Alprostadil Recordati 3 mg/g Crème

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ALPROSTADIL 3 mg/g

Beschikbaar vanaf:

Recordati Ireland Ltd. (Co. Cork) Raheens East RINGASKIDDY (IERLAND)

ATC-code:

G04BE01

INN (Algemene Internationale Benaming):

ALPROSTADIL 3 mg/g

farmaceutische vorm:

Crème

Samenstelling:

DODECYL-2-N,N-DIMETHYLAMINOPROPIONAATHYDROCHLORIDE ; ETHANOL ; ETHYLLAURAAT ; FOSFORZUUR (E 338) ; GUARAPROLOSE ; KALIUMDIWATERSTOFFOSFAAT 0-WATER (E 340) ; NATRIUMHYDROXIDE (E 524) ; WATER, GEZUIVERD,

Toedieningsweg:

Cutaan gebruik

Therapeutisch gebied:

Alprostadil

Product samenvatting:

Hulpstoffen: DODECYL-2-N,N-DIMETHYLAMINOPROPIONAATHYDROCHLORIDE; ETHANOL; ETHYLLAURAAT; FOSFORZUUR (E 338); GUARAPROLOSE; KALIUMDIWATERSTOFFOSFAAT 0-WATER (E 340); NATRIUMHYDROXIDE (E 524); WATER, GEZUIVERD;

Autorisatie datum:

2017-07-27

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALPROSTADIL RECORDATI 3 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 ALPROSTADIL RECORDATI is and what it is used for
2.
What you need to know before you use ALPROSTADIL RECORDATI
3.
How to use ALPROSTADIL RECORDATI
4.
Possible side effects
5.
How to store ALPROSTADIL RECORDATI
6.
Contents of the pack and other information
1.
WHAT ALPROSTADIL RECORDATI IS AND WHAT IT IS USED FOR
Alprostadil Recordati 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 counseling.
After application of Alprostadil
Recordati 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 ALPROSTADIL RECORDATI
DO NOT USE ALPROSTADIL RECORDATI
–
if you have underlying disorders such as drop in blood pressure whe

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alprostadil Recordati 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
Alprostadil Recordati 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
Alprostadil Recordati is applied to the tip of the penis.
Alprostadil Recordati should be used as needed to achieve an erection.
Each Alprostadil
Recordati 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 Alprostadil Recordati 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 2