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OTC - Tydol - Analgesics - Tydol Codein

COMPOSITION:

Active ingredients:

Acetaminophen 500 mg

Codeine phosphate 8 mg

Other ingredients: Pregelatinized starch, colloidal anhydrous silica, maize starch, sodium starch glycolate, povidone K30, magnesium stearate, methylparaben, gelatine, talc, opadry yellow, opadry II white.


ACTION AND PROPERTIES:

Pain reliever.


INDICATIONS:

– Acetaminophen and Codeine combination is used to relief of moderate to severe pain, such as: cancer pain, bone pain, headache, body ache, myalgias, neuralgias, toothache, low back pain.


ADMINISTRATION AND DOSAGE:        

Adults and children over the age of 12 years: take 1 caplet, every 4-6 hours/day.

Children 6 to 12 years: take ½ caplet, every 4 – 6 hours/day.


CONTRAINDICATIONS:

  • Allergic to components of this product.
  • Respiratory depression, anemia, cardiac disease, pulmonary disease, G6PD deficiency.
  • Severe liver failure and/or renal failure.
  • Pregnancy and lactation.

WARNINGS AND PRECAUTIONS:

  • Do not use this product for children under 6 years.
  • Should not be used with other products containing Acetaminophen.
  • Prolonged use and high dose of Acetaminophen may cause hepatocellular impairment.
  • Use with caution when driving vehicle or operating machinery because this product may cause drowsiness.
  • Caution for respiratory disease such as bronchial asthma. People with a history of drug.

SIDE EFFECTS:

  • Frequently: Nausea, vomiting, constipation, drowsiness, vertigo, palpitations, orthostatic hypotension.
  • Rarely: Allergy, leukopenia, anemia, respiratory depression.

In case of an unexpected reaction, consult your physician.


INTERACTION:

  • Antacids can delay and decrease the oral absorption of Acetaminophen.
  • The activity of this product is influenced by concurrent administration of Barbiturate, depressants, Carbamazepine and Phenytoin.
  • Concomitant use of this medicine with other opiate derivatives (e.g. cough suppression, pain relief) may cause respiratory depression.
  • Interaction with anticonvulsant, isoniazide, alcohol (developing hepatotoxicity), quinidine may lose codeine indications. Drugs can reduce cyclosporine metabolism by cytochrome P450 inhibitors codeine

 


OVERDOSE:

Symptoms of Acetaminophen overdosage in the first 24 hours are nausea, vomitting, anoresia, pallor, abdominal pain.

Acetaminophen overdose can lead to liver failure. Overdose, Acetaminophen 10g or more in a single admistration in adults and 150 mg/kg of bodyweighht in a single administration in children, cause hepatic cytolysis to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma or death.

Treatment for overdosage

Immediate treatment is essential in the management of Acetaminophen overdose. When infected with severe poisoning, it is important to treat actively support. Gastric lavage is used in all cases, the best within 4 hours after drinking. In most cases, N-acetylcysteine, will be given by mouth or IV (through the vein) as an antidote.

Symptoms of codeine phosphate overdose : respiratory depression, drowsiness lead to glassy or coma.  Soft muscle, cold skin and moist, sometimes slow vascular and hypotension. In severe cases: stop breathing, vascular collapse, cardiac arrest and possibly death

Treatment for overdosage: To respiratory rehabilitation by providing oxygen and respiratory assistance control. Naloxon is indicated intravenous immediately in case of heavy.


PRESENTATION:

  • Box of 10 blisters x 10 film coated caplets.
  • Box of 1 bottle x 100 film coated caplets.

STORAGE: Store at temperature from 15oC to 30oC.

SHELF-LIFE: 48 months. Do not use after expiry date.

QUALITY SPECIFICATION: Manufacturer’s.