Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 28 March 2018

Indication(s)

Fortacin is indicated for the treatment of primary premature ejaculation in adult men.

Full Prescribing information

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Advisory information

contraindications
Hypersensitivity of the patient or their partner to the active substances or to any of the excipients listed in section 6.1.

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

Usage information

Dosing and administration
The recommended dose is 3 actuations applied to cover the glans penis. Each dose consists of a total of 22.5 mg lidocaine and 7.5 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.
Use in special populations
Elderly
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.

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. Caution is advised in case of severe hepatic impairment.

Paediatric population
There is no relevant use of Fortacin in the paediatric population in the indication: treatment of primary premature ejaculation in adult men.
Pregnancy and lactation
Fortacin is not indicated for use by women. However, there may be some exposure in female partners of men treated with Fortacin.

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.

Pregnancy
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.

Breast-feeding
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.

Fertility
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.

More information

Category Value
Agency product number EMEA/H/C/002693
Orphan designation No
Date First Approved 15-11-2013
Type Medicinal product subject to medical prescription
Marketing authorisation holder Plethora Solutions Limited