Fortacin

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 

1. NAME OF THE MEDICINAL PRODUCT 
 
Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine. 
Each actuation delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine. 
Each container of 6.5 ml delivers a minimum of 20 doses. 
Each container of 5 ml delivers a minimum of 12 doses. 
 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Cutaneous spray, solution 
 
Colourless to light yellow solution 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Fortacin is indicated for the treatment of primary premature ejaculation in adult men. 
 
4.2 Posology and method of administration 
 
Posology 
 
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.  
 
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 (see section 4.4). 
 
Paediatric population 
There is no relevant use of Fortacin in the paediatric population for the indication of treatment of 
primary premature ejaculation in adult men. 
 



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Method of administration 
 
Cutaneous use. 
 
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 it once. 
 
Any foreskin should be retracted from the glans penis. Once the can is held upright (valve up), 1 dose 
of 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. 
 
4.3 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. 
 
4.4 Special warnings and precautions for use 
 
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.  
 
Interactions 
 
Patients on anti-arrhythmic medicinal products class III (e.g. amiodarone) should be treated with 
caution. 
 
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. 
 
Precautions for use 
 
Care should be taken not to allow Fortacin 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 Fortacin 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.  
 
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 



4 

numbness/anaesthesia is likely to result.  This hypoaesthesia may mask normal pain sensations and, 
therefore, increase the dangers of localised injury. 
 
Fortacin sprayed onto a damaged tympanic membrane may cause ototoxicity of the middle ear. 
 
Deterioriation was observed when Fortacin was used with polyurethane-based female and male 
condoms.   
 
A higher rate of erectile dysfunction and male genital hypoaesthesia may be experienced when using 
Fortacin with male condoms. 
 
Due to the risk of partner transfer, 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 (see section 4.6). 
 
Patients with severe hepatic impairment 
 
Patients with severe hepatic disease, because of their inability to metabolise local anaesthetics 
normally, are at greater risk of developing toxic plasma concentrations of lidocaine and prilocaine (see 
section 4.2). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
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 (see also section 4.4). 
 
Medicinal products that reduce the clearance of lidocaine (e.g. cimetidine or betablockers) may cause 
potentially toxic plasma concentrations when lidocaine is given intravenously in repeated high doses 
over a long time period (30 hours). 
 
In vitro interaction studies with topical antifungal (clotrimazole, econazole, imidazole, nystatin, 
miconazole, ketoconazole), antibacterial (clindamycin, metronidazole) and antiviral medicinal 
products (acyclovir), showed no effect on antimicrobial activity.  
 
4.6 Fertility, 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. 
 



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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. 
 
4.7 Effects on ability to drive and use machines 
 
Fortacin has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
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 incidence.   
 
 

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 



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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 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. 
 
4.9 Overdose 
 
As Fortacin is applied topically to the glans penis the risk of overdose is low.  
 
Prilocaine in high doses may cause an increase in the methaemoglobin level particularly in 
conjunction with methaemoglobin-inducing agents (e.g. sulphonamides). Clinically significant 
methaemoglobinaemia should be treated with a slow intravenous injection of methylthioninium 
chloride.  
 
Should other symptoms of systemic toxicity occur, the signs are anticipated to be similar in nature to 
those following the administration of local anaesthetics by other routes. Local anaesthetic toxicity is 
manifested by symptoms of nervous system excitation and, in severe cases, central nervous and 
cardiovascular depression.  
 
Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by 
respiratory support and the administration of anticonvulsive medicinal products. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anaesthetics, amides, ATC code: N01BB20 

Mechanism of action 
 
Fortacin provides topical anaesthesia to the glans penis. The active substances lidocaine and prilocaine 
block the transmission of nerve impulses in the glans penis, reducing the sensitivity of the glans penis. 
This is translated into a delaying of the ejaculatory latency time without adversely affecting the 
sensation of ejaculation. 
 
