Active ingredients: Acarbose
Glucobay 50 mg tablets
Glucobay 100 mg tablets
Why is Glucobay used? What is it for?
Glucobay contains the active substance acarbose, which belongs to the group of medicines known as oral hypoglycaemics.
Glucobay is a medicine used in the treatment of:
- Non-insulin-dependent diabetes mellitus in patients treated by diet alone or by diet in combination with oral hypoglycemic agents.
- Insulin-dependent diabetes mellitus in patients undergoing insulin and diet therapy.
Contraindications When Glucobay should not be used
Do not take Glucobay:
- if you are allergic to acarbose or any of the other ingredients of this medicine
- if you are pregnant or breastfeeding (see 'Pregnancy and breastfeeding');
- if you suffer from chronic enteropathies (intestinal inflammation or ulceration, partial intestinal obstruction or predisposition to intestinal obstruction) associated or not with digestive and absorption disorders (for example gluten diseases);
- if you are under the age of 18;
- if you suffer from diseases which may be aggravated by increased gas production in the gut, such as Roemheld's syndrome, large hernias, intestinal obstructions or ulcerations;
- if you have had a gastrectomy (surgical removal of part or all of the stomach);
- if you have severe kidney problems (severe renal insufficiency [creatinine clearance
- if you have severe liver problems (severe impairment of liver function, for example liver cirrhosis).
Precautions for use What you need to know before taking Glucobay
Talk to your doctor or pharmacist before taking Glucobay.
It is strictly necessary to follow your diet, even when you are taking Glucobay. If you do not respect the dietary regimen, the risk of side effects increases (see paragraph 4).
Do not stop taking Glucobay without consulting your doctor first as you may experience an increase in your blood sugar (blood glucose levels) when you stop treatment.
Glucobay has an antihyperglycemic effect, but by itself it does not induce hypoglycemia (excessive reduction of blood glucose) in people who only take a diet.
If Glucobay is prescribed in addition to other hypoglycaemic medicines (e.g. sulfonylureas, metformin or insulin), a fall in blood glucose values may require a dose adjustment of these medicines. If acute hypoglycaemia develops, your doctor will prescribe glucose for rapid correction of the hypoglycemic state.
Cases of fulminant hepatitis have been reported during Glucobay therapy. Your doctor will check the level of liver enzymes (protein substances found in the liver) in the first 6-12 months of treatment and if he sees an increase in their level, he may reduce the dose of Glucobay or stop treatment (see section 4).
Glucobay therapy must be reported in the document certifying the patient's diabetic status.
Children and adolescents
The tolerability and efficacy of acarbose in patients less than 18 years of age has not been demonstrated
Interactions Which drugs or foods can modify the effect of Glucobay
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those obtained without a prescription.
It is important to tell your doctor if you are taking:
- other antidiabetic medicines (sulfonylureas, metformin or insulin). This is because in patients treated concomitantly with Glucobay and these medicinal products, blood glucose values may fall to hypoglycaemic levels and, therefore, a dose adjustment of the latter may be necessary. Glucobay has an antihyperglycemic effect but does not in itself cause hypoglycemia. Single cases of hypoglycemic shock have been reported.
- digoxin (medicine used to increase the strength and speed of contraction of the heart). In individual cases, Glucobay may affect the bioavailability of digoxin, so that a dosage adjustment is required.
- cholestyramine (medicine used to treat high cholesterol), intestinal adsorbents (substances used in the symptomatic treatment of diarrhea, which adsorb water in the intestine and consequently compact the stool) or digestive enzymes (medicines used to aid digestion). you should take these medicines at the same time as Glucobay as they may affect the way Glucobay works.
- neomycin (antibiotic used to treat infections). Concomitant administration of Glucobay and oral neomycin may lead to a greater reduction in postprandial blood glucose (the level of blood sugar after a meal) and an increased risk of stomach side effects. In this case, your doctor may decide to temporarily reduce your Glucobay dosage.
- no interaction was observed with dimethicone and simethicone (medicines used for intestinal disorders such as meteorism, i.e. excessive presence of air in the belly).
- fluoroquinolone class medicines (antibiotics used to treat infections). Co-administration of these medicines with Glucobay may change glucose levels and increase the risk of hypoglycaemia (excessive reduction in blood glucose) or hyperglycaemia (excessive increase in blood glucose).
