Kendo os drops 12.5ml 200mg/ml

KENDO * OS GTT 12.5ML 200MG / ML

Therapeutic indications

Pain of various origins and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain). Adjuvant in the symptomatic treatment of fever and flu.

Dosage and method of use

Dosage:The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see section 4.4). Adults and adolescents over 12 years: 25-50 drops, two to three times a day (25 drops = ibuprofen 200 mg). Do not exceed doses of 50 drops three times a day. If the use of the medicine is necessary for more than 3 days in adolescents aged 12 years and over, or in the case of worsening of symptoms, the doctor should be consulted. Do not exceed the recommended dose. THEelderly patientsthey should follow the minimum dosages indicated above. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4).Kidney failure:In patients with mild or moderate decreased renal function, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and renal function should be monitored.Liver failure:In patients with mild or moderate liver function impairment, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and liver function should be monitored. Kendo is contraindicated in patients with severe hepatic impairment (see section 4.3).Pediatric population:Kendo is contraindicated in children below 12 years of age (see section 4.3).Method of administration:Kendo can be taken on an empty stomach. In subjects with gastric tolerability problems, it is preferable to take the medicine on a full stomach.

Contraindications

• Hypersensitivity to the active substance (ibuprofen), to acetylsalicylic acid, to other analgesics, antipyretics, antirheumatics, non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in section 6.1; • Do not administer to children under the age of 12; • Third trimester of pregnancy and lactation (see section 4.6); • Active or severe gastroduodenal ulcer or other gastropathies; • History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic bleeding / ulcer (two or more distinct episodes of proven ulceration or bleeding); • Severe hepatic or renal insufficiency; • Severe heart failure (NYHA class IV); • Severe dehydration (caused by vomiting, diarrhea, insufficient fluid intake).

Side effects

The undesirable effects observed with ibuprofen are generally common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and are reported below using the following convention: Very common (≥ 1/10); Common (≥ 1/100, Gastrointestinal disorders: Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Gastrointestinal perforation with the use of ibuprofen has been rarely observed. After administration of KENDO have been reported: feeling of heaviness in the stomach, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, epigastric pain, heartburn, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4 ) Uncommon: gastritis Very rare: pancreatitis.Disorders of the immune system: The following undesirable effects have been reported following treatment with NSAIDs: non-specific allergic reaction and anaphylaxis. Uncommon: hypersensitivity reactions such as various skin rash, urticaria / pruritus, purpura, angioedema, rash, respiratory tract reactions including bronchospasm, dyspnoea, asthma attack (sometimes with hypotension). Rare: lupus erythematosus syndrome. Very rare: severe hypersensitivity reactions. Symptoms may include: severe asthma, face edema, tongue edema, laryngeal edema, airway edema with bronchospasm, dyspnoea, tachycardia, anaphylaxis, exfoliative and bullous dermatitis.Cardiac and vascular disorders: Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary edema, hypertension. Other adverse events for which causality has not necessarily been established include:Disorders of the blood and lymphatic system: Rare: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia, inhibition of platelet aggregationPsychiatric disorders: Uncommon: insomnia, anxiety. Rare: depression, confusional state, hallucinations.Nervous system disorders. Common: dizziness. Uncommon: paraesthesia, somnolence; Rare: optic neuritis.Infections and infestations. Uncommon: rhinitis. Rare: aseptic meningitis. Rhinitis and aseptic meningitis have been observed especially in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of neck stiffness, headache, nausea, vomiting, fever or disorientation (see section 4.4). Exacerbation of infection-related inflammation (e.g. development of necrotizing fasciitis) has been described.Respiratory system disorders. Uncommon: bronchospasm, dyspnoea, apnea.Eye disorders. Uncommon: visual disturbances. Rare: ocular alteration with consequent visual disturbances, toxic optic neuropathy.Ear and labyrinth disorders. Uncommon: impaired hearing, tinnitus, vertigo.Hepatobiliary disorders. Uncommon: abnormal liver function, hepatitis and jaundice. Very rare: hepatic failure.Skin and subcutaneous tissue disorders. Sometimes allergic skin rashes (erythema, itching, urticaria) can occur. Uncommon: photosensitivity reactions. Very rare: bullous dermatitis, including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG). In exceptional cases, severe skin infections and soft tissue disorders can occur during chickenpox infection (see "Infections and Infestations").Renal and urinary disorders. Uncommon: impaired renal function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. Rare: azotemia.General disorders and administration site conditions. Common: malaise, fatigue. Rare: edema.Diagnostic tests. Rare: increased transaminases, increased alkaline phosphatase, decreased hemoglobin, decreased hematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid.Reporting of suspected adverse reactions: The reporting of suspected adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

