Product Details
- The preparation is a combination of two drugs (lidocaine
and prilocaine). They belong to a group of drugs called local
anesthetics.
- It is used to treat premature ejaculation that occurs in
adult men (aged 18 and over) from the first sexual intercourse
onwards. This means that you always or almost always
ejaculate within one minute of starting sexual intercourse
and this has a negative emotional impact
on you. The medicine works by reducing the sensitivity of the
glans of the penis to prolong the time before ejaculation.
The medicine is applied to the glans of the penis 30 minutes before
sexual intercourse.
- The medicine must not be used
- if you or your partner are allergic to
lidocaine or prilocaine or any of the other
ingredients of this medicine.
- if you or your partner have
been allergic or hypersensitive to other
local anesthetics with a similar structure
(known as amide-type local anesthetics)
in the past.
- Always use this medicine exactly as described in this
package insert. Ask your doctor or
pharmacist if you are unsure.
- The recommended dose is 3 sprays (3 sprays = 1 dose)
on the glans before sexual intercourse. Within 24 hours,
a maximum of 3 doses may be used at intervals of at least 4 hours
between each dose.
- The recommended maximum dose (3 doses within 24 hours) should
not be exceeded.
- If you have used more than you should have
- Since this medicine is sprayed onto the surface of the glans
penis
for at least 5 minutes, the risk of
overdose is low. If you have sprayed too much,
wipe off any excess medicine.
- The symptoms of using too much of the
medicine are listed below. Contact
your doctor or pharmacist if you notice any of these
symptoms. It is very unlikely
that this will occur if the medicine is used according to
the
instructions:
- Dizziness or lightheadedness
- Tingling sensation around the mouth and numbness in
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
(methemoglobinemia). This is more likely if
certain medicines have been taken at the same time.
If this occurs, the skin will turn blue-gray due to
the lack of oxygen.
- There is also a risk of a condition in which
the amount of oxygen in the blood is reduced
(methemoglobinemia). This is more likely if
certain medicines have been taken at the same time.
If this occurs, the skin will turn blue-gray due to
the lack of oxygen.
- If you have any further questions about the use of this medicine,
ask your doctor or pharmacist.
- Warnings and precautions
- Please consult your doctor or pharmacist before
using this medicine.
- if you or your partner
have been diagnosed with a genetic disorder or other
condition that affects red blood cells
(glucose-6-phosphate dehydrogenase deficiency,
anemia,
or methemoglobinemia).
- if you have had hypersensitivity reactions
to medicines in the past, especially
if you are unsure which
medicines cause hypersensitivity in you.
- if you suffer from severe liver disease.
- Premature ejaculation can be caused by a medical condition
that requires medical supervision.
If this medicine does not lead to an improvement when used
as intended, consult a doctor.
- Use with condoms
- The medicine must not be used with latex-free
polyurethane condoms for men or women,
as these may be damaged when used with
the preparation and
may therefore not protect against disease
or pregnancy. The medicine
can be used with contraceptives made of latex
rubber,
polyisoprene, nitrile, and silicone,
as no damage has been observed.
Carefully check the material your condom or your
partner's contraceptive is made of before using it.
Ask your pharmacist if you are unsure.
- If you use this medication together with condoms,
there is a higher chance that you will not be able
to
achieve or maintain an erection. You are also more
likely to
experience reduced sensitivity in and around the
penis.
If you are taking this medication and you experience
severe side effects, you should stop taking it and
consult your doctor.
- Avoid accidental contact
- When using this medicine, especially
when preparing the spray can for use,
keep the spray can away from your face to
avoid accidental contact with your ears, eyes,
nose, and mouth.
- If any of the medicine accidentally gets into
your eyes or your partner's eyes,
rinse them immediately with cold water or a
sodium chloride solution and keep them closed as
closed as much as possible until all
effects, such as numbness,
have subsided. Remember that the
normal protective mechanism, such as
blinking or the perception of foreign bodies
in the eye, may not function until
the numbness has subsided.
