PREMJACT DESENSITIZING

Adults: 3-8 sprays (23-62 mg lidocaine base) applied to the glans and shaft of the penis 5 to 15 minutes prior to intercourse. Quantity and advance timing will be determined by individual requirements. The minimum effective dose should be used.

The maximum dose should not exceed 24 sprays (185 mg lidocaine base) in 24 hours. The product should be washed off after intercourse. Do not use on broken or inflamed skin. Do not spray in eyes or nostrils. For external use only. The product should not be used repeatedly for more than 3 months without medical supervision.

There is no relevant use of STUD 100 in the paediatric population.

Elderly:

Not recommended.

In extremely rare cases local anaesthetic preparations have been associated with allergic reactions. Occasional local skin irritation may occur following the use of STUD 100. Systemic adverse reactions to lidocaine are usually the result of high plasma concentrations due to high dosage, rapid absorption or may result from hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.

Such reactions involve excitatory and/or depressant actions on the CNS characterised by nervousness, dizziness, convulsions, unconsciousness and possible respiratory arrest. Cardiovascular reactions are depressant and may include hypotension, myocardial depression, bradycardia and possibly cardiac arrest.

The plasma lidocaine levels attained following application of STUD 100 at the maximum recommended dose are extremely low at about 25 times lower than the concentrations associated with systemic toxicity. 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 national reporting system (see details below). uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Use should be discontinued if a rash or irritation develops. A doctor should be consulted if symptoms persist. Although this topical formulation with limited systemic availability is unlikely to have a clinically meaningful effect on hepatic or renal function, caution is advised prior to prescribing to patients with hepatic or renal failure.

The fragrance components benzyl cinnamate, citral, hexyl cinnamaldehyde and tree moss may cause allergic reactions. In addition to allergic reactions in sensitised patients, non-sensitised patients may become sensitised. g. contact dermatitis), or irritation to the eyes and mucous membranes.

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