In asthmatic patients the product should be used with caution after consulting your doctor. The use of Kendo, as with any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended for women intending to become pregnant. Kendo should be discontinued in women who have fertility problems or who are undergoing fertility investigations. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below on gastrointestinal and cardiovascular risks). Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).Masking of symptoms of underlying infections: Kendo can mask the symptoms of infection, which could delay the initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Kendo is given for the relief of infection-related fever or pain, monitoring of infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen.Cardiovascular and cerebrovascular effects: Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg / day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg / day) should be avoided. ). Careful consideration should also be exercised before initiating long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking) especially if high doses (2400 mg / day) are required. ) of ibuprofen. Caution is required before starting treatment in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. NSAIDs may reduce the effect of diuretics, other antihypertensive drugs (see section 4.5).Gastrointestinal bleeding, ulceration and perforation: The use of Kendo should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors due to an increased risk of ulceration or bleeding (see section 4.5). Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Carefully monitor patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Kendo the treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).Kidney effects: When initiating treatment with ibuprofen, caution should be exercised in patients with considerable dehydration. Ibuprofen can cause water retention and sodium, potassium retention in patients who have never suffered from kidney disorders due to its effects on renal perfusion. This can cause edema or heart failure or hypertension in predisposed patients. Long-term use of ibuprofen, as with other NSAIDs, has led to renal papillary necrosis and other renal pathological changes. In general, the habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent renal lesions, with the risk of renal failure (analgesic nephropathy). Renal toxicity has been reported in patients in whom renal prostaglandins have a compensatory role in maintaining renal perfusion. Administration of NSAIDs in these patients may result in a dose dependent • reduction in prostaglandin formation and, as a secondary effect, in renal blood flow which can rapidly lead to renal failure. Patients most at risk of these reactions are those with reduced kidney function, heart failure, liver dysfunction, the elderly and all those patients taking diuretics and ACE inhibitors. Discontinuation of NSAID therapy is usually followed by recovery from the pretreatment state. There is a risk of impaired renal function in dehydrated adolescents. In case of prolonged use, monitor renal function particularly in the case of diffuse lupus erythematosus.Severe skin reactionsSerious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with medicinal products containing ibuprofen. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other signs of hypersensitivity.Respiratory disorders: Kendo should be prescribed with caution in patients with bronchial asthma, chronic rhinitis, nasal polyps, sinusitis or current or previous allergic diseases as bronchospasm, urticaria and angioedema may occur. The same applies to those subjects who have experienced bronchospasm after the use of acetylsalicylic acid or other NSAIDs.Hypersensitivity reactions: Analgesics, antipyretics, NSAIDs, can cause hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in subjects not previously exposed to this type of drug. The risk of hypersensitivity reactions after taking ibuprofen is higher in subjects who have presented these reactions after the use of other analgesics, antipyretics, NSAIDs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyposis or chronic respiratory diseases obstructive or previous episodes of angioedema (see sections 4.3 and 4.8). Hypersensitivity reactions can occur in the form of asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria. Serious hypersensitivity reactions (e.g. anaphylactic shock) have been observed rarely. At the first signs of a hypersensitivity reaction after administration of ibuprofen the treatment should be discontinued. Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms.Reduced cardiac, renal and hepatic function: Particular caution should be exercised in the treatment of patients with impaired cardiac, hepatic or renal function as the use of NSAIDs may lead to deterioration of renal function. Habitual concomitant use of several painkillers may further increase this risk. In patients with impaired cardiac, hepatic or renal function, the lowest effective dose should be used for the shortest treatment period and periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment.Hematological effects: Ibuprofen, like other NSAIDs, can inhibit platelet aggregation and has been shown to prolong bleeding time in healthy subjects. Therefore, patients with coagulation defects or on anticoagulation therapy should be carefully observed.Aseptic meningitis: Symptoms of aseptic meningitis have been observed on rare occasions in patients receiving ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue disorders, it has also been observed in patients who did not have concomitant chronic diseases (see section 4.8). Since ocular alterations have been detected in animal studies with NSAIDs, it is recommended, in case of prolonged treatments, to carry out periodic ophthalmological checks. Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or central nervous system. Ibuprofen can mask the signs or symptoms of infection (fever, pain and swelling).Kendo contains.Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine;Sodium sulphite:Rarely, it can cause severe hypersensitivity reactions and bronchospasm;Methyl para-hydroxybenzoate: May cause allergic reactions (even delayed)Ethanol (contained in the aroma): This medicine contains 66 mg of alcohol (ethanol) per 50-drop dose (2 mL equivalent to 400 mg of ibuprofen). The amount in 2 mL of this medicine is equivalent to less than 2 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine will not have any noticeable effects.Sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, ie essentially 'sodium-free';Potassium: This medicinal product contains 6.6 mmol (or 259 mg) of potassium per dose. To be taken into consideration in patients with impaired renal function or in patients on a low potassium diet.

