Forxiga tabs 10mg #30

Forxiga instruction

You can buy Forxiga here

Composition

One tablet, film coated, 10 mg contains:
Active substance:
dapagliflozin propandiol monohydrate 12.30 mg, in terms of dapagliflozin 10 mg
Excipients: microcrystalline cellulose 171.45 mg, anhydrous lactose 50.00 mg, crospovidone 10.00 mg, silicon dioxide 3.75 mg, magnesium stearate 2.50 mg;
Tablet shell: Opadray® II yellow 10.00 mg (polyvinyl alcohol partially hydrolyzed 4.00 mg, titanium dioxide 2.35 mg, macrogol 3350 2.02 mg, talc 1.48 mg, dye iron oxide yellow 0.15 mg) .

Description

Film-coated tablets, 10 mg:
Diamond-shaped biconvex tablets covered with a yellow-colored film with an engraving “10” on one side and “1428” on the other side.

Pharmacotherapeutic group

Hypoglycemic agent for oral administration - inhibitor sodium type 2 glucose transporter
ATH code: A10BH09

Pharmacological properties

Mechanism of action

Dapagliflozin is a potent (inhibition constant (Ki) 0.55 nM), a selective reversible inhibitor of type 2 sodium-glucose cotransporter (SGLT2). SGLT2 is selectively expressed in the kidney and is not found in more than 70 other tissues of the body (including the liver, skeletal muscle, adipose tissue, mammary glands, bladder and brain). SGLT2 is the main carrier involved in the process of glucose reabsorption in the renal tubules. The reabsorption of glucose in the renal tubules in patients with type 2 diabetes mellitus (type 2 diabetes) continues despite hyperglycemia. By inhibiting the renal transfer of glucose, dapagliflozin reduces its reabsorption in the renal tubules, which leads to the elimination of glucose by the kidneys. The result of dapagliflozin is a decrease in fasting and postprandial glucose concentrations, as well as a decrease in the concentration of glycosylated hemoglobin in patients with type 2 diabetes.
Glucose excretion (glucosuric effect) is observed already after taking the first dose of Forxiga, it persists for the next 24 hours and lasts for the duration of therapy. The amount of glucose excreted by the kidneys due to this mechanism depends on the concentration of glucose in the blood and on the glomerular filtration rate (GFR). Dapagliflozin does not interfere with normal endogenous glucose production in response to hypoglycemia. The action of dapagliflozin does not depend on insulin secretion and insulin sensitivity. In clinical studies with Forxiga ™, there was an improvement in beta cell function (HOMA test, homeostasis model assessment).
The excretion of glucose by the kidneys, caused by dapagliflozin, is accompanied by loss of calories and weight loss. Inhibition of sodium-glucose cotransport by dapagliflozin is accompanied by weak diuretic and transient natriuretic effects.
Dapagliflozin does not affect other glucose transporters that transport glucose to peripheral tissues, and is more than 1,400 times more selective for SGLT2 than SGLT1, the main transporter in the intestine, which is responsible for glucose absorption.

Pharmacodynamics

After dapagliflozin was taken by healthy volunteers and patients with type 2 diabetes, an increase in the amount of glucose excreted by the kidneys was observed. When receiving dapagliflozin at a dose of 10 mg / day for 12 weeks, patients with T2DM approximately 70 g of glucose per day were excreted by the kidneys (which corresponds to 280 kcal / day). In patients with type 2 diabetes who took dapagliflozin at a dose of 10 mg / day for a long time (up to 2 years), glucose excretion was maintained throughout the entire course of therapy.
The excretion of glucose by the kidneys with dapagliflozin also leads to osmotic diuresis and an increase in urine volume. The increase in urine volume in patients with diabetes mellitus 2 who took dapagliflozin at a dose of 10 mg / day was maintained for 12 weeks and was approximately 375 ml / day. The increase in urine volume was accompanied by a small and transient increase in sodium excretion by the kidneys, which did not lead to a change in serum sodium concentration.

