GLIBOMET - PACKAGE LEAFLET - LEAFLETS

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Glibomet - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life

Active ingredients: Metformin, Glibenclamide

GLIBOMET 400 mg + 2.5 mg film-coated tablets
GLIBOMET 400 mg + 5 mg film-coated tablets

Why is Glibomet used? What is it for?

GLIBOMET is a "combination of oral antidiabetic drugs (drugs used in the treatment of diabetes, chronic metabolic disorder characterized by high levels of glucose in the blood due to insufficient production of insulin by the body and / or alterations in the action of" insulin ), metformin hydrochloride (belonging to the biguanide class) and glibenclamide (belonging to the sulfonylurea class).

As an antidiabetic, GLIBOMET is used in adults for the treatment of Type 2 diabetes mellitus, which cannot be controlled with diet alone or with the diet associated with treatment with sulfonylureas or biguanides.

Contraindications When Glibomet should not be used

Do not take GLIBOMET

If you are allergic to the active substances or any of the other ingredients of this medicine
If you have gestational diabetes (diabetes that occurs during pregnancy).
If you have Type 1 diabetes (a particular form of the disease in which the pancreas is no longer able to produce insulin, a substance that regulates blood glucose levels).
If you are in a state of coma and diabetic precoma.
If you have a blood creatinine value above 12 mg / l.
If you have ever had cases of lactic acidosis (a condition caused by the buildup of lactic acid in the body).
If your liver or kidney function is severely impaired.
If you are being treated with other medicines such as diuretics (medicines that increase the elimination of fluid in the urine) or antihypertensives (medicines that reduce blood pressure) which can change your kidney function (see "Other medicines and GLIBOMET").
If you are to have a radiographic diagnostic test with a contrast medium used to examine the kidneys, ureters, bladder and urethra (intravenous urography) () (see "Warnings and precautions").
If you have had serious heart or blood circulation diseases (heart failure, cardiogenic or toxinfectious shock, peripheral arterial circulation disorders).
If you have severe respiratory diseases.
In case of reduced adrenal function (adrenal insufficiency).
In case of alcohol dependence (chronic alcoholism) (see "Other medicines and GLIBOMET" and section "Possible side effects").
If you are on a low calorie diet and especially if you are fasting.
If you have severe dystrophic diseases.
In case of severe acute blood loss.
In case of shock.
In case of gangrene (a pathological condition characterized by the death of tissues due to lack of blood supply and which is often complicated by bacterial over-infection).
If you are pregnant and breastfeeding (see "Pregnancy and breastfeeding").
Two days before and two days after surgery.
The use of GLIBOMET in children and adolescents is not recommended (see "Children and adolescents")

Precautions for use What you need to know before taking Glibomet

Talk to your doctor or pharmacist before taking GLIBOMET.

Always strictly adhere to the medical prescriptions regarding the dosage, the methods of intake and the diet and physical activity to be followed during treatment with the medicine.

You can only use GLIBOMET if you have Type 2 diabetes mellitus which cannot be controlled with diet.

Stop the treatment 48 hours before performing an angiography (X-ray examination with contrast medium to visualize the blood vessels) or urography (X-ray observation with contrast medium of the urinary tract) and resume it, if necessary, 48 hours after the "test (see" Do not take GLIBOMET ").

Use GLIBOMET with caution or consider taking alternative medicines if you have glucose 6-phosphate dehydrogenase (or G6PD, a condition known as favism) deficiency as the medicine contains glibenclamide (a sulphonylurea).

Treatment of patients with G6PD deficiency with sulfonylureas can lead to haemolytic anemia (red blood cell destruction anemia).

In conjunction with trauma, surgery, infectious and febrile diseases, it may be necessary to temporarily establish insulin-based therapy to maintain adequate metabolic control (of blood sugar values).

After ingestion of alcoholic beverages, the possibility of reactions such as generalized feeling of malaise, difficulty in breathing, palpitations, headache, nausea, vomiting should be borne in mind (see "GLIBOMET and alcohol" and section "Possible side effects").

You will need to be checked frequently in order to identify any factors or conditions capable of favoring the appearance of a "lactic acidosis, taking into account the fact that the risk of this problem is more frequent:

In states of hepatic and / or renal insufficiency (impaired liver and / or kidney function).
In states of insufficiency (impaired function) of the heart or lungs. - In case of alcohol intoxication (see "GLIBOMET and alcohol" and section "Possible side effects").
In case of prolonged fasting (see "Do not take GLIBOMET").
In case of treatment with diuretics (see "Do not take GLIBOMET").
In case of stomach or intestinal complaints.