Pregnancy and breastfeeding

Pregnancy:Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, Kendo should not be administered unless strictly necessary. If Kendo is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can exposethe fetus a: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydroamnios.the mother and the newborn, at the end of pregnancy, to:- possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Kendo is contraindicated during the third trimester of pregnancy.Feeding time: Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of influenza on the newborn seems unlikely. If, on the other hand, the treatment is longer term, early weaning should be considered, NSAIDs should be avoided during breastfeeding.Fertility: The use of ibuprofen may impair female fertility and is not recommended in women attempting to conceive. This effect is reversible upon discontinuation of treatment. In women who have difficulty conceiving or who are being investigated for infertility, discontinuation of ibuprofen treatment should be considered.

Expiration and retention

This medicine does not require any special storage conditions

Interactions with other drugs

It is advisable to seek medical advice in case of any concomitant therapy before administering the product. Ibuprofen (like other NSAIDs) should be taken with caution in combination with the substances listed below, •Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4). •Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin or heparin (see section 4.4). In case of concomitant treatment, monitoring of the coagulation status is recommended. •Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). •Inhibitors of cyclooxygenase-2 (COX-2) and other NSAIDs: these substances may increase the risk of adverse reactions affecting the gastrointestinal tract (see section 4.4). However, it is advisable not to combine ibuprofen with acetylsalicylic acid or other NSAIDs, including selective COX-2 inhibitors, due to potential additive effect (see section 4.4). •Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). •Diuretics, ACE inhibitors (such as captopril), beta blockers and Angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. Diuretics may also increase the risk of NSAID-associated nephrotoxicity. • In some patients withimpaired renal function(e.g. dehydrated patients or elderly patients with impaired renal function) co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, which includes possible acute renal failure, usually reversible. These interactions should be considered in patients taking KENDO concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and thereafter. •Phenytoin and lithium: concomitant administration of ibuprofen and phenytoin or lithium preparations may result in reduced elimination of these drugs with consequent increase in their plasma levels with the possibility of reaching the toxic threshold. If this combination is deemed necessary, monitoring of phenytoin and lithium plasma levels is recommended in order to adjust the appropriate posology during concomitant treatment with ibuprofen. •Methotrexate: NSAIDs may inhibit tubular secretion of methotrexate and some metabolic interactions may occur resulting in reduced clearance of methotrexate and increased risk of toxicity. •Moclobemide: increases the effect of ibuprofen. •Aminoglycosides: NSAIDs can decrease the excretion of aminoglycosides increasing their toxicity. •Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides. Monitoring of serum glycoside levels is recommended. •Cholestyramine: Concomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen from the gastrointestinal tract. However, the clinical relevance of this interaction is unknown. •Ciclosporine: Concomitant administration of cyclosporine and some NSAIDs causes an increased risk of kidney damage. This effect cannot be excluded for the combination of cyclosporine