Glucobay with food and drink
Consumption of sucrose (sugar) and sugar-containing foods during treatment with Glucobay often causes intestinal disturbances or even diarrhea due to the increased fermentation of carbohydrates in the colon.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Glucobay is contraindicated during pregnancy and breastfeeding.
Pregnancy
Glucobay should not be used during pregnancy, as there are no data from clinical studies regarding the use of acarbose in pregnant women.
Feeding time
There are no data available in humans, however since the possibility of effects of acarbose on infants cannot be excluded, it is recommended not to prescribe Glucobay during breastfeeding.
Driving and using machines
There are no data on impaired ability to drive and use machines during treatment with Glucobay.
Dosage and method of use How to use Glucobay: Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Your doctor will determine the appropriate dosage for you, because the efficacy and tolerability of the medicine vary for each individual patient.
Unless otherwise prescribed, the recommended dose for an adult is:
- 1 tablet of 50 mg (or half a tablet of 100 mg) 3 times a day at the start of treatment;
- 2 tablets of 50 mg or 1 tablet of 100 mg 3 times a day for the maintenance phase, if necessary increased to 2 tablets 3 times a day.
If your condition does not improve after 4-8 weeks of starting therapy, your doctor may increase your dosage.
Tell your doctor if you experience side effects, despite strictly adhering to the prescribed diet. In this case, your doctor may reduce your Glucobay dosage. On average, the effective dose for an adult subject is 100 mg of Glucobay 3 times a day.
If you are taking 200 mg of Glucobay 3 times a day, your doctor will need to closely monitor your condition.
How to use
Swallow the Glucobay tablet with a small amount of liquid or chew and swallow the tablet with the first mouthfuls of food. In both cases, take the tablet at the start of a meal.
Checks recommended during treatment
Your doctor will check your liver enzyme level for the first 6-12 months of treatment.
In individual cases, an "increase in liver enzymes can occur without symptoms."
In documented cases these effects disappeared after discontinuation of Glucobay therapy.
Use in the elderly
No dosage adjustments are necessary in relation to the patient's age.
Use in children and adolescents
As insufficient information is available on the effects and tolerability of the medicinal product in children and adolescents, Glucobay should not be administered to patients under 18 years of age.
Use in patients with impaired hepatic (liver) function
No dosage adjustments are required in patients with pre-existing mild or moderate hepatic impairment (for patients with severe hepatic impairment, see section "Do not take Glucobay")
Use in patients with impaired renal (kidney) function
Glucobay must not be used in patients with severe renal impairment (creatinine clearance
Duration of treatment
Glucobay can be taken without any time restrictions.
Overdose What to do if you have taken too much Glucobay
If you take more Glucobay than you should
If Glucobay is taken in combination with foods or drinks containing carbohydrates (sugar, bread, rice, pasta, etc.), the overdose can cause bloating, flatulence (air in the intestine) and diarrhea.
However, in the event that Glucobay is ingested in overdose in the absence of food, no excessive intestinal symptoms are expected.
In the event of an overdose, you should not take any food or drink containing carbohydrates for 4 - 6 hours after taking the medicine.
In case of accidental ingestion / intake of an excessive dose of Glucobay, notify your doctor immediately or go to the nearest hospital.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Glucobay
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Within each frequency class, undesirable effects are reported in descending order of severity. Frequencies are defined as:
Very common (may affect more than 1 in 10 people)
- air in the intestines (flatulence)
Common (may affect up to 1 in 10 people)
diarrhea and gastro-intestinal and abdominal pains.
Uncommon (may affect up to 1 in 100 people)
- nausea, vomiting and indigestion (dyspepsia);
- increased liver enzymes.
Rare (may affect up to 1 in 1,000 people)
- fluid buildup in tissues causing swelling (edema);
- yellowing of the skin and whites of the eyes (jaundice) not known (frequency cannot be estimated from the available data)
- abnormal decrease in the number of platelets in the blood (thrombocytopenia);
- hypersensitivity reactions (drug-induced hypersensitivity) such as rash, erythema (redness of the skin), rash (rash) and hives;
- partial or total blockage of the intestine, causing pain and vomiting (subileus / ileus) and intestinal cystoid pneumatosis (consisting in the presence of gas-filled cysts inside the intestinal wall);
- severe liver impairment (hepatitis);
- red rash with small blisters filled with white / yellow fluid (acute generalized exanthematous pustulosis);
- Cases of hepatic abnormalities, abnormal liver function and liver injury have been reported;
- individual cases of fulminant hepatitis with fatal outcome, particularly in Japan.