In any case, you will need to be instructed to recognize the warning symptoms:

lactic acidosis: anorexia (lack of appetite), nausea, fever, vomiting, muscle cramps, increased breathing rate and width, malaise, abdominal pain, diarrhea, loss of consciousness (see section "Possible side effects") .
hypoglycemia (low blood sugar level): irritability, sleep disturbances, nervous depression, tremors, heavy sweating (see section "Possible side effects")

In this way he will be able to promptly warn the doctor, who must also be informed in case of febrile illnesses or digestive disorders that may arise. The doctor himself will promptly establish the necessary investigations. In case of symptoms of hypoglycaemia, ingest sugary substances; the most serious cases, which rarely can go as far as loss of consciousness, require medical attention (see section "Possible side effects").

It is also necessary to evaluate renal function before the start of treatment and then at least once every 8 weeks during the first six months of treatment and, subsequently, every 6 months since even a mild disturbance of renal function can increase the risk of lactic acidosis. (see section "Possible side effects").

Children and adolescents

The use of GLIBOMET in children and adolescents is not recommended (see "Do not take GLIBOMET").

Interactions Which drugs or foods can modify the effect of Glibomet

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Keep in mind that the hypoglycemic action (reduction of blood sugars) of glibenclamide, one of the active substances contained in GLIBOMET, can be increased by:

Dicumarol and derivatives (drugs used as blood anticoagulants).
Monoamine oxidase inhibitors (drugs used as antidepressants).
Sulfonamides (antibiotic drugs).
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as phenylbutazone and derivatives (drugs used as anti-inflammatory and pain relievers).
Chloramphenicol (antibiotic drug).
Cyclophosphamide (drug used as an anticancer and for autoimmune diseases).
Probenecid (drug used for the prevention of gout).
Phenyramidol and salicylates (pain relieving drugs).
Oral miconazole (drug used as an antifungal).
Sulfinpyrazone (drug that decreases platelet aggregation, used in therapy following a heart attack).
Perexilina (drug used to treat angina).
Ingestion of alcohol in large quantities.

On the contrary, the action of glibenclamide is diminished by:

Adrenaline (substance used as an emergency drug for example for anaphylactic reactions, edema, bronchospasm and in some cases low pressure).
Corticosteroids (drugs used as anti-inflammatories and in some cases of allergic reactions).
Oral contraceptives (birth control pills).
Thiazide diuretics (drugs used to treat high blood pressure, which increase the elimination of fluid in the urine).
Barbiturates (drugs used for the treatment of epilepsy and in anesthesia).

Take particular care in taking GLIBOMET with β-blockers (bisoprolol, metoprolol, propanolol, pindolol; drugs used for various diseases including: angina, high blood pressure, heart attack, altered heart rhythm, heart failure).

Keep in mind that metformin, one of the active substances contained in GLIBOMET, can enhance the action of anticoagulants.

GLIBOMET and alcohol

The hypoglycaemic action of glibenclamide can be increased by the simultaneous ingestion of alcohol (see "Other medicines and GLIBOMET"). After ingestion of alcoholic beverages, the possibility of reactions such as generally feeling unwell, difficulty breathing, palpitations, headache, nausea, vomiting should be borne in mind (see "Do not take GLIBOMET", "Warnings and precautions" and section "Possible effects unwanted ").

Warnings It is important to know that:

Pregnancy and breastfeeding

The use of GLIBOMET is contraindicated during pregnancy and breastfeeding (see "Do not take GLIBOMET").

Driving and using machines

Before driving or using machines, consider that the use of GLIBOMET may lead to a reduction in the ability to concentrate and react due to the possible onset of hypoglycaemia (see section "Possible side effects").

Dose, Method and Time of Administration How to use Glibomet: Posology

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

The recommended dose, modalities and duration of treatment must be established by your doctor specifically for you on the basis of the metabolic tests performed. Usually the initial dosage is 2 tablets per day with main meals. Subsequently, the daily dosage should be gradually decreased until the minimum dose sufficient to maintain glycemic control is reached.

Glibomet 400 mg / 2.5 mg

Never exceed the daily dose of 6 Glibomet 400 mg / 2.5 mg tablets.

Glibomet 400 mg / 5 mg

Never exceed the daily dose of 4 Glibomet 400 mg / 5 mg tablets.