and ibuprofen. •Plant extracts: Ginkgo Bilobamay increase the risk of bleeding in combination with NSAIDs. •Mifepristone: Due to the anti-prostaglandin properties of NSAIDs, their use after administration of mifepristone may result in a reduction in the effect of mifepristone. Limited evidence suggests that co-administration of NSAIDs and prostaglandins on the same day does not adversely affect the effects of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce the drug's clinical efficacy on termination of pregnancy. •Quinolone antibiotics: Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. •Sulfonylureas: NSAIDs may increase the hypoglycemic effect of sulfonylureas. In the case of simultaneous treatment, monitoring of blood glucose levels is recommended. •Tacrolimus: Co-administration of NSAIDs and tacrolimus may lead to an increased risk of nephrotoxicity. •ZidovudineThere is evidence of an increased risk of haemarthrosis and hematoma in HIV-positive haemophiliac patients concomitantly treated with Zidovudine and other NSAIDs. A haematological examination is recommended 1-2 weeks after the start of treatment. •Ritonavir: may 'cause an increase in plasma concentrations of NSAIDs. •Probenecid: slows down the excretion of ibuprofen, with possible increase in its plasma concentrations. •CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may slow the elimination of ibuprofen (CYP2C9 substrate) resulting in increased exposure to lbuprofen. In a study with voriconazole and fluconazole (CYP2C9 inhibitors), increased exposure to S (+) - ibuprofen from approximately 80% to 100% was observed. co • administration with strong CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. •Alcohol, bisphosphonates and oxpentifylline (pentoxyfilline): can potentiate gastrointestinal side effects and the risk of bleeding and ulcer. •Baclofen: high toxicity of baclofen.

Overdose

ToxicitySigns and symptoms of toxicity were generally not observed at doses below 100 mg / kg in children or adults. However, supportive treatment may be required in some cases. Children have been observed to exhibit signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg / kg or greater.SymptomsMost patients who have ingested significant amounts of ibuprofen will experience symptoms within 4-6 hours. The most commonly reported symptoms of overdose include: nausea, vomiting, abdominal pain, lethargy and somnolence. Effects on the central nervous system (CNS) include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, hypothermia, renal effects, gastrointestinal bleeding, coma apnea, diarrhea, and CNS and respiratory depression have also been reported rarely. Disorientation, arousal state, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In case of severe poisoning, metabolic acidosis may occur.TreatmentThere is no specific antidote to ibuprofen overdose. In the event of an overdose, symptomatic and supportive treatment is therefore indicated. Particular attention is paid to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic amount. Alternatively, gastric lavage should be considered in adults within one hour of ingesting a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged seizures should be treated with intravenous diazepam. Depending on the patient's clinical condition, other supportive measures may be necessary. For more information, contact your local poison control center.

Active principles

1 ml of solution contains: Active ingredient: Ibuprofen 200mg. Excipients with known effects: sucrose, methyl parahydroxybenzoate, anhydrous sodium sulphite, ethanol, potassium and sodium. For the full list of excipients, see section 6.1

Excipients

Sucrose, glycerol, potassium hydroxide, anhydrous sodium sulphite, polysorbate 20, methyl para-hydroxybenzoate, sodium citrate dihydrate, sodium saccharin, sodium edetate, orange / lemon / caramel flavor, erythrosine (E127), purified water.