- This medicine should not come into contact with a
damaged eardrum.
- Contact with other mucous membranes
- This medicine may also come into contact with other
mucous membranes of yours or your partner's, such as
those in the mouth, nose, and throat
and cause a slight
numbness for a short time. This reduces the ability
to feel pain in these parts of the body.
Special care should be taken not to injure them
until the numbness has subsided.
If you experience any of the following symptoms,
- Possible transmission to partner(s), e.g.
into the vagina or anus
- During sexual intercourse, a
small amount of the drug may enter the
vagina or anus, for example. As a result,
both partners may experience a slight
numbness for a short time and should exercise
caution
to avoid injury,
especially during sexual activity.
- Discontinue use if you or your partner develop a rash or
skin irritation.
If symptoms persist, consult a physician.
If you or your partner develop a rash or skin irritation,
discontinue use. If symptoms persist, consult a physician.
- Children and adolescents
- This medicine should not be used in children or
adolescents under 18 years of age.
- Roadworthiness and ability to operate machinery
- The drug has no or negligible
effect on the ability to drive
and operate machinery when used in
the recommended dosage.
- This medicine is not approved for use in women.
- Ask your doctor or
pharmacist for advice before using any medicine.
- Pregnancy
- The product should not be used if your
partner is pregnant, unless you use an
effective male condom as listed in category "Patient
information
(use with condoms)" to prevent exposure of the
unborn child to the drug.
- Breastfeeding
- This medicine can be used while your
partner is breastfeeding.
- Reproductive capacity
- The drug may reduce the likelihood of
pregnancy. Therefore, patients who wish to
conceive should either avoid using the
medicine or, if the medicine is essential for
achieving penetration, wash the penis as thoroughly as
possible 5
minutes after using the medicine, but before
sexual intercourse.
- Before using for the first time, shake the spray can briefly and
activate the pump mechanism by spraying into the air three times
to prepare it for use. Keep the spray can away from faces
to avoid contact of the medicine with the eyes, nose, mouth
and ears.
- Before each subsequent dose, shake the spray can briefly and
prime the pump mechanism again by spraying once into the air
to ensure it is ready for use.
- Pull back the foreskin to expose the glans. Hold
the can upright (spray valve facing up) and spray 1 dose (3
sprays) onto the entire glans, so that each spray covers one
third of the glans. Wait 5 minutes and
then wipe off any excess spray before sexual intercourse
. Excess spray must also be wiped off if you
are using a condom.
- Use with other medicines
- Tell your doctor or pharmacist if you are taking/using other
medicines, have recently taken/used other
medicines, or
intend to take/use other medicines.
It is particularly important that you talk to your doctor
before using this product if you are taking/using at least
one
of the following medicines, as they may
interact with this product:
- other local anesthetics such as benzocaine and
procaine
- cardiac drugs (antiarrhythmics such as mexiletine
and
amiodarone)
- Fluvoxamine, cimetidine, or beta-blockers, which can
cause
an increase in blood levels of lidocaine
.
