Opsomit Tablet 10 mg (Macitentan)

Adult dose

Adults: Take 10 mg once daily, regardless of meals. This medicine may be used as monotherapy or in combination with a phosphodiesterase-5 inhibitor or an inhaled/oral prostanoid preparation. Swallow the film-coated tablet whole with water; do not chew, cut, or crush it. Patients with hepatic impairment No dosage adjustment is required in patients with mild, moderate, or severe hepatic impairment. However, there is no clinical experience with this medicine in patients with pulmonary arterial hypertension who have moderate or severe hepatic impairment. This medicine should not be administered to patients with severe hepatic impairment or to patients with clinically significant elevations in hepatic aminotransferases (> 3 x ULN). Patients with renal impairment No dosage adjustment is required in patients with renal impairment. There is no clinical experience with this medicine in patients with severe renal impairment. Administration of this medicine is not recommended in patients undergoing dialysis. Older adults No dosage adjustment is required in adults aged 65 years or older.

Child dose

The safety and efficacy of this medicine in children have not been established.

This medication can cause congenital defects in the fetus if taken during pregnancy, so it should not be used by women who are pregnant or may become pregnant. Reliable contraception must be used from before treatment starts, during treatment, and for one month after stopping treatment, and pregnancy tests must be done monthly during treatment. Individuals allergic to this medication or its ingredients, patients with severe liver impairment, women who may become pregnant and are not using reliable contraception, and nursing mothers should not take this medication. Caution is advised for patients with impaired liver or kidney function or anemia while using this drug, and liver enzymes and blood tests should be continually monitored before and during treatment. Side effects such as headaches, hypotension, infections, anemia, bronchitis can commonly occur, and if symptoms of liver impairment appear, use should be stopped immediately. Caution may be necessary when driving or operating machinery due to potential side effects of this medication. This medication may interact with other drugs, particularly with those metabolized in the liver or strong CYP3A4 inhibitors. Pregnant or nursing women should not take this medication, and a reduction in sperm count has been reported in male animals, potentially affecting male fertility. Children under 18 years of age should not use this medication as its safety and efficacy have not been established. Overdose may result in symptoms such as headache, vomiting, and nausea, and appropriate treatment should be sought if necessary. This medication should be kept out of reach of children, and transferring it to another container should be avoided as it may affect quality.

• nasopharyngitis
• bronchitis
• pharyngitis
• influenza
• urinary tract infection
• anemia
• headache
• hypotension
• hypersensitivity reaction
• angioedema

This medication should be stored in a tightly closed container to prevent air or moisture ingress, and it is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness over time.

Appearance

White or yellowish two-sided convex round film-coated tablet

Package unit

30 tablets (15 tablets/PTP X 2)