Pharmacokinetics

Absorption

After ingestion, dapagliflozin is rapidly and completely absorbed in the gastrointestinal tract and can be taken both during and outside the meal. The maximum concentration of dapagliflozin in plasma (Cmax) is usually achieved within 2 hours after ingestion on an empty stomach. The values ​​of C max and AUC (the area under the curve of concentration versus time) increase in proportion to the dose of dapagliflozin. The absolute bioavailability of dapagliflozin when administered orally at a dose of 10 mg is 78%. Meal had a moderate effect on the pharmacokinetics of dapagliflozin in healthy volunteers. Eating a high fat diet reduced Stach dapagliflozin by 50%, lengthened Tmax (time to reach maximum plasma concentration) by about 1 hour, but did not affect AUC compared to fasting. These changes are not clinically significant.

Distribution

Dapagliflozin is approximately 91% bound to proteins. In patients with various diseases, for example, with impaired renal or liver function, this indicator did not change.

Metabolism

Dapagliflozin is a C-linked glucoside whose aglycone is linked to glucose by a carbon-carbon bond, which ensures its stability against glucosidases. The average half-life from plasma (T½) in healthy volunteers was 12.9 hours after a single dose of dapagliflozin orally at a dose of 10 mg. Dapagliflozin is metabolized to form mainly the inactive metabolite dapagliflozin-3-O-glucuronide.
After ingestion of 50 mg of 14C-dapagliflozin, 61% of the dose taken is metabolized to dapagliflozin-3-O-glucuronide, which accounts for 42% of total plasma radioactivity (AUC0-12 h) - Unchanged drug accounts for 39% of total plasma radioactivity. The shares of the other metabolites do not exceed 5% of the total plasma radioactivity. Dapagliflozin-3-O-glucuronide and other metabolites have no pharmacological action. Dapagliflozin-3-O-glucuronide is formed by the enzyme uridine diphosphate glucuronosyl transferase 1A9 (UGT1A9), which is present in the liver and kidneys, and cytochrome CYP isoenzymes are involved in metabolism to a lesser extent.

Removal

Dapagliflozin and its metabolites are excreted mainly by the kidneys, and only less than 2% is excreted unchanged. After taking 50 mg of 14C-dapagliflozin, 96% of radioactivity was detected - 75% in urine and 21% in feces. Approximately 15% of the radioactivity found in feces was unchanged dapagliflozin.

Pharmacokinetics in special clinical situations

Patients with impaired renal function

In the equilibrium state (average AUC), systemic exposure to dapagliflozin in patients with diabetes mellitus and mild, moderate, or severe renal failure (determined by the yogexol clearance) was 32%, 60%, and 87% higher than in patients with diabetes and normal function kidneys, respectively. The amount of glucose excreted by the kidneys during the day when dapagliflozin is taken in an equilibrium state depended on the state of the kidney function. In patients with type 2 diabetes and normal renal function, and with mild, moderate, or severe renal insufficiency, 85, 52, 18, and 11 g of glucose were removed per day, respectively. There were no differences in the binding of dapagliflozin with proteins in healthy volunteers and in patients with renal insufficiency of varying severity. It is not known whether hemodialysis affects the exposure of dapagliflozin.

Patients with impaired liver function

In patients with mild or moderate hepatic insufficiency, the mean Cmax and AUC values ​​of dapagliflozin were, respectively, 12% and 36% higher compared with healthy volunteers. These differences are not clinically significant, therefore, adjusting the dose of dapagliflozin in mild to moderate hepatic insufficiency is not required (see the section “Dosage and Administration”), In patients with severe hepatic insufficiency (Child-Pugh class C), mean values Dapagliflozin's Cmax and AUC were 40% and 67% higher, respectively, compared with healthy volunteers.

Elderly patients (> 65 years)

There was no clinically significant increase in exposure in patients under the age of 70 years (unless factors other than age were taken into account). However, an increase in exposure can be expected due to a decrease in renal function associated with age. Data on exposure in patients over the age of 70 years are insufficient.

Gender

In women, the average AUC in equilibrium is 22% higher than that in men.

Race

There were no clinically significant differences in systemic exposure among representatives of the Caucasoid, Negroid, and Mongoloid races.

Body mass

Marked lower exposure values ​​with increased body weight. Therefore, in patients with low body mass, there may be a slight increase in exposure, and in patients with increased body mass, a decrease in dapagliflozin exposure can be observed. However, these differences are not clinically significant.

Indications for use

Type 2 diabetes in addition to diet and exercise to improve glycemic control as:
    monotherapy;
    additions to metformin therapy in the absence of adequate glycemic control on this therapy;
    starting combination therapy with metformin, if appropriate this therapy.

