4.1. Therapeutic indications

For the treatment of hyperkeratotic and scaling conditions such as psoriasis.

4.2. Posology and method of administration

Topical.

Recommended dose and dosage schedule

Adults, children and the elderly: apply twice daily to the affected area.

4.3. Contraindications

Contraindicated in patients displaying salicylate hypersensitivity, or sensitivity to any other ingredient in the preparation.

4.4. Special warnings and precautions for use

For external use only.

Avoid contact with broken or inflamed skin.

Salicylate toxicity may occur if applied to large areas of skin or to the skin of neonates.

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.

4.5. Interaction with other medicinal products and other forms of interaction

There are no known interactions when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Salicylic Acid Ointment BP and other topical medicines on the same area of skin should therefore be avoided.

4.6. Pregnancy and lactation

Whilst there are no known contra-indications to the use of Salicylic Acid Ointment BP during pregnancy and lactation, the safety has not been established. Salicylic Acid Ointment BP should therefore be used with caution or following professional advice.

There are no or limited amount of data from the use of Salicylic Acid Ointment during pregnancy.

Salicylic Acid Ointment should not be used during pregnancy, except for short-term treatment of a small single area of the skin.

It is not known if the systemic Salicylic Acid Ointment exposure reached after topical administration can be harmful to an embryo/foetus.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may induce cardiopulmonary and renal toxicity in the foetus. At the end of the pregnancy prolonged bleeding time in both mother and child may occur, and labour can be delayed.

4.7. Effects on ability to drive and use machines

None likely.

4.8. Undesirable effects

Possible sensitivity reactions, drying and irritation.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.

4.9. Overdose

Symptoms of systemic salicylate poisoning (tinnitus, dizziness and deafness) have been reported after the application of salicylic acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is unlikely to occur if Salicylic Acid Ointment BP is used as indicated.

Salicylate poisoning is usually associated with plasma concentrations >350mg/L (2.5mmol/L). Most adult deaths occur in patients whose concentrations exceed 700mg/L (5.1mmol/L). Single doses less than 100mg/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, thrombocytopaenia, 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.