Pharmacodynamic effects 
 
Clinical trials have shown Fortacin to increase the intra-vaginal ejaculatory latency time (IELT), 
increase control over ejaculation and reduce the feelings of distress in patients with premature 
ejaculation as measured by the Index of Premature Ejaculation (IPE). The medicinal product has a 
rapid onset of action and is effective within 5 minutes of application. The effectiveness of the 
medicinal product has been demonstrated to persist on repeat use over time. 
 
Clinical efficacy and safety 
 
The efficacy of Fortacin was demonstrated in two multi-centre, multinational, randomised, 
double-blind, placebo controlled studies, both followed by an open-label phase. Men satisfying the 
International Society for Sexual Medicine (ISSM) criteria for premature ejaculation (PE) who had a 
baseline IELT ≤ 1 minutes in at least 2 of the first 3 sexual encounters during screening were eligible 
to enrol. 
 
The effectiveness of Fortacin in treating PE was assessed by measuring IELT and the co primary 
endpoints of ejaculatory control, sexual satisfaction, and distress using the IPE. During the 3 months 
of the double-blind treatment phase, the geometric mean IELT increased from 0.58 to 3.17 minutes in 
the Fortacin group and from 0.56 to 0.94 minutes in the placebo group.   
 
85.2% of subjects in the Fortacin group achieved a mean IELT of > 1 minute over the course of 
3 months of treatment with it, whereas 46.4% of the placebo subjects had a mean IELT of > 1 minute. 
66.2% of Fortacin-treated subjects and 18.8% of placebo-treated subjects achieved a mean IELT 
> 2 minutes. 
 
The clinically significant increases in IELT were paralleled by significant differences in the IPE scores 
(p <0.0001). Adjusted mean change scores (Fortacin vs. placebo) at Month 3 were 8.2 vs. 2.2 for the 
ejaculatory control score, 7.2 vs. 1.9 for the sexual satisfaction score, and 3.7 vs. 1.1 for the distress 
score.   
 
In Fortacin-treated subjects, IELT and IPE scores increased at the first measured timepoint. Both IELT 
and IPE scores continued to increase slightly more throughout the remainder of the double-blind 
phase. The positive changes in IELT and IPE domain scores were maintained during the open-label 
treatment phase.  
 
At each of the three monthly assessments all subjects completed a Premature Ejaculation Profile (PEP) 
questionnaire relating to perceived control over ejaculation, personal distress related to ejaculation, 
satisfaction with sexual intercourse, and interpersonal difficulty relating to ejaculation. The PEP scores 
followed a similar pattern of improvement to the IELT and IPE scores. For all of the three monthly 
assessments completed by the subjects, there was a significant difference between Fortacin and 
placebo (p < 0.0001). Partners completed the PEP questionnaire at month three. There was also a 
significant difference over placebo in all domains for the responses from the partners (p < 0.0001).  
 



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Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Fortacin in all subsets of the paediatric population in primary premature ejaculation (see section 4.2 
for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
The plasma levels of lidocaine and prilocaine in male and female subjects were below the level 
associated with toxicity (5,000 ng/ml). Male volunteers had maximum plasma concentrations of 
lidocaine which were less than 4% of toxic levels, and prilocaine which were less than 0.4% of toxic 
levels, after repeat dosing. Female volunteers receiving repeated doses directly to the cervix and 
vagina of up to five times the recommended dose for the male partner, had maximum plasma levels of 
lidocaine which were less than 8% of toxic levels, and prilocaine which were less than 1% of toxic 
levels. 
 
Systemic exposure to lidocaine and prilocaine and their metabolites (respectively 2,6-xylidine and 
o-toluidine), is low following application to the glans penis in male patients and application to the 
cervix/vagina fornices in female subjects, at doses higher than recommended.  
 
Distribution 
 
Lidocaine 
The steady-state volume of distribution is 1.1 to 2.1 L/kg after intravenous administration. Lidocaine 
is reported to be 66% bound by plasma proteins, including alpha-1-acid glycoprotein. Lidocaine can 
cross the blood brain barrier and the placenta and is distributed in breast milk.  
 