Contraindications

    Increased individual sensitivity to any component of Forxiga.
    Diabetes mellitus type 1.
    Diabetic ketoacidosis.
    Medium to severe renal failure (GFR <60 ml / min / 1.73 m2) or end-stage renal disease.
    Hereditary lactose intolerance, lactase deficiency and glucose-galactose intolerance.
    Pregnancy and breastfeeding period.
    Children under 18 years of age (safety and efficacy not studied).
    Patients who take "loop" diuretics (see the section "Interaction with other drugs and other types of drug interactions"), or with a reduced volume of circulating blood, for example, due to acute diseases (such as gastrointestinal diseases).
    Elderly patients aged 75 years and older (to start therapy).

Carefully

severe liver failure, urinary tract infection, risk of circulating blood volume reduction, elderly patients, chronic heart failure, increased hematocrit.
Use during pregnancy and during breastfeeding
Due to the fact that the use of dapagliflozin during pregnancy has not been studied, Forxiga is contraindicated during pregnancy. If pregnancy is diagnosed, dapagliflozin therapy should be discontinued.
It is not known whether dapagliflozin and / or its inactive metabolites into breast milk. Risk to newborns / babies cannot be excluded. Dapagliflozin is contraindicated during breastfeeding.

Dosage and administration

Inside, regardless of the meal.
Monotherapy: The recommended dose of Forxiga ™ is 10 mg once daily.
Combination therapy: The recommended dose of Forxiga ™ is 10 mg once daily in combination with metformin.
Starting combination therapy with metformin: the recommended dose of Forxiga ™ is 10 mg once a day, the dose of metformin is 500 mg once a day. In case of inadequate glycemic control, the dose of metformin should be increased.

Use in special patient groups

Patients with impaired liver function

When violations of the liver of mild or moderate severity there is no need to adjust the dose of the drug Forxiga. For patients with severely impaired liver function, an initial dose of 5 mg is recommended. With good tolerance, the dose may be increased to 10 mg (see the sections “Pharmacokinetics” and “Special Instructions”).
Patients with impaired renal function. The effectiveness of dapagliflozin depends on kidney function, in patients with moderate renal impairment, the effectiveness of treatment is reduced, and in patients with severe impairment, it is most likely absent. Forxiga ™ is contraindicated in patients with moderate to severe renal insufficiency (creatinine clearance (CK) <60 ml / min or GFR <60 ml / min / 1.73 m2) or with end-stage renal disease (see Contraindications, "Side Effects" and "Special Instructions").
In cases of mild renal dysfunction, there is no need to adjust the dose of Forxiga.

Children

The safety and efficacy of dapagliflozin in patients under the age of 18 years has not been studied (see the “Contraindications” section).

Elderly patients

Elderly patients do not need to adjust the dose of Forxiga. However, when choosing a dose, it should be borne in mind that this category of patients is more likely to have impaired renal function and the risk of a decrease in circulating blood volume (BCC). Since the clinical experience with the drug Forxiga in patients 75 years and older is limited, it is contraindicated to begin therapy with dapagliflozin in this age group.

