TT-KIDS

CONTRAINDICATION:

• Patients hypersensitive to ingredients of drug.
• Patients with severe liver failure, glaucoma, urinary retention due to urethral disorder, prostate, anemia or have heart disease, lung, kidney.
• Patients with glucose-6-phosphate dehydrogenase deficiency disease.
• Not for breastfeeding, infants, and premature babies.

DOSAGE AND ADMINISTRATION:

• Dissolve one sachet in water, at least 4-6 hours between each dose.
• Kids from 2-3 years old: 1/3 sachet/time.
• Kids from 4-5 years old: 1/2 sachet/time.
• Kids from 6-8 years old: 1 sachet/time.
• Kids from 9-11 years old: 1-1.5 sachet/time
• Adult and kids above 11 years old: 1-2 sachets/time

Notice:

• Do not use product continuously for 7 days without the consultation of a doctor or physician.
• Do not use for self-treatment of pain or fever longer than 10 days in adults and 5 days or high fever (≥ 39.5°C) lasting more than 3 days in children unless indicated by a doctor or medical healthcare because long-lasting pain and fever can be symptoms of other diseases that need serious diagnosis.
• Follow the instruction of a doctor or physician.

PRECAUTION:

• Paracetamol is relatively non-toxic with therapeutic doses. However, due to urinary phenylepton patient or person who has to limit the amount of phenylalanine intake, should avoid use of paracetamol powder with drug containing aspartame. Caution in use at patients having prehistory of anemia, liver and kidney failure, intake of alcohol drinks or wine can increase the toxic of paracetamol to liver, therefore patients should avoid alcohol and wine during use.
• Chlorpheniramine maleate can increase the potency of urinary retention, especially in especially in people with prostatic hypertrophy, obstruction of the urinary tract, duodenal structure, and aggravated in the muscular dystrophy. Caution when used at people having glaucoma, urethral stricture, asthma, or other sedatives product. Caution in use with vehicle driving or operating machine as it can influence alertness.
• Some adverse effects of taking paracetamol should be warning about rash or other serious conditions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, Acute Rhinitis Allergy.
• This product contains Aspartame.

USE IN PREGNANCY AND LACTATION WOMEN:

• Pregnancy: use only in necessary situations. Use Chlorpheniramine maleate in 3 months of pregnancy can cause serious reaction to fetus; never use in infant.

Lactation woman: use with careful consideration: do not use product or not breastfeed during use of product, depend on the necessity of drug to mother.
Consult doctor or physician carefully before use.

DRIVING AND OPERATING MACHINE:
Use with caution when driving or operating machine.

DRUG INTERACTION:
Intake of paracetamol in long time and high dose slightly increases the anticoagulant effect of coumarin and indandion derivatives. Use product together with phenothiazine and heat-reduction therapy can lead to severe heat-reduction consequence. Anticonvulsants (phenytoin, barbiturate, carbamazepine), isoniazid, and anti-tubercular drugs may increase the toxicity to the paracetamol to liver. Excessive and long-term drinking may increase the risk of paracetamol poisoning to the liver. Cholestyramine reduces paracetamol absorption (not drinking within 1 hour).

ADVERSE DRUG REACTION:
Relate to paracetamol:

• Rarely, 1/1,000 <ADR <1/100
  • Skin: rash. Gastrointestinal: nausea, vomiting. Hematology: hematopoietic disorders (thrombopenia, reduction of whole blood cells, neutropenia), anemia. Renal: Kidney disease, kidney toxicity in long-term abuse.
• Rarely, ADR <1/1,000
  • Skin: Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell’s syndrome, acute onset epiglottitis. Other: hypersensitivity reaction.

Unwanted effects are reported at frequencies (1 to 10%), very common (≥ 10%). The incidence of other side effects after delivery to the market has not been documented.

• Very common:
  • Central nervous system: drowsiness, sleepiness.
• Frequent:
  • CNS: attention deficit disorder, dizziness, headache. Gastrointestinal: nausea, dry mouth. Vision: blurred vision. Other: tired.
• Unknown frequency:
  • Blood and lymphatic system: hemoptysis, hemolytic anemia. Immune system: allergy, angioedema, sensitive shock. Metabolism and nutrition: hypokalemia. Mental illness: dizziness, irritability, irritability, nightmare, depression. For hearing and inner ear: tinnitus. Cardiovascular system: tachycardia, arrhythmias. Blood vessels: low blood pressure. Respiratory, thoracic, mediastinal: increased bronchial secretion. Gastrointestinal disorders: vomiting, abdominal pain, diarrhea, dyspepsia. Liver: hepatitis, disease. Skin and subcutaneous tissue: dermatitis, rash, urticaria, sensitive skin. Musculoskeletal and connective tissue: muscle pain, muscle weakness. Renal and urinary: Urinary retention. Other: chest pain
    Caution: Children and adults with undesirable side effects are more likely to be associated with cholinergic blockade and back stimulation (eg restlessness, anxiety).
    Inform your doctor if any of the side effects occur when using the medicine.

STORAGE:
Dry and cool place, below 30°C, protect from light and moisture.

SHELF LIFE: 36 months since manufacture date.

STANDARD: In house

PRESCRIPTION DRUG ONLY
Keep out of reach of children, read usage instructions carefully before use.
Consult physician or pharmacist for more information.

Developed by: Audace Pharma Co., Ltd