Leitlinien & Arzneimittelsicherheit

HOS-216452 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most frequent adverse reactions reported with the use of this medicinal product in male patients were local effects of genital hypoaesthesia (4.5%) and erectile dysfunction (4.4%). These adverse reactions caused discontinuation of treatment in 0.2% and 0.5% of patients, respectively. The most frequent adverse reactions reported with the use of this medicinal product in female partners were vulvovaginal burning sensation (3.9%), and genital hypoaesthesia (1.0%). Vulvovaginal discomfort or burning sensation caused discontinuation of treatment in 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 Uncommon Throat irritation mediastinal disorders Skin and subcutaneous tissue Uncommon Skin irritation disorders 5  Adverse drug reactions in male glans-penis-treated subjects System organ class Frequency Adverse reactions Reproductive system and breast Common Hypoaesthesia of male genital, disorders Erectile dysfunction, Genital burning sensation Uncommon Genital erythema, Ejaculation failure, Paraesthesia of male genital, Penile pain, Penis disorder, Pruritus genital General disorders and Uncommon Pyrexia administration site conditions Adverse drug

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HOS-216448 · has-contraindication-information · PDF-Seite 3

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.

HOS-216447 · has-indication-information · PDF-Seite 2

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

HOS-216450 · has-interaction-information · PDF-Seite 4

Methaemoglobinaemia may be accentuated in patients already taking medicinal products known to induce the condition, e.g. sulphonamides, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenobarbital, phenytoin, primaquine and quinine (see section 4.4). The risk of additional systemic toxicity should be considered when large doses of Fortacin are applied to patients already using other local anaesthetics or structurally related medicinal products, e.g. class I anti-arrhythmics such as mexiletine. Specific interaction studies with lidocaine/prilocaine and anti-arrhythmic medicinal products class III (e.g. amiodarone) have not been performed, but caution is advised due to the potential increase of antiarrhythmic effect. Medicinal products that inhibit cytochrome P450 (CYP) 1A2 reduce the clearance of lidocaine (e.g. fluvoxamine, cimetidine or betablockers) and may cause potentially toxic plasma concentrations when lidocaine is given intravenously in repeated high doses over a long time period (30 hours).

HOS-216451 · has-pregnancy-information · PDF-Seite 4

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 5 minutes after applying the spray but 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. 4 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. Fortacin can be used during breast-feeding if clinically needed. 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 (see section 5.3). This medicinal product may reduce the possibility of pregnancy, but should not be used as a contraceptive.

HOS-216449 · has-warning-information · PDF-Seite 3

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. Anaemia related conditions Patients or their partner with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to medicinal product-induced methaemoglobinaemia (see section 4.5). 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. 3 Hypersensitivities Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) 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. Skin effects In case the patient or their

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