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Components:
Sodium Salicylate
Method of action:
Antiacne, Anti-Inflammatory, Antiproteolytic, Antipsoriatic, Early-Cleaning, Locally Irritating, Other Dermatological Preparations
Available in countries
Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.09.22

Name of the medicinal product

Acnisal

Qualitative and quantitative composition

Sodium Salicylate

Therapeutic indications

The information provided in Therapeutic indications of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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For the treatment of hyperkeratotic and scaling conditions such as psoriasis.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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Topical.

Recommended dose and dosage schedule

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

Contraindications

The information provided in Contraindications of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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Contraindicated in patients displaying salicylate hypersensitivity, or sensitivity to any other ingredient in the preparation.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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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.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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None likely.

Undesirable effects

The information provided in Undesirable effects of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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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.

Overdose

The information provided in Overdose of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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Symptoms of systemic salicylate poisoning (tinnitus, dizziness and deafness) have been reported after the application of Acnisal 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 Acnisal 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.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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Acnisal has a keratolytic action.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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Acnisal may be percutaneously absorbed. However, there is no evidence of any systemic absorption from the use of Acnisal Ointment BP.

Preclinical safety data

The information provided in Preclinical safety data of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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No other information relevant to the prescriber other than that already stated in other sections of the SPC.

Incompatibilities

The information provided in Incompatibilities of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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None known.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Acnisal is based on data of another medicine with exactly the same composition as the Acnisal of the medicine (Sodium Salicylate). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Acnisal directly from the package or from the pharmacist at the pharmacy.
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No special requirements.