Siofor® (Metformin) 1000 mg (60 coated tablets)

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Siofor® (Metformin) oral tablets are used to treat high blood sugar levels caused by type 2 diabetes. They’re used in combination with diet and exercise. Siofor (Metformin) may be used as part of a combination therapy. That means you may need to take it with other drugs. Metformin allows the body to make better use of the lower amount of insulin which occurs in the kind of diabetes known as type 2 diabetes.

Common brand names: Glucophage, Glucophage XR, Glumetza, Fortamet, Meforal®, Metformax®, Metforal®, Metforalmille®, Act Metformin, Metformin, Metformin Hydrochloride, Pg-metformin, Q-metformin, Riomet, Diamin, Formin, Met-500, Bigomet, Bgmet, Diabemet, Kinamet, Glyciphage, Bolamyn®, Diagemet®, Glucient®, Glucorex®, Meijumet®, Metabet®, Metuxtan®, Sukkarto®, Yaltormin®, Obimet, Melmet, Glycomet, Dabex, Carbophage, Biguanil, Carbophage, Cetapin-XR, Cidophage, CO Metformin, Diabesin, Diabex, Diaformin, Dianben, Dimefor, Exermet, Formet, Glafornil, Glifage, Glisulin, Glucofast, Gluconorm-SR, Gluformin, Glumet, Glumet-XR, Glyciphage-SR, Glyformin, Islotin, Meglucon, Metaday, Metbay, Metfogamma, Metforem, Metformin Actavis, Metformin Hexal, Metformin Lich, Metformina Sandoz, Metformine Zentiva, Metformin-ER, Metformin-MR, Metformin-SR, Metformin-XR, MetPro, Metsmall, Metta-SR, Mylan-Metformin, Neodipar, Okamet, Predial, Pro-Metformin, Ratio-Metformin, Riomet-OD, Sandoz Metformin, Siofor, Stagid, Sugamet, Teva-Metformin, Walaphage, XMet-SR

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Structure

One tablet contains 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin)
Contoured cell packaging (blister) made of PVC / aluminum or PVC / PVDC / aluminum. 60 coated tablets per pack.

 

Indications

• Treatment of type 2 diabetes mellitus, especially with overweight, with the ineffectiveness of diet therapy and physical activity.


• In adults, Siofor® 1000 can be used as monotherapy or in combination with other antidiabetic drugs for oral administration, as well as with insulin.


• In children from 10 years of age and adolescents, Siofor® 1000 can be used as monotherapy or in combination with insulin.

 

Mode of application

Adults

Monotherapy
The standard starting dose is 500 mg or 850 mg Siofor® 2-3 times a day during or after meals.
After 10-15 days, the dose should be adjusted based on blood glucose. A slow increase in the dose improves the tolerability of the drug from the gastrointestinal tract.

In patients receiving high doses of Siofor® (2-3 g per day), it is possible to replace two tablets with a dosage of 500 mg per one tablet of Siofor 1000.

The maximum recommended dose of Siofor® 1000 is 3 g per day in 3 divided doses.
When switching from another antidiabetic drug, you should stop taking the latter and start taking Siofor® at the above dose.

Combined use with insulin
Siofor® 1000 and insulin can be used together to improve glycemic control. Siofor® is prescribed in a standard initial dose of 500 mg or 850 mg 2-3 times a day, and the dose of insulin is determined based on the blood glucose content.

Elderly patients

Due to the possible impairment of renal function in elderly patients, the dose of Siofor 1000 is determined on the basis of renal tests. A regular assessment of the condition of the kidneys is necessary.

Children and adolescents

Monotherapy and concomitant use with insulin
Siofor® 1000 can be used in children from 10 years of age and in adolescents.
The standard starting dose is 500 mg or 850 mg Siofor® once a day during or after meals.

After 10-15 days, the dose should be adjusted based on blood glucose. A slow increase in the dose improves the tolerability of the drug from the gastrointestinal tract. The maximum recommended dose of Siofor® 1000 is 2 g per day in 2-3 doses.