Prilocaine 
Following intravenous administration, the steady state volume of distribution of prilocaine is 0.7 to 
4.4 L/kg. Prilocaine is reported to be 55% bound to plasma proteins, including alpha-1-acid 
glycoprotein. Prilocaine crosses the blood-brain barrier and also crosses the placenta. Prilocaine is also 
distributed in breast milk.  
 
Biotransformation 
 
Lidocaine is largely metabolised in the liver by cytochrome P450 (CYP 3A4) and probably to a minor 
extent in the skin. First pass metabolism is rapid and extensive and bioavailability is about 35% after 
oral doses. 
 
Prilocaine is rapidly metabolised in both the liver, by cytochrome P450, and in the kidneys by 
amidases. 
 
The metabolism of lidocaine and prilocaine results in the formation of 2,6-xylidine and o-toluidine, 
respectively, amongst other metabolites. Plasma levels of these metabolites detected after 
administration of Fortacin in clinical trials were low in both male and female subjects, even after doses 
of it many times in excess of the clinical dose were applied. No 2,6-xylidine or o-toluidine was 
detectable at any time-point in vaginal fluids following local application of the medicinal product in 
female volunteers. 
 
Elimination 
 
Lidocaine 
The terminal elimination half-life of lidocaine from the plasma following intravenous administration is 
approximately 65 - 150 minutes and the systemic clearance is 10 - 20 mL/min/kg. Lidocaine is 
excreted in the urine mainly as metabolites, with only a small proportion excreted unchanged.   



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Prilocaine 
The elimination half-life of prilocaine following intravenous administration is approximately 
10 - 150 minutes. The systemic clearance is 18 - 64 mL/min/kg. Prilocaine is excreted in the urine 
mainly as its metabolites, with only a small proportion excreted unchanged.   
 
5.3 Preclinical safety data 
 
Reproductive toxicity 
 
Lidocaine 
No teratogenic effects were observed in studies of embryonic/foetal development in rats and rabbits 
receiving doses during organogenesis. Embryotoxicity was observed in rabbits at doses toxic to the 
mother. The postnatal survival time of the offspring of rats treated during pregnancy and lactation with 
a dose toxic to the mother was shown to be reduced. 
 
Prilocaine 
In a study of pregnant rats receiving a combination of lidocaine and prilocaine during organogenesis, 
no effects on embryonic/foetal development were observed. There are however no systemic exposure 
data available for comparison with clinical exposure. 
 
Genotoxicity and carcinogenicity 
 
Lidocaine 
Lidocaine was not genotoxic and the carcinogenic potential of lidocaine has not been studied. The 
lidocaine metabolite 2,6-xylidine has genotoxic potential in vitro. In a carcinogenicity study of rats 
exposed to 2,6-xylidine in utero, postnatally and throughout their lifetime, tumours in the nasal cavity, 
subcutaneous tumours and liver tumours were observed. The clinical relevance of tumour findings in 
relation to short-term/intermittent use of lidocaine in humans is unknown. Human exposure from 
Fortacin is 20-30 fold less than the minimum dose that did not result in tumours and 200 fold less than 
the minimum dose that did result in tumours. 
 
Prilocaine 
Prilocaine was not genotoxic and the carcinogenic potential of prilocaine has not been studied. The 
prilocaine metabolite o-toluidine has genotoxic potential in vitro. In carcinogenicity studies of 
o-toluidine in rats, mice and hamsters, tumours were observed in several organs. The clinical relevance 
of tumour findings in respect of short-term/intermittent use of prilocaine in humans is unknown. 
Human exposure is 1000 fold less than than the minimum dose studied. Note, this dose did result in 
tumours.   
  
