STADIUM - PACKAGE LEAFLET - LEAFLETS

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Stadium - Package Leaflet

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

Active ingredients: Cefixime

STADIUM 400 mg film-coated tablets

Why is Stadium used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

Antibacterial for systemic use, belonging to the class of cephalosporins.

THERAPEUTIC INDICATIONS

STADIUM is indicated in the treatment of infections caused by microorganisms sensitive to cefixime and in particular:

Exacerbations of chronic bronchitis

Community-acquired pneumonia

Uncomplicated infections of the lower urinary tract

Uncomplicated pyelonephritis.

In the treatment of:

Otitis media

Sinusitis

Pharyngitis.

Contraindications When Stadium should not be used

Hypersensitivity to the active substance, to other cephalosporins, to soya or to any of the excipients. The medicine is also generally contraindicated in subjects with hypersensitivity to penicillins and cephalosporins (see "Precautions for use").

Precautions for use What you need to know before taking Stadium

STADIUM should be administered with caution in patients who have shown hypersensitivity to other medicinal products. Cephalosporins should be administered with caution to penicillin sensitive patients, as there is some evidence of partial cross-allergenicity between penicillins and cephalosporins.

Some patients have shown severe reactions (including anaphylaxis) to both drug classes. Particular caution is recommended in patients who have developed allergic reactions to penicillins or other beta-lactam antibiotics, as cross-reactions may occur (for relative contraindications). to known hypersensitivity reactions, see "Contraindications").

If severe hypersensitivity reactions or anaphylactic reactions occur after administration of cefixime, use of cefixime should be discontinued immediately and appropriate emergency measures undertaken.

Kidney failure

STADIUM should be administered with caution to patients with creatinine clearance <20 ml / min (see "Dose, method and time of administration"). There are insufficient data on the use of cefixime in children and adolescents with renal insufficiency. Therefore the use of cefixime is not recommended in these patient groups.

Renal function should be monitored during combination therapy with cefixime and aminoglycoside antibiotics, polymyxin B, colistin or high doses of loop diuretics (eg furosemide) due to the possibility of additional renal impairment. This particularly affects patients. who already have reduced kidney function (see "Interactions").

Interactions Which drugs or foods can modify the effect of Stadium

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription. Concomitant administration of potentially nephrotoxic substances (such as glycosamide antibiotics, colistin, polymyxin and viomycin) and intensely acting diuretics (e.g. ethacrynic acid or furosemide) leads to an increased risk of impaired renal function (see "Precautions for use" ").

Nifedipine, a calcium channel blocker, can increase the bioavailability of cefixime by up to 70%.

As with other cephalosporins, increases in prothrombin time have been noted in a few patients. Therefore, caution should be exercised in patients on anticoagulant therapy.

Administration of cefixime may reduce the efficacy of oral contraceptives. Therefore, it is recommended to use additional non-hormonal contraceptive measures.

Warnings It is important to know that:

Treatment with STADIUM at the recommended dose (400 mg / day) can significantly alter the normal flora of the colon and lead to superinfection with Clostridium. Studies indicate that a toxin produced by Clostridium difficile is the main cause of antibiotic-associated diarrhea.

In patients who develop severe persistent diarrhea during or after use of cefixime, the risk of life-threatening pseudomembranous colitis should be kept in mind. The use of STADIUM should be discontinued and appropriate treatment measures instituted. . Treatment of pseudomembranous colitis includes sigmoidoscopy, appropriate bacteriological tests, administration of fluid, electrolyte and protein supplements. If colitis does not improve after stopping the drug, or if symptoms are severe, oral vancomycin is the drug of choice for the treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile. Other causes of colitis must be excluded. The use of drugs that inhibit intestinal peristalsis is contraindicated.

Influence on laboratory diagnostic tests

False positive reactions due to the presence of glucose in the urine can occur with Benedict's or Fehling's solutions or with copper sulphate tablets, but not with tests based on enzymatic reactions with glucose oxidase.

False Coombs test positives have been reported during cephalosporin treatment, therefore it should be noted that a positive Coombs test may be due to the drug.

The tablet coating contains 0.6 mg of soy lecithin.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

There are no adequate data on the use of cefixime in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo-fetal development, parturition or postnatal development. STADIUM should not be used in women. pregnant unless considered essential by your doctor.

