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METFOGAMMA 1000 mg. 30 tablets

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As monotherapy or in combination with sulphonylureas for the treatment of non-insulin-dependent diabetes mellitus (NIDD, type II) in overweight and obesity.


Metfogamma should not be taken when the following risks are present:

* Restriction of kidney function
* Restriction of hepatic function
* In acetabular decompensation in metabolism, ancestral, and hyperosmolar or ketoaccidic diabetic coma
* Severe functional cardiovascular failure, including peripheral arterial stenosis
* respiratory failure
* Hypoxic conditions (eg as a consequence of anemia, gangrene, collapse, shock)
* Diabetic retinopathy at a heavier I stage
* Catabolic conditions, e.g. In tumor diseases
* Severe chronic or severe acute infections
* Alcoholism
* Known hypersensitivity to metformin hydrochloride or to other ingredients contained in Metfogamma

Metfogamma should be discontinued:

* Before planned total narcosis operations
* Before X-ray studies with intravenous contrast agents
* For weight loss diet
* At a planned or existing pregnancy and during breastfeeding

In these cases, switch to another blood glucose lowering therapy

A relative contraindication is the advanced age of the patient (over 65 years of age).

Because elderly patients often show a limitation in organ function and altered pharmacokinetics and / or multimodality, metformin therapy increases the risk of lactic acidosis. It is necessary to check thoroughly whether the patient's medical condition allows Metphagam therapy.


The preparation is not shown:

* For insulin-dependent type 1 diabetes mellitus
* In the case of complex secondary exhaustion of suflanylureal therapy in Type II diabetes mellitus

There is no experience with metformin therapy of very rare type II diabetes, age-related type of diabetes in young people (so-called MODY-diabetes).

Use in pregnancy and lactation

With regard to use during pregnancy and lactation, there is insufficient experience. There is evidence of increased perinatal mortality in exposed children, but this may be due to insufficient control of the underlying disease with metformin hydrochloride during late pregnancy. Insulin should be considered as a preferred drug during pregnancy.

There is no experience with breastfeeding. It is not known whether metformin or its metabolites are excreted in breast milk.

When it is needed during breast-feeding, breast-feeding should be discontinued.

Unwanted reactions

At the beginning of therapy, gastrointestinal complaints such as nausea, vomiting, abdominal pain, flatulence, weight loss, diarrhea and metallic taste in the mouth occurred in 5-20% of the treated patients. In connection with this, in principle, it is not necessary to stop the therapy, since even with unchanged dosing the complaints most often resolve. An eventual prolonged gastrointestinal disorder is discontinued after discontinuation of therapy. By gradually increasing the dosage and taking Metformin during a meal, the frequency and severity of gastrointestinal symptoms may be reduced.

Sometimes headaches, dizziness and fatigue occur.

In very rare cases, skin hypersensitivity reactions occur.

In one case, when treating Metphagamma, leukocytoblastic vasculitis and pneumonitis were described.

In single cases, suppression of the absorption of vitamin B12 and folic acid may lead to hematopoiesis disorders - megaloblastic anemia.

In rare cases, treatment with Metformin may result in lactic acidosis, which may be life-threatening (eg coma). One such metformin-based lactic acidosis causes death in 50% of cases. As a cause of lactic acidosis, in addition to overdosage, it may also appear: decreased renal and hepatic function, alcohol consumption, the occurrence of additional diseases affecting the oxidative metabolism of substances such as cardiac decompensation or severe infections, catabolic states, and interactions With other medicines.

The symptoms of a starting lactic acidosis may mimic the direct gastrointestinal side effects of metformin: nausea, vomiting, diarrhea and stomach pain. The full picture, with muscle aches and cramps, hyperventilation, blurring of consciousness and coma, can occur within hours.
When combined with sulphonylureas, hypoglycaemia may be exceptional. Signs of this may include sudden sweating, trembling, palpitations, anxiety, severe hunger, tingling in the mouth, paleness, headache, drowsiness, sleep disturbance, a fit of fear, movement uncertainty, irritability, depressed moods. With deeper hypoglycaemia, the patient may become unconscious.