Effect on fertility 
 
In an in vitro study of rats Fortacin has shown a reduction in sperm motility when 22.5 mg lidocaine 
and 7.5 mg prilocaine (i.e. the amount in 1 human dose) was in direct contact with rat sperm. However 
this study did not reproduce the circumstances of clinical use, as the concentration of Fortacin in direct 
contact with the sperm would be many fold lower. The potential for reduction of sperm motility 
following the clinical use of the medicinal product can not be excluded; therefore it is not possible to 
state whether Fortacin would prevent pregnancy. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Norflurane 
 



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6.2 Incompatibilities 
 
Deterioriation was observed when Fortacin was used with polyurethane-based female and male 
condoms (see section 4.4). Patients should be advised to use alternative methods of contraception. 
 
6.3 Shelf life 
 
18 months. 
After first use: 12 weeks 
 
6.4 Special precautions for storage 
 
Store below 25°C.  Do not freeze. 
 
6.5 Nature and contents of container 
 
Aluminium spray container with metering valve. 
Each pack contains one spray container with 6.5 ml or 5 ml solution.  
 
6.6 Special precautions for disposal and other handling 
 
The metal container is pressurised. It should not be punctured, broken or burnt, even when apparently 
empty.  
 
A residual volume of fluid that is not usable will remain in the container after all doses have been 
administered. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Recordati Ireland Ltd. 
Raheens East 
Ringaskiddy Co. Cork 
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/881/001 
EU/1/13/881/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 15 November 2013 
Date of latest renewal: 17 September 2018  
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 

http://www.ema.europa.eu/


11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE  
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 



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A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Pharmaserve (North West) Ltd 
9 Arkwright Road 
Astmoor Industrial Estate 
Runcorn WA7 1NU  
United Kingdom 
 
Recordati Industria Chimica e Farmaceutica S.p.A. 
Via Matteo Civitali 1 
20148 Milano 
Italy  
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal products subject to medical prescription.  
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports  
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 

USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result 
of an important (pharmacovigilance or risk minimisation) milestone being reached.  

 



13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 



14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



15 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution 
lidocaine/prilocaine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine. 
Each actuation delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine 
Each spray container of 6.5 ml delivers a minimum of 20 doses  
Each spray container of 5 ml delivers a minimum of 12 doses 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: norflurane 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Cutaneous spray, solution 
6.5 ml 
5 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For external use only. 
Cutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
Discard 12 weeks after first use. 
 



16 

9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C. Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Recordati Ireland Ltd. 
Raheens East 
Ringaskiddy Co. Cork 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/881/001 
EU/1/13/881/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
fortacin 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



17 

 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
SPRAY CONTAINER LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution 
lidocaine/prilocaine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine. 
Each actuation delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine 
Each spray container of 6.5 ml delivers a minimum of 20 doses  
Each spray container of 5 ml delivers a minimum of 12 doses. 
 
3. LIST OF EXCIPIENTS 
 
Also contains: norflurane 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Cutaneous spray, solution 
6.5 ml 
5 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For external use only. 
Cutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
Discard 12 weeks after first use. 
 
 



18 

9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C. Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Recordati Ireland Ltd. 
Raheens East 
Ringaskiddy Co. Cork 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/881/001 
EU/1/13/881/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



20 

Package leaflet: Information for the user 
 

Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution 
lidocaine/prilocaine 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Fortacin is and what it is used for 
2. What you need to know before you use Fortacin 
3. How to use Fortacin 
4. Possible side effects 
5. How to store Fortacin 
6. Contents of the pack and other information 
 
 
1. What Fortacin is and what it is used for 
 
Fortacin is a combination of two medicines: lidocaine and prilocaine. These belong to a group of 
medicines called local anaesthetics. 
 
Fortacin is indicated for the treatment of lifelong premature ejaculation in adult men. It works by 
decreasing the sensitivity of the head of the penis to increase time before ejaculation. 
 
