Stalevo 125 Tablets
It is used to treat Parkinson's disease.
Drug Class
Anti-Parkinsonian Agents
Pharmacologic Class
Dopamine precursor; DOPA decarboxylase inhibitor; COMT inhibitor
Pregnancy Category
Category C
FDA Approved
Jun 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Stalevo is a medication used to treat Parkinson's disease. It combines three medicines: levodopa, carbidopa, and entacapone. Levodopa helps replace a natural substance in your brain called dopamine, which is low in Parkinson's disease. Carbidopa helps more levodopa get to your brain and reduces side effects. Entacapone helps levodopa work longer by preventing its breakdown. Together, these medicines help improve your movement, stiffness, and tremors.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it.
If you take an iron supplement or a multivitamin that contains iron, consult your doctor or pharmacist about how to take it with this medication. Iron may interfere with your body's ability to absorb this medication properly.
Your diet may also affect how well your body absorbs this medication. Diets high in protein, fat, or calories, as well as acidic foods, may reduce absorption. Discuss your diet with your doctor, especially if you plan to make any changes.
Do not stop taking this medication suddenly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to taper off gradually.
Continue taking this medication even when you are not experiencing symptoms. Keeping a diary of your symptoms can be helpful in tracking your progress. Take this medication at the same time every day, as directed by your doctor or healthcare provider, even if you feel well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it.
If you take an iron supplement or a multivitamin that contains iron, consult your doctor or pharmacist about how to take it with this medication. Iron may interfere with your body's ability to absorb this medication properly.
Your diet may also affect how well your body absorbs this medication. Diets high in protein, fat, or calories, as well as acidic foods, may reduce absorption. Discuss your diet with your doctor, especially if you plan to make any changes.
Do not stop taking this medication suddenly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to taper off gradually.
Continue taking this medication even when you are not experiencing symptoms. Keeping a diary of your symptoms can be helpful in tracking your progress. Take this medication at the same time every day, as directed by your doctor or healthcare provider, even if you feel well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take Stalevo exactly as prescribed by your doctor. Do not take more or less than directed.
- Do not stop taking Stalevo suddenly, as this can lead to serious side effects, including a condition similar to neuroleptic malignant syndrome.
- Take Stalevo with or without food. If you experience stomach upset, taking it with a small amount of food (not high in protein) may help. Avoid high-protein meals close to your dose, as protein can interfere with absorption.
- Your urine, sweat, or saliva may turn dark (red, brown, or black). This is a harmless side effect due to entacapone.
- Be aware of potential sudden sleep attacks or drowsiness. Avoid driving or operating machinery if you experience these.
- Monitor for and report any new or worsening unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating).
- Stand up slowly to avoid dizziness or lightheadedness due to a drop in blood pressure (orthostatic hypotension).
- Stay hydrated to help prevent constipation and orthostatic hypotension.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized, based on levodopa requirements. Stalevo 125 contains 125 mg levodopa, 31.25 mg carbidopa, and 200 mg entacapone. Max 8 tablets/day (1600 mg entacapone).
Dose Range:
1 - 8 mg
Condition-Specific Dosing:
Parkinson's Disease:
Typically, one tablet per dose, with a maximum of 8 tablets per day. Dosing frequency is determined by the patient's response and levodopa requirements. Should replace current levodopa/carbidopa and entacapone doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor for adverse effects.
Moderate:
No specific adjustment recommended, but monitor for adverse effects.
Severe:
Use with caution; monitor for adverse effects, especially with entacapone accumulation. Dose reduction may be necessary.
Dialysis:
Use with caution; entacapone is highly protein-bound and not significantly removed by dialysis. Monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended, but monitor for adverse effects.
Moderate:
Use with caution; entacapone exposure is significantly increased. Consider dose reduction or increased dosing interval.
Severe:
Contraindicated or not recommended due to significantly increased entacapone exposure and potential for hepatotoxicity.