Overdose What to do if you have taken too much Glibomet

If you take more GLIBOMET than you should

Taking an excessive dose may lead to symptoms of hypoglycaemia (see "Warnings and precautions" and "Possible side effects" section) which may require the administration of sugar or, in severe cases, medical intervention. You may also experience stomach and bowel disorders and symptoms of lactic acidosis (see "Warnings and precautions" and "Possible side effects" section) which require medical attention.

If you forget to take GLIBOMET

Do not take a double dose to make up for a forgotten recommended dose. 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 Glibomet

Like all medicines, this medicine can cause side effects, although not everybody gets them

The following side effects may occur with the use of GLIBOMET:

Symptoms of hypoglycaemia (these occur rarely) especially if you are debilitated, elderly, if you are subjected to unusual physical exertion, if you have an "irregular diet or drink alcohol or if you have" impaired kidney and / or liver function ( see "Warnings and Precautions").
Allergic skin reactions, however, which are transient and generally disappear with the continuation of therapy (they occur rarely).
Symptoms of "lactic acidosis (see" Warnings and precautions ") that require adequate medical treatment (occur rarely). These manifestations are more likely, although very rare, if you have kidney failure, severe heart disease or respiratory insufficiency. Lactic acidosis can become severe if treatment is not interrupted and adequate measures are not taken and can be favored by the simultaneous intake of alcohol (see "Warnings and precautions" and "GLIBOMET and alcohol").
Changes in the number of blood cells (very rare, usually reversible).
Possible headache and upset stomach and intestines (nausea, decreased appetite, stomach pains, vomiting or diarrhea) which may require discontinuation of treatment.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

It is important to inform the doctor or pharmacist of any undesirable effect, even if not described in the package leaflet.

Additional side effects in children and adolescents

You don't notice. The use of GLIBOMET in children and adolescents is not recommended.

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 about 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 package. The expiry date refers to the last day of that month and to the product in intact packaging, correctly stored.

No special storage precautions are required.

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 GLIBOMET contains

GLIBOMET 400 mg + 2.5 mg film-coated tablets

Each film-coated tablet contains:

Active principles : Glibenclamide 2.5 mg and metformin hydrochloride 400 mg.

Other components: Microcrystalline cellulose, macrogol 6000, povidone, croscarmellose sodium, silicon dioxide, glycerol dibenate, magnesium stearate, opadry white (hydroxypropyl methyl cellulose, titanium dioxide, talc, macrogol 6000).

GLIBOMET 400 mg + 5 mg film-coated tablets

Each film-coated tablet contains:

Active principles : Glibenclamide 5 mg and metformin hydrochloride 400 mg.

Other components: Microcrystalline cellulose, macrogol 6000, povidone, croscarmellose sodium, silicon dioxide, glycerol dibenate, magnesium stearate, opadry white (hydroxypropyl methyl cellulose, titanium dioxide, talc, macrogol 6000).

Description of the appearance of GLIBOMET and contents of the pack

GLIBOMET 400 mg + 2.5 mg film-coated tablets

White to off-white, round, biconvex film-coated tablets, scored on one side.The number "2.5" is stamped on the smooth side, the letter "B" is stamped on one of the halves of the scored side and the number "1" on the other.

Packs of 40 and 60 film-coated tablets in opaque blisters.

GLIBOMET 400 mg + 5 mg film-coated tablets White to off-white, round, biconvex, film-coated tablets, scored on one side. The number "5" is stamped on the smooth side, the letter "B" is stamped on one of the halves of the scored side and the number "3" on the other.

Packs of 40 and 60 film-coated tablets in opaque blisters.

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.

Further information on Glibomet can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

GLIBOMET TABLETS COATED WITH FILM

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Glibomet 400 mg + 2.5 mg film-coated tablets

Each film-coated tablet contains:

Glibenclamide 2.5 mg;

metformin hydrochloride 400 mg.

Glibomet 400 mg + 5 mg film-coated tablets

Each film-coated tablet contains:

Glibenclamide 5 mg;

metformin hydrochloride 400 mg.

For the full list of excipients see 6.1.

03.0 PHARMACEUTICAL FORM

Film-coated tablets.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Type 2 diabetes mellitus (NIDDM, non-insulin dependent) that cannot be controlled with diet alone or with diet and sulfonylureas or biguanides.