Side effects of Forxiga

Security Profile Overview
The pre-planned analysis of pooled data included the results of 12 placebo-controlled studies in which 1,193 patients took dapagliflozin at a dose of 10 mg and 1,393 patients received placebo.
The overall incidence of adverse events (short-term therapy) in patients taking dapagliflozin at a dose of 10 mg was similar to that in the placebo group. The number of adverse events leading to discontinuation of therapy was small and balanced between treatment groups. The most frequent adverse events that led to the cancellation of therapy with dapagliflozin at a dose of 10 mg were an increase in the concentration of creatinine in the blood (0.4%), urinary tract infection (0.3%), nausea (0.2%), dizziness (0, 2%) and rash (0.2%). In one patient who took dapagliflozin, the development of an adverse event on the part of the liver was diagnosed with drug-induced hepatitis and / or autoimmune hepatitis.
The most common adverse reaction was hypoglycemia, the development of which depended on the type of basic therapy used in each study. The incidence of mild hypoglycemia episodes was similar in treatment groups, including placebo.
Description of individual unwanted reactions
Hypoglycemia
The incidence of hypoglycemia depended on the type of basic therapy used in each study.
In studies of dapagliflozin as monotherapy, combination therapy with metformin for up to 102 weeks, the incidence of episodes of mild hypoglycemia was similar (<5%) in treatment groups, including placebo. In all studies, episodes of severe hypoglycemia were rarely observed, and their frequency was comparable between the dapagliflozin group and the placebo group.
Lower bcc
Adverse reactions associated with a decrease in BCC (including reports of dehydration, hypovolemia, or arterial hypotension) were observed in 0.8% and 0.4% of patients taking dapagliflozin 10 mg and placebo, respectively; serious reactions were noted in <0.2% of patients, and they were comparable in the dapagliflozin 10 mg and placebo groups (see section “Special Instructions”).
Vulvovaginitis, balanitis and similar genital infections
Vulvovaginitis, balanitis, and similar genital infections are noted in 4.8% and 0.9% of patients taking dapagliflozin 10 mg and placebo, respectively. Most infections were mild or moderate; the initial course of standard therapy was effective, and therefore patients rarely stopped taking dapagliflozin. These infections more often developed in women (6.9% and 1.5% with dapagliflozin and placebo, respectively), and in patients with such infections in history, they often recur.
Urinary tract infections
Urinary tract infections are more common with dapagliflozin 10 mg than with placebo (4.3% versus 3.7%, respectively; see “Special Instructions”). Most infections were mild or moderate; the initial course of standard therapy was effective, and therefore patients rarely stopped using dapagliflozin. These infections more often developed in women, and in patients with such infections in history, they more often recurred.
Parathyroid hormone (PTH)
A slight increase in serum PTH concentration was noted, and to a greater extent in patients with higher initial PTH concentrations. Studies of bone mineral density in patients with normal renal function or mild renal dysfunction did not reveal bone loss during one year of therapy.
Malignant tumors
In clinical studies, the overall proportion of patients with malignant or unspecified tumors was similar in the dapagliflozin group (1.47%) and the placebo / comparator group (1.35%). According to animal studies, Forxiga showed no carcinogenic or mutagenic properties. When considering cases of the development of tumors of various organ systems, the relative risk associated with dapagliflozin was above 1 for some tumors (bladder, prostate gland, breast) and below 1 for others (for example, blood and lymphatic system, ovaries, urinary system) , generally without increasing the risk of developing tumors associated with dapagliflozin. Increased / decreased risk was not statistically significant for any organ system. Given the lack of information on the development of tumors in preclinical studies, as well as a short latent period between the first exposure of Forxiga and the diagnosis of the tumor, the causal relationship is assessed as unlikely. Since the numerical imbalance of breast, bladder and prostate tumors requires special attention, the study of this issue will be continued in the framework of post-registration studies.
Elderly patients (> 65 years)
Adverse reactions associated with impaired renal function or renal failure were reported in 2.5% of patients who received dapagliflozin and 1.1% of patients who received placebo in a group of patients> 65 years of age (see the section "Specific Instructions"). The most common adverse reaction associated with impaired renal function was an increase in serum creatinine concentration. Most of these reactions were transient and reversible. Among patients aged> 65 years, a decrease in BCC, most often recorded as arterial hypotension, was observed in 1.5% and 0.4% of patients taking dapagliflozin and placebo, respectively (see the section "Special Instructions")

Overdose

Dapagliflozin is safe and well tolerated by healthy volunteers when taken once in doses up to 500 mg (50 times higher than the recommended dose). Glucose was determined in the urine after taking Forxiga (at least 5 days after taking a dose of 500 mg), while no cases of dehydration, hypotension, electrolyte imbalance, or clinically significant effect on the QTc interval were detected. The incidence of hypoglycemia was similar to the frequency with placebo. In clinical studies in healthy volunteers and patients with T2DM who took the drug Forxiga once in doses up to 100 mg (10 times higher than the maximum recommended dose) for 2 weeks, the incidence of hypoglycemia was slightly higher than when taking placebo, and did not depend on the dose . The incidence of adverse events, including dehydration or hypotension, was similar to the frequency in the placebo group, with no clinically significant, dose-dependent changes in laboratory parameters, including serum electrolyte levels and biomarkers of renal function.
In the case of overdose, it is necessary to carry out maintenance therapy, taking into account the condition of the patient. Dapagliflozin excretion via hemodialysis has not been studied.