Failure to comply with the prescribed antidiabetic diet can accentuate the intensity of the undesirable effects affecting the gastrointestinal system (flatulence, diarrhea and gastro-intestinal and abdominal pains, nausea, vomiting and dyspepsia). If these occur despite proper dietary compliance, tell your doctor and your doctor will most likely consider temporarily or permanently reducing the dose of Glucobay you are taking.
In patients treated with the recommended dose of 150-300 mg / day of Glucobay, clinically relevant abnormalities in liver function tests (3 times above the upper limit of normal) have been observed rarely. Temporary abnormal values may occur during treatment with Glucobay (see section "Warnings and precautions").
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. The expiry date indicated refers to the product in intact packaging, correctly stored.
Store in the original packaging, at a temperature not exceeding 30 ° C. Protect from moisture.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Glucobay contains
- The active ingredient is acarbose. Each tablet contains 50 mg or 100 mg acarbose.
- The other ingredients are: corn starch, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica.
What Glucobay looks like and contents of the pack
40 tablets of 50 mg
40 tablets of 100 mg
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
GLUCOBAY 50 - 100 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
GLUCOBAY 50 mg tablets
One tablet contains:
Active ingredient: acarbose 50 mg.
GLUCOBAY 100 mg tablets
One tablet contains:
Active ingredient: acarbose 100 mg.
For the full list of excipients see section 6.1
03.0 PHARMACEUTICAL FORM
50 mg tablets: Round, convex, white to yellow tablets with a diameter of 7 mm and a radius of curvature of 10 mm. The tablet is marked with "G" and "50" on one side and the Bayer cross on the other.
100 mg tablets: oblong, oval, convex, white to yellow tablets, 13 mm long, 6 mm wide and 5.5 mm bend radius. The tablet is marked with "G", score line and "100" on one side and the score line on the other.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Non-insulin-dependent diabetes mellitus in patients undergoing treatment with diet alone or with the combination of diet and oral hypoglycemic agents.
Insulin-dependent diabetes mellitus in patients undergoing insulin and diet therapy.
04.2 Posology and method of administration
The dosage must be established case by case by the attending physician as the efficacy and tolerability of the preparation vary for each individual patient.
Unless otherwise prescribed, the dosage for an adult is:
- 1 tablet of 50 mg or ½ tablet of 100 mg 3 times a day at the start of treatment;
- 2 tablets of 50 mg or 1 tablet of 100 mg 3 times a day for the maintenance phase, if necessary increased to 2 tablets of 100 mg 3 times a day.
The posology can be increased after 4-8 weeks from the start of therapy if the patient does not obtain an adequate improvement in the clinical picture.
If unwanted effects occur, despite scrupulous compliance with the prescribed diet, it is advisable not to further increase the dosage of the drug and possibly reduce it.
On average, the effective dose for an adult subject is 100 mg of Glucobay x 3 times a day.
The patient receiving 200 mg 3 times a day should be carefully monitored by the doctor.
How to use
Glucobay tablets should be taken whole with a small amount of liquid or chewed and swallowed with the first bites of food: in both cases at the beginning of the meal.
Checks recommended during treatment
In individual cases, an "asymptomatic elevation of liver enzymes may occur.
Therefore, consideration should be given to monitoring the level of liver enzymes in the first 6-12 months of treatment.
In documented cases these effects disappeared after discontinuation of Glucobay therapy.
Geriatric patients
No dosage adjustments are necessary in relation to the patient's age.
Children and adolescents
As insufficient information is available on the effects and tolerability of the drug in children and adolescents, Glucobay should not be administered to patients under 18 years of age.
See also section 4.4.
Patients with impaired hepatic function
No dosage adjustments are required in patients with pre-existing mild or moderate hepatic impairment (for patients with severe hepatic impairment, see section 4.3).
Patients with impaired renal function
Glucobay must not be used in patients with severe renal impairment (creatinine clearance
Duration of treatment
Glucobay can be taken without any time restrictions.