 
2. What you need to know before you use Fortacin 
 
Do not use Fortacin 
- if you or your sexual partner are allergic to lidocaine or prilocaine or any of the other 

ingredients of this medicine (listed in section 6); 
- if you or your sexual partner have a history of allergy or sensitivity to other local anaesthetics 

with a similar structure (known as amide-type local anaesthetics). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before using Fortacin 
- if you, or your sexual partner, have been diagnosed with a genetic disease or other condition 

affecting your red blood cells (glucose-6-phosphate deficiency, anaemia or 
methaemoglobinaemia); 

- if you have a history of medicine sensitivities, especially if you are not certain which medicine 
causes sensitivity; 

- if you suffer from severe liver problems. 
 
When you use this medicine, particularly during priming of the container, aim the container away 
from the face to avoid accidental contact with ears, eyes, nose and mouth. 
 
If some medicine accidentally gets into your eyes or your partner’s eyes, rinse them immediately with 
cold water or saline solution and cover them gently until any effects, such as numbness, wear off. Be 
aware that normal protective mechanisms, such as blinking, or sensation of a foreign body in the eye, 
may not occur until the numbness has worn off. 



21 

 
Fortacin may also come into contact with other mucous membranes such as your, or your partner’s, 
mouth, nose and throat, causing them to feel slightly numb for a short while.  As this will reduce the 
ability to feel pain in these areas, extra care should be taken not to injure them until the numbness has 
worn off. 
 
During sexual intercourse, a small amount of this medicine may be transferred e.g. to the vagina or the 
anus. Therefore, both partners may feel slight numbness for a short while and should take care not to 
injure themselves, particularly during sexual activity.   
 
Fortacin should not come into contact with a damaged ear drum.   
 
Children and adolescents 
Do not give this medicine to children or adolescents under 18 years of age. 
 
Other medicines and Fortacin 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This is particularly important if you are taking the following medicines which may interact 
with Fortacin: 
 

• other local anaesthetics 
• heart medicines (anti-arrhythmic medicines) 
• medicines for high blood pressure and to regulate your heart rhythm (so-called beta blockers) 
• medicines reducing your stomach acid (cimetidine)  

 
The risk of a disorder reducing the amount of oxygen in the blood (methaemoglobinaemia) may be 
increased if you are already taking medicines known to cause the condition, such as those listed 
below: 

• Benzocaine – a local anaesthetic used to treat pain and itching 
• Chloroquine, pamaquine, primaquine, quinine - used to treat malaria  
• Metoclopramide – used to treat feelings of sickness (nausea) and vomiting, including in patients 

with migraine 
• Glyceryl trinitrate (GTN, nitroglycerin), isosorbide mononitrate, erythrityl tetranitrate, 

pentaerythritol tetranitrate and other nitrate and nitrite medicines - used to treat angina (chest 
pain caused by the heart) 

• Sodium nitroprusside, isosorbide dinitrate – used to treat high blood pressure and heart failure 
• Nitrofurantoin – an antibiotic used to treat urinary and kidney infections 
• Sulphonamides (also called sulpha medicines) e.g. sulfamethoxazole – an antibiotic used to treat 

urinary infections, and sulfasalazine – used to treat Crohn’s disease, ulcerative colitis and 
rheumatoid arthritis 

• Dapsone – used to treat skin conditions such as leprosy and dermatitis and also to prevent 
malaria and pneumonia in high-risk patients 

• Phenobarbital, phenytoin – used to treat epilepsy 
• Para-aminosalicylic acid (PAS) – used to treat tuberculosis 

 
The risk of methaemoglobinaemia can also be increased by the use of certain dyes (aniline dyes), or 
the pesticide naphthalene, so let your doctor know if you work with any dyes or chemical pesticides. 
 
Any barrier contraceptives (e.g. male or female condom), which are made from polyurethane-based 
material cannot be guaranteed to protect against disease or pregnancy when you are also using 
Fortacin. Check the material that your contraceptive or your partner’s contraceptive is made of. Ask 
your pharmacist if you are unsure. 
 