- Medicines known to reduce the amount of oxygen
in the blood (methemoglobinemia), such as the
following:
- Benzocaine - a local anesthetic for
treating pain and itching
- Chloroquine, pamaquine, primaquine, quinine
-
for the treatment of malaria
- Metoclopramide - for the treatment of nausea
and vomiting, including in patients
with migraine
- Glyceryl trinitrate (GTN, nitroglycerin),
isosorbide mononitrate, erythrityl
tetranitrate,
pentaerythritol tetranitrate, and other
nitrates and nitrites—for the treatment of
angina (chest pain caused by the heart)
- Nitroprusside sodium, isosorbide dinitrate -
for the treatment of high blood pressure and
heart failure
- Nitrofurantoin - an antibiotic used to
treat urinary tract and
kidney infections
- Sulfonamides (also known as sulfa drugs),
e.g., sulfamethoxazole - an antibiotic used
to
treat urinary tract infections, and
sulfasalazine – used to treat Crohn's
disease
ulcerative colitis and rheumatoid
arthritis
- Dapsone - for the treatment of
skin diseases such as leprosy and
dermatitis, as well as for the prevention of
malaria
and pneumonia in high-risk patients
- Phenobarbital, phenytoin – for the treatment
of epilepsy
- Para-aminosalicylic acid (PAS) – for the
treatment of tuberculosis
- The risk of methemoglobinemia may also be increased by the
use of certain dyes (aniline dyes) or the
pesticide naphthalene. Therefore, inform your
doctor 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 contraceptive or your partner's
contraceptive is made of. Ask your pharmacist if you are
unsure. Check the material
your contraceptive or your partner's contraceptive is made
of.
Ask your pharmacist if you are unsure.
- If you use this medication together with condoms,
there is a higher chance that you will not be
able to achieve or
maintain an erection. You are also more likely to
experience reduced sensitivity in and around the penis.
Fortacin® Delay spray – No more visits to the doctor for
premature ejaculation!
Up to 20% of all men regularly suffer from premature ejaculation. The
enormous psychological strain this causes men can often lead to long-term relationship
problems. However, only a small fraction of affected men confide in a doctor.
The time has finally come! Fortacin® Delay Spray, for application on the skin
to treat premature ejaculation (premature ejaculation) without alcohol or other
solvents, has been removed from prescription requirements and is available in pharmacies
without a doctor's prescription. Fortacin® is the only topical medication for the
indication
"premature ejaculation" and generally the only OTC preparation with
official approval and thus also proven safety and efficacy. With this
decision, those affected now have the opportunity to purchase Fortacin® in pharmacies
without a prior doctor's visit. Fortacin® Spray reduces sensitivity.
The spray, with the active ingredient combination of lidocaine (150 mg/ml) and
prilocaine (50 mg/ml),
is free of alcohol or other solvents and thus has a
unique galenic formulation based on the eutectic mixture of the two active ingredients.
Another special feature of the spray is that it can be used discreetly, easily, and
predictably. Only three sprays are necessary, and the active ingredient combination is
completely absorbed. The application window begins after just five minutes and lasts up
to four hours. Since Fortacin® Spray is an approved OTC medication, its effectiveness
has been impressively proven in studies. Fortacin® works quickly, even from the first
application. In patients suffering from premature ejaculation, Fortacin® can prolong the
time to ejaculation sixfold after three months of use. With continuous use over 12
months, patients can even achieve a normal average intravaginal ejaculatory latency time
(IELT). And all this while maintaining full orgasmic sensation. Fortacin® is also safe
for use with latex condoms.
Practical and precise: Fortacin® delay spray
The efficacy and safety of Fortacin® have been proven in clinical studies. It can be
used spontaneously at any time and as needed. Fortacin® is effective from the first
use. After 3 months of use, it can increase the time to ejaculation by a factor of 6.
After 12 months of use, normalization of IELT is possible:
- Fortacin® reduces sensitivity
- Fortacin® has a unique galenic formulation
- Fortacin® works quickly and is effective from the
first application
- Fortacin® is discreet and easy to use
- Fortacin® can prolong the time to ejaculation by a
factor of 6 after
3 months of use
- Fortacin® enables normalization of the time to
ejaculation with long-term use
- Fortacin® is a topical OTC medication with no
interactions with other medications.
- Fortacin® provides full orgasmic sensation for both
partners.
Application
The drug is approved for adult men:
- The recommended dose is 3 sprays over the
entire glans penis (head of the penis). Each dose contains a total of 22.5 mg
lidocaine and 7.5
mg prilocaine per application (1 dose corresponds to 3 sprays).
- A maximum of 3 doses can be applied within 24 hours,
with at least 4 hours between each dose.