Summary of Product Characteristics Updated 24-May-2016 | Bristol-Myers Squibb Pharmaceuticals limited
PosologyVidex gastro-resistant capsules are administered on a once daily or a twice daily regimen (see section 5.1).The recommended total daily dose is based on patient body weight (kg): • for patients weighing at least 60 kg: 400 mg per day• for patients weighing less than 60 kg: 250 mg per dayThe following table defines the administration schedule for all strengths of the gastro-resistant capsules:
|Patient Weight||Total Daily Dose||Corresponding Regimen|
|at least 60 kg||400 mg||1 capsule of 400 mg (once daily) or 1 capsule of 200 mg (twice daily)|
|less than 60 kg||250 mg||1 capsule of 250 mg (once daily) or 1 capsule of 125 mg (twice daily)|
Special populationsElderly population: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. In addition, renal function should be monitored and dosage adjustments should be made accordingly (see below).Renal impairment: The following dose adjustments are recommended:
|Creatinine Clearance (ml/min) / Patient Weight||Total Daily Dose|
|at least 60 kg (dose, mg)||less than 60 kg (dose, mg)|
|at least 60 30 59 10 29 less than 10||400 mg 200 mg 150 mg* 100 mg*||250 mg 150 mg* 100 mg* 75 mg*|
Paediatric populationPaediatric patients older than 6 years: The use of Videx gastro-resistant capsules has not been specifically studied in paediatric patients. The recommended daily dose (based on body surface area) is 240 mg/m2.Paediatric patients younger than 6 years: The gastro-resistant capsules should not be opened as there is a potential for inadvertent aspiration. Therefore, this medicine is contraindicated in this age group. Other more appropriate Videx formulations are available.
Method of administrationTo optimise absorption, the gastro-resistant capsule should be taken intact with at least 100 ml of water. Patients should be instructed not to open the capsule to facilitate administration, since this could reduce absorption (see section 5.2).
|Lactic acidosis: lactic acidosis, usually associated with hepatomegaly and hepatic steatosis, has been reported with the use of didanosine. Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness). Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure, or renal failure.Lactic acidosis generally occurred after a few or several months of treatment.Treatment with didanosine should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels. Caution should be exercised when administering didanosine to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol). Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.Patients at increased risk should be followed closely. (See also section 4.6).|
Weight and metabolic parametersAn increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy. Such changes may in part be linked to disease control and life style. For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment. For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines. Lipid disorders should be managed as clinically appropriate. Osteonecrosis: although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.Opportunistic infections: Patients receiving didanosine or any antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection or therapy. They therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.Interaction with other medicinal products: Tenofovir: Co-administration of didanosine and tenofovir disoproxil fumarate results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosine-related adverse events (see section 4.5). Rare cases of pancreatitis and lactic acidosis, sometimes fatal, have been reported.A reduced didanosine dose (250 mg) has been tested to avoid over-exposure to didanosine in case of co-administration with tenofovir disoproxil fumarate, but this has been associated with reports of high rate of virological failure and of emergence of resistance at early stage within several tested combinations. Co-administration of didanosine and tenofovir disoproxil fumarate is therefore not recommended, especially in patients with high viral load and low CD4 cell count. Co-administration of tenofovir disoproxil fumarate and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine. If this combination is judged strictly necessary, patients should be carefully monitored for efficacy and didanosine related adverse events.Ganciclovir and valganciclovir: Co-administration of didanosine with ganciclovir or valganciclovir may result in didanosine-associated toxicities. Patients should be closely monitored (see section 4.5).
