WARNING

Brisdelle is a medication primarily used to treat hot flashes in menopausal women. However, like any medication, it carries certain risks. Some potential risks associated with taking Brisdelle include:

• Serotonin Syndrome: Brisdelle contains paroxetine, which can increase serotonin levels in the brain. Taking it with other medications that also increase serotonin levels can lead to serotonin syndrome, a potentially serious condition characterized by symptoms like confusion, rapid heart rate, and high blood pressure.
• Suicidal Thoughts or Behavior: Antidepressants like paroxetine, which is the active ingredient in Brisdelle, carry a warning about an increased risk of suicidal thoughts or behavior, especially in young adults.
• Withdrawal Symptoms: Suddenly stopping Brisdelle can lead to withdrawal symptoms such as dizziness, nausea, headache, and irritability.
• Bone Health: There is evidence suggesting that long-term use of selective serotonin reuptake inhibitors (SSRIs) like paroxetine may be associated with a slight increase in the risk of bone fractures, particularly in older adults.
• Other Side Effects: Common side effects of Brisdelle can include nausea, dizziness, fatigue, headache, and dry mouth. Some users may also experience weight gain or sexual dysfunction.

It’s important for individuals considering Brisdelle to discuss the potential risks and benefits with their healthcare provider to determine if it’s the right choice for them.

Why is this medication prescribed?

Brisdelle is a brand name for the medication paroxetine, specifically formulated for treating moderate to severe hot flashes in menopausal women. Hot flashes, a common symptom of menopause, can be disruptive and uncomfortable, impacting daily life for many women. Paroxetine, a selective serotonin reuptake inhibitor (SSRI), has been found to reduce the frequency and severity of hot flashes in some women experiencing menopause. While originally developed as an antidepressant, paroxetine in the form of Brisdelle is prescribed at a lower dose specifically for hot flash relief.

How should this medicine be used?

Brisdelle, containing paroxetine, is typically prescribed to treat hot flashes associated with menopause. Here’s how it should be used:

• Dosage: Brisdelle is usually taken orally once daily. The recommended starting dose is 7.5 mg once daily, preferably in the evening. Depending on the individual’s response and tolerance, the dose may be increased to 15 mg once daily after four weeks. Your healthcare provider will determine the appropriate dosage for you based on your specific condition and response to treatment.
• Administration: Brisdelle can be taken with or without food. It’s generally recommended to take it at the same time each day to maintain a consistent level of the medication in your bloodstream.
• Swallowing: Swallow the Brisdelle capsule whole with water. Do not crush, chew, or break the capsule, as it may cause the medication to be released too quickly, increasing the risk of side effects.
• Consistency: Take Brisdelle exactly as prescribed by your healthcare provider. Do not adjust the dosage or stop taking the medication without consulting your doctor, even if you start to feel better. Abruptly stopping Brisdelle can lead to withdrawal symptoms.
• Missed Dose: If you miss a dose of Brisdelle, take it as soon as you remember. However, if it’s almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
• Duration: Continue taking Brisdelle for as long as prescribed by your healthcare provider, even if your hot flashes improve. Discontinuing the medication abruptly can lead to withdrawal symptoms.

Always follow the instructions provided by your healthcare provider and read the medication guide included with Brisdelle for detailed information on its use, dosage, and potential side effects. If you have any questions or concerns about how to use Brisdelle, consult your doctor or pharmacist for clarification.

Other uses for this medicine

While Brisdelle is primarily indicated for the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopause, its active ingredient, paroxetine, is also used in other forms to treat depression, anxiety disorders, and other mental health conditions. However, Brisdelle itself is not approved for these other uses.

What special precautions should I follow?

If you’re taking Brisdelle for hot flashes, it’s essential to follow specific precautions:

• Suicidal Thoughts: Antidepressants, including paroxetine in Brisdelle, carry a warning about the increased risk of suicidal thoughts or behavior, especially in young adults. It’s crucial to monitor for any changes in mood or behavior, especially when starting treatment or changing the dosage.
• Serotonin Syndrome: Brisdelle contains paroxetine, which can increase serotonin levels in the brain. Taking it with other medications that also increase serotonin levels can lead to serotonin syndrome, a potentially serious condition. Inform your healthcare provider about all medications, including over-the-counter drugs and supplements, to avoid interactions.
• Withdrawal Symptoms: Abruptly stopping Brisdelle can lead to withdrawal symptoms such as dizziness, nausea, headache, and irritability. If you need to discontinue Brisdelle, your healthcare provider may recommend tapering off the medication gradually to minimize withdrawal effects.
• Bone Health: Long-term use of selective serotonin reuptake inhibitors (SSRIs) like paroxetine may be associated with a slight increase in the risk of bone fractures, particularly in older adults. Discuss strategies to promote bone health with your healthcare provider.
• Pregnancy and Breastfeeding: Brisdelle is not approved for use during pregnancy, as it may harm the developing fetus. If you become pregnant while taking Brisdelle, inform your healthcare provider immediately. Additionally, paroxetine can pass into breast milk, so breastfeeding while taking Brisdelle is not recommended. Discuss the potential risks and benefits with your healthcare provider if you are pregnant or breastfeeding.

