Avogesic Cream indicated for the local treatment of muscular and tendino-ligamentous pains.

Posology
Adults (including the elderly) and children 6 years and over:
For cutaneous use. Apply three times daily to the affected area, massaging until cream is fully absorbed.
Children under 6 years:
Not recommended.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. should not be used if the surface of the skin is broken. Avogesic should not be used by children who have a history of convulsions. Hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (including when taken by mouth) especially where associated with a history of asthma.

Consult your doctor before use if you are pregnant, breastfeeding, asthmatic or on any other medicines.
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For external use only. Not to be used on broken skin. Avoid contact with eyes and sensitive areas of the skin. Always try on a small area first. Always use sparingly.
Some people may experience discomfort, particularly those with sensitive skin or if used in hot weather/after a hot bath. Temporary skin redness/burning sensation may occur. Discontinue use if excessive irritation or unwanted effects occur. Not to be used on children under 6 years of age. If symptoms persist consult your doctor. Keep all medicines out of the sight and reach of children.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin. It is therefore advisable that caution should be exercised with patients who are on coumarin anticoagulants.
Salicylates (as NSAIDs) may increase blood levels and therefore toxicity of methotrexate by delaying its excretion.

Pregnancy
There is inadequate evidence of safety in human pregnancy, Avogesic should not be used in pregnancy unless there is no safer alternative.
Breast-feeding
Not recommended

Not applicable.

Temporary skin reactions (redness, burning sensation and rashes) may occur.
To Report any side effects:
Saudi Arabia:
The National Pharmacovigilance Centre (NPC)
o SFDA call center: 19999
o E-mail: npc.drug@sfda.gov.sa
o Website: https://ade.sfda.gov.sa
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Other GCC States:
- Please contact the relevant competent authority

Overdose is unlikely when used as recommended. If applied to a large area of skin, or in the unlikely event of oral ingestion, the product may cause systemic adverse effects depending on the amount absorbed.
Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
Symptoms
Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.

Management
Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
If used to excess by elderly patients, there is a risk of terpene-related agitation and confusion

Diethylamine salicylate is a topical analgesic, with the anti-inflammatory properties of salicylates.

After topical application small amounts of salicylic acid are detectable in the plasma. Elimination in the urine occurs over a period of 48 hours.

Not applicable

Ethylene Glycol Monostearate (Jeechem EGMS), Glyceryl Monostearate (Cutina GMS), Triethanolamine 99%, Stearic Acid, Vaseline, Paraffin Oil, Microcrystalline Wax, Sodium Sulfite Anhydrous, Lavender Oil and Purified Water

Not known

Unopened tube: 24 monthsAfter first opening of the tube: 30 days

Store below 30°C.

Avogesic is white to off-white smooth homogenous cream.
Avogesic cream is available in 30g aluminum tube

-Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
-Wash hands well after use.