Not recommended combinations:Pancreatitis (fatal and nonfatal) and peripheral neuropathy (severe in some cases) have been reported in HIV infected patients receiving didanosine in association with hydroxyurea and stavudine (see section 4.3 and 4.5). Hepatotoxicity and hepatic failure resulting in death were reported during postmarketing surveillance in HIV infected patients treated with antiretroviral agents and hydroxyurea; fatal hepatic events were reported most often in patients treated with stavudine, hydroxyurea and didanosine. Hence, this combination must be avoided.Allopurinol: Co-administration of didanosine and allopurinol results in increased systemic exposure to didanosine, which can result in didanosine-associated toxicity. Therefore, co-administration of allopurinol and didanosine is not recommended. Patients treated with didanosine who require allopurinol administration should be switched to an alternative treatment regimen (see section 4.5).Co-administration of ribavirin and didanosine is not recommended due to an increased risk of adverse events, in particular of mitochondrial toxicity (see section 4.5).Triple nucleoside therapy: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when didanosine was combined with tenofovir disoproxil fumarate and lamivudine as a once daily regimen.
Patients on sodium restricted diet:125 mg: Each gastro-resistant capsule contains 0.53 mg sodium.200 mg: Each gastro-resistant capsule contains 0.85 mg sodium.250 mg: Each gastro-resistant capsule contains 1.0 mg sodium.400 mg: Each gastro-resistant capsule contains 1.7 mg sodium.
Paediatric populationMitochondrial dysfunction: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues. The main adverse events reported are haematological disorders (anemia, neutropenia), metabolic disorders (hyperlactatemia, hyperlipasemia). These events are often transitory. Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour). Whether the neurological disorders are transient or permanent is currently unknown. Any paediatric patient exposed in utero to nucleoside and nucleotide analogues, even HIV-negative paediatric patients, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms. These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Not recommended for concomitant useRibavirin: Based on in vitro data, ribavirin increases the intracellular triphosphate levels of didanosine. Fatal hepatic failure, as well as peripheral neuropathy, pancreatitis and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving didanosine and ribavirin with or without stavudine. Co-administration of ribavirin and didanosine is not recommended (see section 4.4). Tenofovir: The co-administration of didanosine and tenofovir disoproxil fumarate is not recommended (see Table 1 and section 4.4).Allopurinol: Co-administration of allopurinol (a xanthine oxidase inhibitor) with didanosine is not recommended. Patients treated with didanosine who require allopurinol administration should be switched to an alternative treatment regimen (see Table 1 and section 4.4). Xanthine oxidase is an enzyme involved in the metabolism of didanosine. Other inhibitors of xanthine oxidase may increase exposure to didanosine when administered concomitantly and thus increase the potential for didanosine associated undesirable effects. Patients should be closely monitored for didanosine related undesirable effects (see section 4.8).
Other interactionsInteractions between didanosine and antiretroviral agents or other non-antiretroviral medicinal products are listed in Table 1 below (increase is indicated as ↑, decrease is indicated as ↓, no change as ↔). Unless otherwise noted, studies were conducted in HIV-infected patients.