Interaction with other drugs

Diuretics

Dapagliflozin may increase the diuretic effect of thiazide and "loop" diuretics and increase the risk of dehydration and arterial hypotension (see the section "Special Instructions").

Pharmacokinetic interaction

The metabolism of dapagliflozin is mainly carried out by glucuronide conjugation under the action of UGT1A9.
During in vitro studies, dapagliflozin did not inhibit cytochrome P450 isoenzymes of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, and did not induce CYP1A2, CYP22 isoenzymes, CYP2A6, CYP3A4, CYP2A6, CYP2A6. In this regard, the effect of dapagliflozin on the metabolic clearance of concomitant drugs that are metabolized by these isoenzymes is not expected.

Effect of Other Drugs on Dapagliflozin

Studies of interactions involving healthy volunteers, mainly taking a single dose of Forxiga, have shown that metformin, pioglitazone, sitagliptin, glimepiride, voglibose, hydrochlorothiazide, bumetanide, valsartan or simvastatin do not affect the pharmacokinetics of dapagliflozin. After joint use of dapagliflozin and rifampicin, an inducer of various active transporters and drug metabolizing enzymes, a decrease in systemic exposure (AUC) of dapagliflozin by 22% was observed, with no clinically significant effect on daily glucose excretion by the kidneys. It is not recommended to adjust the dose of the drug. No clinically significant effect is expected when used with other inducers (for example, carbamazepine, phenytoin, phenobarbital).
After the combined use of dapagliflozin and mefenamic acid (UGT1A9 inhibitor), a 55% increase in systemic exposure to dapagliflozin was noted, but without a clinically significant effect on the daily excretion of glucose by the kidneys. It is not recommended to adjust the dose of the drug.

The effect of dapagliflozin on other drugs

In studies of interactions involving healthy volunteers, mainly taking a single dose of Forxiga, dapagliflozin ctcct did not affect the pharmacokinetics of metformin, pioglitazone, sitagliptin, glimepiride, hydrochlorothiazide, bumetanide, valsartan, digoxin (substrate P-gr, an, or an, an, or an, an, an, an, or an, or an anti-cholerazide, bumetanide, valsartan, digoxin (substrate P-gp, or an, an, or an, or an orc, digoxin) CYP2C9 isoenzyme), or on the anticoagulant effect, as measured by the International Normalized Ratio (MHO). The use of a single dose of dapagliflozin 20 mg and simvastatin (CYP3A4 isoenzyme substrate) resulted in an increase of 19% in AUC of simvastatin and in 31% of AUC of simvastatin acid. Increasing the exposure of simvastatin and simvastatinic acid is not considered clinically significant.

Other interactions

The effects of smoking, diet, taking herbal remedies and drinking alcohol on the parameters of dapagliflozin pharmacokinetics have not been studied.

special instructions

Use in patients with impaired renal function

The effectiveness of dapagliflozin depends on the renal function, and this effectiveness is reduced in patients with moderate renal insufficiency and is probably absent in patients with severe renal impairment (see section “Dosage and administration”). Among patients with moderate renal failure (CC <60 ml / min or estimated GFR <60 ml / min / 1.73 m2), a greater proportion of patients receiving dapagliflozin showed an increase in creatinine, phosphorus, parathyroid hormone and arterial hypotension than patients receiving placebo. Forxiga ™ is contraindicated in patients with moderate to severe renal failure (CC <60 ml / min or estimated GFR <60 ml / min / 1.73 m2). Forxiga ™ was not studied in severe renal failure (CC <30 ml / min or estimated GFR <30 ml / min / 1.73 m2) or end-stage renal disease.
It is recommended to monitor kidney function as follows:
    before starting therapy with dapagliflozin and at least once a year thereafter (see the sections “Dosage and administration”, “Adverse effect”, “Pharmacodynamics” and “Pharmacokinetics”);
    before taking concomitant medications that can reduce kidney function, and periodically thereafter;
    in violation of renal function, close to moderate severity, at least 2-4 times a year. With a decrease in kidney function below the CC value <60 ml / min or estimated GFR <60 ml / min / 1.73 m2, dapagliflozin should be stopped.

