Instruction for use: Artrocare

Active substance Diacerein

ATX M01AX21 Diacerein

Pharmacological group

Other non-narcotic analgesics, including non-steroidal and other anti-inflammatory drugs

Nosological classification (ICD-10)

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

Composition

Capsules 1 caps.

active substance:

diacerein 50 mg

auxiliary substances: lactose monohydrate - 188 mg; povidone - 5 mg; croscarmellose sodium - 4 mg; sodium lauryl sulfate - 1 mg; magnesium stearate - 0.5 mg; silicon dioxide colloidal - 0.5 mg

hard gelatin capsule (body): gelatin - 12,3959 mg; water 2.175 mg; color of diamond blue - 0.1035 mg; titanium dioxide - 0.1463 mg; dye floxin B - 0.0173 mg; methyl parahydroxybenzoate 0.12 mg; propyl parahydroxybenzoate 0.03 mg; sodium lauryl sulfate - 0.012 mg

hard gelatin capsule (lid): gelatin - 20,0085 mg; water 3.48 mg; color of diamond blue - 0,0045 mg; titanium dioxide - 0.234 mg; dye quinoline yellow - 0.009 mg; dye floxin B - 0.0048 mg; methyl parahydroxybenzoate 0.192 mg; propyl parahydroxybenzoate 0.048 mg; sodium lauryl sulfate - 0.192 mg

Description of dosage form

Hard gelatin capsules number 2, with the inscription "Micro / Micro", consisting of a gray body and a blue lid.

Contents of the capsule: yellow granular powder.

pharmachologic effect

Pharmacological action - anti-inflammatory.

Pharmacodynamics

Diacerein inhibits the synthesis and activity of IL-1, which plays an important role in the development of inflammation, degradation and subsequent destruction of cartilage in osteoarthritis. Diacerein also slows down the formation of metalloproteinases (collagenases), which are involved in the process of damage to the cartilaginous tissue. With long-term use, diacerein stimulates the synthesis of proteoglycans and does not affect the synthesis of PG.

Pharmacokinetics

After oral administration, diacerein is rapidly absorbed from the digestive tract and completely deacetylated to rhein. Simultaneous intake of the drug with food increases bioavailability by 25%. Cmax rhein in plasma is achieved after 144 min. T1 / 2 from the plasma is 255 minutes. The connection of rhein with albumin is almost 100%. With a single admission 50 mg Cmax reaches 3.15 mg / l. With repeated administration of the drug, Cmax increases in connection with the cumulation of the drug. Rein is excreted by the kidneys unchanged (20%) and in the form of glucuronide (60%) and sulfate (20%). Rein penetrates the placental barrier and the BBB.

Indication

Primary and secondary osteoarthritis.

Contraindications

individual intolerance of drug components or high sensitivity to anthraquinone drugs (eg laxatives);

severe hepatic or renal insufficiency;

intestinal obstruction;

inflammatory bowel disease;

lactose intolerance;

deficiency of lactase;

glucose-galactose malabsorption;

pregnancy;

lactation period;

children's age (under 18 years).

With caution: patients with irritation of the lower intestine - only in special cases.

Side effects

If hypersensitivity to the components of the drug may be allergic reactions of varying degrees, rash, itching.

On the part of the digestive system: in the initial period of taking the drug, diarrhea, nausea, vomiting, and abdominal pain may temporarily occur. In this case, the dose should be reduced to 1 caps. in a day.

An intense urine coloration may appear, from yellow to brown (depending on pH), which does not require a reduction in the dose (withdrawal) of the drug.

Interaction

It is not recommended to take an arthroker together with drugs or products that affect the consistency of the intestinal contents (for example, a large amount of cellulose).

Antacids reduce the absorption of the drug.

With simultaneous administration with antibiotics or chemotherapeutic drugs that affect the intestinal microflora, the frequency of adverse events from the intestine can increase.

Dosing and Administration

Inside, after eating (wholly, without chewing, washing with water).

The standard dosage is 1 caps. 2 times a day (morning and evening). The effect of treatment should be expected in 2-4 weeks. The arthroker is applied continuously, for a long time or by courses lasting not less than 4 months. The length of the break between the courses of treatment is set by the doctor.

Overdose

Symptoms: possible diarrhea, weakness. In case of overdose or accidental medication, children should consult a doctor.

Treatment: symptomatic.

special instructions

The duration of treatment (depending on the result achieved) can be prolonged.

In the period preceding the development of the therapeutic effect, the arthroker can be taken simultaneously with non-narcotic analgesics and other NSAIDs.

Precautions for use. Periodic monitoring of blood levels, activity of liver enzymes, urine is necessary. If the kidney function worsens, the doctor must decide whether to reduce the dose or to cancel it.

Influence on the ability to drive vehicles and mechanisms. The drug does not affect the driving of motor vehicles and employment by other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form of issue

Capsules, 50 mg. For 10 caps. in aluminum strips or aluminum / aluminum blisters; 1, 3 or 10 strips or blisters in a pack of cardboard.

Conditions of leave from pharmacies

On prescription.

storage Conditions

In a dry, the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.