If you use Fortacin with condoms, you may be more likely to be unable to develop or maintain an 
erection. You may also be more likely to have reduced feeling in and around the penis. 
  



22 

Pregnancy, breast-feeding and fertility 
 
Fortacin is not approved for use by women.  
Ask your doctor or pharmacist for advice before taking any medicine. 
 
Pregnancy 
Fortacin is not recommended for use whilst your partner is pregnant unless you use a male condom, as 
listed above, to prevent exposure of the unborn child. 
 
Breast-feeding 
This medicine may be used while your partner is breast-feeding. 
 
Fertility 
Fortacin may reduce the possibility of pregnancy, but is not a reliable contraceptive. Therefore, 
patients hoping to achieve conception should either avoid using Fortacin, or, if this medicine is 
essential to achieve penetration, should wash the penis as thoroughly as possible five minutes after 
Fortacin has been applied, but prior to intercourse. 
 
 
3. How to use Fortacin 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure.  
 
The recommended dose of Fortacin is 3 sprays (3 sprays = 1 dose) on the head of the penis before 
sexual intercourse.  A maximum of 3 doses can be used within 24 hours with at least 4 hours between 
doses. 
 
Instructions for use 
Before initial use, briefly shake the spray container and then prime the pump mechanism by spraying 
the valve three times into the air. Aim the container away from faces to avoid contact with eyes, nose, 
mouth and ears. 
Before each subsequent dose, briefly shake the spray container and then re-prime the pump by 
spraying 1 time into the air. 
Retract any foreskin from the head of the penis. Holding the can upright (valve up), apply 1 dose 
(3 sprays) of Fortacin to the entire head of the penis, by covering one third with each spray. Wait 
5 minutes then wipe off any excess spray prior to having sexual intercourse.  
 
If you use more Fortacin than you should 
As this medicine is applied to the surface of the head of the penis the risk of overdose is low.  If you 
do apply too much, wipe it off. 
 
Symptoms of using too much Fortacin are listed below. Contact your doctor or pharmacist if you 
experience any of these. They are very unlikely to happen if it is used as instructed: 

• Feeling light-headed or dizzy 
• Tingling of the skin around the mouth and numbness of the tongue 
• Abnormal taste 
• Blurred vision 
• Ringing in the ears 
• There is also a risk of a disorder reducing the amount of oxygen in the blood 

(methaemoglobinaemia). This is more likely when certain medicines have been taken at the same 
time. If this happens, the skin becomes bluish-grey due to a lack of oxygen. 

 
In serious cases of overdose, symptoms may include fits, low blood pressure, slowed 
breathing, stopped breathing and altered heart beat. These effects may be life-threatening. 
 



23 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
The following side effects have been reported with Fortacin in male patients: 
 
Common (may affect up to 1 in 10 people) 
 

• Inability to develop or maintain an erection 
• reduced feeling in and around the penis 
• feeling of burning in and around the penis 

 
Uncommon (may affect up to 1 in 100 people) 
 

• headache 
• local irritation of the throat (if inhaled)  
• irritation of the skin 
• redness on and around the penis 
• failure to ejaculate during sexual intercourse 
• abnormal orgasm 
• tingling in and around the penis 
• pain or discomfort in and around the penis 
• itching in and around the penis 
• a high temperature 

 
The following side effects have been reported with Fortacin in female partners: 
 
Common: (may affect up to 1 in 10 people) 
 

• feeling of burning in and around the vagina 
• reduced feeling in and around the vagina 

 
Uncommon (may affect up to 1 in 100 people) 
 

• headache 
• local irritation of the throat (if inhaled) 
• vaginal thrush (Candida) infection 
• discomfort in the anus and rectum 
• loss of feeling in the mouth 
• difficulty or pain passing urine 
• pain in the vagina 
• discomfort or itching in the vulva and vagina 

 
Reporting of side effects 
If you or your sexual partner get any side effects, talk to your doctor or pharmacist. This includes any 
possible side effects not listed in this leaflet. You can also report side effects directly via the national 
reporting system listed in Appendix V. By reporting side effects you can help provide more 
information on the safety of this medicine. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


24 

5. How to store Fortacin 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the spray container label and the 
carton after “EXP”. The expiry date refers to the last day of that month.   
 
