time of the test and will not be resumed until 48 hours after the test, after ensuring that kidney function is normal.
If a patient is going to have a major surgery, treatment with Glucophage must be discontinued 48 hours before the surgery. Glucophage will not be re-instituted until 48 hours after the
surgery, and only after ensuring that kidney function is normal.
– Avoid consumption of alcoholic beverages.
– patients have to inform their doctor of any other treatment they are receiving and of any infectious illnesses such as influenza, respiratory tract infection or urinary tract infection.
– In children, a follow-up of the metformin effect on growth and puberty especially in pre-pubescent children is recommended.
Effect on ability to drive and use machines :
When used alone, Glucophage does not cause hypoglycemia. Consequently, there is no particular risk when driving or using machines. However, if certain antidiabetic medicines are taken together with GJucophage, such as sulphonylurea, insulin, glinides or other hypoglycemic agents, the mental concentration may be impai-red in the event of hypog1ycaemia.
Undesirable effects :
As with all medicines, Glucophage can cause undesirable effects.
The following undesirable effects were observed in clinical studies or in routine patient management. They are presented by frequencies which are defined as follows: very common: ~100!0;common ~ 1%, <10%; uncommon: ~O.l%, <1%; rare ~
0.01%, <0.1%; very rare: <0.01% and isolated cases.
Very common: Gastrointestinal discomfort such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite may occur especially at the beginning of treatment. These symptoms are
generally transient and can be reduced by taking the tablets with meals. Should symptoms persist, stop taking the treatment and consult your doctor
– Lactic acidosis is a very serious complication, which results in vomiting, abdominal pain with muscle cramps and/or a general feeling of malaise with severe fatigue and which requires specific treatment. If this occurs, patients should stop taking Glucophage immediately and consult their doctor promptly. Lactic acidosis is a medical emergency and must be treated in a hospital.
Skin reactions such as erythema (red skin), itching or urticarial (eruption with itching).
– Decreased vitamin B 12 levels (to take into consideration if the patient is suffering from megaloblastic anaemia).
Isolated cases: Liver function tests abnormalities or hepatitis resolving upon Glucophage discontinuation.
Patients must report any undesirable or distressing effect to their doctor or pharmacist. To prevent serious reactions, they mu~ speak to their doctor immediately, if an undesirable effect is severe, occurred suddenly or gets worse rapidly.
While taking Glucophage, patients must not use iodinated contrast agents (see section ‘Contraindieations’j Special precautions may be required if patients take Glucophage and any of the following medicines at the same time: corticosteroids, non-steroidal anti-inflammatory medicines, antihypertensive agents of the angiotensin- converting enzyme inhibitors class,
Medicinal products with intrinsic hyperglycaemic activity :
(e.g. glucocorticoids and tetracosactides [systemic and local routes). beta-2-agonists, danazol, and chlorpromazine at high dosages of lOO mg per day, diuretics): More frequent blood glucose monitoring may be required, especially at the beginning of treatment. If necessary, adjust the metformin dosage during therapy with the respective medicinal product and upon its discontinuation.
Diuretics. especially loop diuretics, may increase the risk of lactic acidosis due to their potential to decrease renal function (further to th-eir intrinsic hyperglycaemic effect, see above).
Interaction with alcohol :
The risk of lactic acidosis is increased in acute alcohol intoxication, particularly in case of fasting or malnutrition or hepatic insufficiency. It is recommended that consumption of alcohol and alcohol-containing medicinal product be avoided. As a general rule, patients have to consult their doctor or pharmacist, if they are taking or have recently taken another medicine, including over-the-counter medicines.
Effect on body weight :
In contrast to other commonly used antihyperglycaemic agents, such as sulphonylureas or thiazolinediones, treatment with metformin offers a considerable benefit for patients with type 2 diabetes by not causing an increase in body weight. By maintaining or reducing body weight, metformin limits other risk factors associated with increased weight. Over the long term this translates into more stable glycaemic control and a decreased risk of diabetes complications. The clinical studies conducted with metformin in both adults and children fully support that metformin improves glycaemic control without increasing body weight or even with a small weight loss
Dosage and administration :
The dosage of Glucophage is determined by the doctor on an individual basis according to the results of laboratory blood glucose measurement
Usual starting dose
1 tablet of Glucophage 1000mg once daily in children from 10 years old and adolescents 1 tablet of Glucophage 1000mg 2 or 3 times daily in adults.ln case Glucophage is used in combination with insulin, the usual starting dose is also ttablet once daily for children from 10 years old and adolescents and 1 tablet 2 to 3 times daily in adults, while insulin dosage is adjusted on the basis of blood glucose measurements.
After 10 to 15 days, the dose may be slowly increased by increment of one tablet depending on blood glucose measurements.
Maximum daily dose
2 g daily in children, taken as 2 or 3 divided doses.
3 g daily in adults, taken as 3 divided doses.
Patients with renal impairment
Metformin may be used in patients with moderate renal impairment, stage 3a (creatinine clearance [CrCII 59 -45 mL/min or estimated glomerular filtration rate [eGFRI 59- 45 mL/min/1.73m2) only in the absence of other conditions that may increase the risk of lactic acidosis and with the following dose adjustments: The starting dose is 500 mg or 850 mg metformin hydrochloride, once daily. The maximum dose is 1000 mg daily, given as 2 divided doses. The renal function should be closely monitored (every 6-3 months). If CrCI or eGFRrall <45 ml/min or <45 ml/min/1.73m2 respectively, metformin must be discontinued immediately.
Due to the potential for decreased renal function in elderly subjects, it is recommended that the metformin dosage be adjusted based on renal function. Regular assessment of renal function is necessary. Administration Swallow the tablets without chewing during or at the end of the meals. For example, for a dosage of two tablets daily, take 1 tablet with breakfast and 1 tablet with evening meal.
Duration of treatment
Glucophage must be taken daily without interruption. Patients who have stopped the treatment must contact their doctor.
In case of missed dose, patients have to take the next dose at the usual time. Patients must not double the dose of Glucophage.
In case of overdose, patients must contact their doctor immediately. High overdose 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.
Store below “30C in a dry place. Do not use after the expiry date shown on the outer packaging.
KEEP OUT OF THE REACH OF CHILDREN: Parents and caregivers are advised to oversee treatment in children.
Pharmaceutical form :
Glucophage 1000mg tablets are white, circular, convex and film-coated.
Boxes of 30 film-coated tablets in blister pack.
Not all p-“ek sizes may be registered or marketed
GENERAL RECOMMENDATIONS :
This medicine has been prescribed by your doctor for the treatment of diabetes, a disease characterized by hyperglycaemia, i.e. an excess of glucose in the blood. Glucose appears in the urine only when it exceeds a certain level in the blood
Produced by :
Neopharma abu dhabi united arab emirates