Formina Pliva - instructions for use, dose, side effects, contraindications

Composition:1 tablet, film-coated, contains:
active substance: metformin hydrochloride - 1000 mg;
Excipients: hypromellose 15000 CPS, povidone, magnesium stearate; shell: hypromellose 5 CPS, macrogol 6000, titanium dioxide (E 171).

Description:White biconvex tablets, film-coated, oblong in shape, on both sides with risks along which the canted recesses, on one side of the tablet the notch is more pronounced.

Pharmacotherapeutic group:Hypoglycemic agent for oral administration of the biguanide group.

ATX: & nbsp

A.10.B.A.02 Metformin

Pharmacodynamics:Metformin inhibits gluconeogenesis in the liver,reduces absorption of glucose from the intestine, enhances peripheral utilization of glucose, and also increases the sensitivity of tissues to insulin. In this case, it has no effect on the secretion of insulin by beta cells of the pancreas. Reduces the level of triglycerides and low density lipoproteins in the blood. Stabilizes or reduces body weight. Has a fibrinolytic effect due to inhibition of the inhibitor of tissue-type plasminogen activator.

Pharmacokinetics:After oral administration metformin is absorbed from the gastrointestinal tract. Bioavailability after taking a standard dose is -50-60%. The maximum concentration in the blood plasma (C max) is reached after 2 hours after ingestion. The intake of food reduces Cmax by 40% and slows its achievement by 35 min. It is able to accumulate in red blood cells. Virtually does not bind to plasma proteins. It accumulates in the salivary glands, muscles, liver and kidneys. The half-life is 6.5 hours.

Indications:Diabetes mellitus type 2, without a tendency to ketoacidosis (especially in patients with obesity) with ineffectiveness of diet therapy.

Contraindications:- hypersensitivity to the drug;
- diabetic ketoacidosis, diabetic precoma, coma;
- severe renal dysfunction;
- cardiac and respiratory insufficiency, acute phase of myocardial infarction, acute disturbance of cerebral circulation, dehydration, chronic alcoholism, severe infectious diseases, shock and other conditions that may contribute to the development of lactic acidosis;
- Lactic acidosis and indication in the anamnesis;
- pregnancy and the period of breastfeeding;
- Serious surgical operations and trauma, when insulin therapy is shown;
- liver failure, acute alcohol poisoning;
- use for at least 2 days before and within 2 days after carrying out radioisotope or X-ray studies with the introduction of iodine-containing contrast agent;
- adherence to a hypocaloric diet (less than 1000 calories / day).

Carefully:People over 60 years of age who perform severe physical problems are associated with an increased risk of developing lactic acidosis.

Dosing and Administration:The dose of the drug Formin Pliva is set individually, taking into account the level of glucose in the blood.The initial dose is usually 500-1000 mg (1/2 - 1 tablet) per day, there may be a further gradual increase in the dose depending on the effect of therapy, it is possible to further gradually increase the dose depending on the effect of therapy.
The maintenance daily dose of the drug is 1000-2000 mg (1-2 tablets) per day. The maximum daily dose of -3000 mg (3 tablets), the appointment of higher doses does not contribute to an increase in the effect of the treatment.
Tablets Formin Pliva should be taken with food, squeezed with a small amount of liquid (a glass of water). The course of treatment with the drug is long. Due to the increased risk of lactic acidosis, the dose of the drug should be reduced in case of severe metabolic disorders.

Side effects:From the gastrointestinal tract (GIT): nausea, vomiting, pain in the stomach, diarrhea, flatulence, lack of appetite, change in taste. In these cases, it is usually not necessary to stop treatment, and the symptoms go away without changing the dose of the drug. The frequency and severity of GIT side effects may decrease with a gradual increase in the dose of metformin or in dividing the daily dose by 2-3 doses.In rare cases - abnormal abnormalities of liver samples or hepatitis that disappear after discontinuation of the drug.
Allergic reactions: skin rash, itching
From the endocrine system: hypoglycemia (mainly when used in inadequate doses and / or in combination with other hypoglycemic drugs).
From the side of metabolism: in rare cases - lactic acidosis (requires discontinuation of treatment), with prolonged treatment - hypovitaminosis B12 (impaired absorption).
On the part of the hematopoiesis system: in some cases - megaloblastic anemia.