Confidence:
Medium
Pharmacology
Mechanism of Action
Stalevo combines three active ingredients: Levodopa, Carbidopa, and Entacapone. Levodopa is a metabolic precursor of dopamine that crosses the blood-brain barrier and is converted to dopamine in the brain, alleviating Parkinsonian symptoms. Carbidopa is an aromatic L-amino acid decarboxylase inhibitor that does not cross the blood-brain barrier. It inhibits the peripheral conversion of levodopa to dopamine, thereby increasing the amount of levodopa available to the brain and reducing peripheral side effects. Entacapone is a selective and reversible catechol-O-methyltransferase (COMT) inhibitor. It acts peripherally to prevent the breakdown of levodopa by COMT, prolonging the half-life of levodopa and increasing its bioavailability to the brain, leading to more sustained dopaminergic stimulation.
Pharmacokinetics
Absorption:
Bioavailability:
Levodopa: ~30% (highly variable); Carbidopa: ~40-70%; Entacapone: ~35%
Tmax:
Levodopa: ~0.5-2 hours; Carbidopa: ~1-2 hours; Entacapone: ~1 hour
FoodEffect:
Food (especially high-protein meals) can delay and decrease the absorption of levodopa. Entacapone absorption is not significantly affected by food.
Distribution:
Vd:
Levodopa: ~0.5-1 L/kg; Entacapone: ~20 L
ProteinBinding:
Levodopa: Low; Carbidopa: ~36%; Entacapone: >98% (primarily to albumin)
CnssPenetration:
Levodopa: Yes; Carbidopa: No; Entacapone: Limited
Elimination:
HalfLife:
Levodopa: ~1-2 hours (prolonged with carbidopa and entacapone); Carbidopa: ~2-3 hours; Entacapone: ~0.4-0.7 hours
Clearance:
Not available
ExcretionRoute:
Levodopa: Primarily renal; Carbidopa: Primarily renal; Entacapone: Primarily fecal (90%), renal (10%)
Unchanged:
Levodopa: <1% (renal); Entacapone: ~10% (renal)
Pharmacodynamics
OnsetOfAction:
Levodopa effect: ~30-60 minutes
PeakEffect:
Levodopa effect: ~1-2 hours
DurationOfAction:
Levodopa effect: ~3-5 hours (can be shorter in advanced disease, entacapone helps prolong this)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening behavior or mood changes, including:
+ Depression
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there)
Severe dizziness or fainting
Confusion
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
Muscle pain or weakness, dark urine, or difficulty urinating
A new skin lump or growth
Changes in the color or size of a mole
Strong, uncontrollable urges (such as eating, gambling, sex, or spending money)
New or worsening trouble controlling body movements
Chest pain or pressure
Shortness of breath
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Sudden, unexplained sleepiness, especially during activities like driving, eating, or talking
If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience this side effect or feel extremely sleepy.
Neuroleptic Malignant Syndrome (NMS): This is a rare but potentially life-threatening condition that can occur when this medication is stopped suddenly or the dose is lowered. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Changes in thinking
Fast or irregular heartbeat
Excessive sweating
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness
Sleepiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dry mouth
Headache
Trouble sleeping
* Back pain
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening behavior or mood changes, including:
+ Depression
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there)
Severe dizziness or fainting
Confusion
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
Muscle pain or weakness, dark urine, or difficulty urinating
A new skin lump or growth
Changes in the color or size of a mole
Strong, uncontrollable urges (such as eating, gambling, sex, or spending money)
New or worsening trouble controlling body movements
Chest pain or pressure
Shortness of breath
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Sudden, unexplained sleepiness, especially during activities like driving, eating, or talking
If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience this side effect or feel extremely sleepy.