Table 1: Interactions between didanosine and other medicinal products
|Medicinal product by therapeutic areas (dose in mg)||Effects on drug levels Mean percent change in AUC, Cmax||Recommendation concerning co-administration with didanosine|
|Non-Nucleoside/nucleotide reverse transcriptase inhibitors (NNRTIs)|
|Etravirine/Didanosine buffered tablet (200 mg twice daily / 400 mg single dose)||Didanosine: AUC: ↔ Cmax: ↔ Etravirine: AUC: ↔ Cmax: ↔||No dose adjustment is necessary for either medicinal product.|
|Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)|
|Stavudine / Didanosine buffered tablet (40 mg every 12 hours for 4 days / 100 mg every 12 hours for 4 days)||Didanosine: AUC: ↔ Cmax: ↔ Stavudine: AUC: ↔ Cmax: ↑ 17%||This combination is contraindicated given that both drugs exhibits high risk of mitochondrial toxicity (see section 4.3 and 4.4).|
|Tenofovir disoproxil fumarate||Co-administration of tenofovir disoproxil fumarate and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosine-related adverse reactions. Rarely, pancreatitis and lactic acidosis, sometimes fatal, have been reported. Co-administration of tenofovir disoproxil fumarate and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine. A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil fumarate therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.||Co-administration of didanosine and tenofovir disoproxil fumarate is not recommended.|
|Zidovudine / Didanosine (200 mg every 8 hours for 3 days / 200 mg every 12 hours for 3 days)||Didanosine: AUC: ↔ Cmax: ↔ Zidovudine: AUC: ↓ 10% Cmax: ↓ 16.5%||No dose adjustment is necessary for either medicinal product.|
|Darunavir/ Ritonavir/Didanosine gastro-resistant capsules (600 mg administered with low-dose ritonavir twice daily / 400 mg once daily)||Didanosine (administered on an empty stomach 2 hours prior to darunavir/ritonavir given with food.): AUC: ↓ 9% Cmax: ↓ 16% Darunavir (co-administered with low dose ritonavir): AUC: ↔ Cmax: ↔||No dose adjustment is necessary for either medicinal product.|
|Indinavir / Didanosine gastro-resistant capsules (800 mg single dose / 400 mg single dose)||Indinavir: AUC: ↔ Cmax: ↔||No dose adjustment is necessary for either medicinal product.|
|Ciprofloxacin / Didanosine gastro-resistant capsules (750 mg single dose / 400 mg single dose)||Ciprofloxacin: AUC: ↔ Cmax: ↔||No dose adjustment is necessary for either medicinal product.|
|Dapsone / Didanosine buffered tablet (100 mg single dose / 200 mg every 12 hours for 14 days)||Dapsone: AUC: ↔ Cmax: ↔||No dose adjustment is necessary for either medicinal product.|
|Ganciclovir / Didanosine buffered tablet (1000 mg every 8 hours / 200 mg every 12 hours) Valganciclovir||Didanosine (ganciclovir administered concurrent with or 2 hours after): AUCsteady-state: ↑ 111% Cmax: not available Ganciclovir (administered 2 hours after but not concurrent with didanosine): AUCsteady-state: ↓ 21% Cmax: not available Although the magnitude of increase in didanosine exposure when co-administered with valganciclovir has not been established, an increase in didanosine exposure would be anticipated when these agents are co-administered.||Patients taking didanosine in combination with ganciclovir and valganciclovir should be closely monitored for didanosine-associated toxicities.|
|Rifabutin / Didanosine buffered tablet (300 or 600 mg per day for 12 days / 167 or 250 mg every 12 hours for 12 days)||Didanosine: AUC: ↑ 13% Cmax: ↑ 17%||No dose adjustment is necessary for either medicinal product.|
|Sulfamethoxazole / Didanosine buffered tablet (1000 mg single dose / 200 mg single dose)||Didanosine: AUC: ↔ Cmax: ↔ Sulfamethoxazole: AUC: ↓ 11% Cmax: ↓ 12%||No dose adjustment is necessary for either medicinal product.|
|Trimethoprim / Didanosine buffered tablet (200 mg single dose / 200 mg single dose)||Didanosine: AUC: ↔ Cmax: ↑ 17% Trimethoprim: AUC: ↑ 10% Cmax: ↓ 22%||No dose adjustment is necessary for either medicinal product.|
|ACID REDUCING AGENTS|
|Ranitidine / Didanosine buffered tablet (150 mg single dose, 2 hours before didanosine / 375 mg single dose)||Didanosine: AUC: ↑ 14% Cmax: ↑ 13% Ranitidine: AUC: ↓ 16% Cmax: ↔||No dose adjustment is necessary for either medicinal product.|
|Metoclopramide / Didanosine buffered tablet (10 mg single dose / 300 mg single dose)||Didanosine: AUC: ↔ Cmax: ↑ 13%||No dose adjustment is necessary for either medicinal product.|
|Allopurinol / Didanosine buffered tablet (healthy volunteer, 300 mg once daily for 7 days / 400 mg single dose at Day 1 and Day 8)||Didanosine: AUC: ↑ 105% Cmax: ↑ 71%||Co-administration of didanosine and allopurinol is not recommended. Patients treated with didanosine who require allopurinol administration should be switched to an alternative treatment regimen and be closely monitored for didanosine related undesirable effects.|
|Loperamide / Didanosine buffered tablet (4 mg every 6 hours for 1 day / 300 mg single dose)||Didanosine: AUC: ↔ Cmax: ↓ 23%||No dose adjustment is necessary for either medicinal product.|
|Methadone / Didanosine buffered tablet (chronic maintenance dose / 200 mg single dose) gastro-resistant capsules (chronic maintenance dose / 400 mg single dose)||Didanosine: AUC: ↓ 57% Cmax: ↓ 66% AUC: ↓ 29% Cmax: ↓ 41%||If didanosine is used in combination with methadone, patients should be closely monitored for adequate clinical response.|
Paediatric populationInteraction studies have only been performed in adults.