04.2 Posology and method of administration

The daily dosage, methods and duration of treatment must be established by the attending physician based on the patient's metabolic situation. In general, the initial dosage is 2 tablets per day with main meals. In any case, the dose of 6 Glibomet 400 mg / 2.5 mg tablets and 4 Glibomet 400 mg / 5 mg tablets should never be exceeded. Subsequently, the daily dosage should be gradually decreased until the minimum dose sufficient to maintain glycometabolic control is reached.

04.3 Contraindications

Hypersensitivity to the individual active substances (glibenclamide, metformin) or to any of the excipients listed in section 6.1; gestational diabetes, Type 1 diabetes (insulin dependent); coma and diabetic precoma; serum creatinine level above 12 mg / l; a history of lactic acidosis in diabetics; severely impaired liver or kidney function; ongoing treatment with diuretics or antihypertensive agents likely to cause impaired renal function or during intravenous urography; severe cardiovascular diseases (heart failure, cardiogenic or toxinfectious shock, peripheral arterial circulation disorders); severe respiratory diseases; adrenal insufficiency; chronic alcoholism; strongly hypocaloric regimes and, above all, fasting states; severe dystrophic diseases; severe acute bleeding; shock; gangrene; pregnancy and breastfeeding. During the two days before or after surgery.

04.4 Special warnings and appropriate precautions for use

Each treatment and in particular the transition from or to other hypoglycemic agents, must be prescribed by the doctor.

The patient must strictly adhere to the medical prescriptions regarding the dosage and methods of recruitment, as well as with regard to the concomitant dietary regimen and physical activity.

Due to the presence of a sulfonylurea derivative, use should be limited to patients with Type 2 diabetes mellitus which cannot be controlled with diet.

In case of hypoglycaemic manifestations (see below and Side effects) give carbohydrates (sugar); in the most serious cases, which rarely can go as far as loss of consciousness, it is necessary to carry out a slow i.v. infusion of glucose solution.

In conjunction with trauma, surgery, infectious and febrile diseases, it may be necessary to temporarily initiate insulin therapy to maintain adequate metabolic control.

The possibility of antabuse-like reactions after ingestion of alcoholic beverages should be borne in mind.

Treatment must be suspended 48 hours before performing an angiography or urography and resuming it, if necessary, 48 hours after the examination.

Treated patients should be frequently monitored in order to identify any factors or conditions capable of inducing or aggravating a state of cellular hypoxia and therefore favoring the onset of lactacidosis, taking into account that the risk of this problem is more frequent in states of hepatic and / or renal insufficiency, cardiorespiratory insufficiency, ethyl poisoning, prolonged fasting, in case of treatments with diuretics and in case of gastrointestinal disorders; in any case, patients should be instructed to recognize the warning symptoms of lactic acidosis (anorexia, nausea, fever, vomiting, muscle cramps, increased width and frequency of breathing, malaise, abdominal pain, diarrhea, possible drowsiness or loss consciousness) and hypoglycemia (headache, irritability, sleep disturbances, nervous depression, tremors, heavy sweating) in order to promptly warn the doctor who must also be informed in the event of feverish illnesses or intercurrent digestive disorders. In this case, the doctor himself must promptly establish the necessary investigations (determination of serum electrolytes, arterial blood pH, lactate, pyruvate, glycaemia and ketonemia). Since even a slight disturbance of renal function can considerably increase the risk of lactacidosis, it is necessary to repeatedly check its status before starting the treatment and then at least og n eight weeks during the first semester of therapy and every six months thereafter.

Since lactacidosis can have a fatal outcome, as soon as it is suspected that it is developing it is necessary to interrupt the administration and hospitalize the patient urgently. Observation of a metabolic acidosis with evidence of keto-acidosis in a diabetic without a particular state of exogenous intoxication (from salicylic, alcohol, etc.) is to be considered suspect.

Treatment of patients with G6PD deficiency with sulfonylureas can lead to haemolytic anemia.

Glibenclamide should therefore be used with caution in such patients and should be considered a "therapeutic alternative."

04.5 Interactions with other medicinal products and other forms of interaction

The hypoglycemic action of sulfonylurea can be increased by dicumarol and derivatives, monoamine oxidase inhibitors, sulfonamides, phenylbutazone and derivatives, chloramphenicol, cyclophosphamide, probenecid, phenyramidol and salicylates, oral miconazole, sulfinpyrazone perexilina and the ingestion of alcohol in high quantities; it can instead be diminished by adrenaline, corticosteroids, oral contraceptives and thiazide diuretics, barbiturates.

Caution should also be exercised in concurrently administering b-blockers. It should be borne in mind that biguanides can enhance the action of anticoagulants.

