Vitaros 3mg/g cream

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Alprostadil

Tilgængelig fra:

The Simple Pharma Company UK Ltd

ATC-kode:

G04BE01

INN (International Name):

Alprostadil

Dosering:

3mg/1gram

Lægemiddelform:

Cutaneous cream

Indgivelsesvej:

Cutaneous

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 07040500; GTIN: 05015919235677

Indlægsseddel

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 phamacist. 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 available in two dosage strengths of 200 and 300 mcg
alprostadil in 100
mg of cream.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 counseling. 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 a

Produktets egenskaber

OBJECT 1
VITAROS 3 MG/G CREAM
Summary of Product Characteristics Updated 16-Nov-2017 | Ferring
Pharmaceuticals Ltd
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. AccuDose is a
container consisting of a plunger, barrel, and protective cap provided
in a protective sachet.
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 is available in two dosage strengths of 200 and 300 mcg
alprostadil in 100 mg of cream. 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 ope