PregnancyThere are no adequate data from the use of didanosine in pregnant women and it is not known whether didanosine can cause foetal harm or affect reproductive capacity when administered during pregnancy. Lactic acidosis (see section 4.4), sometimes fatal, has been reported in pregnant women who received the combination of didanosine and stavudine with or without other antiretroviral treatment. Therefore, the use of didanosine during pregnancy should be considered only if clearly indicated, and only when the potential benefit outweighs the possible risk.Teratology studies in rats and rabbits did not produce evidence of embryotoxic, foetotoxic, or teratogenic effects. A study in rats showed that didanosine and/or its metabolites are transferred to the foetus through the placenta.
BreastfeedingIt is unknown whether didanosine is excreted in human milk. It is recommended that women taking didanosine do not breast-feed because of the potential for serious adverse reactions in nursing infants. At the 1000 mg/kg/day dose levels in rats, didanosine was slightly toxic to females and pups during mid and late lactation (reduced food intake and body weight gains), but the physical and functional development of the subsequent offspring were not impaired. A further study showed that, following oral administration, didanosine and/or its metabolites were excreted in the milk of lactating rats.
FertilityIn rats, didanosine did not impair the reproduction ability of male or female parents following treatment prior to and during mating, gestation and lactation at daily didanosine doses up to 1000 mg/kg/day. In a perinatal and postnatal reproduction study in rats, didanosine did not induce toxic effects.
|Infections and infestations:||uncommon: sialoadenitis*|
|Blood and lymphatic system disorders:||uncommon: anemia*, leukopenia*, thrombocytopenia*|
|Immune system disorders:||uncommon: anaphylactic reaction**|
|Metabolism and nutrition disorders:||common: anorexia*uncommon: lactic acidosis*, diabetes mellitus*, hypoglycaemia**, hyperglycaemia*|
|Nervous system disorders:||common: peripheral neurologic symptoms (including neuropathy), headache|
|Eye disorders:||uncommon: dry eyes*, retinal depigmentation**, optic neuritis**|
|Gastrointestinal disorders:||very common: diarrhoea common: nausea, vomiting, abdominal pain, flatulence*, dry mouth*rare: parotid gland enlargement*|
|Hepatobiliary disorders:||common: hepatitis*uncommon: hepatic steatosis*, liver failure**rare: non-cirrhotic portal hypertension* (see section 4.4)|
|Skin and subcutaneous tissue disorders:||common: rashuncommon: alopecia*|
|Musculoskeletal and connective tissue disorders:||common: myalgia (with or without increases in creatine phosphokinase)*, arthralgia*uncommon: rhabdomyolysis including acute renal failure and haemodialysis** rare: myopathy*|
|Reproductive system and breast disorders:||common: gynaecomastia*|
|General disorders and administration site conditions:||common: fatigue, asthenia*, chills and fever*, pain*|
|Investigations:||common: increased/abnormal serum amylase*, increased/abnormal creatine phosphokinase* uncommon: increased/abnormal alkaline phosphatase*|
Paediatric populationSafety data for paediatric patients were generally similar to those seen in adults. A higher haematotoxicity has been reported with the combination with zidovudine compared to didanosine monotherapy. Retinal or optic nerve changes have been reported in a small number of paediatric patients usually at doses above those recommended (see section 4.4). Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Mechanism of actionAfter didanosine (2', 3'-dideoxyinosine) enters the cell, it is enzymatically converted to dideoxyadenosine-triphosphate (ddATP), its active metabolite. In viral nucleic acid replication, incorporation of this 2', 3'-dideoxynucleoside prevents chain extension, and thereby inhibits viral replication. In addition, ddATP inhibits HIV-reverse transcriptase by competing with dATP for binding to the enzyme's active site, preventing proviral DNA synthesis. Antiviral activity in vitroDidanosine is an inhibitor of HIV-1 and HIV-2 replication in cultured human cells and cell lines.
