Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Lidocaine, Prilocaine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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 premature ejaculation occurring in adult men (aged 18 years and over) from first sexual intercourse. This is when you always, or nearly always, have ejaculated within one minute of sexual intercourse and this causes you negative emotional effects. Fortacin works by decreasing the sensitivity of the head of the penis to increase time before ejaculation.
e Fortacin Do not use Fortacin
If you or your partner develop a rash or irritation, discontinue use of Fortacin. If symptoms persist, consult a doctor. Children and adolescents This medicine should not be used in 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. It is particularly important that you talk to a doctor before using Fortacin if you are taking any of the following medicines which may interact with Fortacin:
Fertility Fortacin may reduce the possibility of pregnancy. 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.
Driving and using machines Fortacin has no or negligible influence on the ability to drive and use machines when used at the recommended doses.
Contact with other mucous membranes:
35104437-01
5174 B
DRAFT N.: 4 DATE: 04/02/2025 DESCRIPTION: FORTACIN-United KingdomLEAFLET-150mg/ml+50mg/ml COUNTRY: United Kingdom PACK TYPE: LEAFLET MANUFACTURING SITE: Genetic SpA COMPONENT CODE: 5174 B
PRINTABLE COLORS
NON PRINT
COLOR 1: K
PROFILE TECHNICAL INFO
IF APPLICABLE
EXTERNAL CODE: 35104437-01 DRAWING REFERENCE: N/A SIZE (mm): 160 x 550 MARKET SEGMENT: Sale FONT TYPE TEXT: Helvetica Neue FONT MINIMUM SIZE: 9 pt PHARMACODE LAETUS: N/A BRAILLE TEXT: N/A
BACK
COPYRIGHT / PROPRIETÀ Recordati S.p.A
DO NOT TAMPER / VIETATA LA MANOMISSIONE
BAR PRINTS 70 mm @ 100%
Marketing Authorisation Holder Recordati Ireland Ltd. Raheens East Ringaskiddy Co. Cork Ireland
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Manufacturer Genetic S.p.A. The following side effects have been reported Via Canfora, 64 with Fortacin in male patients: 84084 Fisciano (SA) Italy Common (may affect up to 1 in 10 people)
Recordati Pharmaceuticals Ltd. Tel: + 44 (0) 1491 576 336 This leaflet was last revised in 02/2025. Other sources of information Detailed and updated information on this medicine is available by scanning the QR code below and the outer carton with a smartphone. The same information is also available on the following URL: www.fortacin.eu
www.fortacin.eu
Common: (may affect up to 1 in 10 people)
5174 B
Fortacin
Always use this medicine exactly as described in this leaflet. 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 at least 5 minutes before sexual intercourse.
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.
A maximum of 3 doses can be used within 24 hours with at least 4 hours between doses. Store below 25°C. Do not freeze. You must throw away the container 12 weeks after you first use it. The maximum recommended dose (3 doses within The metal container is pressurised. Do not 24 hours) should not be exceeded. puncture, break or burn it even when apparently empty. A residual volume of fluid that is not usable Instructions for use will remain in the container after all doses have
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. The metering valve's components are the stainless steel, POM, TPE, polypropylene, chlorobutyl rubber and HDPE.
Each pack contains 1 spray container with 6.5 ml or 5 ml of solution.
Fortacin 150 mg/ml + 50 mg/ml Cutaneous spray solution comes as spray containing 150mg/ml / 50mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Fortacin 150 mg/ml + 50 mg/ml Cutaneous spray solution is lidocaine, prilocaine.
This leaflet reproduces the patient information leaflet approved for Fortacin 150 mg/ml + 50 mg/ml Cutaneous spray solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Fortacin is indicated for the treatment of primary premature ejaculation in adult men.
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
Dose adjustments are not required in the elderly (see section 5.1).
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. 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.
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 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.
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.
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.
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 partner develop a rash or skin irritation treatment with Fortacin should be discontinued. If symptoms persist, the patient should consult a doctor
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).
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).
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.
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.
Fortacin has no or negligible influence on the ability to drive and use machines.
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 mediastinal disorders
Uncommon
Throat irritation
Skin and subcutaneous tissue disorders
Uncommon
Skin irritation
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
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
It is unlikely that Fortacin at the recommended dosages to result in an overdose. .
However should 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 (e.g. restlessness, vertigo, hearing and visual disorders, nausea, vomiting, tremor and muscle twitching) and, in severe cases, central nervous and cardiovascular depression (e.g hypotension, bradycardia and circulatory collapse which may lead to cardiac arrest).
Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive medicinal products.
Prilocaine in high doses may cause an increase in the methaemoglobin level particularly in conjunction with methaemoglobin inducing medicinal products (e.g. sulphonamides). Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylthioninium chloride
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Fortacin 150 mg/ml + 50 mg/ml Cutaneous spray solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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