04.3 Contraindications
- Hypersensitivity to the active substance and / or to any of the excipients.
- Pregnancy and breastfeeding.
- Chronic enteropathies (inflammatory bowel disease, colon ulceration, partial intestinal obstruction or predisposition to intestinal obstruction) associated or not with digestive and absorption disorders.
- Glucobay must not be used in patients under the age of 18.
- Pathological states that can be aggravated by an increase in the production of gas in the intestine, such as Roemheld's syndrome, large hernias, intestinal obstructions or ulcerations.
- Gastroresected patients.
- Severe renal insufficiency (creatinine clearance
- Severe impairment of liver function (e.g. liver cirrhosis).
04.4 Special warnings and appropriate precautions for use
Strict adherence to the dietary regimen remains a necessary condition even when Glucobay is administered.
Regular intake of Glucobay should not be discontinued without the advice of the treating physician as an increase in blood glucose may occur upon discontinuation of treatment.
Glucobay has an antihyperglycemic effect, but by itself it does not induce hypoglycemia in subjects who take only a dietary regimen.
If Glucobay is prescribed in addition to other hypoglycemic drugs (e.g. sulfonylureas, metformin or insulin), a fall in blood glucose values in the hypoglycemic range may require a dose adjustment of the latter. If acute hypoglycaemia develops, glucose should be used for rapid correction of the hypoglycaemic state (see section 4.5). Reversible asymptomatic elevations of liver enzymes may occur after discontinuation of treatment. Therefore, consideration should be given to monitoring the level of liver enzymes for the first 6-12 months of treatment.
Glucobay therapy must be reported in the document certifying the patient's diabetic status.
The safety and efficacy of acarbose in patients under the age of 18 has not been established.
04.5 Interactions with other medicinal products and other forms of interaction
Consumption of sucrose (sugar) and sugar-containing foods during Glucobay treatment often causes intestinal disturbances or even diarrhea due to the increased fermentation of carbohydrates in the colon.
Glucobay has an antihyperglycemic effect but does not in itself cause hypoglycemia. In patients treated concomitantly with Glucobay and sulfonylureas, metformin, or insulin, blood glucose values may be reduced to hypoglycaemic levels and, therefore, a dose adjustment of the latter may be necessary.
Single cases of hypoglycemic shock have been reported.
In the presence of acute hypoglycemia, it should be remembered that the metabolism of sucrose to fructose and glucose occurs more slowly during therapy with Glucobay; oral administration of sucrose is therefore inadequate as an immediate remedy for hypoglycaemia. Alternatively, glucose should be administered.
In individual cases Glucobay may affect the bioavailability of digoxin, so that its dosage adjustment is required.
During the treatment with Glucobay the concomitant administration of products containing cholestyramine, intestinal adsorbents or digestive enzymes should be avoided, due to the influence on the action of Glucobay.
Concomitant administration of Glucobay with oral neomycin may result in a greater reduction in postprandial blood glucose and an increase in the frequency and severity of gastrointestinal side effects. If symptoms are severe, a temporary dose reduction of Glucobay may be considered.
No interaction was observed with dimethicone and simethicone.
The concomitant use of fluoroquinolones could modify glucose levels and increase the risk of hypoglycemia or hyperglycemia.
04.6 Pregnancy and lactation
Pregnancy
Glucobay should not be used during pregnancy, as there are no data from clinical studies regarding the use of acarbose in pregnant women.
Feeding time
A small amount of radioactivity was found in milk after administration of labeled acarbose to lactating female rats. There are no corresponding data in man to date.
However, since the possibility of acarbose effects on infants cannot be excluded, it is recommended not to prescribe Glucobay during breastfeeding.
04.7 Effects on ability to drive and use machines
There are no data on impaired ability to drive and use machines during treatment with Glucobay.
04.8 Undesirable effects
Below is the frequency of acarbose side effects occurring in placebo-controlled clinical trials classified by CIOMS III frequency categories (placebo-controlled trials in the clinical trial database: acarbose N = 8,595; placebo: N = 7,278; to 10.02.06).
Within each frequency class, undesirable effects are reported in descending order of severity.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100,
Adverse reactions identified only during post-marketing surveillance (as of 31.12.05), and for which a frequency estimate could not be made, are listed under the frequency "not known".