Use in patients with impaired liver function

In clinical studies, limited data on the use of Forxiga in patients with impaired liver function were obtained. Exposure of dapagliflozin is increased in patients with severely impaired liver function (see the sections “Dosage and administration”, “With caution” and “Pharmacokinetics”),
Use in patients at risk of lowering BCC, development of arterial hypotension and / or electrolyte imbalance
In accordance with the mechanism of action of dapagliflozin increases diuresis, accompanied by a slight decrease in blood pressure (see the Pharmacodynamics section), the diuretic effect may be more pronounced in patients with very high blood glucose concentrations.
Dapagliflozin is contraindicated in patients taking “loopback” diuretics (see the section “Interaction with other drugs and other types of drug interactions”) or in patients with decreased OC, for example, due to acute diseases (such as gastrointestinal diseases). Care should be taken in patients for whom dapagliflozin-induced reduction in blood pressure may pose a risk, for example, in patients with a history of cardiovascular disease, in patients with a history of arterial hypotension, or in antihypertensive therapy, or in elderly patients.
When taking dapagliflozin, careful monitoring of the state of the BCC and electrolyte concentrations (for example, physical examination, blood pressure measurement, laboratory tests, including hematocrit) are recommended against the background of concomitant conditions that may lead to a decrease in the BCC. With a decrease in BCC, it is recommended to temporarily stop taking dapagliflozin until this condition is corrected (see the “Side Effects” section).

Urinary tract infections

When analyzing the combined data of dapagliflozin use up to 24 weeks of urinary tract infection, it is more often noted when dapagliflozin is used in a dose of 10 mg compared with placebo (see the section “Side Effects”). The development of pyelonephritis was noted infrequently, with a similar frequency in the control group. The excretion of glucose by the kidneys may be accompanied by an increased risk of developing urinary tract infections, therefore, when treating pyelonephritis or urosepsis, the possibility of temporary discontinuation of therapy with dapagliflozin should be considered (see the section “Side Effects”).

Elderly patients

Older patients are more likely to have impaired renal function and / or use of antihypertensive drugs that can affect kidney function, such as angiotensin-converting enzyme inhibitors (ACE inhibitors) and type 1 angiotensin II receptor antagonists (ARA). For older patients, the same recommendations apply for kidney dysfunction as for all patient populations (see the sections “Dosage and Administration”, “Adverse Effects”, and “Pharmacodynamics”). In the group> 65 years of age, a greater proportion of patients who received dapagliflozin, developed adverse reactions associated with impaired renal function or renal failure compared with placebo. The most frequent adverse reaction associated with impaired renal function was an increase in serum creatinine, most cases were transient and reversible (see the “Side Effects” section).
In elderly patients, the risk of lowering BCC may be higher, and diuretics are more likely to be taken. Among patients aged> 65 years, a greater proportion of patients who received dapagliflozin showed adverse reactions associated with a decrease in BCC (see the “Adverse Effects” section).
Experience with the drug Forxiga in patients aged 75 years and older is limited. It is contraindicated to begin therapy with dapagliflozin in this population (see the sections "Dosage and Administration" and "Pharmacokinetics").

Chronic heart failure

The experience of using the drug in patients with chronic heart failure I-II functional class according to the NYHA classification is limited, and in clinical studies dapagliflozin was not used in patients with chronic heart failure III-IV functional class according to NYHA.

Hematocrit increase

When using dapagliflozin, an increase in hematocrit was observed (see the “Side Effects” section), and therefore caution should be exercised in patients with an elevated hematocrit value.

Evaluation results of urine analysis

Due to the mechanism of action of Forxiga, the results of urine glucose testing in patients taking Forxiga ™ will be positive.

Influence on ability to drive vehicles and mechanisms

Studies on the effect of dapagliflozin on the ability to drive vehicles and mechanisms was not conducted.

Release form

Film coated tablets, 5 mg, 10 mg.
On 14 tablets in the blister from aluminum foil; 2 or 4 blisters in a carton pack with instructions for use or 10 tablets in a perforated blister of aluminum foil; 3 or 9 perforated blisters in a carton box with instructions for use.
The places where the cardboard pack is opened are sealed with two protective, transparent, colorless stackers; On the middle part of each stacker, bounded by tear-off lines, there is a pattern in the form of a yellow grid.

Storage conditions

At a temperature not higher than 30 ° С, in places inaccessible for children.
Keep out of the reach of children.

Shelf life - 3 years.
Do not use after the expiration date printed on the package.

Terms of sell

You don't need a prescription to buy Forxiga.