Fortacin

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. 1).

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). Paediatric population There is no relevant use of Fortacin in the paediatric population for the indication of treatment of primary premature ejaculation. Method of administration Cutaneous use. 3 Fortacin 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 into the air once.

Any foreskin should be retracted from the glans penis. The spray container should be held in an upright position before use. Fortacin 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 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 6 Adverse drug reactions in male glans-penis-treated subjects System organ class Frequency Adverse reactions 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 sexual 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.

Precautions for use Premature ejaculation may be due to a condition requiring medical supervision. If this product used as directed does not provide relief, the patient should discontinue use and seek medical advice. Avoid contact with the eyes and ears When applied in the vicinity of the eyes, Fortacin may cause eye irritation.

Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If eye contact occurs, the eye should immediately be rinsed with water or sodium chloride solution and protected until sensation returns. When applied to an impaired tympanic membrane, Fortacin may cause ototoxicity of the middle ear.

Risk of injury Fortacin 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 numbness/anaesthesia is likely to result.

This hypoaesthesia may mask normal pain sensations and, therefore, increase the dangers of localised injury. Use with condoms Fortacin must not be used with polyurethane-based female and male condoms as deterioration was observed and protection from sexually transmitted diseases or pregnancy may be reduced.

Fortacin can be used with contraceptive devices made of latex rubber, polyisoprene, nitrile and silicone as no deterioration has been shown with these materials. A higher rate of erectile dysfunction and male genital hypoaesthesia may be experienced when using Fortacin with male condoms.

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

) have not shown cross sensitivity to lidocaine and/or prilocaine; however, Fortacin 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.

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