Feeding time

There is no data on the passage of the drug into breast milk. Animal studies have shown excretion of cefixime in milk. A decision must be made whether to continue / discontinue breastfeeding or to continue / discontinue cefixime therapy, taking into account the benefit of breastfeeding for the child and the benefit of cefixime therapy for the mother. However, until further clinical experience is available, STADIUM should not be prescribed to women who are breastfeeding.

Effects on the ability to drive a vehicle or use machines

Cefixime has no known effects on the ability to drive and use machines. However, side effects may occur (see also section "Undesirable effects"), which may affect the ability to drive or use machines.

Dosage and method of use How to use Stadium: Dosage

Adults

The recommended adult dose is 400 mg / day taken as a single dose (see "Precautions for use").

The usual duration of treatment is 7 days. If necessary, it can be continued for up to 14 days.

Elderly patients

Elderly patients can be treated with the same dose as adults. In severe renal impairment, renal function should be evaluated and the dose adjusted (see "Precautions for use").

Adolescents ≥ 12 years of age

Adolescents> 12 years may receive the same recommended dose as adults.

Children from 6 months to 11 years of age

In children from 6 months to 11 years it is recommended to administer cefixime in the form of an oral suspension. The recommended dosage in children is 8 mg / kg / day given as a single dose or in two divided doses.

Children under 6 months of age

The safety and efficacy of cefixime have not been evaluated in children less than 6 months of age.

Kidney failure

STADIUM can be administered in the presence of impaired renal function. The normal dose and treatment schedule can be used in patients with creatinine clearance> 20 ml / minute. In patients with creatinine clearance <20 ml / minute, it is recommended not to exceed a dose of 200 mg once daily. The dose and schedule in patients on chronic outpatient peritoneal dialysis or on hemodialysis should follow the same recommendations as for patients with creatinine clearance less than 20 ml / minute.

There are insufficient data on use in children and adolescents with renal insufficiency. Therefore the use of cefixime is not recommended in these patient groups.

Method of administration

STADIUM tablets are for oral use only. STADIUM tablets should be taken with a sufficient amount of water. STADIUM can be taken with or without food.

Overdose What to do if you have taken an overdose of Stadium

Up to 2 grams per day (equal to 5 tablets of 400 mg), STADIUM showed, in healthy volunteers, the same tolerability observed in patients treated with the recommended therapeutic doses. However, in case of accidental ingestion / intake of an overdose of STADIUM, notify your doctor immediately or go to the nearest hospital.

WHAT TO DO IF YOU HAVE FORGOTTEN TO TAKE ONE OR MORE DOSES

If the patient forgets the daily dose at the appointed time (for example in the evening) he should take it as soon as possible (for example the next morning: in this case, two doses will be taken on the same day).

Side Effects What are the side effects of Stadium

If you have any questions about the use of STADIUM, ask your doctor or pharmacist.

Like all medicines, Cefixime can cause side effects, although not everybody gets them.

The following side effects are important and require immediate action if they occur. You must stop taking Cefixime and consult your doctor immediately if the following symptoms appear:

Very rare side effects (affects less than 1 user in 10,000) include:

Severe watery diarrhea, which may also contain blood
Sudden severe allergic reactions (anaphylactic shock) such as rash or hives, itching, swelling of the face, lips, tongue or other parts of the body, tightness in the chest, wheezing and collapse.
Serious skin disease with blistering of the skin, mouth, eyes and genitals (Stevens Johnson Syndrome, Toxic Epidermal Necrolysis). The following side effects have also been reported:

Common side effects (affects less than 1 in 10 patients) include:

Diarrhea.

Uncommon side effects (affecting less than 1 in 100 patients) include:

Headache
Nausea
He retched
Abdominal (belly) pain
Changes in blood tests that affect how the liver works
Rash.

Rare side effects (affects less than 1 in 1000 patients) include:

Increased risk of getting infections caused by germs that Cefixime does not act on, for example thrush
Increase in the number of white blood cells called eosinophils
Allergic reaction
Loss of appetite
Dizziness
Flatulence (air in the intestine)
Itching
Inflammation of mucous membranes such as those of the mouth and / or internal surfaces
Fever
Changes in blood tests that measure how your kidneys are working.

Very rare side effects (affects less than 1 user in 10,000) include:

Decrease in the number of different blood cells (symptoms may include tiredness, new infections and easy bruising or bleeding)
Allergic reactions characterized by rash, fever, pain in the joints and enlargement of organs
Restlessness and increased activity
Liver problems, including jaundice (yellowing of the skin and whites of the eyes)
Inflammation of the kidneys.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Expiry and Retention

STADIUM must be consumed by the expiry date shown on the box and blister.