Overdose:With an overdose of the drug, lactoacidosis can develop with a fatal outcome. The cause of the development of lactic acidosis may also be cumulation of the drug due to impaired renal function. The early symptoms of lactic acidosis are nausea, vomiting, diarrhea, lower body temperature, abdominal pain, and muscle pain. Later on, there may be more breathing, dizziness, impaired consciousness and coma development. In case of signs of lactic acidosis, treatment with Formin Pliva should be stopped immediately, the patient should immediately hospitalize and, after determining the concentration of lactate, confirm the diagnosis.The most effective measure for excretion from the body of lactate and metformin is hemodialysis. Conduct also symptomatic treatment. With combined therapy with the drug Formina Pliva with drugs of sulfonylureas hypoglycemia can develop.

Interaction:When used simultaneously with derivatives of sulfonylurea, salicylates, acarbose, insulin, nonsteroidal anti-inflammatory agents, monoamine oxidase inhibitors, oxytetracycline, angiotensin converting enzyme inhibitors, clofibrate derivatives, cyclophosphamide, 6-adrenoblockers, hypoglycemic action of metformin may be enhanced. With simultaneous use (systemic and local) with glucocorticosteroids, oral contraceptives, sympathomimetics, glucagon, thyroid hormones, thiazide and loop diuretics, phenothiazine derivatives, nicotinic acid derivatives, a decrease in the hypoglycemic effect of metformin is possible.
Nifedipine increases absorption, C max, slows down excretion.
Cimetidine slows the excretion of metformin, which increases the risk of developing lactic acidosis.
Cationic drugs (amiloride, digoxin, morphine, procain, quinidine, quinine, ranitidine, triamterene and vancomycin), secreted in the tubules, compete for tubular transport systems and, with prolonged therapy, can increase Cmax by 60%.
Metformin can weaken the effect of anticoagulants (coumarin derivatives). By simultaneously taking alcohol, lactoacidosis can develop.
Possible cumulation of metformin and the development of lactic acidosis with intravascular injection of iodine-containing contrast agents.

Special instructions:During the treatment it is necessary to monitor the kidney function. At least 2 times a year, and also with the appearance of myalgia, a determination of the lactate content in the plasma should be carried out. Possible use of the drug Formin Pliva in combination with derivatives of sulfonylureas or insulin. In this case, careful monitoring of blood glucose levels is necessary.
Large surgical interventions and trauma, extensive burns, infectious diseases with febrile syndrome may require the abolition of oral glycemic drugs and the administration of insulin.

Effect on the ability to drive transp. cf. and fur:When using the drug in monotherapy does not affect the ability to drive vehicles and work with mechanisms.
When metformin is combined with other hypoglycemic agents (derivatives of sulfonylureas, insulin, etc.) hypoglycemic conditions may develop, in which the ability to drive vehicles and engage in other potentially dangerous activities that require increased attention and rapid psychomotor reactions deteriorates.

Form release / dosage:Film coated tablets 1000 mg.

Packaging:For 15 tablets in a blister of PVC / aluminum foil.
For 2 or 4 blisters together with instructions for use in a cardboard box.

Storage conditions:Store at a temperature not exceeding 25 ° C. Keep out of the reach of children!

Shelf life:4 years.
Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006972/08

Date of registration:01.09.2008

Expiration Date:Unlimited

The owner of the registration certificate:Pliva of Hrvatska dooPliva of Hrvatska doo Croatia

Manufacturer: & nbsp

PLIVA HRVATSKA, d.o.o. Croatia

Information update date: & nbsp2016-09-27

Illustrated instructions

Instructions

Formin Pliva (Formin Pliva)