In addition, reported effects such as hepatic changes, abnormal liver function and hepatic injury have been observed.
Single cases of fulminant hepatitis with fatal outcome have been reported in Japan. It is not clear whether they are a consequence of taking Glucobay.
Failure to comply with the prescribed antidiabetic diet can accentuate the intensity of the undesirable effects affecting the gastrointestinal system. If these occur despite the correct observance of the diet, the doctor should be consulted and the dosage of Glucobay should be temporarily or permanently reduced.
In patients treated with the recommended dose of 150-300 mg / day of Glucobay, clinically relevant abnormalities in liver function tests (3 times above the upper limit of normal) have been observed rarely. During therapy with Glucobay, temporary abnormal values may occur (see section 4.4 Special warnings and precautions for use).
04.9 Overdose
When the drug is taken in combination with foods and / or drinks containing carbohydrates (oligosaccharides, disaccharides and polysaccharides), overdose can cause bloating, flatulence and diarrhea.
However, in the event that Glucobay is ingested in overdose in the absence of food, excessive intestinal symptoms should not be expected.
In the event of an overdose, the patient should not take any food or drink containing carbohydrates for 4 - 6 hours after taking the drug.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: drug used in diabetes; oral hypoglycemic agents.
ATC code: A10BF01.
Glucobay contains as the active ingredient acarbose, a pseudotetrasaccharide of microbial origin. In all the species examined acarbose exerts its activity at the level of the small intestine.
Glucobay is an inhibitor of intestinal enzymes (α-glucosidase), responsible for the degradation of di-, oligo-, and poly-saccharides present in the diet.
The inhibition of these enzymes leads to a dose-dependent delay in the digestion of carbohydrates, whereby the glucose deriving from them is released and absorbed more slowly into the bloodstream. In this way Glucobay reduces post-prandial glycemic increases. the preparation exerts on the intestinal absorption of carbohydrates and also results in a drop in average glycemic levels and their daily excursions.
Glucobay reduces the pathologically elevated levels of glycosylated hemoglobin.
05.2 "Pharmacokinetic properties
Absorption and bioavailability
The pharmacokinetics of acarbose were studied by oral administration of the radiolabelled substance (200 mg) to healthy volunteers.
Absorption: since on average 35% of the total radioactivity (deriving from the unchanged substance and from all possible degradation products) is eliminated by the kidney within 96 hours, it can be assumed that the degree of absorption is at least of the same order of magnitude.
The trend in plasma concentration of total radioactivity shows two peaks. The first, with an average concentration equivalent to 52.2 ± 15.7 mcg / l of acarbose after 1.1 ± 0.3 hours, is in line with the data related to the unchanged substance (49.5 ± 26.9 mcg / l after 2.1 ± 1.6 hours). The second is equal to 586.3 mcg / l ± 282.7 mcg / l and is reached after 20.7 ± 5.2 hours. Compared to total radioactivity, the maximum plasma concentrations of the unchanged substance are 10-20 times lower. This second, higher peak, which occurs after 14-24 hours, is believed to be due to absorption of bacterial degradation products from more distal regions of the intestine.
The bioavailability is only 1-2%. Since acarbose acts only locally in the intestine, the fact that the systemic availability is so low has no relevance for the therapeutic effect but, on the contrary, represents an advantage.
Distribution
From the trend of plasma concentrations in healthy volunteers, an apparent volume of distribution of 0.32 l / kg body weight (after intravenous administration of 0.4 mg / kg body weight) was calculated.
Metabolism and elimination
The plasma half-life of the parent substance is 3.7 ± 2.7 hours for the distribution phase and 9.6 ± 4.4 hours for the elimination phase.
1.7% of the administered dose is excreted in the urine as unchanged substance.
51% is eliminated in the faeces in the first 96 hours.
05.3 Preclinical safety data
Acute toxicity
The results of acute toxicity studies for oral and intravenous administration performed in mice, rats and dogs are shown in the following table:
On the basis of these results, acarbose can be defined as non-toxic after single oral doses; not even doses of 10 g / kg have allowed to determine a true LD50.
Furthermore, within the doses used, no symptoms of intoxication were manifested in any of the examined species. The substance is practically free of toxicity even after intravenous administration.