DO NOT EXCEED THE EXPIRY DATE. This date is valid only if the packaging is intact.

Keep this medicine out of the reach and sight of children.

Store the product at a temperature not exceeding 25 ° C.

The expiry date indicated refers to the intact product, correctly stored.

COMPOSITION

One film-coated tablet contains:

Active principle: cefixime trihydrate 447.68 mg, equivalent to 400 mg of anhydrous cefixime.

Excipients: anhydrous calcium hydrogen phosphate, pregelatinised starch, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide, talc, soy lecithin, xanthan gum.

PHARMACEUTICAL FORM AND CONTENT

Film-coated tablets, 5 tablets.

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 Stadium 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

STADIUM

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 447.68 mg of cefixime trihydrate, equivalent to 400 mg of anhydrous cefixime.

Each tablet contains 0.6 mg of soy lecithin.

For the full list of excipients see section 6.1.

03.0 PHARMACEUTICAL FORM

Film-coated tablet

White to off-white, film-coated, rectangular tablet with a score line on both sides.

The tablet can be divided into equal halves.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

STADIUM is indicated in the treatment of the following infections caused by microorganisms

sensitive (see section 5.1):

Exacerbations of chronic bronchitis

Community-acquired pneumonia

Uncomplicated infections of the lower urinary tract

Uncomplicated pyelonephritis.

In the treatment of:

Otitis media

Sinusitis

Pharyngitis.

The use of STADIUM should be reserved for infections of which the responsible organism is known or suspected to be resistant to other common antibacterial agents or where failure to treat with other commonly used antibacterials could pose a significant risk.

Official guidelines on the appropriate use of antibacterial agents should be considered.

04.2 Posology and method of administration

Dosage

Adults

The recommended dose in adults is 400 mg / day taken in a single dose (see sections 4.4 and 5.1).

The usual duration of treatment is 7 days. If necessary, it can be continued for up to 14 days.

Elderly patients

Elderly patients can be treated with the same dose as adults. In severe renal impairment, renal function should be evaluated and the dose adjusted (see section 4.4).

Adolescents ≥ 12 years of age

Adolescents ≥ 12 years old may receive the same recommended dose as in adults.

Children from 6 months to 11 years of age

Children under 6 months of age

The safety and efficacy of cefixime have not been evaluated in children less than 6 months of age.

Renal damage in adult patients

STADIUM can be administered in the presence of impaired renal function. The normal dose and treatment schedule can be used in patients with creatinine clearance ≥ 20 ml / minute. In patients with creatinine clearance on outpatient or hemodialysis chronic peritoneal dialysis, the same recommendations should be followed as in patients with creatinine clearance less than 20 ml / minute.

There are insufficient data on use in children and adolescents with renal insufficiency. Therefore the use of cefixime is not recommended in these patient groups.

Method of administration

STADIUM tablets are for oral use only. STADIUM tablets should be taken with a sufficient amount of water.

STADIUM can be taken with or without food (see section 5.2).

04.3 Contraindications

Hypersensitivity to the active substance, to other cephalosporins, to soya or to any of the excipients. The medicinal product is also generally contraindicated in subjects with hypersensitivity to penicillins and cephalosporins (see section 4.4).

04.4 Special warnings and appropriate precautions for use

Some patients have experienced severe reactions (including anaphylaxis) to both drug classes.

Particular caution is recommended in patients who have developed allergic reactions to penicillins or other beta-lactam antibiotics, as cross-reactions may occur (for contraindications related to known hypersensitivity reactions, see section 4.3).

Kidney failure

STADIUM should be administered with caution in patients with creatinine clearance

Treatment with STADIUM at the recommended dose (400 mg / day) can significantly alter the normal flora of the colon and lead to superinfection with Clostridium. Studies indicate that a toxin produced by the Clostridium difficile it is the main cause of antibiotic-associated diarrhea.

In patients who develop severe persistent diarrhea during or after use of cefixime, the risk of life-threatening pseudomembranous colitis should be kept in mind. The use of STADIUM should be discontinued and appropriate treatment measures instituted. . Treatment of pseudomembranous colitis includes sigmoidoscopy, appropriate bacteriological tests, administration of fluid, electrolyte and protein supplements. If colitis does not improve after stopping the drug, or if symptoms are severe, oral vancomycin is the drug of choice for the treatment of antibiotic-associated pseudomembranous colitis produced by C. difficult. Other causes of colitis must be excluded. The use of drugs that inhibit intestinal peristalsis is contraindicated.