Side effects

Very often greater than or equal to 1/10
- nausea, vomiting, diarrhea, abdominal pain and loss of appetite. These adverse events often occur at the beginning of therapy and in most cases go away on their own. In order to prevent them, the dose of Siofor® 1000 is recommended to be divided into 2-3 doses during or after meals. A slow increase in the dose improves the tolerability of the drug from the gastrointestinal tract.
Often greater than or equal to 1/100, <1/10
- taste disturbance
Very rare ‹1/10 000
- skin reactions: redness, itching, urticaria
- megaloblastic anemia
- lactic acidosis
Not established (frequency cannot be determined from available data)
- deviations in functional liver function tests or hepatitis that pass after the cancellation of Siofor 1000.
According to the published data, the experience of post-marketing use and the results of controlled clinical studies of one-year use of the drug in a small number of children aged 10-16 years, the described adverse events were similar in nature and severity to those found in adults.

Contraindications

- hypersensitivity to metformin hydrochloride or excipients
- diabetic ketoacidosis, diabetic precoma
- renal failure or dysfunction (creatinine clearance <60 ml / min)
- acute conditions that can have a negative effect on renal function (dehydration, serious infectious disease, shock, intravascular administration of an iodine-containing contrast agent)
- an acute or chronic disease that can cause tissue hypoxia (heart or respiratory failure, recent myocardial infarction, shock)
- liver failure,
- acute alcohol intoxication, alcoholism
- pregnancy and breastfeeding

During pregnancy

If a diabetic patient is pregnant or planning to become pregnant, Siofor 1000 should not be used; it is necessary to use insulin to normalize the blood glucose level, if possible, in order to reduce the risk of developing fetal defects due to abnormalities in glycemia.

Pregnancy categories:

C - Australia
B - United States (No evidence of risk in humans)

Application for breastfeeding
There are no data on penetration into breast milk for humans, so a decision must be made to stop either breastfeeding or taking metformin hydrochloride, taking into account the importance of the drug for the mother

Interaction

NOT RECOMMENDED TO BE USED TOGETHER

Alcohol

The risk of developing lactic acidosis increases with acute alcohol intoxication, especially against the background of fasting or malnutrition, as well as liver failure.
Drinking alcohol and using alcohol-containing medications should be avoided.

Iodine contrast agents

Intravascular administration of iodine-containing contrast agents can lead to renal failure, as a result of which Siofor® 1000 accumulates in the body and the risk of lactic acidosis increases. Siofor® 1000 should not be taken within 48 hours before and after the administration of iodine-containing contrast agents; you can resume taking the drug only after confirming the normal functioning of the kidneys.

JOINT USE WITH CAUTION

Glucocorticoids (systemic and topical), beta-2 agonists, and diuretics

These drugs have hyperglycemic activity. You should inform the patient about this and more often determine the level of glucose in the blood, especially at the beginning of treatment. If necessary, the dose of the antidiabetic agent should be adjusted for the period of use and after the withdrawal of these drugs.

ACE inhibitors (angiotensin converting enzyme)

ACE inhibitors can lower blood glucose levels. If necessary, the dose of the antidiabetic agent should be adjusted for the period of use and after the withdrawal of these drugs.

In some patients with type 1 diabetes mellitus, Siofor 1000 was used in combination with insulin, however, the clinical advantage of such combination therapy has not been officially established.

A patient with megaloblastic anemia has impaired absorption of vitamin B12 and a decrease in its serum level with prolonged use of Siofor® 1000.

Overdose

Symptoms
When Siofor®1000 was used in doses up to 85 g, hypoglycemia was not observed, the development of lactic acidosis is possible. Lactic acidosis can be caused by an overdose of Siofor 1000 and associated risk factors.
Treatment
Urgent hospital care is required - hemodialysis.

 

How to store Siofor® (Metformin)

Keep all medicines out of the reach and sight of children
Store in a cool, dry place, away from direct heat and light

Shelf life - 3 years