Subchronic toxicity
Tolerability studies were performed in rats and dogs for 3-month periods. In rats, doses of 50-450 mg / kg were used. All haematological and biochemical parameters remained unchanged compared to a control group.
Similarly, histopathological examinations did not reveal changes in any of the groups of animals.
The same oral doses were studied in the dog. Compared to the control group, substance-attributable changes in weight gain, serum α-amylase activity and blood urea concentration were observed.
An "influence on" weight gain was observed in all dose groups.
By administering a constant amount of food (350 g / day) during the first 4 weeks, there was a marked decrease in the average body weight of each group, while when, during the fifth week, the amount of food was increased to 500 g / day, the weight of the animals remained constant. These alterations, induced by acarbose at higher than therapeutic doses, should not be considered a toxic effect, but rather the expression of an excessive pharmacodynamic activity of the substance which has determined an isocaloric nutritional imbalance (loss of carbohydrates). modest increases in urea levels represent an indirect effect of the treatment, resulting from an accentuated catabolism resulting from weight loss. Finally, the reduction in α-amylase activity is also one of the signs of an exalted pharmacodynamic effect.
Chronic toxicity
Chronic studies were performed in rats, dogs and hamsters, with treatments lasting 24 months, 12 months and 80 weeks, respectively. The studies in rats and hamsters had the objective of evaluating, in addition to possible damage from chronic administration, any carcinogenic effects.
Carcinogenesis
The carcinogenic potential of acarbose has been evaluated in several studies.
a) Sprague-Dawley rats: Acarbose was administered at concentrations up to 4,500 ppm in the feed, for a period of 24-26 months. Administration with food resulted in a marked state of malnutrition in the animals. Under these experimental conditions , the incidence of tumors of the renal parenchyma (adenoma, hypernephroid carcinoma) showed a dose-dependent trend, while the incidence of tumors (particularly hormone-dependent ones) was globally decreased. To prevent malnutrition, in subsequent studies the animals received glucose supplements. At a dose of 4,500 ppm, their body weight was 10% lower than that of controls. There was no increase in the incidence of kidney tumors. When the study was repeated without glucose intake for a period of 26 months, an increase in benign Leydig cell tumors of the testis was observed. In all groups that received glucose supplementation, blood glucose levels they were elevated, sometimes pathologically (dietary diabetes from excess glucose). With gavage administration of acarbose, body weight remained within the limits of the control group. An excessive pharmacodynamic activity was avoided with this experimental design.
The incidence of tumors was found to be normal.
b) Wistar rats: Acarbose was administered at concentrations of 0-4,500 ppm with food or by gastric tube. In the first case, no marked weight loss was observed. Starting with the 500 ppm dose, the cecum appeared The overall rate of tumors had decreased and there was no increase in the incidence of particular forms of cancer.
c) Hamsters: Acarbose was administered at concentrations of 0-4,000 ppm in food for 80 weeks, with and without glucose supplements. In animals treated with the higher dose, an increase in blood glucose levels was observed. of tumors did not appear to be increased.
Reproductive toxicity
Trials to evaluate the teratogenic effects of acarbose were conducted in rats and rabbits, with doses of 0, 30, 120 and 480 mg / kg po in both species. In rats, the treatment was carried out from the 6th to the 15th. Day of gestation, in the rabbit from the 6th to the 18th.
As part of the doses examined, no teratogenic effects of the drug appeared in either of the two species.
In male and female rats, no reduction in fertility was observed up to a dose of 540 mg / kg / day.Administration of doses up to 540 mg / kg / day during fetal development and lactation had no effects on parturition or offspring in the rat.
Mutagenesis
The numerous mutagenicity studies performed have not shown any genotoxic action on the part of acarbose.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Corn starch, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store in the original packaging, at a temperature not exceeding 30 ° C. Protect from humidity.
06.5 Nature of the immediate packaging and contents of the package
Nature of the container
Opaque white PVC / PVDC-Aluminum blister
Opaque white PVC / PE / PVDC-Aluminum blisters
Packs
40 tablets of 50 mg
40 tablets of 100 mg
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Bayer S.p.A. Viale Certosa 130 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
Glucobay 50 mg tablets AIC 026851028
Glucobay 100 mg tablets AIC 026851016
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Authorization renewal: 15.11.2009
(on the market since May 2, 1995)
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 03/2013
