Fortacin
lidocaine, prilocaine
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told
you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
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.
You must talk to a doctor if you do not feel better or if you feel worse.
What Fortacin is and what it is used for
What you need to know before you use Fortacin
How to use Fortacin
Possible side effects
How to store Fortacin
Contents of the pack and other information
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.
if you or your partner are allergic to lidocaine or prilocaine or any of the other ingredients of this medicine (listed in section 6);
if you or your partner have a history of allergy or sensitivity to other local anaesthetics with a similar structure (known as amide-type local anaesthetics).
Talk to your doctor or pharmacist before using Fortacin
if you, or your 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.
Premature ejaculation may be due to a condition requiring medical supervision. If this product used as directed does not provide relief, consult a doctor.
Fortacin must not be used with latex-free female and male condoms made of polyurethane as these condoms may deteriorate when used together with Fortacin and therefore may fail to protect from sexually transmitted disease or pregnancy. Fortacin can be used with contraceptive devices made of latex rubber, polyisoprene, nitrile and silicone as no deterioration has been shown. Carefully check the material that your contraceptive or your partner’s contraceptive is made of before using this product. 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.
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 keep them closed as much as possible 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.
Fortacin should not come into contact with a damaged ear drum.
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 you and your partner may feel slight numbness for a short while and should take care not to injure yourselves, particularly during sexual activity. For more information regarding possible side effects in sexual partners, see section 4.
If you or your partner develop a rash or irritation, discontinue use of Fortacin. If symptoms persist, consult a doctor.
This medicine should not be used in children or adolescents under 18 years of age.
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:
other local anaesthetics
heart medicines (anti-arrhythmic medicines)
medicines known to increase the risk of a disorder reducing the amount of oxygen in the blood (methaemoglobinaemia), 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.
Fortacin is not approved for use by women.
Ask your doctor or pharmacist for advice before taking any medicine.
Fortacin should not be used whilst your partner is pregnant unless you use an effective male condom, as listed above in section 2 “Use with condoms”, to prevent exposure of the unborn child.
This medicine may be used while your partner is breast-feeding.
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.
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. A maximum of 3 doses can be used within 24 hours with at least 4 hours between doses.
The maximum recommended dose (3 doses within 24 hours) should not be exceeded.
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. It is important that you wipe off any excess spray also if you use a condom (see also section 2 for other important information regarding use with condoms).
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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
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
feeling of burning in and around the vagina
reduced feeling in and around the vagina
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
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 thenational reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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. A residual volume of fluid that is not usable will remain in the container after all doses have been administered.
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.
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.
1 dose is equal to 3 actuations.
The other ingredient is norflurane.
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.
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.
Recordati Ireland Ltd. Raheens East Ringaskiddy Co. Cork Ireland
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:
Recordati Ireland Ltd. Tel: + 353 21 4379400
Recordati Ireland Ltd. Teл.: + 353 21 4379400
Recordati Ireland Ltd. Tlf: + 353 21 4379400
Recordati Ireland Ltd. Tel: + 353 21 4379400
Recordati Pharma GmbH Tel: + 49 (0) 731 7047 0
Recordati Ireland Ltd. Tel: + 353 21 4379400
Recordati Ireland Ltd. Tel: + 353 21 4379400
Recordati Ireland Ltd. Tlf: + 353 21 4379400
Recordati Hellas Pharmaceuticals A.E. Τηλ: + 30 210-6773822
Recordati Ireland Ltd. Tel: + 353 21 4379400
Casen Recordati, S.L. Tel: + 34 91 659 15 50
RECORDATI POLSKA sp. z o.o. Tel.: + 48 22 206 84 50
Laboratoires BOUCHARA-RECORDATI Tél: + 33 1 45 19 10 00
Jaba Recordati, S.A. Tel: + 351 21 432 95 00
Recordati Ireland Ltd. Tel: + 353 21 4379400
Recordati România S.R.L. Tel: + 40 21 667 17 41
Recordati Ireland Ltd. Tel: + 353 21 4379400
Recordati Ireland Ltd. Tel: + 353 21 4379400
Recordati Ireland Ltd. Sími: + 353 21 4379400
Recordati Industria Chimica e Farmaceutica S.p.A.
Tel: + 39 02 487871
Recordati Ireland Ltd. Puh/Tel: + 353 21 4379400
Recordati Ireland Ltd.
Recordati Ireland Ltd.
Τηλ: + 353 21 4379400 Tel: + 353 21 4379400
Recordati Ireland Ltd. Tel: + 353 21 4379400
Recordati Ireland Ltd. Tel: + 353 21 4379400
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
QRcode www.fortacin.eu