Fortacin ^® 150mg / ml + 50mg / ml spray, lidocaine and prilocaine

solution for use on the skin

Fortacin is used to treat lifelong premature ejaculation in adult men. It works by reducing the sensitivity of the glans of the penis to increase the time before ejaculation.

FORTACIN spray is a combination of two medicines (lidocaine and prilocaine). They belong to a group of medicines called local anesthetics.

FORTACIN spray lidocaine and prilocaine For information on risks and side effects, read the package insert and ask your doctor or pharmacist.

Manufacturer: Recordati Pharma GmbH
Item name: FORTACIN 150 mg/ml + 50 mg/ml spray z.Anw.a.Skin
Quantity: 5 ml
Dosage form: Spray

active ingredients

• 150 mg lidocaine
• 50 mg prilocaine

excipients

• norflurane

Indication/Application

• The preparation is a combination of two medicines (lidocaine and prilocaine).
• It is used to treat lifelong premature ejaculation in adult men. It works by reducing the sensitivity of the glans of the penis to prolong the time before ejaculation.

dosage

• 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 is 3 sprays (3 sprays = 1 dose) on the glans before intercourse. A maximum of 3 doses may be used in any 24 hour period with at least 4 hour intervals between each dose.

• If you use more than you should
  • Because this medicine is sprayed onto the surface of the glans, the risk of overdose is low. If you spray too much, wipe off excess medicine.
  • The symptoms of using too much of the drug are listed below. Contact your doctor or pharmacist if you notice any of these symptoms. It is very unlikely that this will happen if the medicine is used as directed:
    • light-headedness or dizziness
    • Tingling of the skin around the mouth and numbness of the tongue
    • taste disorders
    • blurred vision
    • tinnitus
    • There is also a risk of a condition in which the amount of oxygen in the blood is reduced (methaemoglobinaemia). This is more likely if certain medicines have been taken at the same time. When this happens, the skin turns blue-grey due to lack of oxygen.
  • In severe cases of overdose, seizures, low blood pressure, slow breathing, cessation of breathing and changes in heartbeat may occur. These effects can be life-threatening.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

way

• Before using for the first time, shake the spray can briefly and prime the pump mechanism by spraying 3 times in the air. Keep the spray can away from faces to avoid getting the medicine in your eyes, nose, mouth and ears.
• Before each further dose, shake the spray can briefly and prime the pump mechanism again by spraying once into the air.
• Pull back the foreskin to expose the glans. Hold the can upright (spray valve up) and spray 1 dose (3 sprays) over the entire glans, covering 1/3 of the glans with each spray. Wait 5 minutes and then wipe off excess spray before intercourse.

side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• The following side effects have been reported with this medicine in male patients:
  • Common (may affect up to 1 in 10 people)
    • Inability to get or maintain an erection
    • Decreased sensitivity on and around the penis
    • Burning in and around the penis
  • Uncommon (may affect up to 1 in 100 people)
    • headache
    • Local irritation of the throat (if inhaled)
    • skin irritation
    • Redness on and around the penis
    • Failure to ejaculate during intercourse
    • Abnormal orgasm
    • Tingling in and around the penis
    • Pain or discomfort in and around the penis
    • Itching in and around the penis
    • High temperature
• The following side effects have been reported in connection with this preparation in female partners:
  • Common: (may affect up to 1 in 10 people)
    • Burning in and around the vagina
    • Decreased sensitivity in and around the vagina
  • Uncommon (may affect up to 1 in 100 people)
    • headache
    • Local irritation of the throat (if inhaled)
    • Fungal infection of the vagina (Candida)
    • Discomfort in the anus and rectum
    • numbness in the mouth
    • Difficulty or pain when urinating
    • 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 also applies to side effects that are not specified.

