Ortofen
25 mg № 10, № 30
Group of action
Active ingredient
Dosage form
Enterosoluble tablets
ATC code
M01AB05
RX/OTC
RX
Marketing authorisation no.
UA/5047/01/01
General properties
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic agents. Acetic acid derivatives and related compounds.
Indications
- inflammatory and degenerative forms of rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylitis), pain syndromes localized in the spine, extra-articular rheumatism;
- acute attacks of gout;
- post-traumatic and postoperative pain, accompanied by inflammation and swelling, e.g. following dental or orthopedic surgery;
- gynecological diseases accompanied by pain and inflammation, e.g.primary dysmenorrhoea or adnexitis;
- As an adjuvant in severe inflammatory diseases of the upper respiratory tract, accompanied by a sensation of pain, e.g. faringotonzilite, otitis.
In keeping with generally accepted therapeutic principles, the main 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 any other components of the preparation.
- In anamnesis allergic reactions in the form of bronchospasm, urticaria, acute rhinitis, nasal polyps or symptoms related to allergies, after application of aspirin or other nonsteroidal anti-inflammatory drugs.
- Gastric and/or duodenal ulcers, gastrointestinal bleeding or perforation.
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
- Severe hepatic insufficiency (class C Child-Pugh cirrhosis and ascites).
- Severe renal impairment (creatinine clearance <30 mL/min.).
- 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.
- Treatment of peri-operative pain in coronary artery bypass grafting (or the use of heart-lung machine).
Pharmaceutical characteristics
Basic physical and chemical properties
Film-coated tablets from yellow to orange in color, with bi-convex surface. At fault when viewed with a magnifying glass can see a core surrounded by one continuous layer.
Shelf life
3 years
Storage conditions
Keep in original packaging at temperature not exceeding 25°С. Keep out of reach of children.
Rx
Manufacturer
PJSC "Technolog"
Location
8, Stara Prorizna st., Uman 20300 Cherkasy region, Ukraine
