Storage:
active substance: ibuprofen;
1 tablet contains 200 mg of ibuprofen;
excipients: microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silicon dioxide, corn starch, magnesium stearate.
Medicinal form. Tablets.
The main physicochemical properties: tablets of white or almost white color, round shape, with a biconvex surface.
Pharmacotherapeutic group.
Non-steroidal anti-inflammatory and anti-rheumatic drugs. Derivatives of propionic acid.
Clinical characteristics.
Indication.
Symptomatic treatment of headache, toothache, dysmenorrhea, neuralgia, back pain, joint pain, muscle pain, rheumatic pain, and treatment of cold and flu symptoms.
Contraindication.
• Hypersensitivity to ibuprofen or to any of the components of the drug.
• History of hypersensitivity reactions (such as asthma, rhinitis, angioedema, or urticaria) after using ibuprofen, acetylsalicylic acid (aspirin), or other NSAIDs.
• Active gastric and duodenal ulcer disease/bleeding or history of recurrences (two or more severe episodes of confirmed ulcer disease or bleeding).
• History of gastrointestinal bleeding or perforation of the gastrointestinal tract wall associated with NSAID use.
• Severe heart failure (NYHA class IV), severe renal failure, or severe hepatic failure.
• Active inflammatory bowel disease.
• Hemorrhagic diathesis or other blood coagulation disorders.
• Last trimester of pregnancy.
Use during pregnancy or breastfeeding.
During the I and II trimesters of pregnancy, the use of the drug should be avoided. The drug is contraindicated in the third trimester of pregnancy.
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetus development. Data from epidemiological studies indicate an increased risk of miscarriage, congenital heart defects and gastroschisis after the use of prostaglandin synthesis inhibitors in early pregnancy. The risk is believed to increase with increasing dose and duration of therapy.
Starting from the 20th week of pregnancy, the use of ibuprofen can cause oligohydramnios due to fetal kidney dysfunction. This pathology can occur shortly after starting treatment and is usually reversible after stopping treatment. In addition, there are reports of narrowing of the ductus arteriosus after treatment in the second trimester of pregnancy, which in most cases disappeared after treatment was stopped. Therefore, during the first and second trimester of pregnancy, ibuprofen should not be prescribed if there is no need for it. If ibuprofen is used by a woman who is trying to conceive or during the first and second trimesters of pregnancy, the dose should be as low as possible and the duration of treatment should be as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus after exposure to ibuprofen for several days starting at 20 weeks’ gestation may be appropriate. Use of Ibuprofen-Darnytsia should be discontinued if oligohydramnios or narrowing of the ductus arteriosus is detected.
Expiration date. 3 years.
Storage conditions.
Store in the original packaging at a temperature not higher than 25 °C.
Keep out of the reach of children.
Packaging.
10 tablets each in a contoured blister pack; 1, 2 or 5 contour envelopes in a pack.
Leave category. Without a prescription.
Manufacturer. PJSC “Pharmaceutical firm “Darnytsia”.
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