Senstend

Posology The recommended dose is 3 actuations applied to cover the glans penis. 5 mg prilocaine per application (1 dose is equal to 3 actuations). A maximum of 3 doses can be used within 24 hours with at least 4 hours between doses. Special populations Elderly Dosage adjustments are not required in the elderly.

There is limited data on the efficacy and safety of Senstend in patients 65 years and over. Renal impairment Clinical studies have not been performed in patients with impaired renal function, however due to its method of administration and very low systemic absorption, no dosage adjustment is required.

Hepatic impairment Clinical studies have not been performed in patients with impaired hepatic function, however due to its method of administration and very low systemic absorption, no dosage adjustment is required. 4). “Medicinal Product no longer authorised” 3 Method of administration Cutaneous use.

Senstend is only indicated for application to the glans penis. Before initial use, the spray container should be briefly shaken and then primed by spraying it into the air three times. Before each subsequent use, it should be briefly shaken and then the spray container should be re-primed by spraying it once.

Any foreskin should be retracted from the glans penis. Once the can is held upright (valve up), 1 dose of Senstend should be applied to the entire glans penis, by actuating the valve 3 times. One third of the glans penis should be covered with each actuation.

After 5 minutes any excess spray should be wiped off prior to intercourse.

4%). 5% of patients, respectively. 0%). 3% of subjects. Tabulated list of adverse reactions Frequency of the adverse reactions is defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

“Medicinal Product no longer authorised” 6 Adverse drug reactions in male glans-penis-treated subjects System Organ Class Frequency Adverse Reactions Psychiatric disorders Uncommon Abnormal orgasm Nervous system disorders Uncommon Headache Respiratory, thoracic and mediastinal disorders Uncommon Throat irritation Skin and subcutaneous tissue disorders Uncommon Skin irritation Reproductive system and breast disorders Common Hypoaesthesia of male genital, erectile dysfunction, genital burning sensation Uncommon Genital erythema, ejaculation failure, paraesthesia of male genital, penile pain, penis disorder, pruritus genital General disorders and administration site conditions Uncommon Pyrexia Adverse drug reactions in female partners System Organ Class Frequency Adverse Reactions Infections and infestations Uncommon Vaginal candidiasis Nervous system disorders Uncommon Headache Respiratory, thoracic and mediastinal disorders Uncommon Throat irritation Gastrointestinal disorders Uncommon Anorectal discomfort, oral parasthesia Renal and urinary disorders Uncommon Dysuria Reproductive system and breast disorders Common Vulvovaginal burning sensation, hypoaesthesia Uncommon Vulvovaginal discomfort, vaginal pain, vulvovaginal pruritus 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 listed in Appendix V.

5). Although the systemic availability of prilocaine by cutaneous absorption of Senstend is low, caution should be exercised in patients with anaemia, congenital or acquired methaemoglobinaemia or patients on concomitant therapy known to produce such conditions.

g. amiodarone) should be treated with caution. ) have not shown cross sensitivity to lidocaine and/or prilocaine; however, Senstend should be used with caution in patients with a history (or partner with a history) of sensitivities to medicinal products, especially if the aetiologic medicinal product is uncertain.

Precautions for use Care should be taken not to allow Senstend to come in contact with the eye, as it may cause eye irritation. Also the loss of protective reflexes can permit corneal irritation and potential abrasion. Absorption of Senstend in conjunctival tissues has not been determined.

If contact with the eye occurs, immediately rinse the eye with water or sodium chloride solution and protect it until sensation returns. Senstend sprayed onto mucous membranes of the patient or their partner, such as the mouth, nose and throat, or transferred onto female genitalia or anal lining, could be absorbed and temporary local“Medicinal Product no longer authorised” 4 numbness/anaesthesia is likely to result.

This hypoaesthesia may mask normal pain sensations and, therefore, increase the dangers of localised injury. Senstend sprayed onto a damaged tympanic membrane may cause ototoxicity of the middle ear. Deterioriation was observed when Senstend was used with polyurethane-based female and male condoms.

A higher rate of erectile dysfunction and male genital hypoaesthesia may be experienced when using Senstend with male condoms. 6). 2).

1. Patients or their partner with a known history of sensitivity to local anaesthetics of the amide type.