Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 28 March 2018
Patients or their partner with a known history of sensitivity to local anaesthetics of the amide type.
A maximum of 3 doses can be used within 24 hours with at least 4 hours between doses.
Dosage adjustments are not required in the elderly.
There is limited data on the efficacy and safety of Fortacin in patients 65 years and over.
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.
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. Caution is advised in case of severe hepatic impairment.
There is no relevant use of Fortacin in the paediatric population in the indication: treatment of primary premature ejaculation in adult men.
Women of childbearing potential / contraception in male and females
Patients hoping to achieve conception should either avoid using Fortacin, or, if it is essential to achieve penetration, should wash the glans penis as thoroughly as possible prior to intercourse.
There are no or limited amount of data from the use of lidocaine and prilocaine in pregnant women. Animal studies do not indicate reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Fortacin during pregnancy unless effective male barrier contraceptive measures are taken in order to avoid potential foetal exposure.
Lidocaine and prilocaine are excreted in human milk, but at therapeutic doses of Fortacin no effects on the breastfed newborns/infants are anticipated due to active substance transfer from the male patient to his female partner.
There are no adequate data from the use of lidocaine and prilocaine on fertility in humans. A study in rats showed that Fortacin caused a reduction in sperm motility. This medicinal product may reduce the possibility of pregnancy, but should not be used as a contraceptive.
|Agency product number||EMEA/H/C/002693|
|Date First Approved||15-11-2013|
|Type||Medicinal product subject to medical prescription|
|Marketing authorisation holder||Plethora Solutions Limited|