Brintellix Tablets 5mg (Vortioxetine Hydrobromide)

Adult dosage

1. Adults The initial and recommended dose of this medicine is 10mg once daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg daily or reduced to a minimum of 5mg daily. This medicine may be taken with or without food. 1) Maintenance treatment Drug treatment for at least 6 months is recommended to ensure a satisfactory treatment effect, even after depressive symptoms have resolved. 2) Discontinuation Gradual dose reduction may be considered to minimize the occurrence of withdrawal symptoms (see “4. Adverse reactions” under Precautions for Use). However, there are insufficient data to provide a specific dose-reduction schedule applicable to patients treated with this medicine. 2. Use in elderly patients In patients aged 65 years or older, the initial dose is 5mg once daily. Use caution when treating with this medicine at doses of 10mg or more daily. 3. Use with cytochrome P450 inhibitors and inducers 1) Cytochrome P450 inhibitors When co-administered with potent cytochrome P450 inhibitors (e.g., bupropion, quinidine, fluoxetine, paroxetine), reduce the dose of this medicine according to the patient's response (see section 6. Interactions). 2) Cytochrome P450 inducers When co-administered with broad-spectrum cytochrome P450 inducers (e.g., rifampicin, carbamazepine, phenytoin), the dose of this medicine may be adjusted according to the patient's response (see section 6. Interactions). 4. Use with monoamine oxidase inhibitors (MAOIs) 1) Switching MAO inhibitors for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medicine. 2) Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue must not start this medicine because of the increased risk of serotonin syndrome. For patients requiring other interventions, including hospitalization, or more urgent treatment of a psychiatric condition, whether to administer this medicine should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be stopped immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after receiving linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous doses of 1mg/kg or less of this medicine is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

This medication is an antidepressant used for the treatment of major depression. Patients, especially children, adolescents, and young adults should be closely monitored as there may be an increased risk of suicidal thoughts or behavior while taking this medication. This medication may cause a serious side effect called serotonin syndrome, which includes symptoms such as changes in mental state, high fever, tremors, and vomiting. The risk of these symptoms may increase when taken with other serotonergic medications, so it's essential to consult a doctor when combining medications. This medication should not be taken with MAO inhibitors, and at least 14 days must pass after stopping MAO inhibitors before starting this medication. Patients with a history of seizures or epilepsy should use this medication cautiously, and caution is also needed in individuals with mania or bipolar disorder. Patients with tendencies towards bleeding or those taking anticoagulants or medications affecting platelet function should be aware that the risk of bleeding may be increased with this medication. Common side effects of this medication include nausea, diarrhea, dizziness, and insomnia, most of which are transient. Abruptly stopping this medication can lead to withdrawal symptoms such as dizziness, headache, and anxiety, so it is recommended to taper off the dosage gradually. Women who are pregnant or breastfeeding should discuss the use of this medication thoroughly with their doctor as it may affect the fetus or newborn. Elderly patients or those with decreased liver or kidney function should be particularly careful when using this medication, and dosage adjustments or monitoring may be necessary. This medication is not recommended to be taken with alcohol, and caution should be exercised when driving or operating machinery. The use of this medication in children and adolescents is not recommended, as the likelihood of side effects may be higher. When storing this medication, it should be kept out of reach of children, and it is advisable not to transfer it to another container. In case of overdose, symptoms such as nausea, dizziness, and diarrhea may occur, and immediate contact with a medical institution is necessary.

Suicidal thoughts, suicidal tendencies, agitation, hallucinations, delirium, stupor, tachycardia, unstable blood pressure, dizziness, sweating, flushing, fever, tremor, euphoria, myoclonus, akathisia, dyskinesia, seizures, nausea, vomiting, diarrhea, anaphylactic reaction, hyperprolactinemia, nosebleed, decreased appetite, abnormal dreams, bruxism, insomnia, restless legs syndrome, dizziness, serotonin syndrome, headache, blurred vision, mydriasis, flushing, hemorrhage, vaginal bleeding, sexual dysfunction, nausea, diarrhea, constipation, vomiting, gastrointestinal bleeding, systemic itching, night sweats, angioedema, urticaria, rash, hyperhidrosis, withdrawal syndrome, dizziness, headache, sensory disturbance, sleep disturbance, anxiety, irritability, agitation, fatigue, tremor, sexual dysfunction, abdominal pain, gastroesophageal reflux, abdominal discomfort, gastritis, esophagitis, atrophic gastritis, gum pain, worsening headache, limb tremors, sensory abnormalities, tremor, vertigo, akathisia, worsening depression, intentional self-harm, suicide, sleep disorder, anxiety, hallucinations, emotional lability, mood disorders, hypersomnia, mood disorder, increased appetite, motivational deficit syndrome, increased sweating, hair loss, skin discoloration, dermatitis, systemic weakness, chest discomfort, bodily discomfort, facial edema, cold, tinea, bronchitis, cough, asthma, increased phlegm, arthralgia, myalgia, diabetes, weight gain, thirst, weight loss, diabetes, dysuria, frequent urination, acute cholecystitis, hepatitis, tinnitus, varicose veins, benign prostatic hyperplasia, incontinence, syncope, iron deficiency anemia, orthostatic hypotension, cyst of unspecified origin, dyspepsia, heartburn, dry mouth, epigastric pain, gastrointestinal disease of unspecified origin, drowsiness, sedation, fatigue, palpitations, nausea, vomiting, headache, dizziness, abdominal pain

This medication must be stored in a tightly sealed container to protect it from air and moisture, and it should be stored at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance

Pink oval film-coated tablets engraved with "TL" on one side and "5" on the other side.

Package unit

28 tablets (14 tablets/PTP × 2)