ResistanceCurrent evidence indicates that the incidence of resistance to didanosine is an infrequent event and the resistance generated is modest in degree. Didanosine-resistant isolates have been selected in vivo and are associated with specific genotype changes in the reverse transcriptase codon region (codons L74V (most prevalent), K65R, M184V and T69S/G/D/N). Clinical isolates that exhibited a decrease in didanosine susceptibility harbored one or more didanosine-associated mutations. Mutant viruses containing the L74V substitution show a decline in viral fitness and these mutants quickly revert to wild type in the absence of didanosine.
Cross-resistanceCross-resistance between didanosine and any antiretroviral class except nucleoside reverse transcriptase inhibitor (NRTIs) is unlikely. Cross-resistance between didanosine and NRTIs is observed in isolates containing multi-resistant mutations such as the Q151M complex, K65R, 3 or more thymidine analog mutations (TAMs), T69ins or multiple nucleoside analogue associated mutations (NAMs).Clinical resultsUsing the Videx tablet formulation, the effect of Videx twice daily administration, alone or in combination with zidovudine, was evaluated in several major randomised, controlled clinical trials (ACTG 175, ACTG 152, DELTA, CPCRA 007). These trials confirmed the reduced risk of HIV disease progression or death with Videx tablets therapy, alone or in combination with zidovudine, as compared with zidovudine monotherapy in HIV infected individuals, including symptomatic and asymptomatic adults with CD4 counts < 500 cells/mm3 and paediatric patients with evidence of immunosuppression. The primary demonstration of clinical benefits of didanosine has been made through the ACTG 175 trial with the buffered tablet formulation of Videx administered twice daily. This study showed that 8 weeks of treatment with zidovudine (200 mg) three times daily, Videx tablets (200 mg) twice daily, or Videx tablets (200 mg) twice daily plus zidovudine (200 mg) three times daily decreased mean plasma HIV RNA by 0.26, 0.65 and 0.93 log10 copies/ml, respectively.
In antiretroviral naive patientsThe efficacy of Videx tablet or powder was evaluated in treatment-naive HIV infected patients in two (48-week) randomised open label clinical trials.Study START II (n=205) was a multicenter, randomized, open label study comparing Videx (200 mg or 125 mg if weight <60 kg) twice daily plus stavudine (40 mg or 30 mg if weight <60 kg) twice daily and indinavir (800 mg) three times daily to zidovudine (200 mg) three times daily plus lamivudine (150 mg) twice daily and indinavir (800 mg) three times daily. Through 48 weeks of treatment, results were in favour of the Videx arm. However, no formal conclusion can be drawn on the equivalence of the two regimens.Since didanosine exhibits a very long intracellular half-life (> 24 hours), permitting the accumulation of its pharmacologically active ddATP-moiety for extended time periods, administration of the total daily dose of Videx in a once daily dosing regimen has been explored through clinical studies.Study 148 (n= 756) was a randomised open label study comparing Videx (400 mg or 250 mg if weight < 60 kg) once daily plus stavudine (40 mg or 30 mg if weight <60 kg) twice daily and nelfinavir (750 mg) three times daily to zidovudine (300 mg) twice daily plus lamivudine (150 mg) twice daily and nelfinavir (750 mg) three times daily (Table 2). After 48 weeks of treatment, results were in favour of the zidovudine, lamivudine and nelfinavir arm compared to Videx, stavudine and nelfinavir arm in terms of proportion of patients with undetectable viral load (the proportion of patients with HIV RNA copies < 400 copies/ml was 53% for the Videx-containing arm and 62% for the comparator). However, no formal conclusions can be drawn on this study due to methodological issues.