Influence on laboratory diagnostic tests

False Coombs test positives have been reported during cephalosporin treatment, therefore it should be noted that a positive Coombs test may be due to the drug.

The tablet coating contains 0.6 mg of soy lecithin.

04.5 Interactions with other medicinal products and other forms of interaction

Concomitant administration of potentially nephrotoxic substances (such as glycosamide antibiotics, colistin, polymyxin and viomycin) and strongly acting diuretics (e.g. ethacrynic acid or furosemide) leads to an increased risk of impaired renal function (see section 4.4).

Nifedipine, a calcium channel blocker, can increase the bioavailability of cefixime by up to 70%.

As with other cephalosporins, increases in prothrombin time have been noted in a few patients. Therefore, caution should be exercised in patients on anticoagulant therapy.

Administration of cefixime may reduce the efficacy of oral contraceptives. Therefore, it is recommended to use additional non-hormonal contraceptive measures.

04.6 Pregnancy and lactation

Pregnancy

There are no adequate data on the use of cefixime in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo-fetal development, parturition or postnatal development (see section 5.3). STADIUM must not be used. in pregnant women unless considered essential by the doctor.

Feeding time

However, until further clinical experience is available, STADIUM should not be prescribed to women who are breastfeeding.

04.7 Effects on ability to drive and use machines

Cefixime has no known effects on the ability to drive and use machines. However, side effects may occur (see also section 4.8), which may affect the ability to drive or use machines.

04.8 Undesirable effects

In this section, the following convention has been used for the classification of undesirable effects in terms of frequency:

• Common: ≥1 / 100 e

• Uncommon: ≥1 / 1,000 e

• Rare: ≥1 / 10,000 e

• Very rare:

Classes of systems and organs Adverse reaction Frequency Infections and infestations Bacterial superinfections, fungal superinfections Rare Antibiotic associated colitis Very rare Disorders of the blood and lymphatic system Eosinophilia Rare Leukopenia, agranulocytosis, pancytopenia, thrombocytopenia, haemolytic anemia Very rare Disorders of the immune system Hypersensitivity Rare Anaphylactic shock, serum sickness Very rare Metabolism and nutrition disorders Anorexia Rare Nervous system disorders Headache Uncommon Dizziness Rare Psychomotor hyperactivity Very rare Gastrointestinal disorders Diarrhea common Abdominal pain, nausea, vomiting Uncommon Flatulence Rare Hepatobiliary disorders Hepatitis, cholestatic jaundice Very rare Skin and subcutaneous disorders Rash Uncommon Angioneurotic edema, pruritus Rare Stevens-Johnson syndrome, toxic epidermal necrolysis Very rare Renal and urinary disorders Interstitial nephritis Very rare General disorders and administration site conditions Inflammation of the mucous membranes, pyrexia Rare Diagnostic tests Increased liver enzymes (transaminases, alkaline phosphatase) Uncommon Increased blood urea Rare Increased blood creatinine Very rare

04.9 Overdose

There is no experience of overdose with cefixime.

Up to 2 grams per day, in healthy volunteers, the drug exhibited the same tolerability profile observed in patients treated with recommended therapeutic dosages.

However, in the event of an overdose, consideration should be given to the possibility of gastric lavage. Cefixime is not eliminated from the circulation in significant quantities by dialysis.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: antibacterial for systemic use, belonging to the third generation cephalosporin class.

ATC code: J01DD08.

Mechanism of action:

Cefixime is a new cephalosporin for oral use characterized by a broad spectrum bactericidal activity and by a high resistance to the hydrolytic activity of beta-lactamases.

The bactericidal activity of cefixime is due to the inhibition of the synthesis of the bacterial cell wall.

PK / PD relationship

In PK / PD studies, the time during which plasma concentrations of cefixime exceed the minimum inhibitory concentration (MIC) of the infecting organism was found to correlate better with efficacy.

Resistance mechanism

Bacterial resistance to cefixime may be due to one or more of the following mechanisms:

- Hydrolysis by increased spectrum beta-lactamases and / or chromosome-encoded enzymes (AmpC) which can be induced or de-repressed in some aerobic Gram-negative species

- Reduced affinity to penicillin binding proteins

- Reduced permeability of the outer membrane in certain Gram-negative organisms which restricts access to the proteins that bind penicillins

- Drug efflux pumps.

Several of these resistance mechanisms can coexist in a single bacterial cell. Depending on the mechanism (s) present, bacteria may express cross-resistance to several or all beta-lactam and / or antibacterial drugs of the other classes.

