Brintexa 5

✔️ Stop taking Brintexa 5 and consult your doctor immediately if you experience any of the following side effects:

• signs of serotonin syndrome (such as feeling agitated, hallucinations, confusion, loss of consciousness, fast heartbeat, feeling dizzy, increased sweating, flushing, tremors, stiff muscles or muscle twitching, loss of coordination, nausea, vomiting, diarrhea, or seizures)
• signs of allergic reactions (such as skin rash, swelling of the hands, face, tongue, neck or throat, increased fluid in tissues, fast heart rate, difficulty in breathing)
• unexplained bleeding
• feeling anxious, aggressive, irritated, or angry
• worsening of depression, suicidal thoughts or behavior
• fits (seizures)

✔️ Side Effects | Brintexa 5

• nausea, vomiting
• diarrhoea, constipation
• dizziness
• itching of the whole body
• abnormal dreams (nightmares)
• increased sweating

✔️ Before taking Brintexa 5 TABLET, inform your doctor if you:

• currently have or have a previous history of fits
• have ever had mania
• have an increased tendency to bleed or bruise easily
• have low sodium levels in the blood
• Currently have or have a previous history of glaucoma
• are going to have a urine test
• have a history of bleeding problems
• have a previous history of suicidal thoughts

✔️ Dosage & Administration of Brintexa | Vortioxetine 5

Recommended Dose:
The usual starting dose of Vortioxetine is 10 mg taken orally once daily, with or without food. Based on patient tolerance and clinical response, the dose may be increased to a maximum of 20 mg per day. The safety and effectiveness of doses exceeding 20 mg daily have not been established in controlled clinical studies.

For patients who experience intolerance at higher doses, a dose reduction to 5 mg once daily may be considered. In elderly patients (≥65 years), treatment should always be initiated at the lowest effective dose of 5 mg once daily.

Maintenance Therapy:
In patients with major depressive disorder (MDD), Vortioxetine may be continued for several months or longer as maintenance therapy. For long-term use, patients should be periodically reassessed to determine the ongoing need and benefit of treatment.

Discontinuation of Treatment:
Although Vortioxetine can be stopped abruptly, clinical trials have reported temporary adverse effects such as headache and muscle tension, particularly following sudden discontinuation of 15 mg or 20 mg daily doses. To minimize these effects, it is recommended to taper the dose to 10 mg once daily for one week before complete discontinuation when stopping higher doses.

Switching To or From Monoamine Oxidase Inhibitors (MAOIs):
To reduce the risk of serotonin syndrome, a minimum of 14 days should elapse between stopping an MAOI intended for psychiatric disorders and initiating Vortioxetine therapy. Conversely, at least 21 days should pass after discontinuing Vortioxetine before starting treatment with an MAOI.

✔️ Before taking Brintexa, inform your doctor if you are taking any of the following medicines such as:

• medicines used to manage pain (such as tramadol, fentanyl, nefopam, morphine,or morphine related substances like codeine, dihydrocodeine, buprenorphine)
• medicines used to manage migraine headache (Ex. sumatriptan)
• other medicines used to manage depression (Ex. phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, moclobemide, fluoxetine, paroxetine, amitriptyline, imipramine etc.)
• medicines used to manage Parkinsonism (Ex. selegiline, rasagiline)
• linezolid (an antibiotic used to manage bacterial infections)
• Lithium (a medicine used to manage depression and mental disorders)
• tryptophan (an amino acid used to induce sleep)
• rifampicin (a medicine used to manage tuberculosis)
• medicines used to manage epilepsy (Ex. carbamazepine, phenytoin)
• medicines used to manage blood clots (Ex. warfarin, dipyridamole, phenprocoumon, aspirin)
• mefloquine (a medicine used to manage malaria)
• bupropion (a medicine used to quit smoking)
• St. John’s wort (an herbal medicine used to manage depression)
• Quinidine (a medicine used to manage irregular heartbeat)
• medicines used to manage psychiatric disorders (Ex. haloperidol, chlorpromazine, chlorprothixene)

✔️ Storage:

• Keep Brintexa out of sight and reach of children
• Store Brintexa below 25°C