Instruction for street traffic participants

Metphagamma alone does not impair the ability to drive. Also, hypoglycemia can not be expected to endanger the ability to actively participate in street traffic. Combination therapy with sulphonylureas or other medications with a blood glucose lowering effect may impair the ability to drive and service machinery due to possible hypoglycaemia.

Interaction with other medicinal products

In prolonged treatment with Metformin, diabetes may be impaired if it is started or discontinued by additional medication therapy.

Enhancement of hypoglycaemic effect is possible with concomitant use of medicinal products such as:

* Insulin, peripalan antidiabetic agents (eg, sulphonylureas, acarbose)
* Non-steroidal anti-inflammatory drugs (silicates and pyrazolones)
* ACE - inhibitors
* Fibrates
Cyclophosphatite, respectively. Its derivatives, as hypoglycaemias are possible

Beta-blockers and anticonvotants (adrenergic inhibitors), such as clonidine, reserpine and guanethidine, can also reduce blood sugar levels during prolonged use. Clinical importance in hypoglycaemia is primarily the reduction of hormonal and nerve regression, which reduces the subjective sensation of warning symptoms.

Metformin releasing substances, e.g. Cimetidine, increase the risk of lactic acidosis.

The hypoglycaemic effect of Metphagamma may be reduced by:

* Glucocorticoids
* Combinations of estrogens with gestagens, oral contraceptives
* Epinephrine and other sympathomimetics
* Glucagon
* Thyroid hormones
* Thiazide and loop diuretics
* Diazoxide
* Phenothiazides
* Nicotinic acid derivatives

Substances that reduce the absorption of Metphagamma, e.g. Guar, cholestyramine, reduce Metphagamma activity.

During Metphagamma therapy, fenprocoumon, and possibly other coumarins, is accelerated. If concomitant coumarin therapy is administered or discontinued, metabagam should be controlled, and blood clotting should be controlled at short intervals.

Acute and chronic alcohol use may enhance blood glucose lowering and elevated serum lactate action of metformin at an unpredictable rate.

Warning instructions

Since the accumulation of metformin hydrochloride and thus the risk of lactic acidosis is primarily determined by renal function, a ensured normal renal function is a prerequisite for Metphagamma therapy. When liver function is reduced, special caution is also recommended as lactate clearance may be limited.

Prior to initiation of treatment and for 6-month breaks (in the case of some patients, it may be earlier, eg in intercurrent infections, in adult patients), serum creatinine should be determined.

Consideration should be given to the fact that, especially in older patients, only serum creatinine levels can not always be indicative, The creatinine clearance should be determined before the start of therapy.

Liver counts should also be determined before and during therapy.

The metformin may be combined with sulphonylureas, taking into account contraindications.

Since, in some cases, a disruption of vitamin B12 metabolism can not be ruled out, patients should be monitored once a year for blood counts.

In the event of a disorder, the change in blood count should be eliminated by supplementary intake of vitamin B12.

The use of larger amounts of alcohol poses a risk of hypoglycaemia and lactic acidosis. Therefore, alcohol should not be used during metformin therapy.

Most important incompatibilities

Until now, they are not known.

Emergency measures, symptoms and antidotes

1. Symptoms of overdose:
Metoxin hydrochloride intoxication does not lead to hypoglycaemia but is at risk of lactic acidosis.

The most common cause is not acute overdose, but the manifestation of contraindications such as, Restricted kidney function.
Symptoms of a lactic acidosis start with nausea, vomiting, diarrhea, abdominal pain, muscle pain, then hyperventilation, blurred
2. Overdose therapies:

Hemodialysis is the most effective way to remove lactate and metformin. Symptomatically, blood circulation should be stabilized, acidosis compensated, and hypoxia removed. The diagnosis should be confirmed by the determination of lactate and metformin in serum. Concentration of metformin in erythrocytes is a good indicator of available accumulation and the need for repeated hemodialysis.

Other instructions

Since the risk of accumulation is primarily determined by renal function, one provided normal renal function is a prerequisite for initiating metformin therapy. During treatment, the serum creatinine level should be repeated over a half-year period. Pay attention to the fact that, especially in older patients, serum creatine is not always self-evident, Creatinine clearance should be determined.

Hepatic function disorder should be given special attention because lactate clearance may be limited.


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