Table 2: Outcome of Randomized Treatment at Week 48 (Study -148)
|Parameter||Videx + stavudine + nelfinavir n=503||zidovudine + lamivudine + nelfinavir n=253|
|HIV RNA < 400 copies/ml, treatment response, %|
|HIV RNA < 50 copies/ml, treatment response, %|
|HIV RNA Mean Change from Baseline, log10 copies/ml|
|-2.46 (n=321a)||-2.65 (n=173a)|
|CD4 Mean Change from Baseline, cells/mm3|
|208.5 (n=320a)||215.7 (n=173a)|
Table 3: Outcome of Randomized Treatment at Week 48 (Study -152)
|Parameter||Videx (capsule) + stavudine + nelfinavir n=258||Zidovudine + lamivudine + nelfinavir n=253|
|HIV RNA < 400 copies/ml, treatment response, %|
|HIV RNA < 50 copies/ml, treatment response, %|
|HIV RNA Mean Change from Baseline, log10 copies/ml|
|-2.51 (n=194a)||-2.51 (n=185a)|
|CD4 Mean Change from Baseline, cells/mm3|
|157.3 (n=188a)||188.6 (n=183a)|
In treatment experienced patientsStudy 147 (n= 123) was a randomized open label two-arm study comparing Videx (400 mg or 250 mg if weight <60 kg) once daily versus Videx (200 mg or 125 mg if weight <60 kg) twice daily, in combination with stavudine and zidovudine. In the tritherapy setting, the study indicates that, in mostly asymptomatic patients that were stable on their first combination therapy containing Videx twice daily, the shift to a similar combination therapy with Videx once daily did not impact at short term (24 weeks) on the existing antiviral efficacy.
Paediatric populationThere are no specific pharmacokinetic data from paediatric patients treated with Videx gastro-resistant capsules.
Capsule content:Carmellose sodiumDiethyl phthalate30% methacrylic acid copolymer dispersion (EUDRAGIT L30D-55)Sodium starch glycolate (Type A)TalcSodium hydroxide (for pH adjustment)
Capsule shell:GelatinSodium laurilsulfateTitanium dioxide (E171) 125 mg:
Capsule shell imprints (edible ink):ShellacPropylene glycolPotassium hydroxideTitanium dioxide (E171)Yellow and red iron oxide (E172)200 mg:
Capsule shell imprints (edible ink):ShellacPropylene glycolFD&C Blue #2 Aluminium Lake (E132)Titanium dioxide (E171)Yellow iron oxide (E172)250 mg:
Capsule shell imprints (edible ink):ShellacPropylene glycolFD&C Blue #2 Aluminium Lake (E132)400 mg:
Capsule shell imprints (edible ink):ShellacPropylene glycolAmmonium hydroxideSimethiconeRed iron oxide (E172)
|PL 11184/0083||Videx EC 125 mg gastro-resistant hard capsule|
|PL 11184/0084||Videx EC 200 mg gastro-resistant hard capsule|
|PL 11184/0085||Videx EC 250 mg gastro-resistant hard capsule|
|PL 11184/0086||Videx EC 400 mg gastro-resistant hard capsule|
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