TONREN CAPSULES

I. Warnings and Precautions

1. This medication contains a potent drug. Use strictly according to the prescribed method and dosage.
2. If other antipyretics, analgesics, or cold medications are being used during treatment, avoid repeated use.
3. If symptoms do not improve after several applications of this medication, discontinue use immediately.
4. Chlormezanone, contained in this medication, has been reported to cause erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrosis in rare cases.
5. This medication contains Acetaminophen (Paracetamol). The following precautions should be taken:
   • Hepatotoxicity:
     • There have been cases of acute liver failure caused by the use of Acetaminophen (Paracetamol), which may lead to liver transplantation and death.

     Most cases of liver damage are caused by the use of more than 4,000 mg of Acetaminophen daily, and often involve the use of more than one medication containing Acetaminophen. Overdosing on Acetaminophen may occur in an attempt to achieve greater pain relief, or unknowingly by using other medications containing Acetaminophen simultaneously. Patients with underlying liver disease, and those who drink alcohol while using Acetaminophen, are at higher risk of acute liver failure. Healthcare professionals should advise patients, and patients should also check the labeling of medications for Acetaminophen or Paracetamol, and should not use more than one medication containing Acetaminophen simultaneously. If more than 4,000 mg of Acetaminophen is accidentally ingested in a day, even without experiencing any discomfort, immediate medical attention should be sought.
6. Concomitant use with alcohol: Acetaminophen should not be taken concurrently with alcoholic beverages, as it may cause liver damage. Chronic heavy alcohol abusers may also have an increased risk of hepatotoxicity due to excessive use of acetaminophen; this product should not be used concurrently with alcohol.

II. Important Clinical Side Effects / Adverse Reactions

1. Allergy/Anaphylactic Reactions: Post-marketing reports have documented allergic and anaphylactic reactions associated with the use of acetaminophen. Clinical manifestations include swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, itching, and vomiting. There have been rare cases of life-threatening anaphylactic reactions requiring emergency medical attention. Healthcare professionals should advise patients to discontinue use immediately and seek medical attention if these symptoms occur.

   Patients with a history of allergy to Acetaminophen should inform their healthcare provider and should never use medications containing this ingredient. Serious skin reactions: A small number of patients using Acetaminophen have been reported to experience severe and potentially fatal skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Patients should be informed of the symptoms of severe skin reactions, and should discontinue use of this medication if a rash or other allergic reaction occurs.

III. Overdose

1. Overdose of Acetaminophen may cause initial symptoms within 24 hours of ingestion, which may include: gastrointestinal upset, loss of appetite, nausea, vomiting, malaise, pallor, and sweating.
2. Single or repeated overdose of this product carries the potential for drug addiction or abuse. Consulting an appropriate specialist is recommended if possible.
3. The most serious adverse reaction to Acetaminophen overdose is fatal liver necrosis. Renal tubular necrosis, hypoglycemic coma, and coagulation disorders may also occur. Early symptoms of hepatotoxicity from overdose may include: nausea, vomiting, sweating, and general malaise. Clinical and laboratory evidence of hepatotoxicity may not be apparent until 48–72 hours after ingestion.