Diclofenac

0,1 g № 10
Group of action
Agents affecting musculo-skeletal system
Active ingredient
Diclofenac sodium
Dosage form
Rectal suppositories
ATC code
M01AB05
RX/OTC
RX
Marketing authorisation no.
UA/7239/01/01

General properties

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic agents.

Indications
  •  Inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylitis including;
  •  spine pain syndromes;
  •  extra-articular rheumatism of soft tissues;
  •  acute gout;
  •  post-traumatic and postoperative pain, accompanied by inflammation and edema, particularly after dental or orthopedic surgery;
  •  migraine attacks;
  •  gynecological diseases accompanied by pain and inflammation, such as primary dysmenorrhea and adnexitis;
  •  as an adjunct in severe inflammatory diseases of ENT - organs, accompanied by painful sensations, such as pharyngitis, tonsillitis, otitis media.

In accordance with general therapeutic principles, the underlying disease should be treated by means of basic therapy. Fever by itself is not an indication for the use of the drug.

Contraindications
  •  Hypersensitivity to the active substance or to any - or excipient;
  •  bleeding or perforation of the gastro - intestinal tract in history related to previous NSAIDs therapy;
  •  the active form of peptic ulcer / bleeding or recurrent peptic ulcer / bleeding history (two or more distinct episodes of established ulceration or bleeding);
  •  inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis);
  •  last 3 months of pregnancy;
  •  proctitis;
  •  severe liver, kidney or heart failure;
  •  congestive heart failure (NYHA II-IV);
  •  coronary heart disease in patients with angina pectoris, myocardial infarction;
  •  cerebrovascular disease in patients who have had a stroke or have episodes of transient ischemic attacks;
  •  peripheral arterial disease;
  •  the treatment of perioperative pain in coronary artery bypass surgery (or the use of cardiopulmonary bypass);

The drug is contraindicated in patients who have a response to acetylsalicylic acid or other NSAIDs as attacks of asthma, urticaria, angioedema, or acute rhinitis.

Pharmaceutical characteristics

Basic physical and chemical properties

Suppositories from white to white with yellowish or creamy shade in color, bullet-shaped form. Presence of plaque on the surface of a suppository is allowed.

Shelf life
2 years.
Storage conditions

Keep out of reach of children at or above 25 °C.

Manufacturer
PJSC "Lekhim-Kharkiv".
Location
36, Severyna Pototskoho St., 61115 Kharkiv, Ukraine.