04.6 Pregnancy and lactation

Contraindicated in pregnancy and during lactation (see also point 4.3)

04.7 Effects on ability to drive and use machines

The patient must be informed of the risk of hypoglycaemia and consequent reduction in the ability to concentrate and react, and take this into account before driving or operating machinery.

04.8 Undesirable effects

Hypoglycemic phenomena may occur, although rarely, especially in debilitated subjects, in old age, in case of unusual physical exertion, in case of irregular feeding or intake of alcoholic beverages, in case of renal and / or hepatic impairment (see alsoSpecial warnings and appropriate precautions for use). Headache and gastrointestinal intolerances, such as nausea, anorexia, stomach pain, vomiting or diarrhea, may sometimes occur and may require discontinuation of treatment.

Skin allergic manifestations may rarely occur but are transient and generally disappear with the continuation of therapy. It is possible, although very rare are the cases described in the literature during treatment with metformin, in patients with predisposing factors such as renal insufficiency and cardiovascular collapse, the occurrence of lactic acidosis, which can occur severely if treatment is not interrupted and adequate measures are not taken.

In fact, cases have been described with high blood levels of lactic acid, increase in the lactate / pyruvate ratio, lowering of blood pH, azotemia which exceptionally had an unfavorable course. Lactic acidosis can be favored by the simultaneous intake of alcohol.

Alterations in the haematopoietic system are very rare and generally reversible.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. at the address www.agenziafarmaco.gov.it/it/responsabili.

04.9 Overdose

In the event of an overdose, hypoglycemia can occur, which can even lead to behavioral disturbances or coma. Depending on the severity, administer glucose orally or intravenously (hypertonic glucose solution) and hospitalize. Gastrointestinal disorders and signs of hyperlactacidemia may also occur, requiring treatment for lactic acidosis and hospitalization.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: combinations of oral antidiabetics.

ATC code: A10BD02.

In Glibomet 400 mg / 2.5 mg and in Glibomet 400 mg / 5 mg there are associated glibenclamide, second generation sulphonylurea, active at low doses and able to act on the secretory kinetics of insulin for not excessively prolonged periods of time. and repeatedly at each administration, and metformin, biguanide capable of inducing peripheral sensitization to the action of insulin (increase in insulin receptor binding, enhancement of the post-receptor effect), a control of enteric glucose absorption , an "inhibition of neoglucogenesis and a rebalancing of lipid metabolism, a reduction in the excess weight of the obese diabetic, a" platelet anti-adhesiveness action and a "fibrinolytic activity, effects all accompanied by greater tolerability and manageability, with reduced risk of hyperlactacidemia , compared to other biguanides.

The complementary action existing between these two active ingredients, stimulating action on the secretion of endogenous insulin induced by the sulfonylurea (point of pancreatic attack), integrated by the direct action of the biguanide on the muscle tissue which promotes a net increase in the utilization of glucose ( point of "extra-pancreatic attack), and hepatic (reduction of gluconeogenesis) allowed to obtain, for a given dosage ratio, an authentic synergistic effect that allowed the reduction of the doses of the individual components, thanks to which too intense a stimulation of pancreatic β-cells, resulting in a reduced danger of functional exhaustion of the organ, as well as greater safety of use and lower incidence of side effects.

05.2 Pharmacokinetic properties

Glibenclamide is 84% absorbed from the gastrointestinal tract and is eliminated by the digestive and urinary tract after being transformed by the liver into inactive metabolites, the elimination half-life is 5 hours; 97% is bound to plasma proteins.

Metformin, absorbed through the gastrointestinal tract, is rapidly eliminated in the urine and with the faeces; it does not bind to plasma proteins; it is not metabolized by the body; its plasma half-life is approximately 2 hours.

05.3 Preclinical safety data

The results of the acute toxicity studies carried out in mice and rats highlighted the absence of synergistic toxicity of the two active ingredients.

Oral treatment in rats and dogs for 26 weeks did not lead to mortality, health changes, or decreased water and food consumption. The treatment did not affect the growth curve, blood count, liver function, biochemical blood tests, urinalysis, weight and macro-microscopic appearance of organs and systems.

Teratogenic studies did not reveal any toxic effects on gestation and fetuses.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Macrogol 6000, povidone, croscarmellose sodium, silicon dioxide, microcrystalline cellulose, glycerol dibenate, magnesium stearate, Opadry white (hydroxypropyl methyl cellulose, titanium dioxide, talc, macrogol 6000).