Fortacin
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
22-09-2023
Charakterystyka produktu
(SPC)
22-09-2023
Sprawozdanie z oceny publicznego
(PAR)
19-10-2020
Składnik aktywny:
lidocaine, prilocaine
Dostępny od:
Recordati Ireland Ltd.
Kod ATC:
N01BB20
INN (International Nazwa):
lidocaine, prilocaine
Grupa terapeutyczna:
Anesthetics
Dziedzina terapeutyczna:
Sexual Dysfunction, Physiological
Wskazania:
Treatment of primary premature ejaculation in adult men.
Podsumowanie produktu:
Revision: 12
Status autoryzacji:
Authorised
Data autoryzacji:
2013-11-15
Ulotka dla pacjenta
22
B. PACKAGE LEAFLET
23
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.
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 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 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FORTACIN
DO NOT USE FORTACIN
•
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).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Fortacin
•
if you, or your partner, have been diagnosed with a genetic disea
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Charakterystyka produktu
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.
1 dose is equal to 3 actuations.
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 _
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.
3
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
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