Cool Time Tablet (Levosulpiride)

Adult dose

Adults: Administer levosulpiride 25 mg orally 3 times daily before meals.

This medication should not be used by pregnant women or women who may become pregnant, and by nursing mothers. In patients with gastrointestinal bleeding, mechanical obstruction, or perforation, the gastrointestinal motility stimulating effect of this medication may be harmful, so it should not be administered. In patients with a specific tumor known as chromaffin cell tumor, it may cause hypertension, so this medication should be avoided. Do not use it if there is an allergic reaction to this medication or if it is intolerable. This medication is also not suitable for patients with liver disease or in the manic phase of bipolar disorder. Patients with malignant lesions of the mammary glands should be cautious as this medication may increase prolactin secretion causing breast formation disorders. This medication contains lactose and should not be given to patients with genetic metabolic disorders such as lactose intolerance or galactose intolerance. Patients with hypertension, children, and the elderly should be administered this medication carefully, and especially children are at risk for extrapyramidal symptoms; therefore, care should be taken to avoid overdose. This medication may cause symptoms of amenorrhea, excessive lactation, and gynecomastia due to endocrine disorders; if these symptoms occur, use should be discontinued immediately. Extrapyramidal symptoms such as tremors, tongue twisting, and restlessness may rarely occur, and medication should be stopped if these symptoms arise. Long-term use may lead to involuntary movements around the mouth, and these symptoms may persist even after discontinuing the medication. Gastrointestinal side effects may include dry mouth, heartburn, nausea, vomiting, diarrhea, and constipation. Cardiovascular abnormalities such as hypertension or arrhythmias may occur, so caution is needed. Rarely, a serious side effect known as neuroleptic malignant syndrome may occur, manifesting as high fever, muscle rigidity, and altered consciousness; in this case, discontinue use immediately and seek treatment. Rarely, other symptoms such as rash, swelling, burning sensation, lethargy, insomnia, drowsiness, dizziness, staggering, and erectile dysfunction may also occur. With prolonged use, reproductive-related adverse reactions may appear, though these are reversible. This medication should inform the patient in advance of the possibility of increased prolactin secretion and lactation leakage, and caution should be exercised in its administration as it can induce endocrine dysfunction and extrapyramidal symptoms. It is also advisable to avoid activities requiring concentration, such as driving or operating machinery, during treatment. In rare cases of high-dose intake, cardiac rhythm abnormalities may occur; therefore, patients with heart disease should be particularly cautious. The risk of stroke may increase in patients taking antipsychotic medication, hence strict adherence to dosage and administration is necessary for patients with risk factors for stroke. When combined with anticholinergics or narcotic analgesics, the gastrointestinal motility effect of this medication may be reduced; thus, it is recommended not to use them together. Patients taking digitalis preparations may have their symptoms such as nausea and vomiting obscured, so monitoring is necessary. When used in conjunction with other benzamide compounds, there may be a tendency for endocrine dysfunction or extrapyramidal symptoms, so caution is advised. When used alongside psychiatric medications, unexpected side effects may occur; therefore, it should not be taken with alcohol. Concurrent use with drugs that prolong the QT interval may increase the risk of cardiac arrhythmias and should be closely monitored. It is safest not to combine with drugs that cause electrolyte imbalances. Pregnant women, women who may become pregnant, and nursing mothers should not take this medication due to the lack of established safety for the fetus or newborn. The elderly should be cautious as reduced kidney function may prolong drug retention in the body, thus requiring careful adjustment of dosage and intervals to avoid adverse effects. This medication may suppress vomiting symptoms; thus, conditions that cause vomiting should be fully observed before administration. Animal studies have reported possible reproductive impairment and tumor occurrence with high-dose long-term use, highlighting the need for caution with extended use.

• Amenorrhea
• galactorrhea
• 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 best to maintain a storage temperature between 1 degree and 30 degrees Celsius. This way, the efficacy of the medication will be preserved for a longer time and can be used safely.

Appearance

White round tablet

Package unit

[Domestic] 30 tablets/bottle, 300 tablets/bottle [Export] 20 tablets/box ((10 tablets/PTP)×2) 100 tablets/box ((10 tablets/PTP)×10)