Vitaros 3 mg/g cream

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Alprostadil

Dostupno od:

Recordati Ireland Limited

ATC koda:

G04BE; G04BE01

INN (International ime):

Alprostadil

Doziranje:

3 milligram(s)/gram

Farmaceutski oblik:

Cream

Administracija rute:

external use

Jedinice u paketu:

100 mg

Tip recepta:

Product subject to prescription which may not be renewed (A)

Proizveden od:

Recordati Industria Chimica e Farmaceutica

Terapijska grupa:

: Drugs used in erectile dysfunction

Područje terapije:

Drugs used in erectile dysfunction; alprostadil

Terapijske indikacije:

Treatment of men
18 years of age with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance

Status autorizacije:

Marketed

Datum autorizacije:

2015-10-09

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
VITAROS 3MG/G CREAM
Alprostadil
READ
ALL
OF
THIS LEAFLET
CAREFULLY
BEFORE YOU
START
USING
THIS MEDICINE
BECAUSE
IT
CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
:
1.
What VITAROS is and what it is used for
2.
What you need to know before you use VITAROS
3.
How to use VITAROS
4.
Possible side effects
5.
How to store VITAROS
6.
Contents of the pack and other information
1.
WHAT VITAROS IS AND WHAT IT IS USED FOR
Vitaros is used to treat erectile dysfunction (ED) in men 18 years of
age or older. ED is the inability to
attain or maintain an erection sufficient for sexual intercourse.
There are several causes of ED including
medications that you may be taking for other conditions, poor blood
circulation in the penis, nerve damage,
emotional problems, too much smoking or alcohol use, and hormonal
problems. Often ED is due to more
than one cause. Treatments for ED include switching medications, if
you are taking a medication that causes
ED, prescription medications, medical devices
that produce an erection,
surgical procedures to correct
blood flow to the penis, penile implants and psychological
counselling. After application of Vitaros the onset
of erection is within 5 to 30 minutes. You should not stop taking any
prescription medications, unless told
to do so by your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VITAROS
DO NOT USE VITAROS
–
if you have underlying disorders such as drop in blood pressure when
going from a lying/sitting to a
standing position, history of a heart attack, and syncope (dizziness).
–
if you are allergic to alprost

Svojstava lijeka

Health Products Regulatory Authority
11 January 2024
CRN00F1XK
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitaros 3 mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single use container contains 300 micrograms of alprostadil in
100 mg of cream (3 mg/g).
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Cream
Vitaros is a white to off-white cream supplied in AccuDose, a single
dose container.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of men ≥ 18 years of age with erectile dysfunction, which
is the inability to achieve or maintain a penile erection
sufficient for satisfactory sexual performance.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Vitaros is applied to the tip of the penis.
Vitaros should be used as needed to achieve an erection. Each Vitaros
AccuDose container is for single use only and should be
properly discarded after use. The onset of effect is within 5 to 30
minutes after administration. The duration of effect is
approximately 1 to 2 hours. However, the actual duration will vary
from patient to patient. Each patient should be instructed by
a medical professional on proper technique for administration of
Vitaros prior to self-administration. The maximum frequency
of use is no more than 2-3 times per week and only once per 24-hour
period.
The initial dose should be recommended by a physician. A starting dose
with the 300 mcg dose can be considered especially in
patients with serious ED, co-morbidity or failure to PDE-5 inhibitors.
Those patients that do not tolerate the 300 mcg dose due
to local side effects can be titrated to the lower 200 mcg dose.
Patients should be given instruction on proper administration
technique, information on possible side effects (e.g., dizziness,
fainting) and the need to avoid operating machinery until one is aware
of their tolerance to the drug. In the clinical trial there
was a higher withdrawal rate in the 300 mcg treated group compared to
the 200 mcg group, 30% compared to 20%
respectiv