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Diafleks 50 mg (30 capsules)




The instruction for medical use

of Diaflex Torgovoye medicine a name
of Diaflex

the International unlicensed

name Diatserein Lekarstvennaya a form
of the Capsule, 50.0 mg

One capsule contains
active agent – diatserein 50.0 mg,
excipients: magnesium stearate, lactoses monohydrate,
structure of a cover of the capsule: titan dioxide (E 171), ferrous oxide yellow
(E 172), gelatin.

Solid gelatin capsules glossy, body and cover of yellow color. Contents of capsules – uniform powder of yellow color.

Pharmacotherapeutic group
Other non-steroidal anti-inflammatory drugs.
The code of automatic telephone exchange M01AX21

the Pharmacological

Pharmacokinetics At properties intake diatserein is exposed to full deacetylation in its active metabolite Rhine even before hit in a system blood stream. Visible bioavailability of Rhine of 35-60%. Stable concentration is reached to the third reception and elimination half-life averages 7-8 hours. Reception of a diatserein with food delays system absorption, but increases amount of the soaked-up substance by 25%. After intake at most concentration in blood plasma is reached in 2.2 hours and makes 3.2 mg/l.
Distribution volume after intake of a single dose of a diatserein of 50 mg is 13.2 l. Rein well contacts proteins of blood plasma – up to 99%.
Rein turns in a liver into a glucuronide (60%) or sulfate (20%). Up to 20% of not changed Rhine and the main part of metabolites are removed by kidneys. After introduction of a single dose of a diatserein of 50 mg the elimination half-life made 4.3 hours, visible general clearance of blood plasma – 1.6 l/hour, renal clearance – 0.13 l/hour.
The pharmacodynamics
of Diaflex activates recovery of cartilages, stimulating development of TGF-b which puts chondrocytes in action and stimulates production of collagen II of type, proteoglycan and a gialuronan. Rein, an active metabolite of a diatserein, reduces production of metalloproteinase-1,-3,-9 and-13 and renders hondroprotektivny effect.
Renders anti-inflammatory activity on models of an acute inflammation. Diaflex does not inhibit synthesis of prostaglandins. Diaflex restores changes in bone metabolism, keeping the mineral density of a bone, by means of improvement of balance formation/absorption.

– primary and secondary osteoarthrosis

the Route of administration and doses
Adult, inside, after a meal, it is necessary to swallow entirely, without chewing, washing down with water, on 1 capsule (50 mg) 2 times a day (in the morning and in the evening).
Diaflex during the first 2 weeks can cause acceleration of transit in intestines therefore it is recommended to begin treatment with one capsule a day in the evening after a meal during 4 weeks. Then the dose is increased to 100 mg/days.
Elderly people, patients with disturbances of functions of kidneys or a liver
dose adjustment is not required.
Patients with an acute renal failure (clearance of creatinine of less than 30 ml / mi):
The daily dose is reduced by a half.
A course of treatment – 6 months.

Side effects
Very often
– diarrhea
– a soft chair, abdominal pain

– an itching, eczema, rash
– pigmentation of a mucous membrane of a rectum
– dark yellow color of urine

of the Contraindication
– hypersensitivity to a diatserein, or any component
of drug
– a colopathy (an ulcer rectocolitis, Crohn’s disease)
– an occlusal or subocclusal syndrome
– pain abdominal syndromes of an unspecified etiology
– heavy abnormal liver functions
– children’s age up to 18 years
– pregnancy and the period of a lactation.

Medicinal interactions
It is necessary to show special attention at association of a diatserein with some medicines accepted in digestive tract diseases (salts, oxides and aluminum hydroxides, calcium and magnesium).
Perhaps some potentiation of diuretics.

Special indications
of Diaflex works slowly, the analgetic effect is shown in 30 – 45 days and during this period the co-administration of analgetics and anti-inflammatory drugs can be necessary. Patients with earlier present coloenterites, with a heavy renal failure have to use this drug with extreme care under strict observation of the doctor.
Medicine can lead to coloring of urine in saturated yellow color.
Lactose, to patients with hereditary shipping of a galactose, deficiency of lactose (Lapp) or a syndrome of weak absorption of glucose, a galactose is a part of drug, it is not necessary to take this drug.
Features influence of medicine on ability to run vehicles and potentially dangerous mechanisms
does not influence.

Symptoms: it is necessary to expect strengthening of side effects, mainly, of diarrhea and its consequences.
Treatment: symptomatic. Specific antidote is not known. The investigation of high extent of linking with blood proteins should not be expected efficiency of a hemodialysis.

A form of release and packing
On 10 capsules in blister strip packagings from a film of polyvinylchloride and aluminum foil. On the 3rd blister strip packagings together with the instruction for use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions in the dry, protected from light place, at a temperature not above 25 °C.
To store out of children’s reach!

3 years
not to apply a period of storage after the expiry date specified on packing.
Prescription status
According to the prescription

of Proizvoditel Rompharm Company of S.R. L.,
Romania Eroilor St. 1A, Otopen.
ph. +40 21 208 9743, +40 21 208 97 42, fax: +40 21 266 49 38

The address of the organization accepting claims from consumers on quality of a product in the territory of the Republic of KazahstanPredstavitelstvo of Rompharm Company in RK, Almaty, Tolya St. bi, 305, office 19, phone/fax 8/7272/232952,

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