Entacom (Comtan) 200mg – 100 tablet

Entacapone Information

What is this drug used for?

• It is used to treat Parkinson’s disease.

Possible side effects

Entacapone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Feeling tired or weak.
• Dizziness.
• Belly pain.
• Constipation.
• Upset stomach or throwing up.
• Diarrhea.
• Dry mouth.

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• Signs of an allergic reaction, like 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; or swelling of the mouth, face, lips, tongue, or throat.
• Severe diarrhea.
• Diarrhea that will not go away.
• Very bad belly pain.
• Very bad dizziness or passing out.
• Muscle pain or weakness.
• Muscle stiffness.
• Feeling confused.
• Fever.
• Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
• Trouble controlling body movements that is new or worse.
• Shortness of breath.
• Hallucinations (seeing or hearing things that are not there).
• Mood changes.
• Change in the way you act.
• A skin lump or growth.
• Change in color or size of a mole.
• Some people have fallen asleep during activities like driving, eating, or talking. Some people did not feel sleepy and felt alert right before falling asleep. This has happened up to 1 year after this drug was started. If you fall asleep during activities, do not drive or do other tasks or actions that call for you to be alert while you take this drug. Call your doctor right away if this happens or you feel very sleepy.
• If you are having diarrhea, call your doctor right away if you have signs of dehydration like dry skin, dry mouth, dry eyes, thirst, fast heartbeat, dizziness, fast breathing, or confusion; signs of low potassium levels like muscle pain or weakness, muscle cramps, or an abnormal heartbeat; or weight loss.

Storage and Stability

Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Adverse Reactions

>10%:

Gastrointestinal: Nausea (14%)

Neuromuscular & skeletal: Dyskinesia (25%)

1% to 10%:

Cardiovascular: Syncope (1%)

Central nervous system: Dizziness (8%), fatigue (6%), anxiety (2%), drowsiness (2%), agitation (1%), hallucination (≤1%)

Dermatologic: Diaphoresis (increased; 2%)

Gastrointestinal: Diarrhea (10%), abdominal pain (8%), constipation (6%), vomiting (4%), xerostomia (3%), dyspepsia (2%), flatulence (2%), dysgeusia (1%), gastritis (1%), gastrointestinal disease (1%)

Genitourinary: Urine discoloration (brown-orange; 10%)

Hematologic & oncologic: Purpura (2%)

Infection: Bacterial infection (1%)

Neuromuscular & skeletal: Hyperkinesia (10%), hypokinesia (9%), back pain (2% to 4%), weakness (2%)

Respiratory: Dyspnea (3%)

<1%, postmarketing, and/or case reports: Behavioral changes (including psychotic-like behavior), hepatitis (mainly cholestatic features), impulse control disorder (eg, pathological gambling, hypersexuality, spending money), mental status changes, neurological signs and symptoms (hyperpyrexia and confusion [resembling neuroleptic malignant syndrome]), orthostatic hypotension, pulmonary fibrosis, retroperitoneal fibrosis, rhabdomyolysis, sudden onset of sleep –