Always follow your healthcare provider’s instructions and read the medication guide included with Brisdelle for detailed information on precautions, warnings, and potential interactions. If you have any concerns or questions about using Brisdelle, consult your doctor or pharmacist for guidance.

What special dietary instructions should I follow?

Regarding dietary instructions for Brisdelle, there are no specific dietary restrictions. However, it’s essential to maintain a healthy and balanced diet while taking Brisdelle, as it can contribute to overall well-being and may complement the treatment of hot flashes associated with menopause.

What should I do if I forget a dose?

If you forget to take a dose of Brisdelle, take it as soon as you remember. However, if it’s almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you have any concerns or questions about missed doses, consult your healthcare provider for guidance.

What side effects can this medication cause?

Brisdelle, containing paroxetine, may cause various side effects, although not everyone experiences them. Common side effects of Brisdelle may include:

• Nausea: Feeling sick to your stomach or experiencing an urge to vomit.
• Dizziness: Feeling lightheaded or unsteady.
• Headache: Pain or discomfort in the head, ranging from mild to severe.
• Fatigue: Feeling tired, weak, or lacking energy.
• Dry Mouth: A sensation of dryness or stickiness in the mouth.
• Insomnia: Difficulty falling asleep or staying asleep.
• Sweating: Excessive sweating or changes in sweating patterns.
• Decreased Appetite: Reduced desire to eat or changes in eating habits.
• Constipation: Difficulty passing stools or infrequent bowel movements.
• Sexual Dysfunction: Changes in sexual desire, arousal, or performance.
• Weight Changes: Gain or loss of body weight.
• Abnormal Dreams: Unusual or vivid dreams during sleep.
• Anxiety: Feeling nervous, restless, or on edge.
• Tremor: Involuntary trembling or shaking of the body.
• Weakness: Feeling physically weak or lacking strength.

In addition to these common side effects, Brisdelle may also cause more serious adverse reactions in some individuals. These include:

• Serotonin Syndrome: A potentially life-threatening condition characterized by changes in mental status, agitation, hallucinations, fast heart rate, high blood pressure, fever, excessive sweating, tremor, and muscle stiffness. Seek immediate medical attention if you experience any of these symptoms while taking Brisdelle.
• Withdrawal Symptoms: Abruptly stopping Brisdelle may lead to withdrawal symptoms such as dizziness, nausea, headache, irritability, and flu-like symptoms. Your healthcare provider may recommend tapering off the medication gradually to minimize these effects.
• Hyponatremia: Low levels of sodium in the blood, which can cause symptoms like headache, confusion, weakness, and in severe cases, seizures or coma.
• Bleeding: Brisdelle may increase the risk of bleeding, especially if you are also taking other medications that affect blood clotting.
• Mania or Hypomania: Paroxetine, the active ingredient in Brisdelle, may trigger manic or hypomanic episodes in individuals with bipolar disorder.

It’s important to report any new or worsening symptoms to your healthcare provider while taking Brisdelle. If you experience severe or concerning side effects, seek medical attention promptly. Always read the medication guide provided with Brisdelle for detailed information on potential side effects and precautions.

What should I know about storage and disposal of this medication?

Storage and disposal:

Storage:

• Store Brisdelle at room temperature between 20°C to 25°C (68°F to 77°F).
• Keep it in its original container, tightly closed, and away from moisture and heat.
• Do not store Brisdelle in the bathroom or in places exposed to direct sunlight or extreme temperatures.
• Keep Brisdelle out of reach of children and pets.

Disposal:

• Dispose of any unused or expired Brisdelle properly according to local regulations or guidelines.
• Do not flush Brisdelle down the toilet or pour it down the drain unless instructed to do so.
• Consult your healthcare provider or pharmacist for instructions on how to safely dispose of Brisdelle.

In case of emergency/overdose

• In case of an overdose of Brisdelle, seek emergency medical attention or contact a poison control center immediately.
• Symptoms of overdose may include drowsiness, nausea, vomiting, tremors, sweating, rapid heartbeat, and seizures.
• If possible, provide the healthcare provider with information such as the amount of Brisdelle ingested, the time of ingestion, and any other relevant details.

What other information should I know?

• Inform your healthcare provider about all medications, including prescription drugs, over-the-counter medications, and dietary supplements, that you are taking, as they may interact with Brisdelle.
• Avoid consuming alcohol while taking Brisdelle, as it may increase the risk of side effects.
• Brisdelle may cause dizziness or drowsiness, so use caution when driving or operating machinery until you know how it affects you.
• Do not stop taking Brisdelle abruptly without consulting your healthcare provider, as it may lead to withdrawal symptoms.
• Attend all scheduled appointments with your healthcare provider for monitoring and dosage adjustments if necessary.

Always follow the instructions provided by your healthcare provider and read the medication guide included with Brisdelle for detailed information on storage, disposal, emergency procedures, and other important considerations. If you have any questions or concerns, consult your healthcare provider or pharmacist for clarification.