Vitaros 2 mg/g cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Alprostadil

Available from:

Recordati Ireland Limited

ATC code:

G04BE; G04BE01

INN (International Name):

Alprostadil

Dosage:

2 milligram(s)/gram

Pharmaceutical form:

Cream

Administration route:

external use

Units in package:

100 mg

Prescription type:

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

Manufactured by:

Recordati Industria Chimica e Farmaceutica

Therapeutic group:

Drugs used in erectile dysfunction

Therapeutic area:

Drugs used in erectile dysfunction; alprostadil

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.

Authorization status:

Not marketed

Authorization date:

2015-10-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VITAROS 2 MG/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 USE D 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 NEE D 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 alpr

Summary of Product characteristics

Health Products Regulatory Authority
11 January 2024
CRN00F1XK
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitaros 2 mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single use container contains 200 micrograms of alprostadil in
100 mg of cream (2 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