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The following safety information outlines important risks and precautions associated with the use of Entacapone (Comtan), particularly when combined with carbidopa/levodopa medications. It is crucial to be aware of these warnings and discuss any concerns with your healthcare provider.

• Sleepiness and Sudden Sleep Episodes: Entacapone (Comtan) may cause you to fall asleep suddenly during daily activities, even without previous drowsiness. This poses a risk of accidental injury. Exercise caution when driving or engaging in tasks requiring focus until you understand how the medication affects you. If you have a history of sleepiness or suddenly falling asleep, avoid driving and inform your healthcare provider if you experience daytime drowsiness or unexpected sleep episodes.

• Low Blood Pressure and Fainting: The combination of Entacapone (Comtan) with carbidopa/levodopa can lower blood pressure, particularly when standing up. This may result in fainting. To reduce the risk of falls, rise slowly from sitting or lying positions. Notify your provider if you experience dizziness or a significant drop in blood pressure.

• Hallucinations and Behavioral Changes: Some individuals may experience hallucinations or changes in behavior and thoughts, such as paranoia or confusion, when taking Entacapone (Comtan). These symptoms can appear shortly after beginning the medication or increasing the dose. Avoid using Entacapone (Comtan) if you have certain mental health conditions, and inform your provider of any behavioral changes.

• Impulsive Behavior: Entacapone (Comtan) may lead to impulsive behaviors, including intense urges related to gambling, spending, or sexual activity. These urges may not be immediately apparent to you, so discuss any changes with your provider who may adjust your treatment if necessary.

• Diarrhea and Colitis: Diarrhea is a possible side effect of Entacapone (Comtan), and in some cases, it may indicate colitis, an inflammation of the colon. Severe diarrhea can lead to dehydration and low potassium levels. Drink plenty of fluids and contact your provider if you experience persistent or severe diarrhea or symptoms of dehydration.

• Muscle Damage (Rhabdomyolysis): Severe muscle damage, known as rhabdomyolysis, has been reported with Entacapone (Comtan). This can potentially cause kidney damage. Report any muscle pain, weakness, dark urine, or unusual muscle symptoms to your healthcare provider immediately.

• Neuroleptic Malignant Syndrome (NMS): Though rare, a serious condition known as NMS may occur, characterized by high fever, muscle rigidity, and confusion, often when the medication is abruptly stopped or the dose is reduced. Seek medical attention immediately if these symptoms develop.

• Interactions with Other Medications: Entacapone (Comtan) can prolong the presence of certain medications like apomorphine and epinephrine in the body, potentially increasing side effects such as rapid heart rate and blood pressure changes. Discuss all medications you are taking with your healthcare provider to manage these risks effectively.

Common side effects:

• Nausea
• Vomiting
• Diarrhea
• Involuntary movements
• Increased sweating
• Tiredness
• Dry mouth
• Gas
• Abdominal pain
• Dizziness
• Lightheadedness

Less common but important to monitor:

• Falling asleep suddenly during everyday activities
• Persistent diarrhea
• Significant mood or mental changes like confusion or hallucinations
• Severe fever
• Muscle stiffness
• Unusual urges like increased gambling
• Easy bruising
• Muscle pain
• Difficulty breathing

Serious side effects:

• Severe allergic reaction
• Neuroleptic Malignant Syndrome
• Rhabdomyolysis

Interactions with high risk of serious adverse effects and should be avoided:

• Isocarboxazid
• Linezolid
• Methylene Blue
• Phenelzine
• Procarbazine
• Tranylcypromine
• Furazolidone
• Iproniazid
• Nialamide
• Pargyline

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Apomorphine
• Dobutamine
• Methyldopa
• Bitolterol
• Desipramine
• Dopamine
• Epinephrine
• Fluvastatin
• Glimepiride
• Glipizide
• Glyburide
• Irbesartan
• Isoetharine
• Isoproterenol
• Losartan
• Metoclopramide
• Nateglinide
• Norepinephrine
• Rosiglitazone
• Tolbutamide
• Venlafaxine
• Voriconazole
• Warfarin

Interactions with low risk that usually do not require a change in therapy:

• Alcohol
• Marijuana (cannabis)
• Cetirizine
• Diphenhydramine
• Alprazolam
• Diazepam
• Zolpidem
• Codeine