Store below 25°C. Do not freeze. You must throw away the container 12 weeks after you first use it. 
The metal container is pressurised. Do not puncture, break or burn it even when apparently empty.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Fortacin contains  
- The active substances are lidocaine and prilocaine.   
- Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine 
- Each spray delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine. 
- Each spray container of 6.5 ml delivers a minimum of 20 doses. 
- Each spray container of 5 ml delivers a minimum of 12 doses. 
- The other ingredient is norflurane 
 
What Fortacin looks like and contents of the pack 
Fortacin is a colourless to light yellow cutaneous spray, solution in an aluminium spray container with 
metering valve. 
 
Each pack contains 1 spray container with 6.5 ml or 5 ml of solution. 
 
Marketing Authorisation Holder  
Recordati Ireland Ltd. 
Raheens East 
Ringaskiddy Co. Cork 
Ireland 
 
Manufacturer 
Pharmaserve (North West) Ltd 
9 Arkwright Road 
Astmoor Industrial Estate 
Runcorn WA7 1NU 
United Kingdom 
 
Recordati Industria Chimica e Farmaceutica S.p.A. 
Via Matteo Civitali 1 
20148 Milano 
Italy  
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Recordati Ireland Ltd. 
Tél/Tel: + 353 21 4379400 
 

Lietuva 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 



25 

България 
Recordati Ireland Ltd. 
Teл.: + 353 21 4379400 
 

Luxembourg/Luxemburg 
Recordati Ireland Ltd. 
Tél/Tel: + 353 21 4379400 
 

Česká republika 
Herbacos Recordati s.r.o. 
Tel: + 420 466 741 915 
 

Magyarország 
Recordati Ireland Ltd. 
Tel.: + 353 21 4379400 
 

Danmark 
Recordati Ireland Ltd. 
Tlf: + 353 21 4379400 
 

Malta 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Deutschland 
Recordati Pharma GmbH 
Tel: + 49 (0) 731 7047 0 
 

Nederland 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Eesti 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Norge 
Recordati Ireland Ltd. 
Tlf: + 353 21 4379400 
 

Ελλάδα 
Recordati Hellas Pharmaceuticals A.E. 
Τηλ: + 30 210-6773822 
 

Österreich 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

España 
Casen Recordati, S.L. 
Tel: + 34 91 659 15 50 
 

Polska 
RECORDATI POLSKA sp. z o.o. 
Tel.: + 48 22 206 84 50 
 

France 
Laboratoires BOUCHARA-RECORDATI 
Tél: + 33 1 45 19 10 00 
 

Portugal 
Jaba Recordati, S.A. 
Tel: + 351 21 432 95 00 
 

Hrvatska 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

România 
Recordati România S.R.L. 
Tel: + 40 21 667 17 41 
 

Ireland 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Slovenija 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

Ísland 
Recordati Ireland Ltd. 
Sími: + 353 21 4379400 
 

Slovenská republika 
Herbacos Recordati s.r.o. 
Tel: + 420 466 741 915 
 

Italia 
Recordati Industria Chimica e Farmaceutica 
S.p.A. 
Tel: + 39 02 487871 
 

Suomi/Finland 
Recordati Ireland Ltd. 
Puh/Tel: + 353 21 4379400 
 

Κύπρος 
Recordati Ireland Ltd. 
Τηλ: + 353 21 4379400 
 

Sverige 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 



26 

Latvija 
Recordati Ireland Ltd. 
Tel: + 353 21 4379400 
 

United Kingdom 
Recordati Pharmaceuticals Ltd. 
Tel: + 44 (0) 1491 576 336 
 

 
This leaflet was last revised in {MM/YYYY}  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET