SUN LINIMENT

FORMULA:

For 1 bottle
Active pharmaceutical ingredients:
Bottle 20 ml / Bottle 60 ml
   Methyl salicylat 6.21 g / 18.63 g
   Camphor 2.10 g / 6.3 g
   Oleum Cinnamomi 0.11 g / 0.33 g
   Oleum Menthae arvensis 2.48 g / 7.44 g
   Rhizoma Zingiberis 0.63 g / 1.89 g
Excipients: Paraffin oil, ethanol 96%.

DOSAGE FORM:

Topical oil solutions: Yellow to yellowy orange liquid, characteristic aroma.

INDICATIONS:

Massage topically on the affected skin in cases of aches and pains, rheumatism, lumbago, cold, flu.

DOSAGE AND ADMINISTRATION:

Apply about 2 – 5 ml and massage topically on the affected skin 2 – 4 times per day or massage for treatment of cough and cold.

Or follow doctor’s instructions.

CONTRAINDICATIONS:

Under-30-month-old children, children having history of epilepsy or seizure because of high fever.

Pregnant women.

Apply to eye, breast when breast feeding, open wound.

Patents with hypersensitivity to any ingredient of the medicine.

PRECAUTIONS:

Precaution when using for breast-feeding women.

Stop using if having irritation.

Avoid applying to eye, sensitive skin.

Keep out of the reach of children.

Avoid smoking.

PREGNANT WOMEN AND LACTATING WOMEN:

Pregnant women: Do not use.

Lactating women: Use with precautions.

DRIVING AND OPERATING MACHINE ABILITY:

Not reported yet.

DRUGS INTERACTIONS, DRUGS INCOMPATIBILITIES:

a) Drugs interactions:

Not reported yet.

b) Drugs incompatibilities:

Because there has not been any studies about incompatibilities of the drug, do not mix with other drugs.

UNDESIRABLE EFFECTS:

Topical irritation, dermatitis, skin allergy (itch or red skin) may happened.

Limited use for thin skin and it should not be spread immediately after use. Stop using immediately when there is any undesirable effects.

Inform the doctor immediately if any undesirable effect occurs while using this medicine

OVERDOSE AND TREATMENT OF OVERDOSE:

Methyl salicylate:

Common symptoms include: vomit, dehydration, tinnitus, dizziness, deafness, sweating, rapid breath and increased ventilation. Disorders of acid-base balance may occur in almost cases.

Mixed metabolic acidosis and respiratory alkalosis with normal or high arterial blood pH (normal or declined concentration of H+) may occur in adults and above-4-year-old children. 4-year-old or younger children have mostly metabolic acidosis with low arterial blood pH (increased concentration of H+). Acidosis may elevate the amount of salicylate crossing the blood-brain barrier.

Rare symptoms include: vomiting blood, fever, low blood sugar, hypokalemia, low platelet count, increasing INT/PTR, blood clots, kidney failure and non-heart-related pulmonary edema.

Symptoms on the central nervous system: confusion, disorientation, coma and seizure occur less frequently in adult than children.

Treatment: Take activated charcoal if swallow a significant amount of methyl salicylate within 1 hour after poisoning. Concentration of plasma salicylate should be monitored.

Excretion of salicylate increases when alkelizing urine, may be gained after using 1,26% sodium bicarbonate. Urine pH should be monitored. Metabolic alkalosis could be treated by intravenous infusion 8.4% sodium bicarbonate (test for blood potassium levels firstly). Forced diuresis should not be used because of not facilitating excretion of salicylate but causes pulmonary edema.

Dialysis is the choice for severe poisoning and should be considered when salicylate concentration in plasma is greater than 700 mg/L (5.1 mmol/L), or low but there are serious clinical symptoms or serious metabolic characteristics. Under 10 years old or about 70 years old patents get higher risk of salicylat poisoning and could ask for dialysis in the early state.

Camphor:

Swallow or overdose could lead to camphor poisoning, symptoms including: vomiting, epigastric pain, dizziness, burning throat, delirium, myoclonic, epileptic seizure, inhibition of the central nervous system and coma. May occur dyspnoea, specific breath smell, anuria, death because of respiratory failure or epileptic condition, children mortality when using dose of above 1 g has been reported.

Treatment: Supportive care including prevention of seizure is the principal therapy for treating camphor poisoning, gastric suction could be considered for the patents being poisoned within 1 hour, seizure condition must be controlled firstly. Oral activated charcoal could be used.

PRESENTATION:

Box of 1 bottle of 20 ml.

Box of 1 bottle of 60 ml.

STORAGE:

In a cool and dry place, temperature below 30°C.

SHELF LIFE:

36 months from manufacturing date.

SPECIFICATION:

Manufacturer’s.

MANUFACTURER RESPONSIBLE FOR THE GOODS:

OPC Pharmaceutical Joint Stock Company (1017 Hong Bang, Ward 12, District 6, Ho Chi Minh City).

MADE IN VIETNAM.