Diaflex Rompharm (Diafleks Romfarm)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDiacereinDiacerein
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    • Dosage form: & nbspCapsules.
    Composition:

    1 capsule contains:

    active substance: diacerein - 50 mg;

    Excipients: magnesium stearate - 12, 5 mg, lactose monohydrate (Capsulak 60) - up to 250 mg;

    composition of the capsule: titanium dioxide - 0.75 mg, dye gland oxide yellow - v 2,2125 mg, gelatin-up to 75.0 mg.

    Description:Capsules hard gelatinous № 1 yellow color with a weak brownish shade. The contents of the capsules are yellow powder.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug.
    ATX: & nbsp

    M.01.A.X.21   Diacerein

    Pharmacodynamics:Diacerein an anthraquinoline derivative, a diacetylated derivative of rhein. Metabolizing to the active metabolite - rhein, inhibits the activity of interleukin-1, which plays an important role in the development of inflammation and cartilage degradation in osteoarthritis.
    Inhibits the effect of other cytokines (incl.interleukin-6, tumor necrosis factor-alpha). The action develops in 2-4 weeks.
    Diacerein has analgesic anti-inflammatory activity when taken orally.
    Pharmacokinetics:
    Quickly absorbed from the gastrointestinal tract (GIT), bioavailability increases by 25% with simultaneous intake with food. The time to reach the maximum concentration (TCmax) is 144 min. With a single admission of 50 mg of C max - 3.15 mg / l, with repeated admission in connection with the cumulation of the drug Cmax increases. Completely deacetylated to rhein.
    The connection of rhein with proteins (albumin) is practically 100%. Reb penetrates the placental and blood-brain barrier.
    The half-life (T1 / 2) is 255 min. It is excreted by the kidneys unchanged (20%), in the form of glucuronide (60%), in the form of sulfate-20%.
    Indications:Primary and secondary osteoarthritis.
    Contraindications:Hypersensitivity to diacerein, other components (including anthraquinone medicines (laxatives)), age to 18 years. Lactose intolerance, lactase deficiency, glucosogalactose malabsorption.
    Carefully:Severe hepatic or renal failure, intestinal obstruction, inflammatory bowel disease.
    Pregnancy and lactation:The drug is contraindicated in pregnancy and lactation.When taking the drug, you must cancel breastfeeding.
    Dosing and Administration:
    Inside, after eating, you must swallow whole, without chewing, squeezed water, 50 mg 2 times a day (morning and evening).
    Continuously long or courses (at least 4 months).
    Diaflex Rompharm within the first 2 weeks can cause acceleration of transit in the intestine, so it is recommended to start treatment with one capsule per day in the evening with food for 4 weeks. Then the dose is increased to 100 mg / day.
    Side effects:

    From the digestive system: diarrhea, nausea, vomiting, abdominal pain, hepatitis.

    Allergic reactions: urticaria, fever, bronchospasm, angioedema, anaphylactic shock.

    Other: malaise, intense staining of urine (depending on pH) from yellow to brown (has no clinical significance).

    Overdose:
    Symptoms: diarrhea, weakness.

    Treatment: symptomatic. With severe diarrhea, control of the electrolyte composition of the plasma is necessary.
    Interaction:
    Diaflex Rompharm is not recommended together with preparations that increase the volume of intestinal contents (for example, a large amount of fiber).
    Antacids reduce the absorption of the drug.
    When administered simultaneously with antibiotics or chemotherapeutic drugs that affect the intestinal microflora, the incidence of adverse events on the part of the intestine may increase:
    Medicines (LS) containing aluminum hydroxide and / or magnesium hydroxide, reduce the bioavailability of diacerein.
    Simultaneous use with laxatives is not recommended.
    Special instructions:
    The duration of treatment can be long. Before the therapeutic effect, diacerein can be taken simultaneously with analgesic drugs (including NSAIDs). Periodic monitoring of blood counts, functional liver tests (determination of the level of liver transaminases), urine (determination of the level of creatinine and clearance of creatinine) is necessary. If the kidney function worsens, it is necessary to reduce the dose of the drug. In patients with CRF, with QC less than 30 ml / min, the dose of diacerein should be reduced to 50 mg / day and then titrated according to tolerability and clinical effectiveness.
    Staining of urine may make it difficult to interpret the results of the urinalysis (for example, on the glucose content).
    Effect on the ability to drive transp. cf. and fur:
    There is no information.
    Form release / dosage:
    Capsules 50 mg.


    Packaging:
    10 capsules per contour, cell pack of PVC / aluminum foil.

    3 contour packagings along with the instructions for use are placed in a cardboard box.
    Storage conditions:In the dark place at a temperature of no higher than 25 ° C. In a place inaccessible to children.
    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-000788
    Date of registration:03.10.2011
    Date of cancellation:2016-10-03
    The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania
    Manufacturer: & nbsp
    Representation: & nbspРомфарма ОООРомфарма ООО
    Information update date: & nbsp17.01.2016
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