interactions

• Use together with other medicines
  • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. This is particularly important if you are taking/using the following medicines as they may interact with this product:
    • other local anesthetics
    • Heart medicines (antiarrhythmics)
    • Medicines to treat high blood pressure and regulate heart rhythm (called beta-blockers)
    • Medicines to reduce stomach acid (cimetidine)
  • The risk of a condition in which the amount of oxygen in the blood is reduced (methaemoglobinaemia) may be increased if you are already taking medicines known to cause this condition, such as the following:
    • Benzocaine - a local anesthetic used to treat pain and itching
    • Chloroquine, Pamaquine, Primaquine, Quinine- - Used to treat malaria
    • metoclopramide - used to treat nausea and vomiting, including in patients with migraines
    • glyceryl trinitrate (GTN, nitroglycerin), isosorbide mononitrate, erythrityl tetranitrate, pentaerythritol tetranitrate and other nitrates and nitrites - used to treat angina (chest pain caused by the heart)
    • nitroprusside sodium, isosorbide dinitrate - used to treat high blood pressure and heart failure
    • Nitrofurantoin - an antibiotic used to treat urinary tract and kidney infections
    • Sulfonamides (also known as sulfa agents), e.g. B. sulfamethoxazole - an antibiotic used to treat urinary tract 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 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 may also be increased by the use of certain dyes (aniline dyes) or the pesticide naphthalene. So let your doctor know if you work with dyes or chemical pesticides.
  • Barrier contraceptives (e.g. male or female condoms) made of polyurethane cannot be guaranteed to protect against disease or pregnancy when used with this product. Check the material your or your partner's contraceptive is made of. Ask your pharmacist if you are unsure.
  • If you use the preparation with condoms, there is a higher chance that you will not be able to get or keep an erection. You are also more likely to have reduced sensitivity on and around the penis.

Contraindications

• The drug must not be used
  • if you or your sexual partner are allergic to lidocaine or prilocaine or any of the other ingredients of this medicine.
  • if you or your sexual partner have had an allergic or hypersensitive reaction to other local anesthetics with a similar structure (known as amide-type local anesthetics) in the past.

pregnancy and breast feeding period

• The drug is not approved for use in women.
• Ask your doctor or pharmacist for advice before using any medicine.
• pregnancy
  • The medicine is not recommended if your partner is pregnant unless you use a male condom as listed above to prevent exposure of the unborn child to the medicine.
• lactation
  • This medicine can be used while your partner is breastfeeding.
• fertility
  • The medicine can reduce the chance of pregnancy, but it is not a reliable contraceptive. Therefore, patients hoping to conceive should either avoid using the drug or, if the drug is essential to achieving penetration, wash the penis as thoroughly as possible 5 minutes after using the drug but before engaging in sexual activity.

patient notes

• Warnings and Precautions
  • Talk to your doctor or pharmacist before using this medicine
    • if you or your sexual partner have been diagnosed with a genetic disease or other disease that affects the red blood cells (glucose-6-phosphate dehydrogenase deficiency, anemia or methaemoglobinaemia).
    • if you have had an allergic reaction to medicines in the past, especially if you are not sure which medicine causes you to be hypersensitive.
    • if you suffer from severe liver disease.
  • When using this medicine, especially when preparing the aerosol can, hold the aerosol can away from your face to avoid accidental contact with your ears, eyes, nose and mouth.
  • If you accidentally get any medicine in your or your partner's eyes, wash them out immediately with cold water or a saline solution and cover them until any effects, such as numbness, have gone away. Remember that normal protective mechanisms, such as blinking or detecting foreign objects in the eye, may not work until the numbness has resolved.
  • This medicine can also come into contact with other mucous membranes of yours or your partner's, such as the mouth, nose and throat, and cause a slight numbness for a short time. This lowers the ability to feel pain in those parts of the body. Special care should be taken not to injure them until the numbness has resolved.
  • During sexual intercourse, a small amount of the drug e.g. B. get into the vagina or anus. Therefore, both partners may experience slight numbness for a short time and should exercise caution not to injure each other, especially during sexual activity.
  • This medicine should not come into contact with a damaged eardrum.
• children and young people
  • This medicine should not be used in children or adolescents under 18 years of age.