Breakpoints

The minimum inhibitory concentration (MIC) breakpoints, established by EUCAST (May 2009) for cefixime, are as follows:

• H. influenzae: sensitive ≤ 0.12 mg / L, resistant> 0.12 mg / L

• M. catarrhalis: sensitive ≤ 0.5 mg / L, resistant> 1.0 mg / L

• Neisseria gonorrhoeae: sensitive ≤ 0.12 mg / L, resistant> 0.12 mg / L

• Enterobacteriaceae: sensitive ≤ 1.0 mg / L, resistant> 1.0 mg / L (only for uncomplicated urinary tract infections). The breackpoint for theEnterobacteriaceae will discover reduced sensitivities mediated by most clinically important lactamases in Enterobacteriaceae. Occasionally ESBL-producing strains (extended spectrum beta-lactamase) will be considered susceptible. For infection control, epidemiological and surveillance purposes, laboratories may use specific tests to select and confirm ESBL production.

• Non-species related breakpoints: insufficient data.

Sensitivity

The prevalence of resistance may vary geographically and over time for certain species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is problematic.

Commonly sensitive species Aerobes, Gram positive: Streptococcus pyogenes Aerobes, Gram negative: Haemophilus influenzae Moraxella catarrhalis Proteus mirabilis Species for which resistance can be a problem Streptococcus pneumoniae Citrobacter freundii § Enterobacter cloacae § Escherichia coli% & Klebsiella oxytoca% Klebsiella pneumoniae% Morganella morganii § Serratia marcescens § Hardy species Chlamydia spp. Chlamydophila spp. Clostridium difficile Bacteroides fragilis Enterococci Legionella pneumophila Mycoplasma spp. Pseudomonas species Staphylococcus aureus + Streptococcus pneumoniae (Penicillin-intermediate and ± resistant)

+ Cefixime has little activity against staphylococci (regardless of metacillin sensitivity)

§ Intermediate natural sensitivity

% ESBL (extended spectrum beta-lactamase) producing strains are always resistant

& Speed of resistance uncomplicated cystitis, otherwise ≥ 10%.

05.2 Pharmacokinetic properties

Absorption

The absolute oral bioavailability of cefixime is in the range of 22-54%. Absorption is not significantly affected by the presence of food. Cefixime can therefore be given with or without meals.

Distribution

Serum protein binding is well characterized for human and animal serum. Cefixime is almost entirely bound to the albumin fraction, the mean free fraction is 30%. Protein binding of cefixime in human serum is concentration dependent only at very high concentrations, which are not observed after clinical assays.

From studies in vitro, serum or urinary concentrations of 1 mg / l or greater are considered adequate for the most common pathogens against which cefixime is active. Typically, the peak serum levels after the recommended doses in adults and pediatrics lie between 1.5 and 3 mg / l. After multiple dosing there is little or no accumulation of cefixime.

Metabolism and elimination

The pharmacokinetics of cefixime in healthy elderly (age> 64 years) and young volunteers (11-35) are similar to that of a 400 mg once daily dose for 5 days. Mean Cmax and AUC values are slightly higher in the elderly. The elderly may use the same dose as in the general population.

Cefixime is mainly eliminated unchanged in the urine. Glomerular filtration is considered to be the predominant mechanism. Cefixime metabolites have not been isolated from human serum or urine.

Transfer of 14C-labeled cefixime from lactating rats to their offspring via breast milk is quantitatively modest (approximately 1.5% body content of maternal cefixime was found in infants). No data on excretion are available. of cefixime in human milk. Placental transfer of cefixime was small in pregnant rats treated with labeled cefixime.

05.3 Preclinical safety data

There are no results from chronic toxicity studies to suggest that hitherto unknown side effects may occur in humans. in vivo And in vitro did not lead to indications of potential mutagenicity. Long-term carcinogenesis studies have not been conducted.

Reproduction studies were conducted in mice and rats at doses up to 400 times the dose used in humans and revealed no evidence of impaired fertility or harm to the fetus due to cefixime. In rabbits at doses up to 4 times the dose used in humans. "man, there was no evidence of teratogenic effects; there is a high incidence of abortions and maternal deaths, which are an expected consequence of the known sensitivity of rabbits to antibiotic-induced changes in the gut microflora population.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

One film-coated tablet contains: anhydrous calcium hydrogen phosphate, pregelatinised starch, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate. Coating: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, talc, soy lecithin, xanthan gum.