SPC Revo Tablets (Levosulpiride)

Adult dose

Adults: The usual dose is 25 mg of levosulpiride per dose, taken orally 3 times daily before meals.

This medication should not be used by women who are pregnant or may become pregnant, and by nursing mothers. It should not be administered to patients with gastrointestinal problems such as gastrointestinal bleeding, mechanical obstruction, or perforation. It is also not suitable for patients who may develop hypertension due to certain tumors. Patients who have an allergic reaction to this medication or have difficulty tolerating it should avoid use. It is advisable not to administer this medication to patients with liver disease or certain stages of bipolar disorder. Caution should be taken for patients with breast issues since this medication may cause breast developmental disorders. Additionally, this medication contains lactose and should not be given to patients with genetic issues such as lactase deficiency or galactose intolerance. Special care should be taken when using this medication in patients with hypertension, children, and elderly patients, and overdose should be avoided. During treatment, hormonal-related side effects may occur, including amenorrhea, excessive milk secretion, and gynecomastia, and careful monitoring is required. If symptoms of movement disorders such as tremors, tongue twisting, or agitation appear, the use should be immediately discontinued. Long-term use may lead to involuntary movements around the mouth, requiring caution. Gastrointestinal symptoms may include dry mouth, heartburn, nausea, vomiting, diarrhea, and constipation. Cardiac-related side effects such as hypertension or arrhythmia may occur, so caution is warranted. Rarely, severe side effects known as neuroleptic malignant syndrome have been reported, characterized by high fever, muscle rigidity, and altered consciousness, and immediate treatment should be sought if these symptoms occur. Rarely, rashes or swelling may appear; if these symptoms occur, discontinuation of medication is necessary. It is advisable to avoid activities requiring concentration, such as driving or operating machinery, while taking this medication. This medication may interact with other drugs, so caution is needed especially when used with anticholinergics, analgesics, digitalis preparations, and other neuroleptics. Pregnant or nursing women should not use this medication as safety for the fetus and newborn has not been established. Elderly patients may have diminished kidney function, so dosage adjustment and observation of side effects are required. This medication can suppress vomiting symptoms, so it should be used cautiously once the cause has been accurately identified, and prolonged high-dose use may affect reproductive function.

• Amenorrhea
• hyperprolactinemia
• gynecomastia
• tremors
• tongue twisting
• anxiety
• involuntary movements around the mouth
• thirst
• heartburn
• nausea

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance

White round tablet

Package unit

30 tablets/bottle, 500 tablets/bottle