Neuroleptic Malignant Syndrome (NMS): This is a rare but potentially life-threatening condition that can occur when this medication is stopped suddenly or the dose is lowered. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Changes in thinking
Fast or irregular heartbeat
Excessive sweating
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness
Sleepiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dry mouth
Headache
Trouble sleeping
* Back pain
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent diarrhea (especially if accompanied by muscle pain or dark urine)
- New or worsening involuntary movements (dyskinesia)
- Hallucinations or delusions
- Sudden onset of sleep or extreme drowsiness
- Unusual urges or behaviors (e.g., compulsive gambling, hypersexuality)
- Severe dizziness or fainting
- Unexplained muscle pain, tenderness, or weakness (especially with fever or dark urine)
- Signs of liver problems (e.g., persistent nausea/vomiting, yellowing of skin/eyes, dark urine, severe stomach pain)
- Neuroleptic malignant syndrome-like symptoms (e.g., fever, severe muscle stiffness, confusion, sweating, fast or irregular heartbeat) if medication is stopped abruptly.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Glaucoma
+ Skin lumps or growths
+ A history of skin cancer
* If you have taken specific antidepressant medications, such as isocarboxazid, phenelzine, or tranylcypromine, within the last 14 days. Taking this medication within 14 days of these drugs can lead to severe high blood pressure.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Glaucoma
+ Skin lumps or growths
+ A history of skin cancer
* If you have taken specific antidepressant medications, such as isocarboxazid, phenelzine, or tranylcypromine, within the last 14 days. Taking this medication within 14 days of these drugs can lead to severe high blood pressure.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to stay alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution when climbing stairs.
Regular blood tests and other laboratory assessments, as directed by your doctor, are crucial to monitor your condition. Be aware that this medication may interfere with certain lab tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this medication.
You may experience a decrease in the medication's effectiveness as the time approaches for your next dose. If this occurs and causes you concern, discuss it with your doctor. It may take several months to achieve the full therapeutic effect of this medication.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.
You may notice a dark discoloration (red, brown, or black) in your saliva, urine, or sweat, which is harmless but may stain your clothing.
If you experience diarrhea or vomiting, consult your doctor promptly to prevent dehydration and electrolyte imbalances.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to you and your baby.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to stay alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution when climbing stairs.
Regular blood tests and other laboratory assessments, as directed by your doctor, are crucial to monitor your condition. Be aware that this medication may interfere with certain lab tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this medication.
You may experience a decrease in the medication's effectiveness as the time approaches for your next dose. If this occurs and causes you concern, discuss it with your doctor. It may take several months to achieve the full therapeutic effect of this medication.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.
You may notice a dark discoloration (red, brown, or black) in your saliva, urine, or sweat, which is harmless but may stain your clothing.
If you experience diarrhea or vomiting, consult your doctor promptly to prevent dehydration and electrolyte imbalances.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Severe dyskinesia (involuntary movements)
- Agitation, confusion, hallucinations
- Orthostatic hypotension
- Tachycardia, arrhythmias
- Nausea, vomiting
- Muscle rigidity
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management is supportive, including gastric lavage, IV fluids, and careful monitoring of vital signs and cardiac rhythm. Antiarrhythmics may be needed for cardiac arrhythmias.
Drug Interactions
Contraindicated Interactions
- Non-selective monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine) - risk of hypertensive crisis. Must be discontinued at least 2 weeks prior to Stalevo initiation.
Major Interactions
- Antipsychotics (e.g., haloperidol, chlorpromazine, risperidone, olanzapine) - may antagonize the effects of levodopa.
- Iron salts (ferrous sulfate, gluconate) - can chelate levodopa and carbidopa, reducing absorption. Administer at least 2-3 hours apart.
- Metoclopramide - may antagonize the effects of levodopa due to dopamine receptor blockade.
- High-protein diet - can reduce levodopa absorption and transport across the blood-brain barrier.
Moderate Interactions
- Tricyclic antidepressants (TCAs) - may increase the risk of orthostatic hypotension and hypertension.
- Antihypertensives - increased risk of orthostatic hypotension.
- Other COMT inhibitors (e.g., tolcapone) - concurrent use is not recommended.
- Dopamine D2 receptor antagonists (e.g., domperidone) - may reduce levodopa efficacy.
- Sympathomimetics (e.g., epinephrine, norepinephrine, isoproterenol) - increased risk of arrhythmias and hypertension.
Minor Interactions
- Antacids - may increase entacapone absorption slightly.
Monitoring
Baseline Monitoring
Neurological examination
Rationale: To establish baseline motor function, assess Parkinsonian symptoms, and identify any pre-existing dyskinesias or psychiatric symptoms.
Timing: Prior to initiation of therapy
Blood pressure (supine and standing)
Rationale: To establish baseline and assess for orthostatic hypotension, a common side effect.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, bilirubin)
Rationale: Entacapone can cause liver enzyme elevations, though rare. Baseline assessment is important.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC)
Rationale: To assess for baseline hematologic parameters; rare cases of hemolytic anemia have been reported with levodopa.
Timing: Prior to initiation of therapy
Routine Monitoring
Neurological status (motor fluctuations, dyskinesia, 'wearing-off')
Frequency: Regularly, at each follow-up visit (e.g., every 1-3 months initially, then every 3-6 months)
Target: Optimal symptom control with minimal dyskinesia or 'off' time
Action Threshold: Significant increase in 'off' time, new or worsening dyskinesia, or other motor complications warrant dose adjustment or re-evaluation.
Blood pressure (supine and standing)
Frequency: Regularly, at each follow-up visit
Target: Within patient's normal range, without symptomatic orthostatic hypotension
Action Threshold: Symptomatic orthostatic hypotension (e.g., dizziness, syncope) or significant drop (>20 mmHg systolic, >10 mmHg diastolic) upon standing warrants intervention.
Mental status and psychiatric symptoms (hallucinations, delusions, impulse control disorders)
Frequency: Regularly, at each follow-up visit
Target: Absence of new or worsening psychiatric symptoms
Action Threshold: Emergence of new or worsening psychiatric symptoms requires immediate evaluation and potential dose adjustment or medication change.
Liver function tests (ALT, AST)
Frequency: Periodically, especially if symptoms of hepatic dysfunction occur or if patient is on high doses of entacapone. Some guidelines suggest every 6-12 months.
Target: Within normal limits
Action Threshold: Significant elevation (e.g., >3x ULN) warrants discontinuation or dose reduction and further investigation.
Symptom Monitoring
- Dyskinesia (involuntary movements)
- Nausea and vomiting
- Orthostatic hypotension (dizziness upon standing)
- Hallucinations or delusions
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Diarrhea (can be severe and persistent with entacapone)
- Sleep attacks or sudden onset of sleep
- Dark discoloration of urine, sweat, or saliva
- Muscle pain, tenderness, or weakness (signs of rhabdomyolysis, rare but serious)
- Changes in mood or behavior
Special Patient Groups
Pregnancy
Category C. Stalevo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies.
Second Trimester:
Potential for developmental toxicity observed in animal studies.
Third Trimester:
Potential for developmental toxicity observed in animal studies; may affect uterine contractility.
Lactation
Levodopa is excreted into breast milk and may inhibit lactation. Entacapone is also excreted into breast milk in animals. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Moderate risk (L3). Potential for inhibition of lactation, and unknown effects of levodopa, carbidopa, and entacapone on the infant. Monitor for drowsiness, poor feeding, or unusual movements.
Pediatric Use
The safety and effectiveness of Stalevo in pediatric patients have not been established. Use is not recommended in this population.
Geriatric Use
No specific dose adjustment is generally required based solely on age. However, elderly patients may be more sensitive to the central nervous system and cardiovascular side effects (e.g., orthostatic hypotension, hallucinations, dyskinesia) of levodopa/carbidopa/entacapone. Close monitoring and careful titration are recommended.
Clinical Information
Clinical Pearls
- Stalevo is a fixed-dose combination; dose adjustments must consider the individual components, especially the levodopa dose.
- Patients should be warned about the potential for sudden onset of sleep and impulse control disorders.
- Discontinuation of Stalevo should be gradual to avoid a neuroleptic malignant syndrome-like symptom complex.
- Inform patients that urine, sweat, and saliva may turn dark (reddish-brown to black) due to entacapone metabolites; this is harmless.
- Severe, persistent diarrhea can occur with entacapone and may be a sign of colitis; patients should report this immediately.
- Avoid concomitant use with non-selective MAO inhibitors due to the risk of hypertensive crisis.
Alternative Therapies
- Dopamine agonists (e.g., pramipexole, ropinirole, rotigotine, apomorphine)
- MAO-B inhibitors (e.g., rasagiline, selegiline, safinamide)
- Amantadine
- COMT inhibitors (e.g., tolcapone - rarely used due to hepatotoxicity risk, opicapone)
- Adenosine A2A receptor antagonists (e.g., istradefylline)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$800+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about this medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.